Etanercept| Side-effects, uses, time to work

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  What is etanercept and how is it used?
  
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  Uses
  
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  How is it taken?
  
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  Things to know before you start etanercept
  
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  Side-effects and risks
  
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  Effects on other treatments
  
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  Vaccinations
  
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  Having an operation
  
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  Alcohol
  
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  Fertility, pregnancy and breastfeeding
  

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What is etanercept and how is it used?

Etanercept is a type of drug known as a biological therapy.

In rheumatoid arthritis and some other inflammatory conditions, too much of a protein called TNF is produced by the immune system. This causes inflammation, pain and damage to your joints. Anti-TNF drugs, such as etanercept, block TNF and reduce inflammation.

Etanercept isn’t a painkiller, but it can reduce the effects of your condition. Your symptoms should start to improve 2–12 weeks after you start taking it.

Related information

• 
  

  Rheumatoid arthritis

  
  

  Rheumatoid arthritis is the UK’s second most common arthritis. It causes joint pain and inflammation. Learn about the symptoms, causes and treatment.

  
  

Uses

Etanercept can be prescribed by a consultant rheumatologist for:

• rheumatoid arthritis (roo-ma-toy-d arth-ri-tus)
• psoriatic arthritis (saw-ree-at-ik arth-ri-tus)
• ankylosing spondylitis (an-kee-low-sing spon-dee-lie-tus)
• juvenile idiopathic arthritis (joo-vuh-nahyl id-ee-uh-path-ik arth-ri-tus) (JIA).

Biological therapies, such as etanercept, won’t usually be prescribed unless you’ve tried at least two disease-modifying anti-rheumatic drugs (DMARDs). These include drugs like methotrexate, sulfasalazine and leflunomide.

Etanercept is usually used in combination with methotrexate, but it can be taken on its own.

Related information

• 
  

  Disease-modifying anti-rheumatic drugs (DMARDs)

  
  

  Disease-modifying anti-rheumatic drugs (DMARDs) alter the underlying disease rather than treating symptoms. Learn how long they take, uses and side-effects.

  
  

How is it taken?

Etanercept is taken once or twice a week as an injection under the skin, known as a subcutaneous injection.

You can take etanercept by syringe or with an injector pen. You, your partner, or another member of your family can learn to give these injections at home. You should make sure they are stored in the fridge.

If you forget to take your etanercept contact your rheumatology team. They’ll be able to advise you on when to take it next.

Etanercept may not work right away, so it’s important to continue taking it even if it doesn’t seem to be working. You should also continue taking it as prescribed when your symptoms improve and you start to feel better, as this will keep your condition under control.

Most people will have regular blood tests while taking etanercept.

Biosimilars

Etanercept was originally only available as a drug called Enbrel. However, newer versions of biological therapies are becoming available, so you may be prescribed etanercept under a different name, such as Benepali or Erelzi. These drugs are known as biosimilars and work in a similar way.

Things to know before you start etanercept

Etanercept is a very effective drug for many people with arthritis. But it’s not suitable for everyone.

Before you’re prescribed etanercept, doctors sometimes use a scoring system to work out how active your arthritis is. The system used depends on what condition you have, but you’ll probably be asked how well you feel on a scale of 1 to 10 and your doctor will make a note of how many of your joints feel tender and swollen.

You’ll also need blood tests to work out how active your condition is and to check whether the drug is suitable for you.

Your doctor might not prescribe etanercept if:

• you’re pregnant or breastfeeding
• you have HIV
• you have severe heart problems
• you’ve had cancer
• you, or a close family member, have multiple sclerosis (MS)
• you have lung problems.

This drug should be used with caution if you have infections that repeatedly come and go.

Before starting etanercept, you’ll have a chest x-ray and tests to check if you’ve ever been exposed to tuberculosis (TB). If you have, you may need treatment for TB before you can start taking it.

You’ll also be checked for previous hepatitis B or C infections, as etanercept may increase the risk of these conditions starting up again.

Side-effects and risks

Most people don’t have any side effects, and for those who do, they aren’t usually serious. However, if you do have severe side effects, or are concerned about your symptoms, contact one of the healthcare professionals in charge of your care.

Some of the most common side effects include:

• a blocked or runny nose
• a sore throat
• feeling sick or vomiting
• a mild fever
• headaches
• dizziness
• a rash
• stomach pain.

Some people may have reactions at the spot of the injection, such as redness, swelling or pain. These reactions should stop appearing after a month of treatment. Regularly changing the injection spot will help reduce the chances of this happening.

In rare cases, people experience allergic reactions. This could be in the form of swelling, a rash or you may feel short of breath. If you do develop these symptoms, or any other severe symptoms, during or soon after a dose of etanercept you should seek medical advice straight away.

Because etanercept affects the immune system, it can make you more likely to develop the symptoms of a cold or to pick up infections. Tell your doctor or rheumatology nurse straight away if you develop any of the following symptoms:

• a cough that won’t go away
• unexpected weight loss
• fever.

Also make them aware if you notice any unexplained bruising or bleeding. Your rheumatology team might advise you to pause or stop treatment.

You should contact your rheumatology team if you get chickenpox or shingles, or if you come into come into contact with someone who has them and you have never had chickenpox before. These illnesses can be worse than usual if you’re on etanercept. You may need treatment for them and your etanercept may be stopped until you’re better.

Anti-TNF drugs have been associated with some types of skin cancer. However, the link between the two is unclear. Skin cancers can often be treated successfully when diagnosed early. To be on the safe side, make sure to wear sunscreen and regularly check your skin for any new spots or changes to your freckles or moles.

Very rarely, etanercept may cause a condition called drug-induced lupus. Symptoms include a rash, fever and increased joint pain. If you have any of these symptoms, you should tell your rheumatology team. This condition usually clears up if etanercept is stopped.

Tips to reduce your risk of infection

• Try to avoid close contact with people you know have an infection.
• Wash your hands regularly and carry around a small bottle of antibacterial hand gel.
• Keep your mouth clean by brushing your teeth regularly.
• Stop smoking if you’re a smoker.
• Make sure your food is stored and prepared properly.
• Try to keep your house clean and hygienic, especially the kitchen, bathrooms and toilets.

Effects on other treatments

If you’re taking etanercept, you’ll probably be taking methotrexate as well. Check with your doctor before starting any new medications.

Remember to mention you’re on etanercept if you’re treated by anyone other than your usual rheumatology team, as it won’t appear on your repeat prescription list from your GP.

It’s recommended that you carry a biological therapy alert card, so anyone treating you will know that you’re on etanercept.

Ask your rheumatology team for a card or order one for free on our website.

You can carry on taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, or painkillers, such as paracetamol if needed, unless your doctor advises otherwise.

Don’t take over-the-counter preparations or herbal remedies without talking to your healthcare team or a pharmacist, as some of them may react badly with etanercept.

Related information

• 
  

  Methotrexate

  
  

  Methotrexate is a DMARD used to treat rheumatoid arthritis, juvenile idiopathic arthritis, vasculitis and psoriatic arthritis. Learn the risks and side-effects.

  
  

Vaccinations

The pneumonia (new-mow-nee-uh) vaccine and yearly flu vaccines don’t affect etanercept and are perfectly safe to have while you’re taking it. It’s very important to have these to reduce your risk of infection.

It’s usually recommended that you avoid having live vaccines such as MMR (measles, mumps and rubella) or yellow fever and chickenpox.

If you’ve never had chickenpox, it can be good to be vaccinated against it before starting etanercept. But discuss this with your rheumatology team first. It’s also a good idea to get any family or household members vaccinated against chickenpox before you start taking etanercept.

The Zostavax shingles vaccine is a live vaccine and isn’t recommended for people who are on etanercept. However, a non-live shingles vaccine (Shingrix) is available so you may be able to have this instead.

If you’re unsure about whether you should be having a vaccine, make sure to have a chat with your rheumatology team.

Having an operation

Talk this over with your rheumatology team. It’s likely you’ll be advised to stop etanercept for a couple of weeks before and after surgery. 

Alcohol

There’s no known interaction between etanercept and alcohol, so it’s fine to have a drink if you’re taking this medication.

Government guidelines say both men and women should have no more than 14 units of alcohol a week. This is equivalent to about six glasses of wine or six pints of beer.

You can find out more about units of alcohol at www.drinkaware.co.uk.

Fertility, pregnancy and breastfeeding

If you’re planning to try for a baby, if you become pregnant, or if you’re thinking of breastfeeding, we suggest you discuss your medications with your rheumatologist.

Current guidelines say that you can carry on taking etanercept during the first six months of pregnancy. However, if there’s concern that your arthritis may flare up, then your doctors might recommend you keep taking it throughout the whole pregnancy.

If this is the case, your baby shouldn’t have any live vaccines until they’re at least seven months old. For more information talk to your rheumatology team and your child’s doctor, as some vaccines will still be safe for them to have.

There’s only limited information about the use of etanercept while breastfeeding, but there’s no research to show that it’s harmful.

Current guidelines state that men trying to father a baby should be ok to continue taking etanercept or methotrexate. If in doubt discuss this with your rheumatologist first.

Women who are taking methotrexate as well as etanercept should stop taking methotrexate at least three months before trying for a baby. Methotrexate should not be restarted until after you’ve finished breastfeeding.

Etanercept – StatPearls – NCBI Bookshelf

Continuing Education Activity

Etanercept is a medication used to manage and treat autoimmune conditions such as plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. It is a biologic fusion protein in the TNF blocker class of medications. This activity describes the indications, action, and contraindications for etanercept as a valuable agent in managing these diseases and other disorders when applicable. This activity will highlight the mechanism of action, adverse event profile, and other key factors (e.g., off-label uses, dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions) pertinent for members of the interprofessional team in the management of patients with psoriasis, autoimmune arthritis, and related conditions.

Objectives:

• Identify the mechanism of action of etanercept.

• Describe the adverse effects of etanercept.

• Review the appropriate monitoring and toxicity of etanercept.

• Summarize some interprofessional team strategies for improving care coordination and communication to advance etanercept and improve outcomes.

Access free multiple choice questions on this topic.

Indications

Etanercept is a biologic TNF inhibitor commonly used to control ankylosing spondylitis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Etanercept is a soluble receptor that binds both TNF-alpha and TNF-beta to inhibit the inflammatory response in joints and skin that is characteristic of these autoimmune disorders. The drug can be used as a monotherapy or taken with other immunosuppressants, such as methotrexate.[1]

Clinicians can use etanercept for both approved and off-label indications.[2][3][4][5]

FDA Approved Uses

• Ankylosing spondylitis

• Juvenile idiopathic arthritis (2 years or older)

• Plaque psoriasis (4 years or older)

• Psoriatic arthritis

• Rheumatoid arthritis

Off-label Uses (not FDA approved)

• Acute graft-versus-host disease (combined with methylprednisolone)

• Behcet disease

• Hidradenitis suppurativa 

• Kawasaki disease 

• Pemphigus vulgaris 

• Pustular psoriasis 

• Pyoderma gangrenosum 

• Scleroderma/systemic sclerosis 

• Still disease 

Mechanism of Action

Etanercept is a biologic tumor necrosis factor (TNF) inhibitor; the drug acts as a soluble TNF receptor and binds TNF-alpha and TNF-beta. [6] TNF is a cytokine that can bind to TNF receptor 1 (TNFR1) or TNF receptor 2 (TNFR2) and is involved in inflammation and the immune response.[7] TNF binds to TNFR1 or TNFR2, activating important inflammatory pathways, such as NFkB and MAPK. The structure of etanercept consists of two p75 TNF receptors fused to the Fc portion of human IgG.[6] Etanercept works by blocking the effects of TNF-alpha, a pro-inflammatory cytokine that becomes elevated in psoriasis, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.

