MEDICAL INFORMATION FOR HEALTH CARE PROFESSIONALS

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AMPRENAVIR

Other names:  :   141W94, VX-478, Vertex compound

WHY is this medication prescribed ?

Amprenavir belongs to a new class of drugs called the HIV protease inhibitors.   It interferes with a different step in virus reproduction than other drugs previously available to fight HIV.  Amprenavir is an antiretroviral medication that slows down the replication of the human immunodeficiency virus (HIV) and may therefore slow the progression of HIV disease.  Amprenavir does not cure HIV nor does it prevent HIV transmission.  As the effect of amprenavir may decrease with time, it is important that your progress is assessed regularly.  It is not currently known how long the beneficial effects of this medication will last.

HOW should this drug be taken ?

Amprenavir is available in 150mg and 200mg soft gel capsules. The dose most commonly used is 1200mg (6 x 200mg capsules, OR 8 x 150mg capsules) every 12 hours. It is also under study with other protease inhibitors at a dose of 800mg every 8 hours.  It can be taken on an empty stomach or with a light snack.

Capsules should be swallowed whole with some water or non-alcoholic drink.  You should avoid excessive consumption of alcohol during your treatment.  Your doctor may prescribe amprenavir in combination with other drugs which are used to control HIV infection.  Your physician may adjust the recommended dose to suit your particular needs.  FOLLOW THE ADVICE OF YOUR DOCTOR.

What should you do if you FORGET a dose?

The missed dose should be taken as soon as you remember, then return to your regular dosing schedule.  If you skip a dose (i.e. don't remember until the next dose is due), do not double the next dose.  If you are unsure, please consult your doctor or pharmacist.

What ADVERSE EFFECTS can this drug cause ? What should you do about them?

The most common side effect with amprenavir is headache.  This can usually be controlled with non-prescription drugs, such as acetamin-ophen (Tylenol?). Other side effects that may occur are diarrhea, nausea, gas, temporary numbness around the mouth and alterations in taste. Rash has also been reported and may be severe (rare).  If these effects occur and are bothersome, please call the clinic or discuss them at your next visit.

The long-term effects of amprenavir are unknown at this time.  Further clinical studies are being carried out.

Side effects known to be associated with other drugs used to treat HIV may still occur when amprenavir is used in combination with these medications.  If you are concerned about any unexpected effects, please talk to your doctor or pharmacist.

IT IS IMPORTANT THAT YOU KEEP YOUR DOCTOR AND LABORATORY APPOINTMENTS, SO THAT YOUR PROGRESS CAN BE ASSESSED REGULARLY.

IF YOU ARE EXPERIENCING ANY ADVERSE EFFECTS, PLEASE DISCUSS THEM WITH YOUR HEALTH CARE TEAM.

What other PRECAUTIONS should you follow while using this drug ?

This medication can interact with some drugs.  It is important to tell your doctor or pharmacist about other drugs you are taking, even those you can buy without a prescription.

Do not use the following drugs while taking amprenavir: 

  • astemizole (e.g. Hismanal)
  • terfenadine (e.g. Seldane)
  • cisapride (e.g. Prepulsid)
  • rifampin (e.g. Rifadin, Rimactane, Rofact)
  • midazolam (e.g. Versed)
  • triazolam (e.g. Halcion)
  • migrane medications (eg. ergotamine,    Ergomar)

Please inform your physician or pharmacist if you are taking any of the above medications so that your dosage may be adjusted, or an alternative medication may be selected.

Amprenavir may reduce the efficacy of birth control pills.  Alternate or additional contraceptive measures should be used if taking oral contraceptives.

Amprenavir capsules contain vitamin E.  Therefore, avoid taking vitamin E supplements while on amprenavir therapy, in order to avoid toxicity.

There are many other medications that have the potential to interact with amprenavir. Please let your health care provider know what you are taking.
 

The safety of amprenavir in pregnancy and breast feeding has yet to be established.  Please discuss this with your doctor or pharmacist if it is a concern.

How should this medication be STORED?

Amprenavir should be stored in a cool (15-30°C) dry place, protected from light and well out of the reach of children.  Do not store in your bathroom.  Heat and moisture may cause the medicine to lose its effectiveness. 

IF YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT THIS MEDICATION, PLEASE DISCUSS THEM WITH YOUR NURSE, PHARMACIST, OR PHYSICIAN.

PLEASE WRITE DOWN YOUR QUESTIONS OR CONCERNS TO ENSURE THEY ARE ADDRESSED 

Adapted from the Amprenavir Investigator's Brochure/Notes, May 1997, Glaxo Wellcome Inc., USA.  Edited by the CSHP Ontario Branch Professional Specialty Group in HIV Disease, in conjunction with the HIV/AIDS Outpatient Network of Ontario Coordinators Sub-Group, 1998.