What are the common side effects of Humira. How does Humira affect the immune system. What serious infections can occur while taking Humira. Is there an increased cancer risk associated with Humira use. What should patients discuss with their doctor before starting Humira treatment. How can patients monitor for potential side effects of Humira.

Understanding Humira: A Powerful TNF Blocker

Humira (adalimumab) is a prescription medication classified as a tumor necrosis factor (TNF) blocker. It’s used to treat various inflammatory conditions, including moderate to severe hidradenitis suppurativa in patients 12 years and older. While Humira can be highly effective, it’s crucial for patients and healthcare providers to understand its potential side effects and safety considerations.

How Does Humira Work?

Humira works by suppressing certain components of the immune system, specifically by blocking TNF. This action can help reduce inflammation and alleviate symptoms in various autoimmune disorders. However, this immunosuppressive effect also comes with potential risks that patients should be aware of.

Common Side Effects of Humira

While not everyone experiences side effects, it’s important to be aware of the most common reactions associated with Humira use:

• Injection site reactions (pain, redness, rash, swelling, itching, or bruising)
• Upper respiratory infections (including sinus infections)
• Headaches
• Rash
• Nausea

These side effects are generally mild to moderate and often resolve on their own. However, patients should report any persistent or bothersome side effects to their healthcare provider.

Managing Injection Site Reactions

Injection site reactions are one of the most common side effects of Humira. To minimize discomfort, patients can try the following strategies:

1. Rotate injection sites
2. Allow the medication to reach room temperature before injecting
3. Apply a cold compress to the injection site before and after administration
4. Use proper injection technique as instructed by a healthcare provider

Serious Safety Considerations: Infections and Immune System Effects

One of the most critical safety considerations for Humira users is its impact on the immune system. By suppressing certain immune functions, Humira can increase the risk of infections, some of which may be severe.

Increased Risk of Infections

Patients taking Humira may be more susceptible to various types of infections, including:

• Bacterial infections
• Viral infections
• Fungal infections
• Tuberculosis (TB)

Is TB screening necessary before starting Humira? Yes, healthcare providers should test patients for tuberculosis before initiating Humira treatment. This typically involves a skin or blood test to check for latent TB infection. Even if the initial TB test is negative, doctors should monitor patients closely for signs and symptoms of TB during Humira treatment.

Recognizing Signs of Infection

Patients on Humira should be vigilant for signs of infection, which may include:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Unexplained weight loss
• Warm, red, or painful skin or sores on the body
• Diarrhea or stomach pain
• Burning when urinating or urinating more often than normal

If any of these symptoms occur, patients should contact their healthcare provider immediately.

Cancer Risk: Understanding the Potential Implications

Another significant safety consideration for Humira users is the potential increased risk of certain types of cancer. While the overall risk remains relatively low, it’s essential for patients to be informed and vigilant.

Types of Cancer Associated with TNF Blockers

The following types of cancer have been associated with the use of TNF blockers like Humira:

• Lymphoma
• Skin cancer (basal cell and squamous cell carcinoma)
• Hepatosplenic T-cell lymphoma (a rare but often fatal type of cancer)

Can Humira increase cancer risk in children and young adults? There have been reports of unusual cancers in children, teenagers, and young adults using TNF blockers, including Humira. While these cases are rare, they underscore the importance of careful monitoring and risk assessment for younger patients.

Monitoring for Skin Cancer

Patients taking Humira should be particularly vigilant about skin changes. They should inform their doctor if they notice:

• Any new bumps or growths on the skin
• Open sores that don’t heal
• Changes in existing moles or skin marks

Regular skin examinations by a dermatologist may be recommended for some patients on Humira, especially those with risk factors for skin cancer.

Pre-Treatment Considerations: What to Discuss with Your Doctor

Before starting Humira, it’s crucial for patients to have an open and thorough discussion with their healthcare provider about their medical history and potential risks.

