Generic Viracept

NELFINAVIR MESYLATE
Tablets: 250 mg (Rx) Viracept (Agouron)
Powder: 50 mg/g (Rx)

Warning:
Nelfinavir is indicated for the treatment of human immunodeficiency virus (HIV) infection when antiretroviral therapy is warranted. At present, there are no results from controlled trials evaluating the effect of therapy with nelfinavir on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections.

Indications
HIV: For the treatment of HIV infection when antiretroviral therapy is warranted.

Administration and Dosage
Take with a meal or light snack.
Adults: The recommended dose is 750 mg (three 250 mg tablets) 3 times daily in combination with nucleoside analogs (antiretroviral activity is enhanced).
Oral powder - The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplement; once mixed, the entire contents must be consumed in order to obtain the full dose. Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended because of bitter taste. Do not reconstitute with water in its original container. Once mixed, store the oral powder for < 6 hours.

Actions
Pharmacology: Nelfinavir is an inhibitor of the HIV-1 protease. Inhibition of the viral protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, noninfectious virus.
Pharmacokinetics:
Absorption - After single and multiple oral doses of 500 to 750 mg with food, peak nelfinavir plasma concentrations were typically achieved in 2 to 4 hours. After multiple dosing with 750 mg 3 times daily for 28 days (steady-state), peak plasma concentrations averaged 3 to 4 mcg/mL and plasma concentrations prior to the morning dose were 1 to 3 mcg/mL.
Distribution - The apparent volume of distribution following oral administration of nelfinavir was 2 to 7 L/kg. Nelfinavir in serum is extensively protein-bound (>98%).
Metabolism - Unchanged nelfinavir comprised 82% to 86% of the total plasma. In vitro multiple cytochrome P450 isoforms including CYP3A are responsible for metabolism of nelfinavir. One major and several minor oxidative metabolites were found in plasma. The major oxidative metabolite has in vitro antiviral activity comparable with the parent drug.
Excretion - The terminal half-life in plasma was typically 3.5 to 5 hours. The majority (87%) of an oral 750 mg dose was recovered in the feces, which consisted of numerous oxidative metabolites (78%) and unchanged nelfinavir (22%). Only 1% to 2% of the dose was recovered in the urine, of which unchanged nelfinavir was the major component.

Contraindications
Hypersensitivity to any components of the product; concurrent administration with astemizole, cisapride, rifampin, triazolam or midazolam.

Warnings
Hepatic function impairment: Exercise caution when administering this drug to patients with hepatic impairment.
Pregnancy: Category B.
Lactation: The US Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. It is not known whether nelfinavir is excreted in breast milk.
Children: A similar adverse event profile was seen during the pediatric clinical trial as in adult patients. The evaluation of the antiviral activity of nelfinavir in pediatric patients is ongoing.
The safety, efficacy, and pharmacokinetics of nelfinavir have not been evaluated in pediatric patients < 2 years of age.

Precautions
Resistance/Cross-resistance. It is unknown what effect nelfinavir therapy will have on the activity of subsequently administered protease inhibitors.

Drug Interactions
Drugs that may affect nelfinavir include anticonvulsants, indinavir, ketoconazole, rifabutin, rifampin, ritonavir, and saquinavir
Drugs that may be affected by nelfinavir include indinavir, rifabutin, saquinavir, non-sedating antihistamines, didanosine, oral contraceptives, zidovudine, and lamivudine.
Drag/Food interactions: Maximum plasma concentrations and AUC were 2- to 3-fold higher under fed conditions compared with fasting.

Adverse Reactions
Adverse effects occurring in > 3% of patients include diarrhea, nausea, flatulence, and hematologic abnormalities.
HIV

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