Drug Criteria & Outcomes: New FDA Approvals

These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):

New administration of peginterferon alfa-2a (Pegasys) by Roche. The FDA has approved pre-filled syringes of peginterferon alfa-2a (Pegasys) for the treatment of chronic hepatitis C.

Peginterferon alfa-2a, a pegylated alpha interferon, and ribavirin (Copegus) were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.

Pre-filled syringes will be packaged four per box. Pegasys currently is available in vials as a pre-mixed solution.

Pegasys is dosed at 180 mcg as a subcutaneous injection taken once a week. Copegus is available as a 200 mg tablet, and is administered orally two times a day as a split dose.

New indication for oxaliplatin for injection (Eloxatin) by Sanofi-Synthelabo. The FDA has approved oxaliplatin for injection (Eloxatin) in combination with 5FU/LV for the first-line treatment of advanced colorectal cancer. Oxaliplatin was approved in August 2002 for second-line treatment of patients with metastatic carcinoma of the colon or rectum in the United States.

Clinical data show that patients with advanced colorectal cancer treated with oxaliplatin given in combination with 5-FU/LV as first-line chemotherapy had a statistically significant improvement of nearly five months in median survival time compared to patients treated with a standard treatment of irinotecan in combination with 5-FU/LV.

New dosing strategy for saquinavir mesylate 1,000 mg (Invirase) by Roche. The FDA has approved protease inhibitor saquinavir mesylate 1,000 mg (Invirase) for use with ritonavir (100 mg) in combination regimens for the treatment of HIV infection. This new dosing strategy increases blood levels of saquinavir to enable twice-daily dosing and eliminates the inadequate drug levels associated with use of saquinavir mesylate alone.

The FDA-approved dosing is 1,000 mg of saquinavir mesylate (5 x 200 mg capsules) in combination with ritonavir 100 mg, twice a day. Ritonavir should be taken at the same time as saquinavir mesylate. Saquinavir mesylate and ritonavir should be taken within two hours after a meal.

Coadministration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with pre-existing liver disease. Therefore, saquinavir mesylate, when administered with ritonavir, is contraindicated in patients with severe hepatic impairment.

Amlodipine besylate/atorvastatin calcium (Caduet) by Pfizer. The FDA has approved the dual-therapy medicine amlodipine besylate/ atorvastatin calcium (Caduet) for the simultaneous treatment of high blood pressure and high cholesterol.

Caduet is the first medicine to treat two different conditions — high blood pressure and high cholesterol — in one pill. It contains both amlodipine besylate (Norvasc) for the treatment of high blood pressure and atorvastatin calcium (Lipitor) for high cholesterol.

Amlodipine besylate/atorvastatin calcium was well tolerated by patients in clinical trials and has been administered with a variety of antihypertensive medications, including thiazide diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors. The most common side effects reported by amlodipine besylate/atorvastatin calcium patients were fluid retention, headache, dizziness, abdominal pain, and weakness, and were characterized as mild to moderate.

The dual-therapy drug is contraindicated in patients with hypersensitivity to any component of this medication; in patients with active liver disease or unexplained persistent elevations of serum transaminases; and in nursing or pregnant women. With any statin, promptly report muscle pain, tenderness, or weakness, as it could be a sign of serious side effects.