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Label Changes for:

Invirase (saquinavir mesylate) capsules and tablets

April 2010

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010


Table 4 Drugs That Are Contraindicated With Invirase/Ritonavir
  • Alpha 1-adrenoreceptor antagonist: alfuzosin; potentially increased alfuzosin concentrations
  • PDE5 Inhibitors: Revatio (sildenafil) [for treatment of pulmonary arterial hypertension] Increased potential for sildenafil-associated adverse events...


Table 5: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction With Invirase/ritonavir
  • Inhaled beta agonist- salmeterol: Concurrent administration of salmeterol with Invirase/ritonavir is not recommended
  • Endothelin receptor antagonists-Bosentan: Coadministration of bosentan in patients on Invirase/ritonavir:In patients who have been receiving Invirase/ritonavir for at least 10 days, start bosentan at 62.5 mg once daily or every other day based upon individual tolerability...
  • Tadalafil: Use of tadalafil for pulmonary arterial hypertension (PAH), the following dose adjustments are recommended for use of Adcirca (tadalafil) with Invirase/ritonavir: Co-administration of Adcirca in patients on Invirase/ritonavir: Start at or adjust Adcirca to 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability....
  • Colchicine: The addition of new dosing recommendations when prescribed for the treatment of familial Mediterranean fever or gout.  Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and the addition of the recommendation that colchicine should not be given with Invirase/ritonavir in patients with hepatic or renal impairment.