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Enfuvirtide

    Brands

    DEA Class; Rx

    Common Brand Names; Fuzeon

    •  HIV, Fusion Inhibitors

    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

    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.

     

    Hypersensitivity

    • 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

    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 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

    Adults

    180 mg/day subcutaneously.

    Geriatric

    180 mg/day subcutaneously.

    Adolescents

    4 mg/kg/day (Max: 180 mg/day) subcutaneously.

    Children

    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.

    Infants

    weight 11 kg or more: 4 mg/kg/day subcutaneously.
    weight less than 11 kg: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Enfuvirtide 

    injection, powder for reconstitution

    • 90mg/mL (reconstituted)
    • NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL