Pronunciation:

a-BAK-a-veer SUL-fate, la-MI-vyoo-deen

Brand Names:

• Epzicom

Dosage Forms:

• Tablet

Warnings:

Abacavir sulfate/lamivudine contains 2 nucleoside analogues (abacavir sulfate and lamivudine ) and is intended only for patients whose regimen would otherwise include these 2 components.

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

Following a hypersensitivity reaction to abacavir, never restart abacavir sulfate/lamivudine 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/lamivudine or any other-abacavir containing product, even in patients who have no identified history or unrecognized 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, lamivudine, and other antiretrovirals.

Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV) and have discontinued lamivudine, which is one component of abacavir sulfate/lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue abacavir sulfate/lamivudine and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Fatal hypersensitivity reactions have been reported with abacavir sulfate; discontinue if hypersensitivity reaction suspected and do not restart. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients co-infected with HBV and HIV who have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Abacavir

Uses of This Medicine:

Abacavir and lamivudine combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir, and lamivudine combination will not cure or prevent HIV infection or the symptoms of 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 serious health problems usually related to AIDS or HIV infection. Abacavir and lamivudine combination 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 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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of abacavir and lamivudine in children with the use in other age groups.

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.

• Interferon Alfa
• Ribavirin
• Zalcitabine

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—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.

• Kidney disease or
• Liver problems—Patients with kidney or liver disease may have more side effects

• 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.

Do not stop taking abacavir and lamivudine combination without checking with your doctor first.

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.

This medicine works 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 in planning the best times to take your medicine, check with your health care professional.

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

Abacavir and lamivudine combination contains a fixed amount of each medicine.

• For oral dosage form (tablets):
  • For HIV infection:
    • Adults—600 milligrams (mg) of abacavir, and 300 mg of lamivudine (equal to one tablet) once a day. This medicine can be taken with or without food.
    • Children—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. 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:

It is very important that your doctor check your progress at regular visits. Abacavir and lamivudine combination may cause blood problems, and your doctor will want to test your blood regularly.

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 and lamivudine combination. 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.

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:

More common

Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of face, feet, or hands; pain in joints; pain in muscles; shortness of breath; skin rash; sore throat; swelling of feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting

Incidence not known—occurred during clinical practice

Blistering, peeling, loosening of skin

bloating

burning, numbness, tingling, or painful sensations

chest pain

chills

constipation

convulsions

dark urine

decreased appetite

diarrhea

difficulty swallowing

dizziness

fast heartbeat

fast, shallow breathing

feeling of fullness

general feeling of discomfort

hives or welts

indigestion

itching

light-colored stools

loss of appetite

loss of bladder control

muscle cramping

muscle spasm or jerking of all extremities

pains in stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

red irritated eyes

redness of skin

red skin lesions, often with a purple center

sleepiness

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

sudden loss of consciousness

swollen, painful, or tender lymph glands in neck, armpit, or groin

tightness in chest

troubled breathing with exertion

unsteadiness or awkwardness

unusual bleeding or bruising

upper right abdominal pain

weakness in arms, hands, legs, or feet

wheezing

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

Abnormal dreams

burning feeling in chest or stomach

fear

feeling of constant movement of self or surroundings

lightheadedness

nervousness

sensation of spinning

severe and throbbing headache

sleeplessness

stomach upset

tenderness in stomach area

trouble sleeping

unable to sleep

Incidence not known—occurred during clinical practice

Abnormal breathing sounds

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dry mouth

dry skin

fruit-like breath odor

flushed

hair loss

increased hunger

increased thirst

increased urination

muscle weakness

redistribution/accumulation of body fat

sweating

swelling or inflammation of the mouth

thinning of hair

unexplained weight loss

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