2 to 18 years) the most frequent adverse reactions were generally similar to those seen in adults. However, rash was more frequent in pediatric patients than in adults. (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of APTIVUS can alter the concentrations of other drugs and other drugs may alter the concentration of tipranavir. The potential for drug-drug interactions must be considered prior to and during therapy. (4.2, 5.3, 7)
USE IN SPECIFIC POPULATIONS
The risk-benefit has not been established in pediatric patients <2 years of age (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 05/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Adults
2.2 Pediatric Patients (age 2 to 18 years)
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hepatic Impairment
4.2 Drug Interactions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatic Impairment and Toxicity
5.2 Intracranial Hemorrhage
5.3 Drug Interactions
5.4 Effects on Platelet Aggregation and Coagulation
5.5 Vitamin E Intake
5.6 Rash
5.7 Sulfa Allergy
5.8 Diabetes Mellitus/Hyperglycemia
5.9 Immune Reconstitution Syndrome
5.10 Fat Redistribution
5.11 Elevated Lipids
5.12 Patients with Hemophilia
5.13 Resistance/Cross Resistance
6 ADVERSE REACTIONS
6.1 Clinical Trials in Adults
6.2 Clinical Trials in Pediatric Patients
7 DRUG INTERACTIONS
7.1 Potential for APTIVUS/ritonavir to Affect Other Drugs
7.2 Potential for Other Drugs to Affect Tipranavir
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Adult Patients
14.2 Pediatric Patients
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hepatic Impairment and Toxicity
17.2 Intracranial Hemorrhage
17.3 Drug Interactions
