Abacavir and lamivudine

Abacavir and lamivudine

Abacavir and lamivudine

What is abacavir and lamivudine?

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

Abacavir and lamivudine may also be used for purposes not listed in this medication guide.

Side effects of abacavir and lamivudine

Call your doctor immediately if you experience symptoms of an allergic reaction from two or more of these specific groups of side effects:

• Group 1 – fever;

• Group 2 – rash;

• Group 3 – nausea, vomiting, diarrhea, stomach pain;

• Group 4 – general malaise, extreme fatigue, body aches;

• Group 5 – shortness of breath, cough, sore throat.

If you have an allergic reaction to abacavir, you should never use it again.If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking them again.

Also call your doctor immediately if you have:

• other signs of an allergic reaction – hives, swelling of the face or throat, difficulty breathing;

• Lactic acidosis - unusual muscle pain, difficulty breathing, stomach pain, vomiting, fast/slow or irregular heartbeat, dizziness, feeling cold, severe weakness or tiredness; or

• Liver problems - loss of appetite, stomach pain (top right), fatigue, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Abacavir and lamivudine affect your immune system, which may cause certain side effects (including weeks or months after taking this medicine). Tell your doctor if you have:

• Signs of a new infection – fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• difficulty speaking or swallowing, problems with balance or eye movement, weakness or tingling; or

• Swelling in the neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects include:

• allergic reaction;

• depression, sleep disorders;

• feeling weak or tired;

• headaches, dizziness, migraines;

• nausea, diarrhea; or

• Changes in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and torso).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

You should not take this medicine if you have liver disease or if you have ever tested positive for a gene variant called HLA-B*5701.Do not take this medicine if you have ever had an allergic reaction to a medicine that contains abacavir or lamivudine.

Stop taking abacavir and lamivudine and call your doctor immediately if you notice any signs of an allergic reaction:Fever; rash; nausea, vomiting, diarrhea, stomach pain; general malaise, extreme tiredness, body aches; Shortness of breath, cough, sore throat.

If you have ever had hepatitis B, it may become active or worsen after you stop using abacavir and lamivudine. You may need to have frequent liver function tests over several months.

Before you take this medicine

You should not use abacavir and lamivudine if you are allergic to abacavir or lamivudine or:

• if you have liver disease;

• if you have ever tested positive for a gene variant called HLA-B*5701; or

• if you have ever had an allergic reaction to a medicine containing abacavir or lamivudine (Combivir, Epivir, Triumeq, Trizivir, Ziagen).

You can develop furtherlactic acidosis,a dangerous buildup of lactic acid in your blood. This may be more likely if you have other medical conditions, are overweight or are a woman. Ask your doctor about your risk.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• kidney disease;

• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or

• if you drink alcohol.

Tell your doctor if you are pregnant and use your medications properly to control your infection. HIV can be passed on to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track the effects of antiviral medications on the baby.

Women with HIV or AIDS should not breastfeed their babies. Even if your baby is born without HIV, the virus can be passed to the baby through breast milk.

Abacavir and lamivudine should not be given to children who weigh less than 55 pounds.

How should I take abacavir and lamivudine?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Abacavir and lamivudine can be taken with or without food. Tell your doctor if a child taking this medicine has trouble swallowing the tablet.

There is a medication guide and a warning card with the symptoms of an allergic reaction for abacavir and lamivudine.Read this informationand find out what symptoms you should look out for. Always carry the wallet card with you.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop taking any medicine without your doctor's advice. Every person with HIV should continue to be cared for by a doctor.

Store at room temperature, protected from moisture and heat.

If you have ever had hepatitis B, this virus may become active or worsen in the months after you stop abacavir and lamivudine. You may need to have your liver function tested frequently while you are using this medicine and for several months after your last dose.

Abacavir and lamivudine dosage information

Usual adult dose for HIV infection:

1 tablet orally once daily

Use: In combination with other antiretroviral agents to treat HIV-1 infection

Usual adult dose for occupational exposure:

US Public Health Service Working Group recommendations: 1 tablet orally once daily
Duration of therapy: 28 days, if tolerated

Comments:
-Only with specialist advice, as part of alternative antiretroviral therapy for use as HIV post-exposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within a few hours of exposure.
-The optimal duration of prophylaxis is unknown and may vary depending on facility protocol.
– For further information, current guidelines should be consulted.

Usual pediatric dose for HIV infection:

At least 25 kg: 1 tablet orally once daily

Comments:
-The use of each component is recommended for patients under 25 kg; The manufacturer's product information for abacavir and lamivudine should be consulted.
-Before prescribing this medicine, the ability to swallow tablets should be assessed.

Use: In combination with other antiretroviral agents to treat HIV-1 infection

What happens if I miss a dose?

Take the medicine as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not take two doses at the same time.

Get your prescription refilled before you completely run out of medication.If you miss several doses, you may have a dangerous or even fatal allergic reaction when you start taking this medicine again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid when taking abacavir and lamivudine?

Taking abacavir and lamivudine does not prevent the transmission of HIV to other people. Don't have unprotected sex or share razors or toothbrushes. Talk to your doctor about safe ways to prevent HIV transmission during sex. Sharing medicine or medication needles is never safe, even for a healthy person.

What other drugs affect abacavir and lamivudine?

Other medications can affect abacavir and lamivudine, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.