Pronunciation:

am-PREN-a-vir

Brand Names:

• Agenerase

Dosage Forms:

• Capsule, Liquid Filled
• Solution

Warnings:

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 because of the potential risk of toxicity from the large amount of the excipient, propylene glycol .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Protease Inhibitor

Uses of This Medicine:

Amprenavir is a protease inhibitor. It is used in combination with other medicines to treat patients who are infected with the human immunodeficiency virus (HIV).

HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Amprenavir may slow down the destruction of the immune system caused by HIV. This may help delay the development of problems usually related to AIDS or HIV disease. However, this medicine will not cure or prevent HIV infection, and it will not keep you from spreading the virus to other people. Patients who are taking this medicine may continue to have the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine has been tested in children 4 years of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of amprenavir. There is no specific information comparing use of amprenavir in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Cisapride
• Dihydroergotamine
• Disulfiram
• Ergonovine
• Ergotamine
• Lomitapide
• Lovastatin
• Methylergonovine
• Metronidazole
• Midazolam
• Pimozide
• Ranolazine
• Sildenafil
• Simvastatin
• Terfenadine
• Triazolam

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amitriptyline
• Amoxapine
• Artemether
• Bepridil
• Boceprevir
• Bosutinib
• Carbamazepine
• Clomipramine
• Clozapine
• Colchicine
• Crizotinib
• Cyclophosphamide
• Dabrafenib
• Desipramine
• Domperidone
• Dothiepin
• Doxepin
• Efavirenz
• Everolimus
• Fentanyl
• Garlic
• Imipramine
• Ixabepilone
• Lidocaine
• Lofepramine
• Lumefantrine
• Lurasidone
• Methadone
• Nevirapine
• Nortriptyline
• Opipramol
• Primidone
• Protriptyline
• Quinidine
• Rifabutin
• Rifampin
• Rifapentine
• Saquinavir
• St John's Wort
• Tolvaptan
• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Atorvastatin
• Calcium Carbonate
• Cerivastatin
• Clorazepate
• Cyclosporine
• Dapsone
• Delavirdine
• Desogestrel
• Diazepam
• Dienogest
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Felodipine
• Flurazepam
• Fosphenytoin
• Indinavir
• Isradipine
• Ketoconazole
• Levonorgestrel
• Lopinavir
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Medroxyprogesterone Acetate
• Mestranol
• Nelfinavir
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Phenobarbital
• Phenytoin
• Pravastatin
• Ritonavir
• Sirolimus
• Tacrolimus
• Vardenafil
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus or
• Hemophilia—Amprenavir may make these conditions worse

• Kidney failure or
• Liver failure—Amprenavir oral solution should not be used because serious side effects may occur

• Liver disease—Effects of amprenavir may be increased because of slower removal of amprenavir from the body

• Vitamin K deficiency—The high amounts of vitamin E in amprenavir dosage forms may increase the chance of bleeding problems in patients who are deficient in vitamin K

Proper Use of This Medicine:

Amprenavir may be taken with or without food. However, it should not be taken with a high-fat meal. Taking amprenavir with a high-fat meal may decrease the amount of amprenavir that is absorbed by the body and prevent the medicine from working properly.

You should not drink alcoholic beverages while you are taking the oral solution form of this medicine.

It is important to take amprenavir as part of a combination treatment. Your dose of medicine will be based on what other medicines you are taking, as well as your weight. Be sure to take all the medicines your doctor has prescribed for you, including amprenavir.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking amprenavir for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses a day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.

Only take medicine that your doctor has prescribed especially for you. Do not share your medicine with others.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of HIV infection:
    • Adults, adolescents 17 years of age and older, and adolescents 13 through 16 years of age who weigh 50 kilograms (kg) (110 pounds) or more—1200 milligrams (mg) (twenty-four 50-mg capsules) two times a day.
    • Children 4 to 13 years of age and adolescents 13 through 16 years of age who weigh less than 50 kg (110 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two times a day or 15 mg per kg (6.8 mg per pound) of body weight three times a day, up to a maximum dose of 2400 mg per day.
    • Children up to 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (oral solution):
  • For treatment of HIV infection:
    • Adults, adolescents 17 years of age and older, and adolescents 13 through 16 years of age who weigh 50 kg (110 pounds) or more— 1400 mg two times a day.
    • Children 4 to 12 years of age and adolescents 13 through 16 years of age who weigh less that 50 kg (110 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 22.5 mg per kg (10.2 mg per pound) of body weight two times a day or 17 mg per kg (7.7 mg per pound) of body weight three times a day, up to a maximum dose of 2800 mg per day.
    • Children up to 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Do not take any other medicines without checking with your doctor first. This includes prescription and nonprescription medicines. This also includes food supplements, herbs and vitamins. To do so may increase the chance of side effects from amprenavir or other medicines.

This medicine may decrease the effects of some oral contraceptives (birth control pills). To avoid unwanted pregnancy, it is a good idea to use some additional contraceptive measures while being treated with amprenavir.

For patients with diabetes: Amprenavir may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not take vitamin E supplements while you are taking amprenavir. At recommended dosages, amprenavir supplies more than the Reference Daily Intake of vitamin E for adults and children.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects, especially increases in blood sugar.

Amprenavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Burning or prickling sensation in arms or legs

dry or itchy skin

fatigue

increased cholesterol and triglycerides

increased hunger

increased thirst

increased urination

skin rash

Less common

Depression

mood or mental changes

Rare

Back, leg or stomach pains

bleeding gums

blistering, peeling, or loosening of skin and mucous membranes

buffalo hump

chills

dark urine

difficult breathing

fatigue

fever

general body swelling

general feeling of discomfort or illness

loss of appetite

nosebleeds

pale skin

sore throat

unexplained weight loss

yellowing of eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

burning or prickling sensation around the mouth

diarrhea

headache

nausea

vomiting

Less common or rare

Change in sense of taste

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is possible that the fat on your body may distribute itself differently or you may accumulate more body fat while you are taking this medicine. If you have concerns about this, check with your doctor.