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
DRUG INTERACTIONS
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.