Administration

Etanercept administration is via subcutaneous injection, usually on the thigh, lower abdomen, or upper arm. If given on the abdomen, the injection should not be within the 2-inch area around the navel. Injections should be administered at least 1 inch away from previous injection sites. The medication comes in a pre-filled syringe, automatic injection device, or multiple-dose vial. After the initial injection of etanercept at the clinician’s office, the patient can self-inject at home with appropriate training. [8]

To treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, 50 mg of etanercept is injected once a week. An alternative dosing regimen is 25 mg subcutaneously twice weekly, with at least 72 to 96 hours between injections. For psoriasis, the dosage is 50 mg twice weekly for three months, followed by 50 mg once weekly. Children with juvenile idiopathic arthritis are administered 0.8 mg/kg once a week, up to 50 mg.

Adverse Effects

Common Adverse Effects

• Infection (viral, bacterial, and fungal – mostly upper respiratory tract infections)

• Injection site reaction (erythema, itching, pain, swelling, bleeding, bruising)[1]

Rare Adverse Effects (in alphabetical order):

• Blood and lymph disorders: aplastic anemia, leukopenia, myelodysplastic syndrome, neutropenia, pancytopenia, thrombocytopenia[9]

• Cancers: lymphoma, skin cancers[10]

• Cardiopulmonary problems: congestive heart failure, interstitial lung disease[11]

• Gastrointestinal and liver problems: autoimmune hepatitis,[12] diarrhea,[13] elevated transaminases,[14] inflammatory bowel disease,[15] nausea[16] 

• Immune and inflammatory conditions:  angioedema,[17] hypersensitivity reaction,[18] lupus-like syndrome,[11] non-neutralizing anti-Etanercept antibodies,[1] pyrexia,[16] sarcoidosis, uveitis, vasculitis

• Infections: aspergillosis,[19] candidiasis,[19] coccidioidomycosis, cryptococcus,[19] herpes zoster, histoplasmosis,[19] legionella pneumonia,[20] listeriosis,[19] nocardiosis,[19] pneumocystis pneumonia, reactivation of Hepatitis B or TB,[21] salmonella infection,[19] septic arthritis 

• Nervous system disorders: headache,[5] multiple sclerosis, optic neuritis, paresthesias, seizures, transverse myelitis

• Skin disorders: cutaneous lupus erythematosus,[22] erythema multiforme,[22] new or worsening psoriasis, rash, Stevens-Johnson syndrome,[22] toxic epidermal necrolysis,[22] urticaria

US Boxed warnings

Infections, Including Tuberculosis

Patients using etanercept have an increased risk of acquiring serious and/or fatal infections, including the development of active tuberculosis or reactivation of latent tuberculosis. There are reports of various bacterial, viral, and fungal infections, including invasive fungal (aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and pneumocystosis) and opportunistic infections (legionellosis, listeriosis). 

Infections were more common in patients that received adjunct immunosuppressive medications, such as methotrexate or corticosteroids. Medical providers should exercise caution when prescribing etanercept to patients at higher risk for infections, including elderly patients, immunocompromised patients, patients with a history of recurrent/chronic/opportunistic infections, and patients exposed to tuberculosis or endemic mycoses. Physicians should consider empiric antifungal therapy for patients living in or traveling to endemic areas with an increased risk of invasive fungal infections.

Malignancies

Reports exist of malignancies in patients receiving etanercept, especially in children and adolescents. Lymphomas were most commonly reported, followed by melanoma and other skin cancers. Though the connection between etanercept and malignancies is not fully understood, clinical trials and case reports showed an increased rate of lymphoma and other malignancies in patients on etanercept compared to the general population. However, it is worth noting that rheumatoid arthritis alone has associations with increased rates of lymphoma and leukemia.[23]

Contraindications

Etanercept contraindications include patients with sepsis. Patients should not start etanercept during active bacterial infections, including tuberculosis (active or latent), active herpes zoster infection, active or chronic untreated Hepatitis B or C infection, or active invasive fungal infections.[24] Patients should not use etanercept if they have a hypersensitivity reaction to the medication ingredients.

Monitoring

Before starting etanercept, patients should receive screening for any infections, including latent tuberculosis or hepatitis B. Patients on etanercept require monitoring for signs of infection and reactivation or development of tuberculosis and hepatitis B. [25] If a severe infection or sepsis develops during etanercept treatment, discontinue treatment. Also, patients should be monitored for signs or symptoms of hypersensitivity reactions, malignancy, or lupus-like syndrome. Patients with a history of heart failure also require monitoring during etanercept treatment.[26]

Toxicity

There have not been any dose-limiting toxicities observed during clinical trials, in vivo, and in vitro studies. However, the long-term toxicity of etanercept treatment is unknown.[27]

Enhancing Healthcare Team Outcomes

Etanercept is one of several different options for treating plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. The medical providers should weigh the risks and benefits of selecting etanercept as a treatment, such as drug cost, effectiveness, method of administration, and adverse effects. Because it is a biologic, etanercept usage comes with serious side effects such as infections, malignancies, and autoimmune conditions.

An interprofessional team of clinicians, specialists, nurses, and pharmacists must work together to ensure the safety and wellbeing of the patient. When deciding to treat with etanercept, clinicians should know the treatment guidelines, including monitoring the patient for signs of heart failure, tuberculosis, hepatitis B, and other infections before and during treatment. Clinicians and nurses will instruct the patient or the patient’s relative on properly administering etanercept injections at home. Clinicians and pharmacists must ensure that the patient receives the proper medication and dosage and that the patient receives on drug interactions and adverse effects. Nursing can participate in injection administration training and education and should keep the team informed regarding the appearance of any adverse reactions, as well as monitoring the success/failure of therapy. Also, biosimilars of etanercept have been emerging on the market, so healthcare providers need to be kept abreast regarding the different options that they have for treatment. [28][29] Without proper management, the quality of life in patients with these diseases is low. An interprofessional healthcare team can help achieve the best possible outcomes with minimal adverse events. [Level 5]

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References

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Davis JC, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, Kivitz A, Fleischmann R, Inman R, Tsuji W., Enbrel Ankylosing Spondylitis Study Group. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum. 2003 Nov;48(11):3230-6. [PubMed: 14613288]

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Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Nocton JJ, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore J, Finck BK. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med. 2000 Mar 16;342(11):763-9. [PubMed: 10717011]

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van den Bemt BJF, Gettings L, Domańska B, Bruggraber R, Mountian I, Kristensen LE. A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience. Drug Deliv. 2019 Dec;26(1):384-392. [PMC free article: PMC6442222] [PubMed: 30905213]

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Feltelius N, Fored CM, Blomqvist P, Bertilsson L, Geborek P, Jacobsson LT, Lindblad S, Lysholm J, Rantapää-Dahlqvist S, Saxne T, Klareskog L. , ARTIS Group. Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept. Ann Rheum Dis. 2005 Feb;64(2):246-52. [PMC free article: PMC1755333] [PubMed: 15208177]

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Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002 Dec;46(12):3151-8. [PubMed: 12483718]

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Ramos-Casals M, Brito-Zerón P, Muñoz S, Soria N, Galiana D, Bertolaccini L, Cuadrado MJ, Khamashta MA. Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine (Baltimore). 2007 Jul;86(4):242-251. [PubMed: 17632266]

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French JB, Bonacini M, Ghabril M, Foureau D, Bonkovsky HL. Hepatotoxicity Associated with the Use of Anti-TNF-α Agents. Drug Saf. 2016 Mar;39(3):199-208. [PMC free article: PMC4752395] [PubMed: 26692395]

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van der Heijde D, Da Silva JC, Dougados M, Geher P, van der Horst-Bruinsma I, Juanola X, Olivieri I, Raeman F, Settas L, Sieper J, Szechinski J, Walker D, Boussuge MP, Wajdula JS, Paolozzi L, Fatenejad S. , Etanercept Study 314 Investigators. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis. 2006 Dec;65(12):1572-7. [PMC free article: PMC1798458] [PubMed: 16968715]

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Akhlaghi S, Sahebari M, Mahmoodi M, Yaseri M, Mansournia MA, Rafatpanah H, Zeraati H. Additional effect of etanercept or infliximab on the liver function tests of patients with rheumatoid arthritis: a cohort study. Ther Clin Risk Manag. 2018;14:1943-1950. [PMC free article: PMC6186305] [PubMed: 30349273]

