Abacavir and lamivudine

Name: Abacavir and lamivudine

What is abacavir and lamivudine?

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

Abacavir and lamivudine is a combination medicine used to treat HIV, which can cause the 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.

What is the most important information I should know about abacavir and lamivudine?

Abacavir and lamivudine can cause severe or fatal side effects. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Stop taking abacavir and lamivudine and call your doctor at once if you have signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine.

How should I take abacavir and lamivudine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine. Visit your doctor regularly.

Commonly used brand name(s)

In the U.S.

  • Epzicom

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Abacavir

Before Using abacavir and lamivudine

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 abacavir and lamivudine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abacavir and lamivudine 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Epzicom® in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Epzicom® 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 Epzicom®.

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.

Interactions with 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 abacavir and lamivudine, 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 abacavir and lamivudine 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.

  • Dasabuvir
  • Orlistat
  • Ribavirin

Using abacavir and lamivudine 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
  • Tipranavir

Interactions with Food/Tobacco/Alcohol

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 abacavir and lamivudine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Heart disease or
  • Hepatitis B, history of or
  • Hepatitis C, history of 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)
  • Kidney disease, severe or
  • Liver disease, moderate or severe—Should not be used in patients with these conditions.

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.
  • Very bad dizziness or passing out.
  • Chest pain or pressure.
  • Low mood (depression).
  • Mouth sores.
  • Muscle pain or weakness.
  • Swollen gland.
  • A burning, numbness, or tingling feeling that is not normal.
  • 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 and lamivudine. 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.

Pronunciation

(a BAK a veer & la MI vyoo deen)

Pharmacologic Category

  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)

Contraindications

Hypersensitivity to abacavir, lamivudine, or any component of the formulation; patients who have the HLA-B*5701 allele; moderate or severe hepatic impairment

Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (regardless of severity)

Monitoring Parameters

Amylase, bilirubin, blood glucose, serum creatine kinase, liver enzymes, hematologic parameters, triglycerides, viral load, and CD4 count; HLA-B*5701 genotype status prior to initiation of therapy; signs and symptoms of hypersensitivity.

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

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