Key Points to Discuss

Patients should inform their doctor about:

• Any current or recent infections
• History of frequent or recurrent infections
• Diabetes
• Tuberculosis exposure or risk factors
• Travel to or residence in areas with increased risk of certain fungal infections (e.g., Ohio and Mississippi River valleys)
• History of cancer, including skin cancer
• Neurological conditions such as multiple sclerosis or Guillain-Barré syndrome
• Heart conditions
• Liver or kidney problems
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Is it safe to receive live vaccines while on Humira? Patients should avoid live vaccines while taking Humira, as the immunosuppressive effects of the medication may reduce vaccine efficacy and potentially increase the risk of infection from live vaccines. Discuss all vaccination plans with your healthcare provider.

Monitoring and Managing Side Effects During Humira Treatment

Once Humira treatment has begun, ongoing monitoring is essential to ensure patient safety and optimize treatment outcomes.

Regular Check-ups and Tests

Patients on Humira may need:

• Regular blood tests to monitor liver function and blood cell counts
• Periodic skin examinations
• Ongoing assessment for signs of infection or other adverse effects

Strategies for Side Effect Management

To help manage potential side effects, patients can:

1. Keep a symptom diary to track any new or changing symptoms
2. Follow proper injection techniques to minimize injection site reactions
3. Maintain good hygiene practices to reduce infection risk
4. Stay up-to-date with recommended vaccinations (excluding live vaccines)
5. Avoid close contact with people who have active infections

How quickly should patients report new symptoms to their doctor? Any new or worsening symptoms should be reported to a healthcare provider promptly. This is especially important for signs of infection, unusual skin changes, or symptoms that could indicate a more serious reaction to the medication.

Long-Term Safety Considerations for Humira Users

While Humira can be an effective long-term treatment for many patients, it’s important to consider the potential impacts of extended use.

Ongoing Risk Assessment

Over time, healthcare providers may need to reassess the benefits and risks of continuing Humira treatment. This may involve:

• Evaluating the patient’s response to treatment
• Monitoring for cumulative side effects
• Considering the patient’s changing health status and risk factors
• Adjusting treatment plans as needed

Potential Long-Term Effects

While research is ongoing, some potential long-term considerations for Humira users may include:

• Increased susceptibility to certain infections
• Possible effects on the body’s ability to fight off cancerous cells
• Potential impact on the immune system’s overall function

Can patients develop antibodies to Humira over time? Some patients may develop antibodies to Humira with long-term use, which could potentially reduce the medication’s effectiveness. Healthcare providers may monitor for this and adjust treatment plans if necessary.

Special Populations: Considerations for Specific Patient Groups

The safety profile and considerations for Humira may vary for certain patient populations.

Pediatric Patients

For children and adolescents prescribed Humira:

• Close monitoring for growth and development is essential
• The risk of certain cancers may be higher compared to adult patients
• Age-appropriate vaccinations should be discussed with healthcare providers

Elderly Patients

Older adults taking Humira may need:

• More frequent monitoring for infections and other side effects
• Dose adjustments based on overall health status and other medications
• Careful assessment of the risk-benefit ratio, considering age-related changes in immune function

Pregnant and Breastfeeding Women

For women who are pregnant, planning to become pregnant, or breastfeeding:

• The potential risks and benefits of Humira use should be carefully weighed
• Limited data is available on the effects of Humira during pregnancy and breastfeeding
• Close monitoring and consultation with healthcare providers is crucial

Is it safe to use Humira during pregnancy? The safety of Humira during pregnancy has not been fully established. Women who are pregnant or planning to become pregnant should discuss the potential risks and benefits with their healthcare provider. In some cases, the benefits of controlling the underlying condition may outweigh the potential risks to the fetus.

Navigating Insurance and Access to Humira

Ensuring continued access to Humira is an important aspect of treatment management for many patients.

Insurance Coverage Considerations

Patients should be aware of:

• Their insurance coverage for Humira
• Any prior authorization requirements
• Potential out-of-pocket costs
• Options for financial assistance or patient support programs

Dealing with Changes in Coverage

If insurance coverage changes, patients can:

1. Contact the manufacturer’s support line (1.800.4HUMIRA) for assistance
2. Explore patient assistance programs
3. Discuss alternative treatment options with their healthcare provider if necessary

How can patients ensure uninterrupted access to Humira? Maintaining open communication with healthcare providers and insurance companies is key. Patients should proactively address any potential coverage issues and explore all available options for financial assistance if needed.

