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Abacavir, lamivudine, and zidovudine are antiviral medications that prevent human immunodeficiency virus (HIV) cells from multiplying in your body.
Abacavir, lamivudine, and zidovudine (Trizivir) is a combination medicine used to treat HIV, which causes 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.
Stop using this medicine and call your doctor at once if you have any of these 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. Once you have had an allergic reaction to this medicine, you must never use it again.
Trizivir can weaken your immune system. Your blood may need to be tested often.
This medicine may also cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir.
Do not take this medicine if you have ever had an allergic reaction to Trizivir or any medicine that contains abacavir, lamivudine, or zidovudine, including: Combivir, Epivir, Epzicom, Retrovir, or Ziagen. Once you have had an allergic reaction to abacavir, you must never use it again.
Some people taking Trizivir develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.
Trizivir can also cause severe or life-threatening effects on your liver, especially if you have hepatitis B or C.
To make sure Trizivir is safe for you, tell your doctor if you have:
bone marrow suppression;
liver disease (especially if you also use ribavirin or interferon alfa);
heart disease or high blood pressure; or
a risk factor for heart disease such as smoking, diabetes, or high cholesterol.
You may need a blood test before you start taking Trizivir for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.
FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection.
Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Trizivir should not be used to treat HIV in adolescents weighing less than 90 pounds.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Trizivir with or without food.
Trizivir 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.
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 ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.
Store at room temperature away from moisture and heat.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medicine again.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of liver damage.
Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Stop using Trizivir and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:
Group 1 - fever;
Group 2 - rash;
Group 3 - nausea, vomiting, diarrhea, stomach pain;
Group 4 - general ill feeling, extreme tiredness, body aches;
Group 5 - shortness of breath, cough, sore throat.
Once you have had an allergic reaction to this medicine, you must never use it again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking it again.
Trizivir can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:
the first sign of any skin rash, no matter how mild;
low white blood cells--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, trouble concentrating; or
liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
Trizivir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Trizivir. Tell your doctor if you have:
signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
cold sores, sores on your genital or anal area;
rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
Common side effects may include:
nausea, vomiting; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
Usual Adult Dose for HIV Infection:
1 tablet orally every 12 hours
Usual Adult Dose for Nonoccupational Exposure:
(Not approved by FDA)
Centers for Disease Control and Prevention recommendations: 1 tablet orally every 12 hours
Duration: 28 days
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. An alternative regimen recommended for nonoccupational postexposure HIV prophylaxis includes abacavir plus lamivudine plus zidovudine. This triple nucleoside reverse transcriptase inhibitor (NRTI) regimen is recommended only when a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based or a protease inhibitor (PI)-based regimen cannot or should not be used.
Usual Pediatric Dose for HIV Infection:
Adolescents, 40 kg or more: 1 tablet orally every 12 hours
This fixed-dose tablet is not recommended for adolescents who weigh less than 40 kg.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Trizivir, especially:
ribavirin (Copegus, Rebetol, Virazole);
a sulfa drug, such as Bactrim, Septra, SMX-TMP, or SMZ-TMP;
drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection; or
other drugs to treat HIV or AIDS--Atripla, Combivir, Complera, Emtriva, Epivir, Retrovir, Truvada, