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AGENERASE®
(amprenavir) Oral Solution

ALERT: Find out about medicines that should not be taken with AGENERASE Oral Solution. Read the section: “What important information should I know about taking AGENERASE Oral Solution (amprenavir oral solution) with other medicines?”

Read this information carefully before you start taking AGENERASE (ah-GEN-er-ase) Oral Solution. Read the information each time you get more medicine. There may be new information. This information does not take the place of talks with your healthcare provider when you start this medicine and at checkups.

What is the most important information I should know about AGENERASE?

AGENERASE can cause serious and life-threatening side effects if you take it with certain other medicines. For information about these medicines, see the section “What important information should I know about taking AGENERASE with other medicines?”

What is AGENERASE Oral Solution (amprenavir oral solution) ?

AGENERASE Oral Solution (amprenavir oral solution) is a medicine you take by mouth to treat HIV infection. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). AGENERASE belongs to a class of anti-HIV medicines called protease inhibitors.

AGENERASE is used only in combination with other anti-HIV medicines. When used in combination therapy, AGENERASE may help lower the amount of HIV found in your blood, raise CD4 (T) cell counts, and keep your immune system as healthy as possible, so it can help fight infection. However, AGENERASE does not have these effects in all patients.

AGENERASE does not cure HIV infection or AIDS. We do not know if AGENERASE will help you live longer or have fewer of the medical problems (opportunistic infections) that people get with HIV or AIDS. Therefore, be sure to see your healthcare provider regularly. The long-term effects of AGENERASE are not known.

AGENERASE has not been shown to reduce the risk of passing HIV to others through sexual contact or blood. Continue to practice safe sex and do not use or share dirty needles.

Children from 4 to 12 years of age can take AGENERASE. Your healthcare provider will tell you if the oral solution (liquid) or capsule is best for your child. Your child's healthcare provider will decide the right dose based on your child's weight and age.

AGENERASE has not been studied in people who have taken anti-HIV medicine combinations before that included a protease inhibitor.

Who should not take AGENERASE Oral Solution (amprenavir oral solution) ?

AGENERASE Oral Solution (amprenavir oral solution) contains a large amount of propylene glycol, a liquid needed to dissolve amprenavir. Because of the possible side effects of the large amount of propylene glycol, AGENERASE Oral Solution (amprenavir oral solution) should be used only when AGENERASE Capsules or other protease inhibitor formulations are not options.

If you are a woman or an Asian, Eskimo, or Native American, or if you have liver or kidney disease, you may be at increased risk of side effects from the large amount of propylene glycol in AGENERASE Oral Solution (amprenavir oral solution) .

Do not take AGENERASE Oral Solution (amprenavir oral solution) if

• you are taking certain medicines. Read the section entitled “What important information should I know about taking AGENERASE Oral Solution (amprenavir oral solution) with other medicines?”
• you are pregnant.
• you have had an allergic reaction to AGENERASE or any of its ingredients.

Children younger than age 4 should not take AGENERASE Capsules or AGENERASE Oral Solution.

Tell your healthcare provider if

• you are pregnant. Do not use AGENERASE Oral Solution (amprenavir oral solution) if you are pregnant.
• you are breastfeeding. Your baby can get HIV from your milk. Also, AGENERASE can pass through your milk and harm the baby.

Tell your healthcare provider about all your medical conditions . AGENERASE Oral Solution may not be right for you, or you may need a dosage change in AGENERASE. Be sure to tell your healthcare provider if you

• have liver or kidney problems.
• have hemophilia.
• are allergic to sulfa medicines. AGENERASE may cause problems for you.

What important information should I know about taking AGENERASE Oral Solution (amprenavir oral solution) with other medicines?

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and supplements. Some of them may cause dangerous and life-threatening side effects if you take them during treatment with AGENERASE. For other medicines, you may need to change your dose to avoid problems.

Drinking alcoholic beverages is not recommended while taking AGENERASE Oral Solution because it may increase side effects related to propylene glycol content.

Taking AGENERASE Oral Solution (amprenavir oral solution) and NORVIR (ritonavir) oral solution together is not recommended because this may increase side effects related to propylene glycol and ethanol content.

If you are on methadone therapy, talk to your doctor about possible interactions.

Do NOT take the following medicines* with AGENERASE Oral Solution (amprenavir oral solution) . You could develop serious or life-threatening problems.

• FLAGYL® (metronidazole, used to treat certain infections)
• ANTABUSE® (disulfiram, used to treat alcohol dependence)
• HALCION® (triazolam; used for insomnia)
• CAFERGOT® and other ergot medicines (used for migraine headaches)
• PROPULSID® (cisapride, used for certain stomach problems)
• VERSED® (midazolam; used for sedation)
• ORAP® (pimozide; used for Tourette's disorder)

You will need to be monitored with regular blood tests if you take the following medicines* with AGENERASE.

