How is apalutamide used to treat prostate cancer. What are the common side effects of apalutamide. Who should not take apalutamide. How should apalutamide be taken and stored. What precautions should be followed when using apalutamide.

Understanding Apalutamide: A Powerful Treatment for Prostate Cancer

Apalutamide, pronounced as (a’ puh loo” tuh mide), is a medication that has revolutionized the treatment of certain types of prostate cancer. This powerful drug belongs to a class of medications known as androgen receptor inhibitors, which work by blocking the effects of androgen, a male reproductive hormone. By doing so, apalutamide helps to stop the growth and spread of cancer cells.

Prostate cancer is a serious condition that affects many men worldwide. Can apalutamide be used for all types of prostate cancer? Apalutamide is specifically prescribed for two scenarios:

• Prostate cancer that has spread to other parts of the body
• Prostate cancer that has not spread but has not responded to other medical treatments

In these cases, apalutamide offers hope for patients who may have limited treatment options.

Proper Administration of Apalutamide: Dosage and Instructions

Taking apalutamide correctly is crucial for its effectiveness. How should patients take this medication? Apalutamide is available as a tablet to be taken orally, usually once a day. It can be taken with or without food, but it’s important to take it at approximately the same time each day to maintain consistent levels in the body.

Here are some key points to remember when taking apalutamide:

• Swallow the tablet(s) whole without splitting, chewing, or crushing
• If you have difficulty swallowing, consult your doctor or pharmacist for alternative methods
• Follow your prescription label carefully and ask for clarification if needed
• Do not adjust your dosage without consulting your healthcare provider

Is it possible to take apalutamide if you have a feeding tube? Yes, apalutamide can be administered through certain types of feeding tubes. However, it’s essential to follow your doctor’s specific instructions for this method of administration.

Potential Side Effects and Monitoring During Apalutamide Treatment

As with any medication, apalutamide can cause side effects. It’s important for patients and healthcare providers to be aware of these potential effects to ensure proper management and care. What are some common side effects of apalutamide?

• Fatigue
• Joint pain
• Rash
• Hot flashes
• Decreased appetite
• Fall risk
• Weight loss

In some cases, more serious side effects may occur. These can include:

• Seizures
• Fractures and falls
• Heart problems
• Changes in thyroid function

How does monitoring work during apalutamide treatment? Your doctor will closely monitor your progress and may adjust your dosage or temporarily pause treatment if you experience severe side effects. It’s crucial to maintain open communication with your healthcare provider about any changes in your condition or new symptoms that arise during treatment.

Special Precautions and Considerations for Apalutamide Use

Before starting apalutamide treatment, it’s essential to consider various factors that may affect its safety and efficacy. Who should exercise caution or avoid using apalutamide?

Patients should inform their doctor if they have a history of:

• Heart problems (e.g., heart attack, angina, heart failure, hypertension)
• Stroke or mini-stroke
• Seizures
• Brain injury or brain tumor
• High cholesterol
• Diabetes
• Thyroid problems
• Osteoporosis

Is apalutamide safe for all genders? No, apalutamide is specifically designed for use in men. Women, especially those who are pregnant or breastfeeding, should not take this medication due to potential harm to the fetus or infant.

Contraception and Pregnancy Considerations

For men taking apalutamide whose partners are of childbearing age, contraception is crucial. What precautions should be taken regarding pregnancy?

• If your partner is pregnant, use a condom during sexual intercourse throughout treatment and for three months after the final dose
• If your partner could become pregnant, use a condom and another form of birth control during treatment and for three months after the final dose
• Do not donate sperm during treatment and for three months after the final dose

Drug Interactions and Dietary Considerations with Apalutamide

Understanding potential drug interactions is crucial for patient safety and treatment efficacy. Which medications may interact with apalutamide? It’s important to inform your doctor and pharmacist about all medications, supplements, and herbal products you are taking. Some notable interactions include:

• Fexofenadine (Allegra)
• Omeprazole (Prilosec OTC, Zegerid OTC)

Are there specific dietary restrictions when taking apalutamide? While there are no strict dietary restrictions, it’s advisable to maintain a healthy, balanced diet during cancer treatment. Always consult with your healthcare provider or a registered dietitian for personalized nutritional advice.

