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Amprenavir (Agenerase®) Oral Solution: Warning for Some Patients

May 5, 2000

Recently Glaxo Wellcome issued a warning that some patients may be at risk from the liquid form of the drug amprenavir (Agenerase®), because they might not be able to metabolize the large amount of propylene glycol which is used to dissolve the drug in the liquid. This warning does not apply to the capsule form of the medication.

The following has been added to the boxed warning in the official labeling for the liquid form of this drug:

"Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase® Oral Solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic or renal failure, and patients treated with disulfiram or metronidazole (see Contraindications and Warnings).

"Agenerase® Oral Solution should be used only when Agenerase® Capsules or other protease inhibitor formulations are not therapeutic options."

The Warnings section repeats the above and includes additional information:

"Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase® Oral Solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic or renal failure, and patients treated with disulfiram or metronidazole (see Clinical Pharmacology, Contraindications and Precautions).

"Because of the possible toxicity associated with large amounts of propylene glycol and the lack of information on chronic exposure to large amounts of propylene glycol, Agenerase® Oral Solution should be used only when Agenerase® Capsules or other protease inhibitor formulations are not therapeutic options. Certain ethnic populations (Asians, Eskimos, Native Americans) and women may be at increased risk of propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol; no data are available on propylene glycol metabolism in these groups (see Clinical Pharmacology: Special Populations: Gender and Race).

"If patients require treatment with Agenerase® Oral Solution, they should be monitored closely for propylene glycol-associated adverse events, including seizures, stupor, tachycardia, hyperosmolality, lactic acidosis, renal toxicity, and hemolysis. Patients should be switched from Agenerase® Oral Solution to Agenerase® Capsules as soon as they are able to take the capsule formulation.

"Use of alcoholic beverages is not recommended in patients treated with Agenerase® Oral Solution."

Notes:

* There are other changes in the labeling as well; the quotes above address the most important warnings, but are not a complete list.

* According to Glaxo Wellcome, the company has not received any reports of death or serious injury attributed to the propylene glycol in this drug.



ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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