HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use APTIVUS safely and effectively. See full prescribing information for APTIVUS.
APTIVUS® (tipranavir) capsules
APTIVUS® (tipranavir) oral solution
Initial U.S. Approval: 2005
WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE
See full prescribing information for complete boxed warning.
Clinical hepatitis and hepatic decompensation including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. (5.1)
Fatal and non-fatal intracranial hemorrhage (5.2)

RECENT MAJOR CHANGES
Dosage and Administration (2) 5/2010
Contraindications, Drug Interactions (4.2) 4/2010
Warnings and Precautions, Drug Interactions (5.3) 4/2010
INDICATIONS AND USAGE
APTIVUS, a protease inhibitor, co-administered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor (1)
Do not use APTIVUS/ritonavir in treatment-naïve patients (1)
DOSAGE AND ADMINISTRATION
Adults: 500 mg APTIVUS, co-administered with 200 mg ritonavir, twice daily (2.1)
Pediatric patients (age 2 to 18 years): Dosing is based on body weight or body surface area not to exceed adult dose (2.2)
APTIVUS taken with ritonavir capsules or solution can be taken with or without meals (2)
APTIVUS taken with ritonavir tablets must be taken with meals (2)
Store unopened bottles of APTIVUS capsules in the refrigerator (16)
Do not freeze or refrigerate APTIVUS oral solution (16)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg (3)
Oral solution: 100 mg/mL (3)
CONTRAINDICATIONS
Patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (4.1, 5.1)
Use with drugs highly dependent on CYP 3A for clearance or are potent CYP 3A inducers (4.2, 5.3, 7)
WARNINGS AND PRECAUTIONS
Hepatic Impairment: Discontinue for signs and symptoms of clinical hepatitis or asymptomatic increases in ALT/AST >10 times ULN or asymptomatic increases in ALT/AST 5-10 times ULN with concomitant increases in total bilirubin. Monitor liver function tests prior to therapy and frequently thereafter. (5.1)
Intracranial Hemorrhage/Platelet Aggregation and Coagulation: Use with caution in patients at risk for increased bleeding or who are receiving medications that increase the risk of bleeding (5.2, 5.4)
Drug Interactions: Consider drug-drug interaction potential to reduce risk of serious or life-threatening adverse reactions (5.3)
Rash: Discontinue and initiate appropriate treatment if severe skin reaction occurs or is suspected. (5.6) Use with caution in patients with a known sulfonamide allergy. (5.7)
Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia (5.8), immune reconstitution syndrome (5.9), redistribution/accumulation of body fat (5.10), and elevated lipids. (5.11) Monitor cholesterol and triglycerides prior to therapy and periodically thereafter
Hemophilia: Spontaneous bleeding may occur, and additional factor VIII may be required (5.12)
ADVERSE REACTIONS
In adults the most frequent adverse reactions (incidence >4%) were diarrhea, nausea, pyrexia, vomiting, fatigue, headache, and abdominal pain (6.1)
In pediatric patients (age