APTIVUS Rx

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APTIVUS

Viral infections
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Generic Name and Formulations:

Tipranavir 250mg; soft gel caps; contains alcohol.

Select therapeutic use:

Indications for APTIVUS:

Treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor, in combination with ritonavir.

Adult:

Swallow caps whole. Tipranavir 500mg + ritonavir 200mg twice daily.

Children:

<2yrs: not established. Use soln if unable to swallow caps. Calculate dose based on body wt. (kg) or BSA (m2). 2–18yrs: Tipranavir 14mg/kg + ritonavir 6mg/kg (or 375mg/m2 + ritonavir 150mg/m2) twice daily; max tipranavir 500mg + ritonavir 200mg twice daily. May consider reducing dose to tipranavir 12mg/kg + ritonavir 5mg/kg (or 290mg/m2 + ritonavir 115mg/m2) twice daily if intolerance or toxicity occurs provided their virus is not resistant to multiple PIs.

Contraindications:

Moderate-to-severe hepatic insufficiency (Child-Pugh B or C). Concomitant potent CYP3A inducers or substrates (eg, alfuzosin, amiodarone, bepridil, flecainide, propafenone, quinidine, rifampin, ergots, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, lurasidone, sildenafil [Revatio; for PAH], oral midazolam, triazolam).

Warnings/Precautions:

Not for use in treatment-naive patients. Sulfa allergy. Mild hepatic impairment (Child-Pugh A). Increased risk of hepatotoxicity in patients with chronic hepatitis B or C co-infection. Monitor lipids, liver function (baseline and periodically); discontinue if asymptomatic increase in AST/ALT >10xULN, or AST/ALT 5–10xULN and total bilirubin >2.5xULN. Diabetes. Risk of increased bleeding. Hemophilia: monitor for spontaneous bleeding. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Concomitant salmeterol, fluticasone, fosamprenavir, lopinavir, saquinavir, atazanavir, or fluconazole, ketoconazole, itraconazole ≥200mg/day: not recommended. Caps: avoid metronidazole, disulfiram. May be synergistic with enfuvirtide. Potentiates PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil), trazodone, desipramine; reduce dose: see full labeling. Avoid concomitant colchicine if renal or hepatic impairment; otherwise: reduce dose: see full labeling. Reduce rifabutin dose by 75%. Antagonizes estrogens (use non-hormonal contraceptives), methadone, valproic acid, omeprazole. Antagonized by carbamazepine, phenobarbital, phenytoin. Potentiates atorvastatin, rosuvastatin: avoid coadministration. Monitor hypoglycemics, immunosuppressants, tricyclics, SSRIs, warfarin, drugs that affect or are affected by CYP3A4 (eg, azole antifungals, calcium channel blockers, clarithromycin, raltegravir, NRTIs, PIs, statins). Increased risk of bleeding with concomitant anticoagulants, antiplatelet agents, high-dose Vit.E. Separate dosing of didanosine, antacids. Bosentan: adjust dose (see full labeling). Oral soln: avoid high-dose Vit.E supplements.

See Also:

APTIVUS ORAL SOLUTION

Pharmacological Class:

HIV-1 protease inhibitor.

Adverse Reactions:

Diarrhea, nausea, pyrexia, vomiting, fatigue, abdominal pain, headache, rash (discontinue if severe), fat redistribution, severe liver disease, hepatitis (discontinue if symptomatic), hypertriglyceridemia, hyperlipidemia, hyperglycemia, immune reconstitution syndrome, intracranial hemorrhage (may be fatal), others; children: also cough.

Note:

Register pregnant patients exposed to tipranavir by calling (800) 258-4263.

How Supplied:

Caps—120; Soln—95mL (w. dispensing syringe)

APTIVUS 250mg capsules (Qty:120)

appx. price $1557.00