Monograph Details

Infections & Infestations > Viral infections
FUZEON
Manufacturer
Roche Laboratories
Legal Classification
Rx
Pharmacological Class
Fusion inhibitor.
Generic Name
Enfuvirtide 90mg/mL; pwd for SC inj after reconstitution; preservative-free.
Indications
Treatment of HIV-1 infection, in combination with other antiretroviral agents, in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Children
6–16yrs: limited data available; doses of 2mg/kg (max 90mg) twice daily have been used.
Adults
Give by SC inj into upper arm, anterior thigh, or abdomen (not into moles, scar tissue, bruises, or navel). ≥16yrs: 90mg twice daily. Rotate inj sites.
Precautions
Discontinue if hypersensitivity occurs; do not rechallenge. Monitor for pneumonia (esp. if low initial CD4 cell count, high initial viral load, or smoker). Renal insufficiency (CrCl <35mL/min). Supervise 1st dose. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions
May cause false (+) ELISA test for HIV.
Adverse Reactions
Inj site reactions, diarrhea, nausea, fatigue, insomnia, infections (eg, bacterial pneumonia), peripheral neuropathy, pancreatitis, hypersensitivity reactions (eg, rash, fever, GI upset, elevated ALT/AST, eosinophilia), lab abnormalities (eg, elevated amylase).
Extra Text
Note: Register pregnant patients exposed to enfuvirtide by calling (800) 258-4263.
How Supplied
Kit—1 (60 vials w. supplies)
Additional Resources
Related Prescribing Note