a-BAK-a-vir SUL-fate, la-MIV-ue-deen, zye-DOE-vue-deen
The three nucleoside analogue combination (abacavir sulfate, lamivudine, and zidovudine) is intended only for patients whose regimen would otherwise include these 3 components.
Hypersensitivity reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate. 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/zidovudine as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue abacavir sulfate/lamivudine/zidovudine if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, never restart abacavir sulfate/lamivudine/zidovudine 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/zidovudine 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.
Hematologic Toxicity: Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV-1) disease. Prolonged use of zidovudine has been associated with symptomatic myopathy.
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, zidovudine, 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) HIV-1 and have discontinued lamivudine, which is one component of abacavir sulfate/lamivudine/zidovudine. 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/zidovudine and are co-infected with HIV-1 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. Patients with HLA-B*5701 allele are at high risk for hypersensitivity to abacavir sulfate; screening for allele is recommended prior to initiating or reinitiation of therapy. Neutropenia, severe anemia, and symptomatic myopathy has been associated with zidovudine use, particularly in patients with advanced HIV disease. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues 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 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Abacavir
Abacavir, lamivudine, and zidovudine combination is used alone or together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Abacavir, lamivudine, and zidovudine combination will not cure or prevent HIV infection or the symptoms of AIDS. abacavir, lamivudine, and zidovudine 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, lamivudine, and zidovudine combination will not keep you from spreading HIV to other people. People who receive abacavir, lamivudine, and zidovudine may continue to have other problems usually related to AIDS or HIV infection.
abacavir, lamivudine, and zidovudine is available only with your doctor's prescription.
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, lamivudine, and zidovudine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to abacavir, lamivudine, and zidovudine 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.
Abacavir, lamivudine, and zidovudine combination contains a fixed amount of each medicine that cannot be decreased. Therefore, abacavir, lamivudine, and zidovudine is not recommended for patients who weigh less than 40 kilograms (88 pounds) because the amounts of abacavir, lamivudine, and zidovudine in this product cannot be adjusted for smaller body sizes.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abacavir, lamivudine, and zidovudine 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 abacavir, lamivudine, and zidovudine.
|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.|
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.
Using abacavir, lamivudine, and zidovudine 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.
Using abacavir, lamivudine, and zidovudine 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.
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.
The presence of other medical problems may affect the use of abacavir, lamivudine, and zidovudine. Make sure you tell your doctor if you have any other medical problems, especially:
Take abacavir, lamivudine, and zidovudine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not start or stop taking abacavir, lamivudine, and zidovudine combination without checking with your doctor first.
abacavir, lamivudine, and zidovudine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
abacavir, lamivudine, and zidovudine will be given together with other medicines for HIV infection. Take all of the medicines your doctor gives you at the right time of day. These medicines work 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 medicines, check with your doctor.
When your supply of abacavir, lamivudine, and zidovudine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to abacavir, lamivudine, and zidovudine and be harder to treat.
Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.
Abacavir, lamivudine, and zidovudine combination contains a fixed amount of each medicine in the tablet.
The dose of abacavir, lamivudine, and zidovudine 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 abacavir, lamivudine, and zidovudine. 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.
If you miss a dose of abacavir, lamivudine, and zidovudine, 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.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure that abacavir, lamivudine, and zidovudine is working properly. Blood tests may be needed to check for unwanted effects.
abacavir, lamivudine, and zidovudine 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 abacavir, lamivudine, and zidovudine and check with your doctor immediately if you 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; shortness of breath; 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 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 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, 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 or your child have more than one of these symptoms: abdominal 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 (e.g., 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.
You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
abacavir, lamivudine, and zidovudine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles with anyone or use dirty needles. If you have any questions about this, check with your doctor.
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.
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
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
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.
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