New Colcrys dosing when administered with protease inhibitors

URL Pharma, Inc., today announced that the FDA has issued new label information affecting all approved protease inhibitors for treatment of HIV when co-administered with Colcrys (colchicine).  These dosing guidelines are intended to avoid potentially fatal drug-drug interactions.

Several clinical studies designed and conducted by URL Pharma uncovered the risk of serious interactions when colchicine is taken along with certain other prescription medications. In addition to protease inhibitors, the URL Pharma studies discovered potentially dangerous interactions between colchicine and certain hypertension medications and antibiotics. URL Pharma conducted 17 clinical trials as part of its submissions to the FDA in the 3 New Drug Applications (NDAs) filed for Colcrys.

The new dosing adjustment covers all approved protease inhibitors for the treatment of HIV-1 infection, including Lexiva® (fosamprenavir calcium) and ritonavir.

• Patients with hepatic or renal impairment: For the prevention or treatment of gout flares, or for FMF, FDA has recommended against the co-administration of Colcrys with protease inhibitors.
• Acute gout flares: The new recommended dosing for the treatment of gout flares is 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later; this dose to be repeated no earlier than 3 days. 
• For patients taking Lexiva without ritonavir, the suggested dose is 1.2 mg (2 tablets) x 1 dose; this dose is to be repeated no earlier than 3 days.
• Prophylaxis of Gout Flares: In patients taking Colcrys for the prophylaxis of gout flares, FDA recommends that 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. 
• In patients taking Lexiva without ritonavir, FDA recommends that if the original Colcrys 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. However, if the original Colcrys regimen was 0.6 mg once a day, FDA recommends it be adjusted to 0.3 mg once a day.
• Familial Mediterranean fever (FMF): In patients with FMF, FDA recommends a maximum daily dose of Colcrys of 0.6 mg (may be given as 0.3 mg twice a day) when co-administered with protease inhibitors.
• However, in FMF patients taking Lexiva without ritonavir, the maximum daily dose of Colcrys is recommended to be no more than 1.2 mg (may be given as 0.6 mg twice a day).

For more information call (888) 351-3786 or visit www.urlpharma.com.