New label information affecting all approved protease inhibitors for treatment of HIV
The approved protease inhibitors for the treatment of HIV-1 infection now all include the following drug-drug interaction information:
- Revatio (sildenafil) as a contraindicated medication when prescribed for the treatment of pulmonary arterial hypertension
- Uroxatral (alfuzosin) as a contraindicated medication
- Recommendation that salmeterol should not be coadministered
- New dosing recommendation for Tracleer (bosentan) and Adcirca (tadalafil) when prescribed for the treatment of pulmonary arterial hypertension. Note, coadministration of bosentan and Reyataz (atazanavir) without ritonavir is not recommended.
- New dosing recommendations for colchicine when prescribed for the treatment of familial Mediterranean fever or gout
- New dosing recommendations for colchicine when prescribed for the prophylaxis of gout
- Recommendation that colchicine should not be coadministered with protease inhibitors in patients with hepatic or renal impairment
Below is an example of the new dosing recommendations for protease inhibitors and the following concomitant medications:
Note: Coadministration of bosentan in patients on Crixivan (indinavir) or Viracept (nelfinavir) or coadministration of indinavir or nelfinavir in patients on bosentan. Start at or adjust bosentan to 62.5 mg once daily or every other day based upon individual tolerability.
Tadalafil (Adcirca): Treatment of pulmonary arterial hypertension Coadministration of Adcirca in patients already on a protease inhibitor for at least one week: Start tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability. Coadministration of protease inhibitor in patients already on tadalafil: Avoid use of tadalafil during initiation of protease inhibitor. Stop tadalafil at least 24 hours prior to starting protease inhibitor. After at least one week following initiation of protease inhibitor, resume tadalafil at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
Note: Coadministration of Adcirca in patients already on nelfinavir or indinavir or coadministration of nelfinavir or indinavir in patients already on Adcirca: Start at or adjust Adcirca to 20 mg daily. Increase to 40 mg once daily based upon individual tolerability. Richard Klein Office of Special Health Issues Food and Drug Administration Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration