MEDICATION FACT SHEET/FEUILLET DE RENSEIGNEMENTS

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AMPRENAVIR

Other NAMES: Agenerase®

WHY is this drug prescribed?

Amprenavir is an antiretroviral (anti-HIV) drug that belongs to a class of drugs called protease inhibitors.  Protease inhibitors interfere with a different step in virus reproduction than other classes of drugs previously available to fight HIV.  Amprenavir is used together with other antiretrovirals to delay the progression of HIV infection. By doing this, your immune system should improve (increase in CD4+ count) and you will be better protected against infections.

Amprenavir does not cure AIDS or completely kill the HIV virus, but helps to prevent further damage by slowing down the production of new viruses.  Treatment with amprenavir does not reduce the risk of passing infection on to others.  You will still be able to pass HIV by sexual contact, by blood transfer or by sharing needles.  You should always use appropriate precautions to prevent passing HIV on to others. 

HOW should this drug be taken?

Amprenavir is available in 50 mg and 150mg soft gel capsules. The dose most commonly used is 1200mg (8 x 150mg capsules) every 12 hours.  This dose may need to be adjusted if you are taking other protease inhibitors or to meet your particular needs.

Amprenavir is also available as an oral 15 mg/mL solution.  This solution should only be used if amprenavir capsules cannot be taken.

Amprenavir can be taken with or without food.  Avoid taking it with a very high-fat meal.

Your dosage is:

 50 mg capsule

 150 mg capsule

____capsules (____mg) ____ times a day

or

 15 mg / mL oral solution

____mL (____mg) ____ times a day 

Capsules should be swallowed whole with some water or non-alcoholic drink. 

Avoid drinking excessive amounts of alcohol while you are taking amprenavir capsules.  If you are taking amprenavir oral solution, it is best to completely avoid alcoholic beverages. 

What should you do if you FORGET a dose?

If you miss a dose of amprenavir, take it as soon as possible.  However, if it is time for your next dose, do not double the dose, just carry on with your regular schedule.

Why should you not forget to take this drug? 

If you miss doses of amprenavir, the amount of HIV virus in your blood (known as the viral load) will start increasing again and your immune system will be further damaged.  A few missed doses can be enough for amprenavir to stop being active.  A phenomenon known as resistance.  When this happens, other antiretrovirals that work in a similar way as amprenavir may also become inactive.  Therefore, missing doses of amprenavir can decrease treatment options for the future.

Please do not stop amprenavir without talking to your doctor first.

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 acetaminophen (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.

Regular blood tests will be done to detect any changes in your liver or pancreas function.  Also, your doctor will look for increases in your cholesterol, triglyceride and blood sugar level. 

The long-term effects of amprenavir are unknown at this time.  Further studies are being carried out.  Abnormal weight gain or changes in body shape have been reported, but it is uncertain if amprenavir is responsible for these changes.

It is important that you keep your doctor appointments and come for your laboratory tests so that your progress can be followed.

What other PRECAUTIONS should you follow while using this drug?

You must make sure that you are taking the right dose. If you take higher doses of amprenavir than what is prescribed, you may increase the chance of having adverse effects. If you take lower doses of amprenavir than what is prescribed, the HIV virus may become resistant to amprenavir.

Certain drugs can increase or decrease the effect of amprenavir. Also, amprenavir might influence the effect of other drugs you are taking. Inform your doctor and pharmacist of all prescribed and non-prescribed drugs you are taking.  As well, you should inform them of natural products you are taking. If you wish to start a new drug or natural product, please consult with your pharmacist before doing so.

Do NOT take the following medications with amprenavir:

  • Astemizole (Hismanal®)
  • Cisapride (Prepulsid®)
  • Ergot derivatives [Ergotamine (Cafergot®, Bellergal®, Ergodryl®, Gravergol®), ergo-novine, dihydroergotamine (Migranal®), methylergonovine (Methergine®)]
  • Midazolam (Versed®)
  • Pimozide (Orap®)
  • Rifampin (e.g. Rifadin®, Rimactane®, Rofact®)
  • Triazolam (Halcion®)
  • Terfenadine (Seldane®)

If you are taking amprenavir oral solution, you should also avoid:

Disulfiram (Antabuse®) or metronidazole (Flagyl®)

The efficacy of birth control pills or other hormones used to prevent becoming pregnant may decrease if you are taking amprenavir. A second method of contraception should always be used.  In general, even if you are not taking amprenavir, the use of condoms is always recommended to decrease the risk of passing HIV on to others.

Amprenavir capsules contain large amounts of vitamin E.  Therefore, avoid taking vitamin E supplements while on amprenavir.

Amprenavir oral solution should NOT be taken by children less than 4 years of age, pregnant women, and patients with kidney and liver problems.

The safety of amprenavir capsules has not been established during pregnancy.  Please inform your doctor if you are pregnant.  Your doctor can recommend the appropriate treatment to help reduce the risk of passing the HIV virus on to your baby. Breastfeeding is NOT recommended if you have HIV as you can transmit the virus to your baby through your breast milk.

How should this drug be STORED?

Amprenavir capsules should be stored between 15 – 30°C and the oral solution between 5 - 25°C.  Keep in a dry place, protected from light and well out of the reach of children. Ensure that the drug has not expired by checking the expiry date (“EXP”) shown on the outside of the package.

Do not store in your bathroom, as heat and moisture may cause the drug to be less active.

If you have any questions or concerns about this drug or if you are experiencing adverse effects, please discuss them with your pharmacist, doctor or nurse. Write questions or concerns down to ensure they are addressed.

The following pharmacist is available to answer questions:

Pharmacist:  __________________

Telephone:   __________________

Reference:  Product monograph Agenerase® (amprenavir).  Saint-Laurent, Qc, Canada: GlaxoSmithKline, 2001. 

Prepared by the Ontario HIV Pharmacy Professional Specialty Group, 2003.

Additional medication fact sheets and updates may be found at: www.tthhivclinic.com

 
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