MED ALERT

Serious and/or life-threatening drug interactions could occur with co-administration between amprenavir and several medications such as tricyclic antidepressants and quinidine. Review the current package insert for updated information.

Labeling Changes





	Agenerase Made By GlaxoSmithKline Capsules: Product Information

	Oral Solution: Use with caution due to propylene glycol content. This formulation is contraindicated in children below the age of four. Product Information

	FDA Agenerase Patient Information

	Agenerase And Nutrition

	Ampenavir (Agenerase) Fact Sheet

Agenerase has a significant amount of Vitamin E to improve it's bioavailability. Product information notes that each capsule contains 109 IU of vitamin E. Therefore, taking Agenerase as prescribed, the dose of vitamin E for the adult is 1,744 IU per day. The maximum pediatric dose has extremely high levels (up to 8,600 IU per day).

Although patients may not absorb all of the vitamin E, this extremely high dose can exacerbate a vitamin K deficiency or bleeding from Coumadin.

Even though the package insert holds information on the vitamin E content of the drug there's no way to know if people are reading this information. The implications of this blood thinning dose could be life threatening to those already on blood thinners. Doctors should now be advising patients to stop taking additional vitamin E if they are also taking this drug. Glaxo Wellcome product promotions note that patients should not take vitamin E with the drug but fall short of telling them that it is a blood thinner. For those patients on the blood thinner Coumadin it is questionable whether a lower dose could be given.

Glaxo Wellcome is reportedly evaluating the safety of chronic, high-dose vitamin E administration in adults and children receiving Agenerase long-term (48 weeks to two years). Cabrini Medical Center in New York has
reported an incident of intracranial bleed with Coumadin and Agenerase to the FDA MedWatch program. Other adverse events are bound to occur and be reported as more clinicians become aware of this drug's actions within
the body and with other substances.


This MedAlert is From:
*HIV ReSource Review* Volume 4 Issue 1 July/Aug 1999

Clinicians should telephone Glaxo Wellcome at
888/825 5249 to ask for updated information on Agenerase.

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Updated 9/24/2003