Complementary Strategies for Managing Underlying Conditions

While Humira can be an effective treatment, it’s often most beneficial when combined with other strategies to manage the underlying condition.

Lifestyle Modifications

Patients may benefit from:

• Maintaining a healthy diet
• Engaging in regular, appropriate exercise
• Managing stress through relaxation techniques or counseling
• Getting adequate sleep
• Avoiding triggers specific to their condition

Complementary Therapies

Some patients may find additional relief through:

• Physical therapy
• Occupational therapy
• Acupuncture
• Massage therapy
• Mind-body practices like yoga or tai chi

Can complementary therapies enhance the effectiveness of Humira? While scientific evidence varies, some patients report improved symptom management when combining Humira with complementary therapies. It’s important to discuss any additional treatments with a healthcare provider to ensure they are safe and appropriate alongside Humira.

Future Directions: Ongoing Research and Developments

The field of TNF blockers and autoimmune disease treatment continues to evolve, with ongoing research aimed at improving safety and efficacy.

Emerging Treatment Options

Research is focusing on:

• New biologics with potentially improved safety profiles
• Targeted therapies that may offer more precise treatment
• Combination therapies that could enhance efficacy while minimizing side effects

Advances in Monitoring and Personalized Medicine

Future developments may include:

• More sophisticated methods for predicting individual patient responses to TNF blockers
• Advanced techniques for early detection of potential side effects
• Personalized treatment plans based on genetic and biomarker profiles

How might future research impact Humira users? As new treatments and monitoring techniques emerge, patients may have access to more personalized and potentially safer treatment options. However, for many patients, Humira remains an effective and well-established treatment option when used under proper medical supervision.

In conclusion, while Humira can be a powerful tool in managing various inflammatory conditions, it’s crucial for patients and healthcare providers to maintain an ongoing dialogue about its benefits and risks. By staying informed, vigilant, and proactive in their care, patients can maximize the benefits of Humira while minimizing potential risks. As with any medication, the key to successful treatment lies in personalized care, regular monitoring, and open communication with healthcare providers.

Safety Info and Side Effects

Health insurance coverage changing? Call 1.800.4HUMIRA or click to see how we can help ▸

Discuss Important Safety Information for HUMIRA with your doctor.

Before you and your doctor make a decision about treatment, you should discuss the Important Safety Information for HUMIRA. Talk about any concerns you may have. Working together, you and your doctor can find a treatment that is right for you.

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

Learn about the most common side effects of HUMIRA.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

It is possible to experience adverse events or side effects from HUMIRA. If you do experience any side effects, call your doctor right away. These are not all of the possible side effects associated with HUMIRA. Click here to see additional Important Safety Information.

Next Up:
Frequently Asked Questions

HUMIRA Use

¹

HUMIRA is a prescription medicine used to reduce the signs and symptoms of moderate to severe hidradenitis suppurativa in people 12 years and older.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
• Are allergic to rubber, latex, or any HUMIRA ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

Please see the Full Prescribing Information, including the Medication Guide, for HUMIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Legal Notices/Privacy Policy. Copyright 2023, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s HUMIRA.com website that have not been answered click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

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Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

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You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

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You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-210631

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You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

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You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

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Choose Your Condition

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You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

HUMIRA Use

¹

HUMIRA is a prescription medicine used to reduce the signs and symptoms of moderate to severe hidradenitis suppurativa in people 12 years and older.

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test

HUMIRA Use

¹

HUMIRA is a prescription medicine used to reduce the signs and symptoms of moderate to severe hidradenitis suppurativa in people 12 years and older.

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of

HUMIRA Use

¹

HUMIRA is a prescription medicine used to reduce the signs and symptoms of moderate to severe hidradenitis suppurativa in people 12 years and older.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
• Are allergic to rubber, latex, or any HUMIRA ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections.  These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

After Starting HUMIRA® for Rheumatoid Arthritis (RA)

Health insurance coverage changing? Call 1.800.4HUMIRA or click to see how we can help ▸

HUMIRA can help relieve pain, swelling, and joint stiffness

Some patients taking HUMIRA plus methotrexate saw results in as quickly as 2 weeks. For others, it can take up to 3 months or longer. If it’s working, you’ll likely notice less pain, swelling, and joint stiffness. Individual results may vary.

