Pronunciation:

a-BAK-a-vir

Brand Names:

• Ziagen

Dosage Forms:

• Tablet
• Solution

Warnings:

Serious hypersensitivity reactions has been reported. Risk for experiencing a hypersensitivity reaction to abacavir is increased in patients carrying the HLA-B*5701 allele. Abacavir is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. Screening for the HLA-B*5701 allele is required prior to abacavir initiation and when reinitiating therapy in patients with an unknown HLA-B*5701 status who have previously tolerated abacavir. Discontinue abacavir and do not restart if a hypersensitivity reaction is suspected or cannot be ruled out . .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Abacavir is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Abacavir will not cure or prevent HIV infection or the symptoms of AIDS. It helps keep the HIV virus from reproducing, and appears to slow the destruction of the immune system. This may help delay the development of serious health problems that are usually related to AIDS or HIV infection. Abacavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV infection.

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—

Appropriate studies have not been performed on the relationship of age to the effects of abacavir in children younger than 3 months of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abacavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving abacavir.

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 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.

• Cabotegravir
• Levoketoconazole
• Methotrexate
• Orlistat
• Ribavirin
• Tacrolimus

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.

• Methadone
• Riociguat
• Tipranavir

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:

• Diabetes or
• Heart disease or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Genetic condition (eg, gene variation called HLA-B*5701)—This condition may increase the risk for serious and life-threatening side effects.

• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine to the body.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

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 first with your doctor.

This medicine will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is important to take abacavir together with other HIV medicines. Take all of the medicines your doctor prescribed at the right time of day. These medicines work best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help with planning the best times to take your medicines, check with your doctor.

When your supply of this medicine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to this medicine and be harder to treat.

You may take this medicine with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

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 forms (solution or tablets):
  • For HIV infection:
    • Adults—300 milligrams (mg) two times per day or 600 mg once per day.
    • Children 3 months of age and older—Dose is based on body weight and must be determined by your child's doctor. The dose is usually 8 milligrams (mg) per kilogram (kg) of body weight two times per day, or 16 mg per kg of body weight once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 600 mg per day.
    • Children weighing 14 kilograms (kg) or more who can take tablets—Dose is based on body weight and must be determined by your child's doctor. The dose is usually 300 to 600 mg per day, taken as a single dose once a day or in divided doses two times a day.
    • Children younger than 3 months of age—Use and dose must be determined by your child's 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—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may also store the oral liquid in the refrigerator, but do not freeze it.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using other medicines containing abacavir (eg, Epzicom®, Triumeq®, Trizivir®).

This medicine may cause severe allergic reactions in some patients. These reactions usually occur 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. Check with your doctor immediately if you or your child notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, trouble breathing, or sore throat.

When you begin taking this medicine, you or your child 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 using this medicine for any reason, do not start taking it again without talking first to your doctor.

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 or your child have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: stomach discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. Tell your doctor right away if you or your child notice any changes in health.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.

This medicine may increase your risk of having a heart attack. This is more likely to occur if you smoke or already have heart disease, high blood pressure, or high cholesterol or fats in the blood. Call your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back or neck, trouble breathing, sweating, or vomiting. These could be symptoms of a heart attack.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side 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 the hands, feet, or face

redness and soreness of the eyes

skin rash

sore throat

sores in the mouth

swelling of the feet or lower legs

unusual feeling of discomfort or illness

unusual tiredness

vomiting

Rare

Abdominal or stomach swelling

decreased appetite

fast, shallow breathing

sleepiness

Incidence not known

Blistering, peeling, or loosening of the skin

chest pain or discomfort

chills

dark urine

itching

light-colored stools

pain or discomfort in the arms, jaw, back, or neck

red, irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

sweating

unusual weakness

upper right abdominal or stomach pain

yellow eyes and 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

Headache

Less common

Trouble sleeping

Incidence not known

Breast enlargement

buffalo hump

central obesity

facial wasting

gaining weight around your neck, upper back, breast, face, or waist

peripheral wasting

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.