Abacavir, lamivudine, and zidovudine

Name: Abacavir, lamivudine, and zidovudine

What is abacavir, lamivudine, and zidovudine (Trizivir)?

Abacavir, lamivudine, and zidovudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Abacavir, lamivudine, and zidovudine (Trizivir) is a combination medicine used to treat HIV, which can cause the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Trizivir may also be used for purposes not listed in this medication guide.

Precautions While Using abacavir, lamivudine, and zidovudine

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

Do not take any other medicine containing abacavir, emtricitabine, lamivudine, or zidovudine, such as Atripla®, Combivir®, Complera®, Emtriva®, Epivir®, Epivir-HBV®, Epzicom®, Retrovir®, Truvada®, or Ziagen®. Tell your doctor if you also use efavirenz (Sustiva®), rilpivirine (Edurant®), or tenofovir (Viread®).

abacavir, lamivudine, and zidovudine may cause severe allergic reactions in some patients. These reactions 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 or your child notice 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, or vomiting.

When you or your child begin taking abacavir, lamivudine, and zidovudine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir, lamivudine, and zidovudine 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 or your child 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, lamivudine, and zidovudine 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: 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 or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (eg, pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

abacavir, lamivudine, and zidovudine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

abacavir, lamivudine, and zidovudine 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, sweating, or vomiting. These could be symptoms of a heart attack.

abacavir, lamivudine, and zidovudine 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.

Uses of Abacavir, Lamivudine, and Zidovudine

  • It is used to treat HIV infection.

What do I need to tell my doctor BEFORE I take Abacavir, Lamivudine, and Zidovudine?

  • If you have an allergy to abacavir, lamivudine, zidovudine, or any other part of abacavir, lamivudine, and zidovudine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you weigh less than 88 pounds (40 kilograms).
  • If you are taking any of these drugs: Doxorubicin, ribavirin, or stavudine.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with abacavir, lamivudine, and zidovudine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Feeling very tired or weak.
  • Chest pain or pressure.
  • Low mood (depression).
  • Very bad dizziness or passing out.
  • Mouth sores.
  • Muscle pain or weakness.
  • A burning, numbness, or tingling feeling that is not normal.
  • Shortness of breath.
  • Swelling.
  • Change in body fat.
  • This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take abacavir, lamivudine, and zidovudine. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this medicine.

Contraindications

Hypersensitivity to abacavir, lamivudine, zidovudine, or any component of the formulation; patients positive for HLA-B*5701 allele; moderate or severe hepatic impairment.

Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (regardless of severity of impairment); ANC <750 cells/mm3; hemoglobin <7.5 g/dL or 4.65 mmol/L

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Acyclovir-Valacyclovir: May enhance the CNS depressant effect of Zidovudine. Monitor therapy

Amodiaquine: Zidovudine may enhance the neutropenic effect of Amodiaquine. Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy

Clarithromycin: May enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Consider therapy modification

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Dexketoprofen: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

DOXOrubicin (Conventional): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Conventional) may diminish the therapeutic effect of Zidovudine. Consider therapy modification

DOXOrubicin (Liposomal): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Liposomal) may diminish the therapeutic effect of Zidovudine. Consider therapy modification

Emtricitabine: LamiVUDine may enhance the adverse/toxic effect of Emtricitabine. Avoid combination

Fluconazole: May decrease the metabolism of Zidovudine. Monitor therapy

Ganciclovir-Valganciclovir: May enhance the adverse/toxic effect of Zidovudine. Specifically, hematologic toxicity may be enhanced. Monitor therapy

Interferons: May enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Monitor therapy

Methadone: May increase the serum concentration of Zidovudine. Monitor therapy

Methadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Methadone. Monitor therapy

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy

Probenecid: May decrease the metabolism of Zidovudine. Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Protease Inhibitors: May decrease the serum concentration of Zidovudine. Monitor therapy

Protease Inhibitors: May decrease the serum concentration of Abacavir. Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Zidovudine. Monitor therapy

Ribavirin (Oral Inhalation): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Oral Inhalation). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification

Ribavirin (Systemic): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Systemic). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended for ribavirin. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification

Rifamycin Derivatives: May decrease the serum concentration of Zidovudine. Exceptions: Rifabutin. Monitor therapy

Stavudine: Zidovudine may diminish the therapeutic effect of Stavudine. Avoid combination

Tenoxicam: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy

Teriflunomide: May increase the serum concentration of OAT3 Substrates. Monitor therapy

Trimethoprim: May increase the serum concentration of LamiVUDine. Monitor therapy

Valproate Products: May increase the serum concentration of Zidovudine. Monitor therapy

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