HUMIRA dosing and administration

The recommended dose is 1 HUMIRA Pen or syringe (40 mg) every other week. Some patients not taking methotrexate may benefit from increasing the dosage of HUMIRA to 40 mg every week or 80 mg every other week. HUMIRA is given by an injection under the skin. Always follow your doctor’s instructions.

What you need to know about HUMIRA Citrate-free.

It’s the same HUMIRA you’ve come to count on, plus:

• A thinner needle
• 50% less liquid to inject
• A larger viewing window
• Less pain immediately following injection*

Learn about HUMIRA Citrate-free

*Compared to HUMIRA 40 mg/0.8 mL.

Your first injection must be given under the supervision of a health care professional. Make sure you have been shown how to inject HUMIRA before you do it yourself. If your doctor determines that it’s ok, HUMIRA can be taken at home.

Proper injection technique is important. Watch this demonstration video for step-by-step instructions on how to inject HUMIRA.

If you have any questions about injection, you can speak to a registered nurse about your HUMIRA treatment and request in-person injection training. Just call 1.800.4HUMIRA (1.800.448.6472).

For more information, refer to the Patient Instructions for Use, and the Medication Guide located inside your HUMIRA carton, and within the Full Prescribing Information.

Common side effects of HUMIRA include injection site reactions such as pain, redness, rash, swelling, itching, or bruising around the injection site. Call your doctor if these symptoms do not go away within a few days or get worse.

If you experience any adverse reactions or discomfort when taking HUMIRA, discuss them with your doctor right away.

Take Control of Your Care

Locate a Rheumatologist

HUMIRA Complete: Personalized services there when you need them.

We understand that starting a new routine can take some getting used to. So when you make a commitment to treat your RA symptoms with HUMIRA, we make one to you—through HUMIRA Complete.

It’s personalized service that begins the moment you enroll—at no additional cost.

Ready to connect with a Nurse Ambassador?*

Once you’ve enrolled in HUMIRA Complete, you’ll receive a phone call from your dedicated Nurse Ambassador. Your Nurse Ambassador is committed to helping you get off to a good start on HUMIRA, and stay on track with your treatment plan as prescribed.

*Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.

In This Section

What Is Rheumatoid Arthritis?

How HUMIRA Works

What to Expect

Additional Safety Information

Frequently Asked Questions

HUMIRA Citrate Free

HUMIRA Cost

With an Ambassador, you don’t have to go at it alone.

Learn More

HUMIRA Use

¹

HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer.  For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
• Are allergic to rubber, latex, or any HUMIRA ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

Please see the Full Prescribing Information, including the Medication Guide, for HUMIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Legal Notices/Privacy Policy. Copyright 2021, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s HUMIRA.com website that have not been answered, click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-210631

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-210631

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

Choose Your Condition

Leaving AbbVie Web Site

You are leaving the AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site’s endorsement of HUMIRA.com or AbbVie.

Do you wish to leave this site?

US-HUM-220495

HUMIRA Use

¹

HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.  Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include

HUMIRA Use

¹

HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities.

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of 

IMPORTANT SAFETY INFORMATION

¹

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

HUMIRA Use

¹

HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA^® (adalimumab)¹

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
• Are allergic to rubber, latex, or any HUMIRA ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

Adalimumab for the treatment of active Crohn’s disease

What is Crohn’s disease?

Crohn’s disease is a bowel disease in which the walls of the gastrointestinal tract become inflamed. Any part of the gastrointestinal tract can be affected – from the mouth to the anus. Symptoms include abdominal pain, bloody diarrhea, and weight loss. When symptoms are present, the disease is considered “active”. After the cessation of symptoms, the disease goes into a “remission” stage.

What is adalimumab?

