Abacavir and lamivudine

Name: Abacavir and lamivudine

Precautions While Using abacavir and lamivudine

It is very important that your doctor check your or your child's progress at regular visits to make sure abacavir and lamivudine is working properly. Blood tests may be needed to check for unwanted effects.

abacavir and lamivudine may cause severe allergic reactions (including multi-organ failure) 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. Check with your doctor right away if you have sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, trouble breathing, sore throat, lightheadedness, dizziness, or yellow skin or eyes.

When you begin taking abacavir and lamivudine, 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.

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.

Two rare but serious reactions to abacavir and lamivudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. 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 have more than one of these symptoms: abdominal or 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 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. If this occurs, tell your doctor right away.

abacavir and lamivudine 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.

abacavir and lamivudine may cause you to have excess body fat. Tell your doctor if you 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.

abacavir and lamivudine may increase your risk of having a heart attack. This is more likely to occur if you already have heart disease, high blood pressure, high cholesterol or fats in the blood, or if you smoke.

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.

abacavir and lamivudine Side Effects

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
  • Abdominal or stomach pain
  • cough
  • diarrhea
  • fever
  • headache
  • nausea
  • numbness or tingling of the face, feet, or hands
  • pain in the joints
  • pain in the muscles
  • skin rash
  • sore throat
  • swelling of the feet or lower legs
  • unusual feeling of discomfort or illness
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • constipation
  • convulsions
  • dark urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • feeling of fullness
  • general feeling of discomfort
  • hives or welts, itching
  • indigestion
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • muscle cramping
  • muscle spasm or jerking of all extremities
  • pains in the 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 the skin
  • red skin lesions, often with a purple center
  • sleepiness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of consciousness
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing with exertion
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • weakness in the arms, hands, legs, or feet
  • 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 the chest or stomach
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • lightheadedness
  • sensation of spinning
  • severe and throbbing headache
  • stomach upset
  • tenderness in the stomach area
  • trouble sleeping
Incidence not known
  • Abnormal breathing sounds
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • gaining weight around your neck, upper back, breast, face, or waist
  • hair loss
  • increased hunger
  • increased thirst
  • increased urination
  • muscle weakness
  • sweating
  • swelling or inflammation of the mouth
  • thinning of the 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.

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

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time abacavir and lamivudine is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take abacavir and lamivudine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir and lamivudine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Epzicom: Abacavir 600 mg and lamivudine 300 mg [contains fd&c yellow #6 (sunset yellow)]

Generic: Abacavir 600 mg and lamivudine 300 mg

Dosing Renal Impairment

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Use is not recommended.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, insomnia, loss of strength and energy, nausea, or diarrhea. Have patient report immediately to prescriber signs of allergic reaction with organ failure (fever, rash, fatigue, flu-like signs, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, cough, or difficulty breathing), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe dizziness, passing out, angina, depression, mouth sores, muscle pain, enlarged lymph nodes, muscle weakness, burning or numbness feeling, edema, change in body fat, or signs of infection (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Renal Dose Adjustments

CrCl less than 50 mL/min: Not recommended; individual components should be used.

Precautions

US BOXED WARNINGS:
-HYPERSENSITIVITY REACTIONS: Serious and sometimes fatal hypersensitivity reactions (with multiple organ involvement) reported with abacavir. Patients with the HLA-B*5701 allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. This drug is contraindicated in patients with prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with this drug (unless HLA-B*5701 allele assessment previously documented). Regardless of HLA-B*5701 status, this drug should be discontinued without delay if hypersensitivity reaction is suspected, even if other diagnoses are possible. After hypersensitivity reaction to this drug, NEVER restart this or any other abacavir-containing product as more severe symptoms (including death) can occur within hours. Similar severe reactions also reported after restarting abacavir-containing products in patients with no history of abacavir hypersensitivity.
-LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs and other antiretrovirals. This drug should be discontinued if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity.
-EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping lamivudine. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Safety and efficacy of the individual components have not been established in patients younger than 3 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

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