Generic Name and Formulations:
Nelfinavir (as mesylate) 250mg, 625mg; tabs.

Company:
ViiV Healthcare
Indications for VIRACEPT:
HIV infection.

Adults and Children:
Take with food. May dissolve tab and mix in small amount of water; powder may be mixed with a small amount of non-acidic food or beverage. <2yrs: not recommended. 2–<13yrs: 45–55mg/kg twice daily or 25–35mg/kg 3 times daily; max 2.5g/day. ≥13yrs: 1.25g twice daily or 750mg 3 times daily. Reduce concomitant rifabutin dose by ½ and give nelfinavir 1.25g twice daily.

Contraindications:
CYP3A substrates that may cause serious events if blood levels are elevated (eg, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, ergots, amiodarone, quinidine, alfuzosin, rifampin, St. John's wort, sildenafil [Revatio; when used to treat PAH]).

Warnings/Precautions:
Moderate or severe hepatic impairment. Diabetes. Monitor for hyperglycemia, fat redistribution, or immune reconstitution syndrome, hemophiliacs for spontaneous bleeding. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
See Contraindications. Salmeterol: not recommended. Potentiates CYP3A substrates (eg, dihydropyridine calcium channel blockers, cyclosporine, tacrolimus, sirolimus, rifabutin, rosuvastatin, atorvastatin [use lowest dose necessary; max atorvastatin dose is 40mg/day]), PDE5 inhibitors (adjust dose: see full labeling), phenytoin (monitor). Potentiates fluticasone (caution and consider alternatives w. long-term use), trazodone (use lower dose), bosentan, colchicine (adjust dose: see full labeling). Nelfinavir levels decreased by CYP3A inducers (eg, phenytoin, carbamazepine, phenobarbital), omeprazole or CYP2C19 inducers. Nelfinavir levels increased by CYP3A or CYP2C19 inhibitors. Antagonizes methadone, oral contraceptives (use additional or alternative contraception). Indinavir, ritonavir, saquinavir increase nelfinavir levels. Concomitant azithromycin: monitor for azithromycin toxicity (eg, elevated liver enzymes). Administer didanosine 1hr before or 2hrs after nelfinavir. Monitor INR with warfarin. Others: see full labeling.

See Also:
VIRACEPT ORAL POWDER

Pharmacological Class:
HIV-1 protease inhibitor.

Adverse Reactions:
Diarrhea, nausea, flatulence, abdominal pain, rash, redistribution of body fat; diabetes, hyperglycemia, immune reconstitution syndrome.

Note:
Register pregnant patients exposed to nelfinavir by calling (800) 258-4263.

How Supplied:
Tabs 250mg—300; 625mg—120; Oral Pwd—144g