Adalimumab is a biologic drug that helps reduce inflammation and relieve pain in people with inflammatory diseases such as Crohn’s disease. Adalimumab works by binding to tumor necrosis factor-alpha and blocking the inflammatory action, resulting in a reduction in inflammation pain in people with Crohn’s disease. In active Crohn’s disease, adalimumab is usually injected subcutaneously at an initial dose of 160 mg followed by a dose of 80 mg two weeks later.

What did the researchers study?

Researchers studied whether adalimumab could lead to remission in people with moderate to severe active Crohn’s disease. They also looked at whether adalimumab could help with symptoms of Crohn’s disease and whether it was associated with any harm (i. e., side effects). We conducted a literature search up to 16 April 2019.

What did the researchers find?

Researchers found three studies involving 714 adults (over 18 years of age). All participants had moderate or severe Crohn’s disease (active). A total of 451 participants received adalimumab treatment, and 268 participants received placebo (fake drug) treatment. More participants in the adalimumab group achieved remission or symptom reduction compared to participants in the placebo group. The incidence of side effects (adalimumab: 62%, placebo: 72%), serious side effects (adalimumab: 2%, placebo: 5%), and withdrawal from the study due to side effects (adalimumab: 1%, placebo: 3%) were lower in participants who received adalimumab than in participants who received placebo. The most commonly reported side effects were injection site reactions, abdominal pain, fatigue/fatigue, worsening of Crohn’s disease, and nausea.

Terminals

High-certainty evidence suggests that treating participants with adalimumab is better than treating participants with placebo in achieving remission and reducing symptoms in people with moderate to severe active Crohn’s disease. Side effects were observed less frequently in participants treated with adalimumab compared with participants treated with placebo. However, we are uncertain about the side effects associated with adalimumab due to the small number of events, so we cannot draw firm conclusions about harm (side effects) of adalimumab in Crohn’s disease. Further research is needed to examine the long-term benefits and harms of using adalimumab in people with Crohn’s disease.

Translation notes:

Translation: Vinichenko Yulia Viktorovna. Editing: Yudina Ekaterina Viktorovna. Russian translation project coordination: Cochrane Russia – Cochrane Russia, Cochrane Geographic Group Associated to Cochrane Nordic. For questions regarding this transfer, please contact us at: [email protected]

Vedolizumab (Entivio®) achieved better clinical remission rates than adalimumab (Humira®) in the first ever head-to-head clinical trial. biologic research in ulcerative colitis

– Vedolizumab is superior to adalimumab in achieving clinical remission and healing of the intestinal mucosa at week 52 of therapy in patients with moderate to severe active ulcerative colitis

Osaka, Japan – Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) (Takeda) announced the results of the Phase 3b VARSITY head-to-head clinical trial demonstrating that the enteric-selective biologic vedolizumab (Entivio ^® ) is superior to the tumor necrosis factor alpha inhibitor (TNFα inhibitor) adalimumab (Humira ^® ) in achieving clinical remission* in patients with moderate to severe active ulcerative colitis at 52 weeks of therapy. Data showed that at week 52, 31.3% (n = 120/383) of patients treated with IV vedolizumab achieved the primary endpoint of clinical remission compared with 22.5% (n = 87/386) of patients treated with SC adalimumab , with a statistically significant difference (p = 0.0061). These results were announced on 9March 2019 at the 14th European Crohn’s and Ulcerative Colitis Organization (ECCO) Congress in Copenhagen, Denmark. ¹

In addition, treatment with vedolizumab was associated with a higher rate of mucosal healing** at week 52: 39.7% of patients treated with vedolizumab achieved mucosal healing compared to 27.7% of patients treated with adalimumab (p = 0 .0005). A non-statistically significant difference in favor of adalimumab was noted in the percentage of patients initially on oral corticosteroids who discontinued corticosteroids and are in clinical remission*** at week 52. The study did not aim to compare the safety of these biologics, however, patients treated with vedolizumab (62. 7%) had a lower overall rate of adverse events at 52 weeks than patients treated with adalimumab (69.2%), while the incidence of infections in patients treated with vedolizumab (33.5%) was lower compared with patients treated with adalimumab (43.5%). The incidence of serious adverse events was also lower in patients treated with vedolizumab than in patients treated with adalimumab (11.0% vs. 13.7%, respectively). ¹

