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.

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).

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)

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.

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics (DMARDs)

Pharmacologic Classification: anti tnf agents

Pharmacokinetics ⬆ ⬇

Absorption: 60% absorbed after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 115 hr (range 98–300 hr).

Canadian Brand Names ⬆ ⬇

Brenzys, Erelzi, Rymti

Time/Action Profile ⬆ ⬇

(symptom reduction)

ROUTE	ONSET	PEAK	DURATION
SUBQ	2–4 wk	unknown	unknown

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.

Pronunciation ⬆ ⬇

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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Indications ⬇