etanercept

REMS

Moderately to severely active rheumatoid arthritis (as monotherapy or in combination with methotrexate).
Moderate to severely active polyarticular juvenile idiopathic arthritis.
Active ankylosing spondylitis.
Psoriatic arthritis (as monotherapy or in combination with methotrexate).
Active juvenile psoriatic arthritis.
Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

Action ⬆ ⬇

Binds to tumor necrosis factor (TNF), making it inactive. TNF is a mediator of inflammatory response.

Therapeutic effects:

Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis, psoriatic arthritis, juvenile psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.
Reduced severity of plaques.

Pharmacokinetics ⬆ ⬇

Absorption: 60% absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 115 hr (range 98–300 hr).

Time/Action Profile ⬆ ⬇

(symptom reduction)

ROUTE	ONSET	PEAK	DURATION
SUBQ	2–4 wk	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active infection (including localized);
Untreated infections;
Granulomatosis with polyangiitis (receiving immunosuppressive agents);
Concurrent cyclophosphamide or anakinra.

Use Cautiously in:

History of chronic or recurrent infection or underlying illness/treatment predisposing to infection (including advanced or poorly controlled diabetes);
History of exposure to tuberculosis;
History of opportunistic infection;
History of hepatitis B virus (HBV);
Patients residing or who have resided where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic;
Pre-existing or recent demyelinating disorders (multiple sclerosis, myelitis, optic neuritis);
Latex allergy (needle cover of diluent syringe contains latex);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children with significant exposure to varicella virus (temporarily discontinue etanercept; consider varicella zoster immune globulin); ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL]), leukemia, and other malignancies;
Pedi: Safety and effectiveness not established in children <2 yr (juvenile idiopathic arthritis) or <4 yr (plaque psoriasis);
Geri: Older adults may have ↑ risk of infection.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: psoriasis, rash

EENT: rhinitis, pharyngitis

GI: abdominal pain, dyspepsia

Hemat: pancytopenia

Local: injection site reactions

Neuro: headache, dizziness, weakness.

Resp: upper respiratory tract infection, cough, respiratory disorder

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), INFECTION (INCLUDING REACTIVATION TUBERCULOSIS AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER), SARCOIDOSIS

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with anakinra↑ risk of serious infections (not recommended).
Concurrent use of cyclophosphamide may ↑ risk of malignancies.
Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
May ↓ antibody response to live-virus vaccine and ↑ risk of adverse reactions (do not administer concurrently).

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

SC (Adults ): 50 mg once weekly.

Plaque Psoriasis

SC (Adults ): 50 mg twice weekly for 3 mo, then 50 mg once weekly; may also be given as 25–50 mg once weekly as an initial dose.
SC (Children ≥4 yr and ≥63 kg): 50 mg once weekly.
SC (Children ≥4 yr and <63 kg): Enbrel: 0.8 mg/kg once weekly.

Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

SC (Children ≥2 yr and ≥63 kg): 50 mg once weekly.
SC (Children ≥2 yr and <63 kg): 0.8 mg/kg once weekly.

Availability ⬆ ⬇

Powder for injection: 25 mg/vial
Solution for injection: 25 mg/0.5 mL (prefilled syringe and single-dose vial); 50 mg/mL (prefilled syringe and autoinjector)

Assessment ⬆ ⬇

Assess range of motion, degree of swelling, and pain in affected joints before and periodically during therapy.
Assess for injection site reaction (erythema, pain, itching, swelling). Reactions are usually mild to moderate and last 3–5 days after injection.
Closely monitor patients who develop a new infection while taking etanercept. Discontinue therapy in patients who develop a serious infection or sepsis. Do not start etanercept in patients with active infections.
Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness with or without shock). Ascertain whether patient lives in or has traveled to areas of endemic mycoses. Consult with an infectious diseases specialist to evaluate patients at risk of invasive fungal infections for empiric treatment until the pathogens are identified. Consider stopping etanercept until infection has been diagnosed and adequately treated.
Assess for signs and symptoms of active HBV infection in patients at risk or previously infected (fever, fatigue, abdominal pain, nausea, vomiting, dark urine, clay-colored stools, jaundice).

Lab Test Considerations:

Monitor CBC with differential periodically during therapy. May cause leukopenia, neutropenia, thrombocytopenia, and pancytopenia. Discontinue etanercept if symptoms of blood dyscrasias (persistent fever) occur.
- Monitor hepatic function periodically during therapy.
- Obtain HBV panel in patients at risk or previously infected with HBV throughout therapy and for several mo after discontinuation.