“The VARSITY study addresses critical questions regarding the choice of biologic therapy for ulcerative colitis,” said Dr. Dr. Henry D. Janowitz at Mount Sinai Hospital and Icahn Medical School at Mount Sinai in New York. “The goal of treating ulcerative colitis is to achieve clinical remission and mucosal healing. These results demonstrate a clear superiority of vedolizumab over adalimumab in these important criteria. The results of the study also showed a lower incidence of common and serious adverse events, including infections, in patients treated with vedolizumab compared with patients treated with adalimumab. ”

“Results from the VARSITY study, the first clinical trial to directly compare the efficacy and safety of two commonly used biologics in patients with ulcerative colitis, provide invaluable information to help clinicians make decisions about biologic therapy,” said Jeff Bornstein, Medical Director , a Takeda company. “For the first time, a head-to-head comparison has been made between two drugs for the treatment of ulcerative colitis with different mechanisms of action: the enteroselective anti-alpha4beta7 integrin, vedolizumab, and the TNFα inhibitor, adalimumab. This is a unique moment in the treatment of ulcerative colitis, as data from a direct comparative clinical study were not previously available, which complicated the choice of biological therapy.”

“Inflammatory bowel disease (IBD) occupies one of the first places among diseases of the gastrointestinal tract in terms of the severity of the course, the frequency of complications and the negative impact on the quality of life of patients. In Russia, more than 30,000 people suffer from IBD, mostly young people aged 20–40 years. Diseases are not always easy to diagnose, and, unfortunately, moderate and severe forms predominate in our country. Often doctors face a difficult choice of optimal therapy. Thanks to the VARSITY study, more comparative data on various approaches in the treatment of ulcerative colitis has appeared, which means that doctors will be able to help even more patients achieve remission and return to a full life, ”commented Dmitry Koloda, Medical Director of Takeda Russia, on the results of the study.

VARSITY is a randomized, double-blind, active-controlled, multicentre, phase 3b study evaluating the efficacy and safety of intravenous vedolizumab versus subcutaneous adalimumab in patients with moderate to severe active ulcerative colitis at week 52 of therapy. A total of 769 patients (vedolizumab n = 383, adalimumab n = 386) were randomized into the study, all of whom had under-response, loss of response, or intolerance to corticosteroids, immunomodulators, or a single TNF-α inhibitor prior to enrollment, with the exception of adalimumab. Patients were randomized to one of two treatment groups: intravenous vedolizumab and subcutaneous placebo, or subcutaneous adalimumab and intravenous placebo. Patients in the vedolizumab arm received vedolizumab 300 mg IV at weeks 0, 2, 6, and then every 8 weeks until week 46, along with placebo subcutaneously at week 0 and every 2 weeks until week 50. In the adalimumab group, patients received adalimumab 160 mg sc at week 0, then 80 mg at week 2, and then 40 mg every 2 weeks until week 50, and placebo intravenously at weeks 0, 2, 6 and thereafter. every 8 weeks until the 46th week. Dose escalation was not permitted in any of the treatment groups during the study period. ^1.2

* Primary endpoint: Clinical remission – overall Mayo score ≤2 points, with no subscale score greater than 1 point. ²

** Secondary endpoint: Mucosal healing –

endoscopic Mayo index score ≤1 point. The Mayo scale is a tool for assessing the activity of ulcerative colitis. ²

*** Secondary endpoint: Steroid-free remission—clinical remission and no oral corticosteroids at week 52 in patients treated with oral corticosteroids at baseline (week 0). ²

About ulcerative colitis

Ulcerative colitis (UC) is one of the most common forms of inflammatory bowel disease (IBD). UC is a chronic relapsing inflammatory disease of the gastrointestinal tract that is often progressive and affects the inner lining of the colon ^4.5 . Common symptoms of UC are abdominal discomfort, loose stools, including those with blood or pus ^5.6 . The causes of UC are not fully understood; however, recent studies indicate that hereditary, genetic, environmental factors and/or an atypical immune response to microbial antigens in genetically predisposed individuals may lead to the disease ^5,7,8 .