Proper Storage and Disposal of Apalutamide

Correct storage and disposal of apalutamide are essential for maintaining its effectiveness and ensuring safety. How should apalutamide be stored?

• Keep the medication in its original container
• Store at room temperature, away from excess heat and moisture
• Keep out of reach of children and pets

What is the proper method for disposing of unused apalutamide? Unused or expired medication should not be flushed down the toilet or thrown in the trash. Instead, consult your pharmacist or local waste disposal company for guidance on proper medication disposal methods in your area.

Combining Apalutamide with Other Prostate Cancer Treatments

Apalutamide may be prescribed alongside other medications to enhance the overall effectiveness of prostate cancer treatment. Can apalutamide be used in combination with other drugs? Yes, your doctor may prescribe apalutamide in conjunction with other medications such as:

• Goserelin (Zoladex)
• Histrelin (Supprelin LA, Vantas)
• Leuprolide (Camcevi, Eligard, Fensolvi, Lupron)
• Triptorelin (Trelstar, Triptodur)

These medications are often used to suppress testosterone production, working synergistically with apalutamide to combat prostate cancer more effectively.

Importance of Adherence to Treatment Plan

Consistency in taking apalutamide as prescribed is crucial for optimal results. Why is it important to continue taking apalutamide even if you feel well? Cancer treatment often requires long-term medication use to prevent recurrence or progression of the disease. Stopping apalutamide without consulting your doctor could potentially allow cancer cells to resume growth.

If you experience difficulties with your treatment plan or have concerns, always discuss these with your healthcare provider rather than altering or discontinuing the medication on your own.

Monitoring and Follow-up During Apalutamide Treatment

Regular monitoring is an integral part of apalutamide treatment to ensure its effectiveness and manage any potential side effects. What types of follow-up can patients expect during treatment?

• Regular blood tests to check PSA levels and overall health
• Imaging studies to assess cancer progression or regression
• Bone density scans to monitor for osteoporosis risk
• Cardiac evaluations, especially for those with pre-existing heart conditions
• Thyroid function tests

How often should patients see their doctor during apalutamide treatment? The frequency of follow-up appointments may vary based on individual circumstances, but typically, patients will have regular check-ups every few months. These appointments allow for dose adjustments if necessary and provide an opportunity to address any concerns or side effects.

Importance of Reporting Side Effects

Open communication with your healthcare team is crucial during apalutamide treatment. Why is it important to report all side effects, even if they seem minor? Timely reporting of side effects allows for prompt management and can prevent more serious complications. Some side effects may require dose adjustments or additional supportive treatments to ensure you can continue benefiting from apalutamide while maintaining a good quality of life.

Lifestyle Considerations While Taking Apalutamide

While undergoing treatment with apalutamide, certain lifestyle modifications may be beneficial. What lifestyle changes should patients consider?

• Maintain a balanced diet rich in nutrients to support overall health
• Engage in regular, gentle exercise as approved by your doctor to maintain strength and reduce fatigue
• Stay well-hydrated to help manage potential side effects
• Get adequate rest and manage stress through relaxation techniques
• Avoid alcohol and tobacco, which may interact with the medication or exacerbate side effects

Can patients continue their normal activities while taking apalutamide? In most cases, patients can maintain their regular routines. However, it’s important to be aware of potential side effects like fatigue or increased fall risk. Adjusting activities as needed and taking necessary precautions can help ensure safety during treatment.

Support Systems and Resources

Coping with prostate cancer and its treatment can be challenging. What support resources are available for patients on apalutamide? Many healthcare facilities offer support groups, counseling services, and educational resources for prostate cancer patients. Additionally, organizations like the Prostate Cancer Foundation and the American Cancer Society provide valuable information and support networks for patients and their families.

Future Perspectives and Research on Apalutamide

As with many cancer treatments, ongoing research continues to explore the full potential of apalutamide. What future developments can we expect in apalutamide research? Current and upcoming studies are investigating:

• Combination therapies with apalutamide to enhance efficacy
• Use of apalutamide in earlier stages of prostate cancer
• Long-term effects and outcomes of apalutamide treatment
• Biomarkers to predict response to apalutamide therapy

How might these research developments impact future prostate cancer treatment? As we gain more insights into the effectiveness and optimal use of apalutamide, treatment protocols may be refined to maximize benefits while minimizing side effects. This ongoing research holds promise for improving outcomes and quality of life for prostate cancer patients.

Participation in Clinical Trials

For some patients, participating in clinical trials related to apalutamide may be an option. What are the potential benefits of participating in a clinical trial? Clinical trials offer access to cutting-edge treatments and contribute to the advancement of cancer research. However, it’s important to discuss the potential risks and benefits with your healthcare team before deciding to participate in any research study.

Apalutamide represents a significant advancement in the treatment of certain types of prostate cancer. By understanding its proper use, potential side effects, and necessary precautions, patients can maximize the benefits of this powerful medication. As always, close collaboration with your healthcare team is essential for optimal management of your prostate cancer treatment journey.

Apalutamide: MedlinePlus Drug Information

pronounced as (a’ puh loo” tuh mide)

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Apalutamide is used to treat certain types of prostate cancer (cancer in men that begins in the prostate [a male reproductive gland]) and has spread to other parts of the body or that has not spread to other parts of the body but has not been helped by other medical treatments. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Apalutamide comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take apalutamide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take apalutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablet(s) whole; do not split, chew, or crush them. If you cannot swallow the tablet(s) whole, talk to your doctor or pharmacist. Carefully read the manufacturer’s instructions for use that comes with the medication. These instructions describe how to prepare and take a dose of apalutamide tablets if you can not swallow them whole. Be sure to ask your pharmacist or doctor if you have any questions.

Apalutamide tablets may also be given in certain types of feeding tubes. If you have a feeding tube, ask your doctor how you should take the medication. Follow your doctor’s directions carefully.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience serious side effects during your treatment. Be sure to talk to your doctor about how you are feeling during your treatment with apalutamide.

If your doctor has prescribed another medication such as goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Camcevi, Eligard, Fensolvi, Lupron), or triptorelin (Trelstar, Triptodur) to treat your prostate cancer, you will need to continue receiving this medication during your treatment with apalutamide.

Continue to take apalutamide even if you feel well. Do not stop taking apalutamide without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking apalutamide,

• tell your doctor and pharmacist if you are allergic to apalutamide, any other medications, or any of the ingredients in apalutamide tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with apalutamide: fexofenadine (Allegra) and omeprazole (Prilosec OTC, Zegerid OTC). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking apalutamide. Do not start these medications while taking apalutamide without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had heart problems such as a heart attack, angina (chest pain), heart failure, or hypertension or a stroke or ministroke. Also, tell your doctor if you have ever had seizures, a brain injury, a brain tumor, high cholesterol, diabetes, thyroid problems, or osteoporosis.
• you should know that apalutamide is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breastfeeding. If taken by pregnant women, apalutamide may harm the fetus. If a pregnant woman takes apalutamide, she should call her doctor immediately.
• if your partner is pregnant, you must use a condom whenever you have sex during your treatment with apalutamide and for three months after your final dose. If your partner is not pregnant but could become pregnant, you must use a condom and another form of birth control whenever you have sex during your treatment and for 3 months after your final dose. Do not donate semen or sperm while you are taking apalutamide and for 3 months after your final dose.
• you should know that apalutamide may cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that apalutamide may cause your muscles and bones to get weak, which may increase your risk of falling and breaking a bone.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose in one day and do not take a double dose to make up for a missed one.

Apalutamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• tiredness
• joint pain
• muscle weakness or stiffness
• diarrhea
• nausea
• loss of appetite
• weight loss
• hot flashes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• seizures
• loss of consciousness
• swelling of the arms, legs, hands, or feet
• falling
• chest pain
• shortness of breath
• numbness or weakness of face, arm, or leg, especially on one side of the body; difficulty talking or understanding; difficulty seeing in one or both eyes; dizziness; loss of balance or coordination; or difficulty walking
• rash
• skin blistering, peeling, or redness with or without a fever
• fever or flu-like symptoms
• swollen glands

Apalutamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

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Last Revised – 03/15/2023

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apalutamide oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

How to use Apalutamide 60 Mg Tablet

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking apalutamide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not cut, chew, or crush the tablets.

If you are using the 60 milligram tablets and have difficulty swallowing the tablets whole, you may mix the whole tablets in 4 ounces (120 milliliters) of applesauce. Stir the mixture but make sure not to crush the tablets. Wait 15 minutes, and then stir the mixture again. Wait another 15 minutes and stir the mixture for a third time. Make sure the tablets are well mixed with no solid chunks remaining. Swallow the mixture right away using a spoon. After taking the mixture, rinse the container with 2 ounces (60 milliliters) of water and drink the mixture right away. Repeat the rinse to make sure you take the full dose of the medication. The applesauce/drug mixture should be used within 1 hour of making. Do not store for future use.

If you are using the 240 milligram tablet and have difficulty swallowing the tablet whole, you may mix the whole tablet with water as directed. Add 2 teaspoons (10 milliliters) of water to a cup with the tablet inside. Do not split or crush the tablet. Make sure that the tablet is covered with water. Wait 2 minutes for the tablet to break up and then stir the mixture. Then add 2 tablespoons (30 milliliters) of either orange juice, applesauce, or more water to the mixture and stir. Swallow the mixture right away. After taking the mixture, rinse the cup with water and drink the water to make sure you take the full dose of the medication. Do not save any of the mixture for future use.

If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

Hot flashes, tiredness, joint pain, nausea, decreased appetite, weight loss, or decreased sexual interest/ability may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, constipation).

Treatment with this medication can cause bones and muscles to weaken, which may increase your risk for falls and broken bones. Ask your doctor for details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, swollen lymph nodes, chills, cough).

Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Apalutamide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking apalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as coronary artery disease, heart failure, recent heart attack), diabetes, high cholesterol, high blood pressure, stroke/transient ischemic attack (TIA), seizure, increased risk for seizure (such as brain injury, stroke, brain tumor).

Since this medication may rarely cause seizures in some people, ask your doctor if you should avoid activities where a sudden loss of consciousness may cause serious harm to you or others.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should not be used by women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Older adults may be at greater risk for falls while using this drug.

Men who are sexually active with a pregnant woman must use a condom during treatment and for 3 months after stopping treatment. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 3 months after stopping treatment. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away. Do not donate sperm during treatment and for at least 3 months after stopping treatment.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Apalutamide can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include artemether-lumefantrine, azole antifungals (such as isavuconazonium, voriconazole), cobicistat, lurasidone, nifedipine, ranolazine, rilpivirine, certain drugs for hepatitis C (such as asunaprevir, daclatasvir, ledipasvir, sofosbuvir), among others.

Does Apalutamide 60 Mg Tablet interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, thyroid function) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Erleada (apalutamide) showed a significant increase in overall survival in metastatic hormone-sensitive prostate cancer

Erleada (apalutamide) showed a significant increase in overall survival in metastatic hormone-sensitive prostate cancer

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survival among patients with metastatic hormone-sensitive prostate cancer

Moscow, March 5, 2021 — Janssen, the pharmaceuticals division of Johnson & Johnson LLC, announces the results of the final analysis of the Phase 3 TITAN study, in which apalutamide therapy in combination with androgen deprivation therapy ( ADT) demonstrated higher overall survival rates in patients with metastatic hormone-sensitive prostate cancer (mHRPC) compared with placebo in combination with ADT ¹ . The results of the analysis were presented during the online conference of the American Society of Clinical Oncology (ASCO), held from February 11 to 13.

TITAN phase 3 final analysis data, obtained at a median follow-up of 44 months, confirmed an increase in overall survival (OS) and a 35% reduction in the risk of death in patients who used apalutamide in combination with androgen deprivation therapy (ADT) in compared with the group using only ADT (RR = 0. 65; 95% CI: 0.53-0.79; p<0.0001) ¹ . This result was almost similar to the OS achieved in the primary analysis of the TITAN study, despite the subsequent conversion of almost 40% of placebo patients to treatment with apalutamide ¹ . After adjusting the results for the transition of some patients from the placebo group to receiving apalutamide, the reduction in the risk of death increased to 48% (RR = 0.52; 95% CI: 0.42-0.64; p<0.0001) ¹ .

“At Janssen, we are committed to finding new solutions for prostate cancer patients because, until recently, significant progress has not been made in the treatment of people with metastatic hormone-sensitive prostate cancer ² ,” commented Dr. Katherine Taylor, Vice President of Medical Affairs for EMEA at Johnson & Johnson. “According to the results of the final analysis of the TITAN study, the use of apalutamide in combination with androgen deprivation therapy provides new therapeutic options for patients with advanced hormone-sensitive prostate cancer. ”

A sustained effect was observed for other endpoints, including an increase in relapse-free survival (PFS2) (RR = 0.62; 95% CI: 0.51-0.75; p<0.0001), as well as the time to development of castration resistance (RR = 0.34; 95% CI: 0.29-0.41; p<0.0001). ¹ In addition, health-related quality of life, as assessed by the Functional Assessment of Cancer Therapy – Prostate Cancer (FACT-P) questionnaire, did not differ between the two groups of patients. The safety of apalutamide is consistent with data from previous studies. ¹ Side effects observed with the drug included skin rash, fractures, and weakness. ¹

“The final review of the TITAN study is a welcome development in the treatment of metastatic hormone-sensitive prostate cancer ² as its results demonstrate that apalutamide in combination with ADT improves long-term clinical efficacy and increases overall survival without compromising patient quality of life — said Professor Axel Merseburger, Chairman of the Urological Clinic of the University of Schleswig-Holstein and participant in the TITAN study. “The results of the analysis also confirmed the safety profile of the drug, which allows us to provide effective and safe treatment for patients with advanced forms of prostate cancer.”

Initial results from the TITAN study, presented at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) and published in The New England Journal of Medicine, showed that the use of apalutamide in combination with androgen deprivation therapy significantly improved rates of double primary endpoints of OS and radiographic progression-free survival (rFSD) in patients with mHRPC. ³

To date, published results from studies of apalutamide include more than 2,000 patients in phase 3 clinical trials. ³ Apalutamide showed a statistically significant improvement in OS with a robust safety profile in both patients with metastatic hormone-sensitive prostate cancer (TITAN) and non-metastatic castration-resistant prostate cancer (SPARTAN). ³

*Professor Axel Merseburger is a researcher who participated in the TITAN study and received a corresponding compensation for his work with the media.

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About the TITAN study ³ , ⁴

TITAN ( NCT02489318 ) is a phase 3, randomized, double-blind, placebo-controlled study conducted with participation of patients with metastatic hormone-sensitive prostate cancer. The study involved 1,052 patients in 23 countries and 260 clinical centers in North America, Latin America, South America, Europe including Russia, and the Asia-Pacific region. Patients with mHRPC were divided into two groups: one group received apalutamide (240 mg/day) plus ADT (n=525), and the other received placebo plus ADT (n=527). Groups of participants were recruited from December 2015 to July 2017. ³ , ⁴ The study included patients with mHRPC with both large and small metastatic lesions, patients with initially diagnosed mHRPC, as well as those who had previously received radical local treatment or chemotherapy in the amount of up to six cycles docetaxel. ³ , ⁴

The Independent Data Monitoring Committee (IDMC) was selected as the study sponsor to monitor the safety and efficacy of ⁵ therapy. The two primary endpoints of the study were OS and radiographic progression-free survival (rFSD) ¹ . Secondary endpoints included time to cytostatic chemotherapy, time to pain progression, time to chronic use of opiate analgesics, and time to bone complications ³ , ⁴ . Exploratory endpoints included time to prostate specific antigen (PSA) progression, relapse-free survival (PFS2), and time to symptomatic progression. ³ , ⁴ For more information about the trial, visit ClinicalTrials.gov.

