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Safety

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Aptivus (tipranavir) Capsules and Oral Solution


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Drug Interactions
    • Table 1
      • Sedative/hypnotics

WARNINGS AND PRECAUTIONS

  • Effects on Platelet Aggregation and Coagulation
  • Vitamin E Intake
  • Rash

ADVERSE REACTIONS

  • Clinical Trials in Pediatric Patients (new subsection)

DRUG INTERACTIONS

  • Potential for Aptivus/ritonavir to Affect Other Drugs
    • ...Aptivus oral solution co-administered with ritonavir capsules demonstrated similar effects as Aptivus capsules co-administrated with ritonavir...
  • Potential for Other Drugs to Affect Tipranavir
    • Table 4
      • Benzodiazepines:
        Parenterally administered midazolam

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

PATIENT COUNSELING INFORMATION

  • Use of Vitamin E (new subsection)
  • Administration
    • ...Aptivus can be taken with or without food.

PATIENT PACKAGE INSERT

  • Who should not take Aptivus?
    • Do not take Aptivus if you take...
      • Versed (midazolam) orally
  • Tell your healthcare professional...
    • If you are taking Aptivus oral solution, which contains vitamin E, you should not take additional vitamin E...
  • How should I take Aptivus?
  • What are the possible side effects of Aptivus?
    • ...Rash was seen more frequently in children.
  • How should I store Aptivus?

CONTRAINDICATIONS

Drug Interactions: Oral midazolam

WARNINGS AND PRECAUTIONS

Effect on Platelet Aggregation and Coagulation

...In rats, tipranavir treatment alone induced dose-dependent changes in coagulation parameters, bleeding events and death. Co-administration with vitamin E significantly increased these effects [see Nonclinical Toxicology (13.2)]. However, analyses of stored plasma from adult patients treated with Aptivus capsules and pediatric patients treated with Aptivus oral solution (which contains a vitamin E derivative) showed no effect of Aptivus/ritonavir on vitamin K-dependent coagulation factors (Factor II and Factor VII), Factor V, or on prothrombin or activated partial thromboplastin times...

Vitamin E Intake

Patients taking Aptivus oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as Aptivus oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).

Rash

...In the pediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was 21%. Overall, most of the pediatric patients had mild rash and 5 (5%) had moderate rash. Overall 3% of pediatric patients interrupted Aptivus treatment due to rash and the discontinuation rate for rash in pediatric patients was 0.9%...
    
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