About Entivio® (vedolizumab)

Vedolizumab is a enteric-selective biologic approved for intravenous administration ⁹ . These are humanized monoclonal antibodies that specifically bind to α4β7 integrin and intestinal mucosal cell adhesion molecules addressin-1 (MAdCAM-1) rather than vascular cell adhesion molecule 1 (VCAM-1) ¹⁰ . MAdCAM-1 is predominantly expressed on the blood vessels and lymph nodes of the gastrointestinal tract ¹¹ . α4β7-integrin is expressed in the population of circulating leukocytes ¹⁰ . These cells act as a link in the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD) ^10,12,13 . By inhibiting the α4β7 integrin, vedolizumab may limit the ability of certain leukocytes to enter the intestinal tissues ¹⁰ .

IV vedolizumab is approved for use in adult patients with moderate to severe active Crohn’s disease/ulcerative colitis with inadequate response, treatment failure (or reduced efficacy), or intolerance to one or more standard therapy drugs; with poor response, loss of response, or intolerance to one or more inhibitors of tumor necrosis factor-alpha ⁹ . Vedolizumab is registered in more than 60 countries, including the United States of America and the European Union

Indications for use

Ulcerative colitis

Vedolizumab is indicated for use in adults with moderate to severe active ulcerative colitis:

– with an inadequate response, treatment failure (or decrease in effectiveness) or intolerance to one or more standard therapy drugs;

– with an unsatisfactory response, loss of response, or intolerance to one or more inhibitors of tumor necrosis factor-alpha.

Crohn’s disease

Vedolizumab is indicated for use in adult patients with moderate to severe active Crohn’s disease:

– with an inadequate response, treatment failure (or reduced efficacy), or intolerance to one or more standard therapy drugs;

– with an unsatisfactory response, loss of response, or intolerance to one or more inhibitors of tumor necrosis factor-alpha.

Important safety information

P contraindications

Hypersensitivity to vedolizumab or other components of the drug

9 0002 Special instructions and precautions for use

Vedolizumab should be used under close supervision qualified medical personnel capable of managing hypersensitivity reactions, including an anaphylactic reaction. Emergency aid must be available during the infusion. Patients should be closely monitored during and after the infusion for two hours for the first two infusions, and approximately one hour for subsequent infusions.

Infusion reactions

Clinical study results include reports of infusion reactions (IR) and hypersensitivity reactions, mostly mild to moderate in severity.

In the event of a severe IR, anaphylactic reaction, or other severe reaction, Entivio® should be discontinued immediately and appropriate therapeutic measures taken to control the reaction (eg, epinephrine and antihistamines).

If mild or moderate IR develops, reduce infusion rate or interrupt procedure and initiate appropriate treatment (eg, with epinephrine and antihistamines). After the termination of IR, the infusion is continued. Premedication (eg, with antihistamines, hydrocortisone, and/or paracetamol) should be considered before the next infusion in patients with a history of mild or moderate IR on vedolizumab to minimize the potential risk.

Infectious diseases

Vedolizumab is a gut-selective integrin antagonist with no established systemic immunosuppressive activity.

There is a potential increased risk of developing opportunistic infections or infections for which the gut is a protective barrier. Antivio treatment should not be given to patients with active severe infections until the infections are under control. Discontinuation of treatment should also be considered in patients who develop a severe infection during a long course of treatment with Antivio®. Caution should be exercised when prescribing Entivio® to patients with controlled severe chronic infections or a history of recurrent severe infections. Patients should be carefully monitored for infections before, during and after completion of treatment.

Since Entivio® is contraindicated in patients with active TB, patients should be screened for TB according to established guidelines before starting treatment. If latent tuberculosis is detected, it is imperative to treat tuberculosis in accordance with local recommendations before prescribing Antivio®. In case of detection of tuberculosis in patients already undergoing treatment, the administration of the drug Antivio® is stopped until the tuberculosis infection is cured.

Progressive multifocal leukoencephalopathy

Some integrin antagonists and some systemic immunosuppressive drugs have been associated with PML, an opportunistic John Cunningham (JC) virus infection. PML syndrome is a rare demyelinating disease of the CNS resulting from the reactivation of a latent JC virus and is often fatal. By binding to the α4β7-integrin expressed on lymphocytes migrating to the intestine, vedolizumab has an immunosuppressive effect on the gastrointestinal tract. The development of PML usually occurs in patients with weakened immune systems.

Health care providers should monitor patients receiving vedolizumab for new or worsening neurological signs and symptoms and consider referring the patient to a neurologist. If PML is suspected, treatment with vedolizumab should be suspended, and if the diagnosis is confirmed, treatment with vedolizumab should be stopped completely.

The typical signs and symptoms associated with PML are varied, progress over days to weeks, and include hemiparesis, aphasia, behavioral and personality changes, retrochiasmal visual deficits, and seizures. Progression of the disorder usually results in death or severe disability within weeks or months.

Malignancies

Patients with ulcerative colitis and Crohn’s disease have an increased risk of developing malignancies.

Interactions with other medicinal products

Co-administration of vedolizumab with other drugs, including biological immunosuppressants, has not been studied. Therefore, it is not recommended to mix the prepared vedolizumab infusion solution with other drugs or to introduce them into the infusion system.

There are no data from clinical studies of vedolizumab in patients previously treated with natalizumab or rituximab. Caution should be exercised when considering the use of Antivio® in these patients.

Live and oral vaccines

It is recommended that all patients be vaccinated according to current immunization guidelines before starting treatment with Entivio®.

Live and non-live vaccines should not be given concomitantly with vedolizumab unless the benefit far outweighs the risk.

Adverse reactions include : nasopharyngitis, headache, arthralgia, bronchitis, gastroenteritis, upper respiratory infections, influenza, sinusitis, pharyngitis, paresthesia, hypertension, oropharyngeal pain, nasal congestion, cough, anal abscess, anal fissure, nausea, dyspepsia, constipation, bloating, flatulence, hemorrhoids, rash, itching, eczema, erythema, night sweats, acne, muscle cramps, back pain, muscle weakness, fatigue, pain in the extremities, pyrexia.

Takeda in Gastroenterology

Gastrointestinal diseases can be complex, debilitating and life-changing for patients. Recognizing this, Takeda and its partners have been committed to improving the lives of patients for more than 25 years by developing innovative medicines and implementing specialized programs to support patients with these diseases. Takeda is committed to providing patients with ways to manage their disease. In addition, Takeda is a leader in gastroenterology such as inflammatory bowel disease, acid-related diseases, and motility disorders. Our research activities are focused on finding solutions in the field of celiac disease and liver diseases, as well as in the field of microbiome therapy.

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References

[1] Schreiber S, Peyrin-Biroulet L, Loftus EV Jr, et al. VARSITY: A double-blind, double-dummy, randomised, controlled trial of vedolizumab versus adalimumab in patients with active ulcerative colitis. Presented at the 14 ^th Congress of the Crohn’s and Colitis Organization (ECCO), Copenhagen, Denmark. Oral presentation #OP34 (Saturday March 9, 2019, 09:40-09:50).

² An efficacy and safety study of vedolizumab intravenous (IV) compared to adalimumab subcutaneous (SC) in participants with ulcerative colitis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02497469. Last updated: February 28, 2019. Last Accessed: February 2019.

3 Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet . 2007;369:1627-1640.

4Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a progressive disease: the forgotten evidence. Inflamm Bowel Dis . 2012;18:1356-1363.

5Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet . 2012;380:1606-1619.

6Sands B.E. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology . 2004;126:1518-1532.

7 Henckaerts L, Pierik M, Joossens M, et al. Mutations in pattern recognition receptor genes modulate seroreactivity to microbial antigens in patients with inflammatory bowel disease. Gut . 2007;56:1536-1542.

8Kaser A, Zeissig S, Blumberg RS. Genes and environment: How will our concepts on the pathophysiology of IBD develop in the future? Dig Dis. 2010;28:395-405.

9 European Medicines Agency. Entyvio EPAR product information. EMEA/H/C/002782 – IB/0030 ANNEX 1 Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/entyvio-epar-product-information_en.pdf Last updated: September 3, 2018. Last accessed: February 2019.

10 Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases.