Nelfinavir

DEA Class; Rx

Common Brand Names; Viracept

Protease inhibitor
Used for the treatment of HIV-1 infection in combination with other antiretroviral agents
Avoid use of powder formulation in patients with phenylketonuria

Hypersensitivity

Coadministration with major CYP3A4 substrates and/or inducers

Drugs that are contraindicated with nelfinavir include alpha1-adrenoreptor agonists (eg, alfuzosin), antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, quinidine), rifampin, voriconazole, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John’s wort, lovastatin, simvastatin, lurasidone, pimozide, sildenafil (when used for PAH), midazolam, and triazolam

• Diarrhea (14-20%)
• Nausea (3-7%)
• Flatulence (1-5%)
• Abdominal pain (1%)
• Anemia (1%)
• Allergic reaction (1%)
• Impaired concentration (1%)
• Lipodystrophy (1%)
• Metabolic acidosis (1%)
• Rash (1-3%)
• Leukopenia (1%)
• Thrombocytopenia (1%)
• Weakness (1%)
• QTc prolongation
• Torsades de pointes
• Diabetes mellitus, new onset and exacerbation
• Hyperglycemia

Published reports of hepatic adverse events ranging from elevated liver enzymes to hepatic failure in pregnant patients exposed to drug and as part of combination treatment of HIV-1 infection reported; overall adverse event profile, including hepatic adverse events, and literature reports of decreased exposures in second and third trimesters, consider alternative antiretroviral drugs during pregnancy; if drug is used during pregnancy, clinical monitoring recommended

Based on limited published data, drug is present in low levels in human milk, and adverse effects in infants exposed to nelfinavir have been reported; because of potential for HIV-1 transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and the potential for serious adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving therapy