About metastatic hormone-responsive prostate cancer

Metastatic hormone-responsive prostate cancer, also known as metastatic castration-sensitive prostate cancer, is prostate cancer that still responds to hormone therapy but has already spread beyond the prostate by others tissues and organs. ⁵

About Erleada (apalutamide)

Apalutamide is an oral selective androgen receptor inhibitor approved in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer with high the risk of developing metastases, as well as with metastatic hormone-sensitive prostate cancer in combination with ADT. ⁶

About Janssen, Pharmaceutical Companies Johnson & Johnson

At Janssen, we are creating a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson and we spare no effort to make this future a reality for patients around the world. We defeat diseases with advanced science. We invent how to help those who need help. We heal hopelessness with human warmth.

We work in areas of medicine where we can bring the most benefit: cardiovascular diseases, immune-mediated diseases and metabolic disorders, infectious diseases and vaccines, diseases of the central nervous system, oncology, pulmonary arterial hypertension.

Learn more at janssen.com. Follow: twitter.com/JanssenGlobal. Johnson & Johnson LLC is part of the Janssen Pharmaceutical Companies, Johnson & Johnson.

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PROSUCTION measures for forecast statements

This press release contains “Forecast Information”, in accordance with the definition contained in the law on the proceedings on private securities for 1995, in relation further development and study of the potential benefits of apalutamide (Erleada). We emphasize that the reader should not be guided by forward-looking information. These statements are based on current expectations regarding future events. If underlying assumptions prove inaccurate or risks or uncertainties known or unknown to us arise, actual results may differ materially from the expectations and projections of Janssen, Johnson & Johnson Pharmaceuticals, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, the following: problems and uncertainties associated with research and development of new products, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; production difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; difficulties with patents; drug efficacy or safety concerns that require a drug recall or regulatory action; changes in the behavior and spending patterns of consumers of health care products and services; changing relevant laws and regulations, including international health reforms; and trends towards containment of health care costs. An additional list of these risks, uncertainties, and other factors, along with a description of them, is provided in Johnson & Johnson’s Annual Report Form 10-K for the financial year ended 29December 2019, including under the heading “Forward-Looking Statements Warning” and “Item 1A. Risk Factors”, as well as in the company’s subsequent quarterly reports on Form 10-Q and other company documents filed with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or upon request to Johnson & Johnson. None of the Janssen pharmaceutical companies or Johnson & Johnson undertakes to update any forward-looking statements in the light of new information, future events or developments.

¹ Chi, K. Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide (APA) vs Placebo (PBO) in Patients (pts) With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Receiving Androgen Deprivation Therapy (ADT). ASCO GU 2021 oral presentation.
² Hall, M, E. et al. Metastatic Hormone-sensitive Prostate Cancer: Current Perspective on the Evolving Therapeutic Landscape. NCBI . 2020; 13:3571–3581. Electronic resource: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201221/. Retrieved: February 2021.
³ ERLEADA ^® Prescribing Information, September 17, 2019.
⁴ ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Electronic resource: https://clinicaltrials.gov/ct2/show/NCT02489318. Accessed February 2021.
⁵ American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). Electronic resource: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Retrieved: February 2021.
⁶ European Medicines Agency. ERLEADA. Electronic resource: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en. pdf. Accessed February 2021

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According to long-term patient survey results, the use of Erleada® (apalutamide) in metastatic hormone-sensitive prostate cancer improves the quality of life of patients

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According to long-term results of a patient survey, the use of Erleada® (apalutamide) in metastatic hormone-sensitive prostate cancer helps to maintain the quality of life of patients 9

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Results of the final analysis of the 3rd phase of the study TITAN presented by the American Society of Clinical Oncology (ASCO), confirm increased survival and improved quality of life when apalutamide is added to androgen deprivation therapy

Moscow, June 8, 2021 – Janssen, Pharmaceuticals Division of Johnson & Johnson LLC, presents the results of an analysis of the TITAN Phase 3 study in patients with metastatic hormone-responsive prostate cancer (mHRPC). ). The TITAN study has previously demonstrated an improvement in overall survival (OS) in patients treated with apalutamide in combination with androgen deprivation therapy (ADT) at a median follow-up of 44 months ¹ . New Patient Therapy Evaluation (PRO) results showed that the addition of apalutamide to ADT maintained patients’ quality of life and did not worsen the burden of side effects when compared with ADT alone ² . These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting June 4-8, 2021 (document #5068).

