Pronunciation:

a-BAK-a-veer

Brand Names:

• Ziagen

Dosage Forms:

• Tablet
• Solution

Warnings:

Hypersensitivity reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: 1) fever, 2) rash, 3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), 4) constitutional (including generalized malaise, fatigue, or achiness), and 5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue abacavir sulfate as soon as a hypersensitivity reaction is suspected. Permanently discontinue abacavir sulfate if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, NEVER restart abacavir sulfate or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.

Reintroduction of abacavir sulfate or any other abacavir-containing product, even in patients who have no identified history or recognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours.

Lactic acidosis and severe hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir sulfate and other antiretrovirals .

Serious hypersensitivity reactions, lactic acidosis, severe hepatomegaly with steatosis, including fatal cases have been reported. Discontinue if hypersensitivity reaction is suspected and do not restart .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Abacavir is used, in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Abacavir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Abacavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other 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 3 months of age and older and, in effective doses, 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. There is no specific information comparing use of abacavir 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—

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.

• Ribavirin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Allergy to abacavir or any ingredients in the medicine—You should tell your doctor immediately if you have signs of an allergic reaction. If you have ever taken abacavir in the past, you should tell your doctor right away.
• Infections—When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia, herpes virus, or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor .

• Liver problems, moderate or severe—Abacavir has not been studied in patients with moderate or severe liver problems, so it should not be used in patients with this condition .

• Risk factors for liver disease such as:
• Being overweight or
• Taking other HIV medicines for long periods of time—Serious side effects could occur; caution should be used

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered.

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 (oral solution or tablets):
  • For HIV infection:
    • Adults and adolescents 16 years of age and older—300 milligrams (mg) two times a day or 600 mg once a day. This medicine can be taken with or without food.
    • Children 3 months to 16 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 8 mg per kilogram (kg) (3.6 mg per pound) of body weight two times a day.

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. Keep from freezing.

Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

This medicine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking this medicine and check with your doctor immediately if you notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, shortness of breath, or sore throat.

When you begin taking this medicine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

Do not stop using this medicine unless your doctor tells you to do so. If you stop taking this medicine for any reason, do not start taking it again without talking to your doctor first .

If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past .

A rare but serious reaction to this medicine is lactic acidosis (build-up of acid in the blood) and an enlarged liver. Call your doctor right away if you feel very tired, weak, or nauseated, if you vomit or have trouble breathing, or if your skin or eyes have turned yellow .

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk .

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone .

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common

Abdominal or stomach pain

cough

diarrhea

difficult or labored breathing

fever

headache

joint or muscle pain

nausea

numbness or tingling of hands, feet, or face

redness and soreness of eyes

shortness of breath

skin rash

sore throat

sores in mouth

swelling of feet or lower legs

vomiting

unusual feeling of discomfort or illness

unusual tiredness

Incidence not known—occurred during clinical practice

Blistering, peeling, loosening of skin

chills

dark urine

itching

light-colored stools

red, irritated eyes

red skin lesions, often with a purple center

sores, ulcers or white spots in mouth or on lips

unusual weakness

upper right abdominal pain

yellow eyes and skin

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

Rare

Abdominal swelling

decreased appetite

fast, shallow breathing

sleepiness

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

Headache

Less common

Trouble in sleeping

Incidence not known—occurred during clinical practice

Breast enlargement

buffalo hump

central obesity

facial wasting

peripheral wasting

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