FDA safety updates to antiretroviral labels

The following summaries cover revisions to the US drug labels that were recently approved by the FDA in the US. Please check the full update for details.

Revised label are posted to the FDA website:

Maraviroc in patients with renal impairment

On 27 May 2010, the FDA approved changes to the labeling for maraviroc (Celsentri/Selzentry) 150 mg and 300 mg tablets to include:

  • Dosing recommendations for patients with renal impairment,
  • A contraindication for patients with severe renal impairment or end-stage renal disease,
  • A warning regarding postural hypotension for renal impaired patients,
  • New pharmacokinetics information related to renal impairment.

Saquinavir increases QT interval prolongation

Recently the FDA-mandated all manufacturers of protease inhibitors to investigate whether there were any signals for concern for QT interval prolongation with the licensed drugs in this class. The safety study by Roche in HIV-negative volunteers that showed that ritonavir-boosted saquinavir (Invirase) had a greater effect on QT interval prolongation than a control group.

This will results in a label change in both the US and Europe.

Roche will issue a  “Dear Healthcare Provider” letter to inform healthcare professionals that:

  • Saquinavir is contraindicated in patients with congenital or acquired QT prolongation or other predisposing conditions for cardiac arrhythmias, including concurrent therapy with other drugs that prolong the QT and/or PR interval.
  • The combination of saquinavir with drugs known to increase the plasma level of saquinavir is not recommended and should be avoided when alternative treatment options are available.
  • Saquinavir should be discontinued in case of arrhythmias, QT or PR prolongation.

Links to other websites are current at date of posting but not maintained.