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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:
Below is an example of the new dosing recommendations for protease inhibitors and the following concomitant medications:
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).