“Patients are often concerned about the side effects of treatment for a disease,” said Prof. Axel Merseburger, MD, Chairman of the Urological Clinic of the University of Schleswig-Holstein and participant in the TITAN study.* –The latest results from the TITAN clinical study show how we can improve overall patient survival without compromising quality of life, which is an important step towards improving the treatment of advanced prostate cancer. ”

A study found that apalutamide in combination with ADT delayed disease progression to metastatic castration-resistant prostate cancer (mCRPC) by more than 4.5 years. The median time to development of castration resistance was 11.4 months in the placebo plus ADT group, while the median was not reached in the apalutamide plus ADT group at 55 months (4.5 years) of follow-up. The reduction in the risk of developing castration resistance was 66% ¹ .

Quality of life in patients treated with apalutamide in combination with ADT and in patients treated with placebo plus ADT was maintained throughout the study. Overall, patients in both groups reported that quality of life did not decrease; results were assessed using the Brief Pain Intensity Inventory (BPI-SF) and the Functional Evaluation of Cancer Therapy – Prostate Cancer (FACT-P) questionnaire ² . On a pain score ranging from zero (no pain/discomfort with daily activities) to 10 (worst pain/discomfort), the mean patient scores were 1. 1 in the apalutamide group and 1 in the placebo group plus ADT. On the FACT-P quality of life score for prostate cancer patients (1-156, higher score = better quality of life), mean patient scores were 113 in the apalutamide group and 113.3 in the placebo plus ADT group ² . Apalutamide therapy in combination with ADT was also found to maintain physical, social, family, emotional, functional and mental well-being for two years, as assessed by the FACT-P scale. There were no significant differences between groups in the time to deterioration on any BPI or FACT-P measures, further confirming that quality of life was maintained with apalutamide ² .

Previously, apalutamide has been shown to increase OS in both patients with metastatic hormone-sensitive prostate cancer (TITAN) and patients with non-metastatic castration-resistant prostate cancer (SPARTAN) ³ . Data from the final analysis of the results of the TITAN study, presented in 2021 at the American Society of Clinical Oncology (ASCO) Genitourinary Cancer Congress and recently in the Journal of Clinical Oncology, confirmed that the addition of apalutamide to ADT continues to show a significant increase in OS with median follow-up of 44 months in patients with mHRPC. Apalutamide in combination with ADT reduces the risk of death by 35% compared with ADT alone (hazard ratio [HR]=0.65; 95% confidence interval [CI], 0.53-0.79; P<0.0001) ¹ .

“We are delighted to be able to share the results of the TITAN study at this year’s American Society of Clinical Oncology (ASCO) congress. We know they are needed to provide a complete picture of the patient experience with apalutamide in combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer. The results of the study will guide physicians in prescribing the right therapy for a particular patient, said Dr. Katherine Taylor, Vice President of Medical Affairs and Therapeutic Strategy for Janssen Europe, Middle East and Africa. “These results, along with a significant increase in OS, provide additional evidence for apalutamide in combination with ADT for patients with mHRPC as first-line therapy.”

*Professor Axel Merseburger – company consultant Janssen unpaid media work.

About metastatic hormone-sensitive prostate cancer

Metastatic hormone-responsive prostate cancer, also known as metastatic castration-sensitive prostate cancer, is prostate cancer that is still responsive to hormone therapy , but has already spread beyond limits of the prostate to other tissues and organs ⁴ .

