FDA Notifications

FDA approves new dosing for Kaletra

On April 27, 2010, FDA approved a new dosing regimen for lopinavir/ritonavir (Kaletra®) tablets and oral solution.

Lopinavir/ritonavir can be administered once daily (800/200 mg) in patients with less than three lopinavir resistance associated substitutions. Once daily administration of lopinavir/ritonavir is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V. Of note, once daily administration of Kaletra is not recommended in pediatric patients.

The complete revised label will be posted soon at http://www.accessdata.fda.gov/scripts.

PIs have new drug-drug interaction language

The approved protease inhibitors for the treatment of HIV-1 infection now all include the following drug-drug interaction information, according to the U.S. Food and Drug Administration:

  • Sildenafil (Revatio®) as a contraindicated medication when prescribed for the treatment of pulmonary arterial hypertension.
  • alfuzosin (Uroxatral®) as a contraindicated medication.
  • Recommendation that salmeterol (brand names are Advair® and Serevent®) should not be coadministered.
  • New dosing recommendation for bosentan (Tracleer®) and tadalafil (Adcirca®) when prescribed for the treatment of pulmonary arterial hypertension. Note, coadministration of bosentan and atazanavir (Reyataz®) 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:

Colchicine:

Treatment of gout flares: 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Dose to be repeated no earlier than 3 days.

Note: Fosamprenavir (Lexiva®) without ritonavir: 1.2 mg (2 tablets) x 1 dose. Dose to be repeated no earlier than 3 days.

Prophylaxis of gout-flares: If the original colchicine regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once a day. If the original colchicine regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day.

Note: Lexiva without ritonavir: if the original regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg twice a day or 0.6 mg once a day. If the original regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once a day.

Treatment of familial Mediterranean fever (FMF): Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day).

Note: Lexiva without ritonavir: maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day).