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Label Changes for:

Aptivus (tipranavir) 250 mg capsules and 100 mg/mL oral solution

June 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009


Table 4 Updated
  • Fusion Inhibitors: Enfuvirtide- AT steady state, tipranavir trough concentrations were approximately 45% higher in patients co-administered enfuvirtide in the Phase 3 trials.  The mechanism for this increase is not known.  Dose adjustments are not recommended.
  • Calcium Channel Blockers- Caution is warranted and clinical monitoring of patient is recommended.
  • Buprenorphine/naloxone- Aptivus/ritonovir did not result in changes in the clinical efficacy of buprenorphine/naloxone.  Compared to historical controls tipranavir Cmin was decreased approximately 40 % with this combination.  Dose adjustments can not be recommended.