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U.S. Department of Health and Human Services

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 and February 2012

 

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.


 

February 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
 

DRUG INTERACTION

Potential for Aptivus/ritonavir to Affect Other Drugs
Established and Other Potentially Significant Drug Interactions: Alterations in
Dose or Regimen May be Recommended Based on Drug Interaction Studies or
Predicted Interaction (Table)
  • HMG-CoA Reductase Inhibitors: Atorvastatin, Rosuvastatin: Avoid co-administration with atorvastatin.
 

PATIENT COUNSELING INFORMATION

Administration
  • Aptivus is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Aptivus.
  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades…
 

Patient Information:

Does Aptivus cure HIV or AIDS?
  • Aptivus does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Aptivus.
  • Avoid doing things that can spread HIV-1 infection.
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood…
Who should not take Aptivus?
Do not take Aptivus if you:
  • take any of the following types of medicines because you could have serious side effects: Lipitor (atorvastatin)
What should I tell my healthcare professional before I take Aptivus?
Tell your healthcare professional about all of your medical conditions, including if you:
  • are breast-feeding. Do not breastfeed.It is not known if Aptivus can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

 

June 2008

Summary View

 

Sections ModifiedSummary 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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