About the study TITAN ^{3.5 oe with the participation of patients with metastatic hormone-sensitive prostate cancer. The study involved 1052 patients in 23 countries and 260 clinical centers in North America, Latin America, South America, Europe, including Russia, and countries in the Asia-Pacific region. Patients with mHRPC were divided into two groups: one group received apalutamide (240 mg/day) plus ADT (n=525) and the other received placebo plus ADT (n=527). Participant groups were recruited between December 2015 and July 2017 3.6 . The study included patients with mHRPC with both large and small metastatic lesions, patients with initially diagnosed mHRPC, as well as those who had previously received radical local treatment or chemotherapy in the amount of up to six cycles of docetaxel 3.6 .}

The Independent Data Monitoring Committee (IDMC) was selected as the study sponsor to monitor the safety and efficacy of therapy ⁵ . The two primary endpoints of the study were OS and radiographic progression-free survival (rFSD) ⁵ . Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to permanent opioid analgesics, and time to bone complications ^3.6 . Exploratory endpoints included time to prostate-specific antigen (PSA) progression, survival to relapse (FSD2), and time to symptomatic progression ^3.6. For more information about the trial, visit ClinicalTrials.gov.

About Erleada (apalutamide)

Apalutamide is an oral selective androgen receptor inhibitor approved in Russia, the United States and Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer with a high risk of developing metastases, as well as with metastatic hormone-sensitive prostate cancer in combination with ADT ^7,8,9 .

About Janssen Pharmaceutical companies Johnson & Johnson

At Janssen, we are creating a future where disease is a thing of the past. We are the pharmaceutical companies of Johnson & Johnson, and we spare no effort to make this future a reality for patients around the world. We defeat diseases with advanced science. Inventing how to help those who need help. We heal hopelessness with human warmth.

We work in the areas of medicine where we can make the most difference: cardiovascular diseases, immune-mediated and metabolic diseases, infectious diseases and vaccines, diseases of the central nervous system, oncology, pulmonary arterial hypertension.

Find out more at janssen.com. Follow: twitter.com/JanssenGlobal. Johnson & Johnson LLC is part of the Janssen Pharmaceutical Companies, Johnson & Johnson.

Caution regarding forward-looking statements

This press release contains “forward-looking information” as defined in the Private Securities Litigation Reform Act of 1995 year, in regarding the further development and study of the potential benefits of apalutamide (Erleada). We emphasize that the reader should not be guided by forward-looking information. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or risks or uncertainties known or unknown to us arise, actual results could differ materially from expectations and forecasts Janssen , pharmaceutical companies Johnson & Johnson , and/or companies Johnson 90 196 & Johnson . Risks and uncertainties include, but are not limited to, the following: problems and uncertainties associated with the research and development of new products, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; production difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; difficulties with patents; drug efficacy or safety concerns that require a drug recall or regulatory action; changes in behavior and spending patterns of consumers of health products and services; changing relevant laws and regulations, including international health reforms; and trends towards containment of health care costs. An additional list of these risks, uncertainties and other factors, together with their description, is presented in the company’s annual report Johnson & Johnson on Form 10- K for the fiscal year ended January 3, 2021, including under the heading “Forward-Looking Statements Warning” and “ Item 1 A . Risk Factors”, as well as in subsequent quarterly reports of the company in the form 10- Q and other company documents filed with the Securities and Exchange Commission. None of the pharmaceutical companies Janssen or the company Johnson & Johnson does not undertake to update any forward-looking statements in the light of new information, future events or developments.

1. Chi, K, et al. Apalutamide in Patients with Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. Journal of Clinical Oncology. Electronic resource: https://ascopubs.org/doi/full/10.1200/JCO.20.03488. Entry date: May 2021

2. Agarwal, N. et al. Health-related quality of life (HRQoL) and patient-reported outcomes at final analysis of the TITAN study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). Electronic resource: https://meetinglibrary.asco.org/record/197750/abstract. Entry date: May 2021

3. ERLEADA. Summary of Product Characteristics, December 2020.

4. American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). Electronic resource: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Date of entry: May 2021

5. ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Online: https://clinicaltrials.