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O’Toole A, Lucci M, Korzenik J. Inflammatory Bowel Disease Provoked by Etanercept: Report of 443 Possible Cases Combined from an IBD Referral Center and the FDA. Dig Dis Sci. 2016 Jun;61(6):1772-4. [PubMed: 26728477]

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Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ., Pediatric Rheumatology Collaborative Study Group. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003 Jan;48(1):218-26. [PubMed: 12528122]

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Sendur OF, Turan Y, Berkit IK, Tastaban E. Angio-oedema in a patient treated with etanercept for rheumatoid arthritis. Basic Clin Pharmacol Toxicol. 2009 Jun;104(6):488-90. [PubMed: 19371261]

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Cantini F, Niccoli L, Goletti D. Adalimumab, etanercept, infliximab, and the risk of tuberculosis: data from clinical trials, national registries, and postmarketing surveillance. J Rheumatol Suppl. 2014 May;91:47-55. [PubMed: 24789000]

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Kerbleski JF, Gottlieb AB. Dermatological complications and safety of anti-TNF treatments. Gut. 2009 Aug;58(8):1033-9. [PubMed: 19592682]

23.

Esse S, Mason KJ, Green AC, Warren RB. Melanoma Risk in Patients Treated With Biologic Therapy for Common Inflammatory Diseases: A Systematic Review and Meta-analysis. JAMA Dermatol. 2020 Jul 01;156(7):787-794. [PMC free article: PMC7240639] [PubMed: 32432649]

24.

Singh JA, Saag KG, Bridges SL, Akl EA, Bannuru RR, Sullivan MC, Vaysbrot E, McNaughton C, Osani M, Shmerling RH, Curtis JR, Furst DE, Parks D, Kavanaugh A, O’Dell J, King C, Leong A, Matteson EL, Schousboe JT, Drevlow B, Ginsberg S, Grober J, St Clair EW, Tindall E, Miller AS, McAlindon T. , American College of Rheumatology. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jan;68(1):1-25. [PubMed: 26545825]

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Thalayasingam N, Isaacs JD. Anti-TNF therapy. Best Pract Res Clin Rheumatol. 2011 Aug;25(4):549-67. [PubMed: 22137924]

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27.

Wang WM, Jin HZ. Biologics in the treatment of pustular psoriasis. Expert Opin Drug Saf. 2020 Aug;19(8):969-980. [PubMed: 32615817]

28.

Bae SC, Kim J, Choe JY, Park W, Lee SH, Park YB, Shim SC, Lee SS, Sung YK, Choi CB, Lee SR, Park H, Ahn Y., HERA Study Investigators. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis. 2017 Jan;76(1):65-71. [PubMed: 26905864]

29.

Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis. 2018 Apr;77(4):488-494. [PMC free article: PMC5890628] [PubMed: 29259050]

Disclosure: Adrianne Pan declares no relevant financial relationships with ineligible companies.

Disclosure: Valerie Gerriets declares no relevant financial relationships with ineligible companies.

Active substance ETANERCEPT | Compendium – drug reference book

• Pharmacological properties
• Indications ETANERCEPT
• Application of ETANERCEPT
• Contraindications
• Side effects
• Interactions
• Overdose
• Diagnosis
• Recommended alternatives
• Trade names

Medicinal products containing the active substance ETANERCEPT

Enbrel

injection 25 mg syringe 0. 5 ml, No. 4

Pfizer H.C.P. Corporation

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Enbrel

injection 50 mg pen 1 ml, #4

Pfizer H.C.P. Corporation

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Enbrel

injection 50 mg syringe 1 ml, #4

Pfizer H.C.P. Corporation

Pharmacy prices

etanercept is a chimeric protein of human tumor necrosis factor receptor (TNF) and p75Fc. The mechanism of action of etanercept is competitive inhibition of TNF binding to TNF receptors on the cell surface. Thus, etanercept prevents the onset of a TNF-mediated cellular response by biologically inactivating TNF.

