Higher Nelfinavir Dose Available
A 625 mg formulation of the protease inhibitor nelfinavir mesylate (Viracept) by Agouron Pharmaceuticals (San Diego, Calif.) is now approved, decreasing the number of required nelfinavir pills for each twice-daily dosage from five tablets to two tablets.
Nelfinavir is indicated for the treatment of HIV infection and should be used in combination with other antiretroviral agents.
The recommended dosage of nelfinavir is 1,250 mg (two 625 mg tablets or five 250 mg tablets) twice daily, or 750 mg (3 250 mg tablets) three times daily. Nelfinavir should be taken with food to enhance blood levels.
According to clinical studies, the 625 mg tablet showed greater bioavailability than the 250 mg dose under fasting and fed conditions.
Nelfinavir is generally well tolerated. The most frequently reported adverse effect among patients is diarrhea.
New Myeloma Treatment Approved
The FDA approved a new treatment for multiple myeloma, Millennium Pharmaceuticals' (Cambridge, Mass.) bortezomib (Velcade) injection. Approved under the FDA's accelerated approval program, this drug is the first in a new class of anticancer medications called proteasome inhibitors.
Bortezomib is indicated for patients whose multiple myeloma has relapsed after two prior treatments and who have demonstrated resistance to their last treatment. Its approval was based on data from a safety and efficacy study of 202 patients who had received at least two prior therapies and demonstrated disease progression on their most recent therapy. Of the 188 patients who were evaluated for a response, 28% showed a response to bortezomib.
This response lasted for a median time of 1 year. Another trial with 54 patients with relapsed multiple myeloma showed similar responses.
Currently, there are no controlled trials of bortezomib demonstrating clinical benefit, but the manufacturer is performing postapproval studies.
The most commonly reported side effects associated with bortezomib treatment include nausea, fatigue, diarrhea, constipation and headache.