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Enbrel
etanercept
Black Box Warnings .
Serious Infection Risk
weigh tx benefit vs. risk in patients with chronic or recurrent infection; pulmonary and extrapulmonary tuberculosis (TB), invasive fungal infections, and other opportunistic infections including Legionella and Listeria observed; some infections have been fatal; most infections occur in combo with other immunosuppressants; evaluate for TB risk factors and screen for latent TB infection before and during etanercept tx; initiate anti-TB tx before etanercept tx; monitor for infection signs/symptoms during and after etanercept tx; since active TB has developed in patients with negative tuberculin skin test, monitor all patients for active TB signs/symptoms; since histoplasmosis may be present in patients with negative antigen and antibody tests, consider empiric antifungal tx in patients with severe systemic illness if at risk for invasive fungal infection; D/C etanercept tx if serious infection or sepsis occurs
Malignancy
lymphoma and other malignancies, some fatal, reported in children and adolescents treated with TNF blockers
Adult Dosing .
Dosage forms: INJ (SureClick auto-injector): 50 mg; INJ (Mini cartridge): 50 mg; INJ (pre-filled syringe): 25 mg per 0.5 mL, 50 mg per mL; INJ (vial): 25 mg per 0.5 mL, 25 mg per mL
rheumatoid arthritis, moderate-severe
- [50 mg SC qwk]
- Alt: 25 mg SC 2x/wk 72-96h apart
psoriatic arthritis
- [50 mg SC qwk]
- Alt: 25 mg SC 2x/wk 72-96h apart
ankylosing spondylitis
- [50 mg SC qwk]
- Alt: 25 mg SC 2x/wk 72-96h apart
psoriasis, moderate-severe chronic plaque
- [50 mg SC qwk]
- Start: 50 mg SC 2x/wk x3mo; Alt: 25 mg SC 2x/wk 72-96h apart
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (SureClick auto-injector): 50 mg; INJ (Mini cartridge): 50 mg; INJ (pre-filled syringe): 25 mg per 0.5 mL, 50 mg per mL; INJ (vial): 25 mg per 0.5 mL, 25 mg per mL
polyarticular juvenile idiopathic arthritis, moderate-severe
- [2-17 yo, <63 kg]
- Dose: 0.8 mg/kg/dose SC qwk; Max: 50 mg/wk; Alt: 0.4 mg/kg/dose SC 2x/wk 72-96h apart
- [2-17 yo, >63 kg]
- Dose: 50 mg SC qwk; Alt: 25 mg SC 2x/wk 72-96h apart
psoriasis, moderate-severe chronic plaque
- [4-17 yo, <63 kg]
- Dose: 0.8 mg/kg/dose SC qwk; Max: 50 mg/wk; Alt: 0.4 mg/kg/dose SC 2x/wk 72-96h apart
- [4-17 yo, >63 kg]
- Dose: 50 mg SC qwk; Alt: 25 mg SC 2x/wk 72-96h apart
psoriatic arthritis
- [2-17 yo, <63 kg]
- Dose: 0.8 mg/kg/dose SC qwk; Max: 50 mg/wk; Alt: 0.4 mg/kg/dose SC 2x/wk 72-96h apart
- [2-17 yo, >63 kg]
- Dose: 50 mg SC qwk; Alt: 25 mg SC 2x/wk 72-96h apart
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: patients >65 yo
- caution: diabetes mellitus, uncontrolled
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: residents of area with endemic TB
- caution: residents of area with endemic mycosis
- caution: travelers in area with endemic TB
- caution: travelers in area with endemic mycosis
- caution: HBV infection
- caution: HBV infection history
- caution: alcoholic hepatitis, moderate-severe
- caution: malignancy history
- caution: malignancy risk
- caution: CHF
- caution: demyelinating disease
- caution: myelosuppression
- caution: myelosuppression history
Drug Interactions .
Overview
etanercept
TNF blocker
- cardiotoxic effects
- immunomodulatory effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- infection, severe
- opportunistic infection
- tuberculosis
- HBV reactivation
- malignancy
- lymphoma
- leukemia
- skin CA
- hypersensitivity reaction
- anaphylaxis
- skin reaction, severe
- CHF
- neurologic disorders
- optic neuritis
- myelosuppression
- lupus-like syndrome
- hepatitis, autoimmune
- vasculitis
- sarcoidosis
- interstitial lung disease
- glomerulonephritis
Common Reactions
- infection
- URI
- injection site reaction
- diarrhea
- rash
- pruritus
- fever
- urticaria
Safety/Monitoring .
Monitoring Parameters
hepatitis B serology including HBsAg at baseline; TB test at baseline, then periodically; active TB signs/symptoms; dermatologic exams, especially if incr. skin CA risk
Look/Sound-Alike Drug Names
Enbrel confused with: Elavil; Levbid
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of teratogenicity not expected based on conflicting human data; no known risk of fetal harm based on animal data at 48-58x systemic exposure; for infants exposed to etanercept in utero, weigh risk/benefit before administering live vaccines
Lactation
Clinical Summary
may use while breastfeeding; no known risk of infant harm based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for etanercept: unknown; CYP450: unknown
Excretion: for etanercept: unknown; Half-life: 102h
Subclass: DMARDs, Tumor Necrosis Factor (TNF) Inhibitors ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
for etanercept: binds and inhibits tumor necrosis factor, reducing inflammation and altering immune response
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Amgen, Inc. and Pfizer Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
subcutaneous solution:
- 50 mg (1 carton, 4 sureclicks): $5,975.00
subcutaneous kit:
- 25 mg (1 carton, 4 vials): $2,987.00
subcutaneous solution:
- 50 mg (1 carton, 4 mini cartridges): $6,097.00
subcutaneous solution:
- 25 mg (2 carton, 4 syringes): $6,084.00
- 50 mg (1 carton, 4 syringes): $5,975.00
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