C _max is achieved after ≈48 hours. Average C _max in blood plasma was 1.65±0.66 µg/ml, AUC was 235±96.6 µg×h/ml. Absolute bioavailability – 76%. T _½ – ≈70 hours

rheumatoid arthritis

Etanercept in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults where response to DMARDs, including methotrexate (unless contraindicated), is inadequate.

Etanercept as monotherapy is prescribed in case of intolerance to methotrexate or in cases where long-term treatment with methotrexate is inappropriate.

Polyarticular juvenile idiopathic arthritis

Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents 2 years of age or older who have insufficient efficacy or intolerance to methotrexate.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults in cases of insufficient response to DMARD therapy. Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis in cases where conventional therapy has failed.

Plaque psoriasis

Treatment of adult patients with moderate to severe plaque psoriasis who are contraindicated or intolerant to other systemic therapy, including cyclosporine, methotrexate, psoralen, and ultraviolet A (PUVA) therapy, or if this treatment has failed.

Pediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and adolescents aged 6 years and older who have not achieved sufficient disease control with other systemic therapies or phototherapy or have been intolerant to such treatment.

injected s.c.

Rheumatoid arthritis . The recommended dose is 25 mg twice a week.

Psoriatic arthritis and ankylosing spondylitis . The recommended dose is 25 mg twice a week or 50 mg once a week.

Plaque psoriasis. The recommended dose is 25 mg twice a week or 50 mg once a week.

hypersensitivity.

infections, thrombocytopenia, anemia, leukopenia, neutropenia, pancytopenia, aplastic anemia, non-melanoma skin cancers, lymphoma, melanoma, leukemia, seizures, CNS demyelination, uveitis, autoimmune hepatitis, injection site reactions, fever.

During concomitant treatment with etanercept and anakinra preparations, an increase in the incidence of severe infections was observed.

Co-administration of abatacept and etanercept resulted in an increased incidence of severe adverse reactions.

No interactions have been observed with concomitant use of etanercept with corticosteroids, salicylates (with the exception of sulfasalazine), NSAIDs, analgesics or methotrexate.

No toxic effects have been reported.

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ^® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Rinvoq

Brand names: Canada

Rinvoq

Warning

• Serious infections have occurred in patients taking this drug: tuberculosis, herpes zoster, and other bacterial, viral, or fungal infections. In some cases, these violations have led to death. The risk is increased if you are also taking drugs that suppress the activity of the immune system, such as methotrexate or corticosteroids. If you develop a severe infection, your doctor may stop taking this drug until the infection is under control. If you experience symptoms such as fever, chills or sweating; cough; muscle pain; dyspnea; increase in the amount or change in color of sputum; redness, inflammation, soreness of the skin, and a feeling of warmth or blistering; weight loss; abdominal pain; diarrhea; painful or frequent urination; feeling tired or weak, contact your doctor immediately.
• Tuberculosis has developed in patients who started taking this drug. These patients have been in contact with TB patients in the past but have not developed the infection. Before you start taking this medicine, you will need to have a test to see if you have had TB in the past.
• People who take this drug or drugs similar to it have had lymphoma and other cancers. In some cases, fatal. Consult your doctor.
• A similar drug (tofacitinib) has been shown to increase the risk of myocardial infarction, stroke, thrombosis, and death. These events were observed in a study of patients taking tofacitinib for the treatment of rheumatoid arthritis. These were individuals at least 50 years of age who had at least 1 risk factor for heart disease. It is not known if this risk is increased with this drug. If symptoms of myocardial infarction, stroke or thrombosis appear, such as a feeling of tightness, pressure, heaviness or pain in the chest, throat, neck or lower jaw; unusual pain in the arm, back, neck, lower jaw, or abdomen; hemoptysis; dyspnea; cold sweat; severe nausea or vomiting; swelling, feeling hot, numb, cold, skin discoloration, or pain in your leg or arm; impaired speech, swallowing or thinking; weakness on 1 side of the body; imbalance; omission of one side of the face; dizziness or blurred vision, seek medical attention immediately.
• If you smoke, have ever smoked, or have ever had a heart attack, other heart disease, stroke, or thrombosis, tell your doctor.

