Etanercept

Etanercept is a prescription medicine used to treat the symptoms of ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and juvenile rheumatoid arthritis.

• Etanercept is available under the following different brand names: Enbrel, Erelzi, Eticovo, etanercept-szzs, etanercept-ykro

Adult and pediatric dosage

Injection solution, prefilled syringe

• 25mg/0.5mL (Enbrel, Erelzi, Eticovo)
• 50mg/mL (Enbrel, Erelzi, Eticovo)

Injection solution, prefilled autoinjector

• 50mg/mL (Enbrel, Erelzi)

Injection, lyophilized powder for reconstitution

• 25mg/vial (Enbrel)

Injection, prefilled single-dose prefilled cartridge with reusable autoinjector

• 50mg/mL (Enbrel Mini)

Biosimilars to Enbrel

Erelzi (etanercept-szzs)

Eticovo (etanercept-ykro)

• Ankylosing Spondylitis
• Adult dosage
  • 50 mg SC once weekly
• Rheumatoid Arthritis
• Adult dosage
  • 50 mg SC once weekly
• Psoriatic Arthritis
• Adult dosage
  • 50 mg SC once weekly
• Plaque Psoriasis
• Adult dosage
  • Initial: 50 mg SC twice weekly for 3 months
  • Maintenance: 50 mg SC once weekly
• Pediatric dosage
  • Children below 4 years: Safety and efficacy not established
  • Children above 4 years:
  • Less than 63 kg

Enbrel only

• 0.8 mg/kg SC weekly; not to exceed 50 mg weekly 
• More than 63 kg

Enbrel, Eticovo, Erelzi

• 50 mg SC weekly

Juvenile Rheumatoid Arthritis

Pediatric dosage

• Children below 2 years: Safety and efficacy not established
• Children above 2 years (less than 63 kg):
• Less than 63 kg

Enbrel only

• 0.8 mg/kg SC weekly; not to exceed 50 mg weekly
• More than 63 kg

Enbrel, Erelzi, Eticovo

• 50 mg SC weekly
• Glucocorticoids, NSAIDs, or analgesics may be continued during treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Etanercept include:

• pain, swelling, itching, or redness at the injection site, and
• cold symptoms: stuffy nose, sneezing, sore throat.

Serious side effects of Etanercept include:

• fever, chills, flu symptoms,
• pale skin, easy bruising or bleeding,
• pain, redness, or swelling at the injection site (for longer than 5 days after injection),
• signs of lymphoma--fever, night sweats, weight loss, stomach pain or swelling, swollen glands in the neck, armpits, or groin,
• signs of tuberculosis--cough, night sweats, loss of appetite, weight loss, feeling very tired,
• new or worsening psoriasis--skin redness or scaly patches, raised bumps filled with pus,
• nerve problems--dizziness, numbness or tingling, problems with vision, or weak feeling in the arms or legs,
• signs of heart failure--shortness of breath, swelling in lower legs,
• lupus-like syndrome--joint pain or swelling, chest discomfort, feeling short of breath, skin rash on cheeks or arms (worsens in sunlight), and
• liver problems--right-sided upper stomach pain, vomiting, tiredness, loss of appetite, yellowing of the skin or eyes.

Rare side effects of Etanercept include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Etanercept has severe interactions with no other drugs.
• Etanercept has serious interactions with at least 75 other drugs.
• Etanercept has moderate interactions with at least 28 other drugs.
• Etanercept has minor interactions with the following drug: 
  • cat's claw

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Sepsis
• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Etanercept?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Etanercept?”

Cautions

• HBV-positive status, history of or susceptibility to recurring infections, history of blood dyscrasias
• Consider empiric anti-fungal therapy for patients at risk for invasive fungal infections who develop a systemic severe illness while receiving therapy
• Monitor closely for signs or symptoms of demyelinating disease (eg, confusion, numbness, vision changes); use caution in patients with preexisting or recent-onset CNS demyelinating disorders
• Increased risk of TB; monitor for TB
• Possibility of lupus-like symptoms or development of autoimmune hepatitis; discontinue if such symptoms develop
• Use with caution in patients with a history of significant hematologic abnormalities; consider discontinuing if hematologic disorders (eg, pancytopenia, leukopenia, thrombocytopenia, aplastic anemia) occur; consider stopping therapy
• Diluent for multidose vial contains benzyl alcohol as a preservative
• Children should be up to date with immunizations before starting drug
• Increased risk of lymphoma and other cancers reported in children and adolescents; occurrence of leukemia and new-onset psoriasis reported in patients treated with TNF blockers
• Enhanced safety surveillance requirements to capture malignancy data; manufacturers are required to report all malignancies to FDA for complete and consistent analysis
• Worsening or new-onset congestive heart failure reported with TNF blockers; Exercise caution when using in patients who have heart failure; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then only consider in patients with compensated HF
• Reactivation of hepatitis B (HBV) in chronic carriers of the virus was reported; fatal in patients receiving concomitant immunosuppressants; evaluation for HBV before initiation in all patients
• Use caution in patients with moderate to severe alcoholic hepatitis; a significantly higher rate of mortality was reported at 6 months of therapy
• Use caution in patients with a history of seizures, new-onset, or exacerbation of seizures reported with therapy
• Therapy is not recommended in patients with Wegener granulomatosis receiving immunosuppressive therapy due to a higher incidence of noncutaneous solid malignancies
• Use in patients with granulomatosis with polyangiitis receiving immunosuppressive agents is not recommended; use is associated with a higher incidence of non-cutaneous solid malignancies and is not associated with improved clinical outcomes when compared with standard therapy alone
• Children with significant exposure to varicella virus should temporarily discontinue therapy; consider administering varicella-zoster immune globulin
• Hepatosplenic T-cell lymphoma
  • Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL; an aggressive, rare, and usually fatal type of T-cell lymphoma) have been reported, primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers but also in 1 patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
  • Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine (6-MP), though some cases have been reported with azathioprine or 6-MP alone
• Drug interaction overview
  • Vaccines
    • Avoid coadministration of live vaccines
    • No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept
    • Patients with significant exposure to varicella virus should temporarily discontinue etanercept and be considered for prophylactic treatment with varicella-zoster immune globulin
  • Cyclophosphamide
    • Use of etanercept with cyclophosphamide therapy is not recommended
  • Sulfasalazine
    • Patients in a clinical study who were on established therapy with sulfasalazine, to which etanercept was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either etanercept or sulfasalazine alone
    • The clinical significance of this observation is unknown

Pregnancy and Lactation

• Available studies during pregnancy do not reliably support an association between therapy and major birth defects; clinical data are available from the Organization of Teratology Infordies showed the proportion of liveborn infants with major birth defects was higher for women exposed to etanercept compared to diseased etanercept unexposed women; however, the lack of pattern of major birth defects is reassuring and differences between exposure groups (e.g. disease severity) may have impacted the occurrence of birth defects
• The risk of fetal/neonatal adverse reactions with in utero exposure to therapy is unknown; risks and benefits should be considered before administering live or live-attenuated vaccines to infants exposed to the drug in utero
• Lactation
  • Limited data from published literature show that etanercept is present in low levels in human milk and minimally absorbed by a breastfed infant; no data are available on the effects of therapy on the breastfed child or milk production