• CORDARONE® (amiodarone; used for certain abnormal heart rhythms)
• Quinidine (used for certain abnormal heart rhythms)
• COUMADIN® (warfarin; used for blood thinning)
• Lidocaine (used for certain abnormal heart rhythms)
• ELAVIL® (amitriptyline), TOFRANIL® (imipramine) (tricyclic antidepressants)
• SANDIMMUNE® or NEORAL® (cyclosporine), PROGRAF® (tacrolimus), RAPAMUNE® (rapamycin or sirolimus) (immunosuppressants)

You will need to have your dose adjusted if you take the following medicines^* with AGENERASE.

• MYCOBUTIN® (rifabutin; used to prevent Mycobacterium avium complex [MAC])
• NORVIR® Capsules (ritonavir capsules; used to treat HIV infection)
• VIAGRA® (sildenafil; used for impotence). You may get increased side effects such as low blood pressure, changes in vision, or erections that last more than 4 hours. If an erection lasts more than 4 hours, get medical help right away.

The following medicines^* may cause serious problems if you take them with AGENERASE. Tell your healthcare provider if you are taking any of these medicines.

• RESCRIPTOR® (delavirdine; used for HIV) and certain other anti-HIV medicines
• St. John's wort (hypericum perforatum) or products containing St. John's wort
• VASCOR® (bepridil; used for chronic stable angina)
• RIFADIN® , RIFAMATE® , RIFATER® , or RIMACTANE® (rifampin, used for tuberculosis)
• MEVACOR® (lovastatin), ZOCOR® (simvastatin), and LIPITOR® (atorvastatin) (cholesterol- lowering medicines)
• Phenobarbital (used for seizures)
• TEGRETOL® , CARBATROL® (carbamazepine; used for seizures and trigeminal neuralgia)
• DILANTIN® (phenytoin; used for seizures)
• DECADRON® (dexamethasone, used to reduce inflammation)
• Hormonal contraceptives (e.g., birth control pills) because the effectiveness of one or both drugs may be decreased. Talk to your doctor about choosing a different type of contraceptive.
• Vitamin E. AGENERASE contains high daily doses of vitamin E that could interfere with medicines that help you stop bleeding.

This list is not complete. Be sure to tell your healthcare provider about all the medicines you take.

How should I take AGENERASE Oral Solution (amprenavir oral solution) ?

• Take AGENERASE Oral Solution (amprenavir oral solution) every day exactly as your healthcare provider has prescribed it, so it will be as effective as possible. Your healthcare provider will decide the right dose for you.
• If you miss a dose by more than 4 hours, wait and take the next dose at the regular time. However, if you miss a dose by fewer than 4 hours, take your missed dose right away. Then take your next dose at the regular time.
• Do not take more or less than your prescribed dose of AGENERASE Oral Solution atany one time. Do not change your dose or stop taking AGENERASE without talking with your healthcareprovider.
• You can take AGENERASE Oral Solution (amprenavir oral solution) with or without food. However, do not take AGENERASE with a high-fat meal. This could reduce the effectiveness of the medicine.
• If you take AGENERASE with the buffered form of VIDEX^®(didanosine, ddI), take them at least 1 hour apart.
• If you take AGENERASE Oral Solution (amprenavir oral solution) with antacids, take them at least 1 hour apart.
• When your supply of AGENERASE or other anti-HIV medicine starts to run low, arrange to get more from your healthcare provider or pharmacy. The amount of virus in your blood may increase if one or more of the drugs are stopped, even for a short time.
• Stay under the care of a healthcareprovider while using AGENERASE.

What should I avoid while taking AGENERASE? Do not

• take vitamin E while taking AGENERASE. It contains large amounts of vitamin E.
• take AGENERASE with a high- fat meal. It could reduce the effectiveness of the medicine.

What are the possible side effects of AGENERASE?

AGENERASE can cause a severe or life-threatening rash. Call your healthcare provider right away if you have a rash. Your healthcare provider will advise you whether your symptoms can be managed on therapy or whether AGENERASE should be stopped.

Common side effects of AGENERASE are nausea, vomiting, diarrhea, rash, and a tingling feeling, especially around the mouth, and change in taste. These are usually mild to moderate. Depression and mood problems have also been reported in patients taking AGENERASE.

Possible side effects from the large amount of propylene glycol in AGENERASE Oral Solution include seizures, drowsiness, fast heart rate, and kidney and blood abnormalities.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Other side effects include high blood sugar or diabetes, diabetes complications, high cholesterol, or high triglycerides.

This list of side effects is not complete. Your healthcare provider or pharmacist can give you a more complete list of possible side effects. Talk with your healthcare provider about any concerns about the way you are feeling while you are taking AGENERASE.

How should I store AGENERASE Oral Solution (amprenavir oral solution) ?

AGENERASE Oral Solution (amprenavir oral solution) should be stored at room temperature and should not be refrigerated.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use AGENERASE for a condition for which it was not prescribed. Do not give AGENERASE to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about AGENERASE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AGENERASE that is written for health professionals.

AGENERASE is a registered trademark of GlaxoSmithKline.
*The brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

Last reviewed on RxList: 7/18/2008
This monograph has been modified to include the generic and brand name in many instances.