What is this drug used for?

• Used to treat certain types of arthritis.
• Used to treat eczema.
• It is used to treat ulcerative colitis.
• This drug is used to treat ankylosing spondylitis.
• This drug may also be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
• If you have a low level of red blood cells or white blood cells.
• If you have liver disease or have had hepatitis B or hepatitis C.
• If you have kidney disease.
• In case of infection.
• If you are taking any of the following drugs: abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab, or vedolizumab.
• If you are taking any drugs that suppress the activity of the immune system, such as azathioprine or cyclosporine. There are many drugs that can have this effect. If in doubt, consult your doctor or pharmacist.
• If you are taking any other medicines (prescription or over-the-counter, natural products, vitamins). There are a large number of drugs that interact with this drug, incl. certain drugs to treat HIV infection, other infections, or seizures.
• If you are breastfeeding. Do not breastfeed while taking this drug and for 6 days after your last dose.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• You may be at increased risk of developing an infection. Wash your hands frequently. Try not to contact with carriers of the infection, incl. with people who have a cold or the flu.
• If you have had hepatitis B in the past or are a carrier of the virus, consult your doctor. Drugs of this type can activate the virus. This can lead to very serious, sometimes deadly liver problems.
• Get tested for hepatitis before taking this drug.
• Some viral infections, such as those caused by herpes zoster, come back when you use this drug. Tell your doctor if you have ever had a viral infection such as herpes zoster. Consult your doctor.
• Before starting treatment with this drug, make sure you know all the vaccines you have received so far.
• Consult your doctor before any vaccination. Taking some vaccines with this drug may increase your chance of getting an infection or make the vaccine less effective.
• While using this drug, weakened bacteria such as BCG should not be administered to treat bladder cancer. Consult with your doctor.
• The use of this drug was accompanied by an increase in cholesterol levels. If you have any questions, please consult your doctor.
• Perform blood tests as directed by your doctor. Consult with your doctor.
• Do not drink grapefruit or grapefruit juice.
• There may be an increased risk of developing skin cancer. Avoid prolonged exposure to the sun, the use of sun lamps and tanning beds. Use sunscreen, wear long clothes and sunglasses.
• Get a skin examination. Tell your doctor if you have any skin changes, such as a new wart, skin ulcer, or reddish swelling that bleeds or won’t heal, or a change in the color or size of a mole.
• In rare cases, fistulas in the gastrointestinal tract may develop.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
• Possible adverse effects of this drug on the fetus. Before you start taking this drug, you will have a pregnancy test to confirm that you are NOT pregnant.
• If you are at risk of becoming pregnant, you must use birth control during treatment and for some time after your last dose of this drug. Ask your doctor how long to use contraceptives. If you become pregnant, contact your doctor immediately.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of infection, such as fever, chills, very bad pain in the throat, ear, or sinuses, cough, more sputum or change in color, pain when urinating, mouth sores, or a sore that doesn’t heal.
• Signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
• Feeling of warmth, redness or soreness of the skin or sores on the body.
• Herpes zoster.
• Swelling or growth of the skin.
• Dizziness or fainting.
• Feeling extremely tired or weak.
• With the appearance or aggravation of pain in the stomach.
• Change the rhythm of bowel movements.
• Sudden visual disturbances.
• Cough.
• Fever or chills.
• Severe nausea or vomiting.
• Call your doctor right away if you experience symptoms such as swollen lymph nodes, night sweats, shortness of breath, and unexplained weight loss.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

• Signs of a cold.
• Nausea.
• Headache.
• Acne.
• Herpes.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

• Take this drug with or without food.
• Swallow whole. Do not chew, break or crush.

What if I miss a dose of a drug?

• Take the missed dose as soon as you can.
• If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.

How do I store and/or discard this drug?

• Store in original packaging at room temperature or in the refrigerator.
• Store in a dry place. Do not store in the bathroom.
• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes summaries of diagnosis, treatment and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options.