Classes
DEA Class; Rx
Common Brand Names; Fuzeon
- HIV, Fusion Inhibitors
Description
Fusion inhibitor
For use with other antiretroviral agents to treat antiretroviral-experienced patients with evidence of ongoing viral replication
98% of patients develop injection site reactions
Indications
Indicated for the treatment of advanced human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV replication despite ongoing antiretroviral therapy.
Contraindications
Hypersensitivity
Adverse Effects
- Difficult to separate from background regimen
- Multiple inj site rxn (98%)
- Pain & discomfort (96%)
- Erythema (91%)
- Induration (90%)
- Nodules and cysts (80%)
- Pruritis (65%)
- Ecchymosis (52%)
- Diarrhea (31%)
- Nausea (22%)
- Fatigue (20%)
- Periph. neuropathy
- Insomnia
- 1-10%
- Difficult to separate from background regimen
- Asthenia
- Depression
- Pruritis
- Abdominal pain
- Anorexia
- Decreased appetite
- Weight loss
- Myalgia
- Cough
- Herpes simplex
- Influenza-like illness
- Pneumonia
- Sinusitis
- Lymphadenopathy
- Pancreatitis
Warnings
Use only in combination with other antiretrovirals
Each injection should be in a different site than the previous one (upper arm, anterior thigh, abdomen)
Monitor for signs and symptoms of pneumonia
Low initial CD4+ T-cell count and high initial viral load
Pulmonary disease, smoking
If pt becomes pregnant, call Antiretroviral Pregnancy Registry 1-800-258-4263
The possibility exists that this drug could result in a false-positive HIV test using (ELISA); use of a confirmatory test (Western blot) is advised
Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; patients may develop an inflammatory response to indolent or residual opportunistic infection
Pregnancy and Lactation
Pregnancy Category: B
Lactation: Unknown whether enfuvirtide is excreted in milk; avoid in breastfeeding women; the CDC advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV
Maximum Dosage
180 mg/day subcutaneously.
180 mg/day subcutaneously.
4 mg/kg/day (Max: 180 mg/day) subcutaneously.
weight 11 kg or more: 4 mg/kg/day (Max: 180 mg/day) subcutaneously.
weight less than 11 kg: Safety and efficacy have not been established.
weight 11 kg or more: 4 mg/kg/day subcutaneously.
weight less than 11 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Enfuvirtide
injection, powder for reconstitution
- 90mg/mL (reconstituted)
- NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL
