Friday, July 21, 2023

etanercept (e-tan-er-sept) Brenzys, Enbrel, Erelzi

 Indications

Moderately to severely active rheumatoid arthritis (may

be used alone or with methotrexate). Moderate to severely

active polyarticular juvenile idiopathic arthritis.

Psoriatic arthritis (may be used alone or with methotrexate).

Active ankylosing spondylitis. 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 idiopathic

arthritis, and ankylosing spondylitis. Reduced severity

of plaques.

Pharmacokinetics

Absorption: 60% absorbed after subcut administration.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 115 hr (range 98–300 hr).

TIME/ACTION PROFILE (symptom reduction)

ROUTE ONSET PEAK DURATION

Subcut 2–4 wk unknown unknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Active infection

(including localized); Lactation: Lactation; 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; 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); Geri: May haveqrisk of infection; Pedi: Children

with significant exposure to varicella virus (temporarily

discontinue etanercept; consider varicella zoster immune

globulin);qrisk of lymphoma (including hepatosplenic

T-cell lymphoma [HSTCL]), leukemia, and

other malignancies; Pedi: Children 2 yr (juvenile idiopathic

arthritis) or 4 yr (plaque psoriasis) (safety and

effectiveness not established); OB: Use only if needed.

Adverse Reactions/Side Effects

CNS: headache, dizziness, weakness. EENT: rhinitis,

pharyngitis. Resp: upper respiratory tract infection,

cough, respiratory disorder. GI: abdominal pain, dyspepsia.

Derm: psoriasis, rash. Hemat: pancytopenia.

Local: injection site reactions. Misc: INFECTIONS (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 anakinraqrisk of

serious infections (not recommended). Concurrent use

of cyclophosphamide mayqrisk of malignancies.

Concurrent use with azathioprine and/or methotrexate

mayqrisk of HSTCL. Maypantibody response​​to live-virus vaccine andqrisk of adverse reactions

(do not administer concurrently).

Route/Dosage

Rheumatoid Arthritis

Subcut (Adults): 50 mg once weekly.

Psoriatic Arthritis

Subcut (Adults): 50 mg once weekly.

Ankylosing Spondylitis

Subcut (Adults): 50 mg once weekly.

Plaque Psoriasis

Subcut (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.

Subcut (Children 4 yr and 63 kg): 50 mg once

weekly.

Subcut (Children 4 yr and 63 kg): 0.8 mg/kg

once weekly.

Juvenile Idiopathic Arthritis

Subcut (Children 2 yr and 63 kg): 50 mg once

weekly.

Subcut (Children 2 yr and 63 kg): 0.8 mg/kg

once weekly.

Availability

Solution for subcutaneous injection: 25 mg/0.5

mL (prefilled syringe), 50 mg/mL (prefilled syringe and

autoinjector). Powder for subcutaneous injection:

25 mg/vial.

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