Implementation ⬆ ⬇

Do not confuse Enbrel with Levbid.
Administer a tuberculin skin test prior to therapy; patients with active latent TB should be treated for TB before starting therapy.
SC: Prepare injection with single dose prefilled syringe, single-dose vial, or multidose vial for reconstitution.
- Allow solution in prefilled syringe to reach room temperature (15–30 min); do not remove needle cap during this time.
- For single-dose vial, allow solution to reach room temperature for at least 30 min before injecting. Solution may contain small white particles of protein; do not use if discolored, cloudy, or contains other particulate matter. Discard unused solution. Individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges can also be stored at room temperature for up to 30 days.
- For multidose vial, reconstitute with 1 mL of the bacteriostatic sterile water supplied by manufacturer for a concentration of 25 mg/mL. If the vial is used for multiple doses, use a 25-gauge needle for reconstituting and withdrawing solution, and apply "Mixing Date" sticker with date of reconstitution entered. Inject diluent slowly into vial to avoid foaming. Some foaming will occur. Swirl gently for dissolution; do not shake or vigorously agitate to prevent excess foaming. Solution should be clear and colorless; do not administer solution that is discolored or contains particulate matter. Dissolution usually takes <10 min. Withdraw solution into syringe. Some foam may remain in vial. Amount in syringe should approximate 1 mL. Do not filter reconstituted solution during preparation or administration. Attach a 27-gauge needle to inject. Administer as soon as possible after reconstitution; stable up to 6 hr if refrigerated. Solution from single-dose vials and prefilled syringes are stable if refrigerated and used within 14 days.
- May be injected into abdomen, thigh, or upper arm. Rotate sites. Do not administer within 1 inch of an old site or into area that is tender, red, hard, or bruised.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient on self-administration technique, storage, and disposal of equipment. First injection should be administered under the supervision of health care professional. Provide patient with a puncture-proof container for used equipment.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed.
Advise patient not to receive live vaccines during therapy. Parents should be advised that children should complete immunizations to date before starting etanercept. Patients with significant exposure to varicella virus (chickenpox) should temporarily discontinue therapy, and varicella immune globulin should be considered.
Advise patient that methotrexate, analgesics, NSAIDs, corticosteroids, and salicylates may be continued during therapy.
Instruct patient to notify health care professional if upper respiratory or other infections occur. Therapy may need to be discontinued if serious infection occurs.
Advise patient of risk of malignancies such as HSTCL. Instruct patient to report signs and symptoms (splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) to health care professional promptly.
Advise patient with history of HBV infection that reactivation can occur; report signs and symptoms of fever, fatigue, abdominal pain, nausea, vomiting, dark urine, clay-colored stools, or jaundice
Rep: Instruct females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding during therapy. Advise patients who become pregnant during therapy to notify health care professional. May limit administration of live vaccines to infant. May continue breastfeeding if potential maternal benefit justifies potential risk to infant.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in symptoms of rheumatoid arthritis. Symptoms may return within 1 mo of discontinuation of therapy.
Reduced severity of plaques in chronic plaque psoriasis.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Brenzys, Erelzi, Rymti

Code ⬆

NDC Code

50090- A-S Medication Solutions
- 50090-3531- ENBREL
  - 50090-3531-0- 1 mL in 1 KIT (50090-3531-0)

50090- A-S Medication Solutions
- 50090-4490- ENBREL
  - 50090-4490-0- 1 mL in 1 KIT (50090-4490-0)

58406- Immunex Corporation
- 58406-010- ENBREL
  - 58406-010-04- 4 SYRINGE in 1 CARTON (58406-010-04) > .5 mL in 1 SYRINGE (58406-010-01)

58406- Immunex Corporation
- 58406-021- ENBREL
  - 58406-021-04- 4 SYRINGE in 1 CARTON (58406-021-04) > 1 mL in 1 SYRINGE (58406-021-01)

58406- Immunex Corporation
- 58406-032- ENBREL
  - 58406-032-04- 4 SYRINGE in 1 CARTON (58406-032-04) > 1 mL in 1 SYRINGE (58406-032-01)

58406- Immunex Corporation
- 58406-044- ENBREL
  - 58406-044-04- 4 CARTRIDGE in 1 CARTON (58406-044-04) > 1 mL in 1 CARTRIDGE (58406-044-01)

58406- Immunex Corporation
- 58406-425- ENBREL
  - 58406-425-34- 4 KIT in 1 CARTON (58406-425-34) > 1 KIT in 1 KIT (58406-425-41) * 1 mL in 1 VIAL (58406-424-01) * 1 mL in 1 SYRINGE (58406-910-01)

58406- Immunex Corporation
- 58406-435- ENBREL
  - 58406-435-04- 4 SYRINGE in 1 CARTON (58406-435-04) > 1 mL in 1 SYRINGE (58406-435-01)

58406- Immunex Corporation
- 58406-445- ENBREL
  - 58406-445-04- 4 SYRINGE in 1 CARTON (58406-445-04) > 1 mL in 1 SYRINGE (58406-445-01)

58406- Immunex Corporation
- 58406-446- ENBREL
  - 58406-446-04- 4 SYRINGE in 1 CARTON (58406-446-04) > 1 mL in 1 SYRINGE (58406-446-01)

58406- Immunex Corporation
- 58406-455- ENBREL
  - 58406-455-04- 4 SYRINGE in 1 CARTON (58406-455-04) > .5 mL in 1 SYRINGE (58406-455-01)

58406- Immunex Corporation
- 58406-456- ENBREL
  - 58406-456-04- 4 CARTRIDGE in 1 CARTON (58406-456-04) > 1 mL in 1 CARTRIDGE (58406-456-01)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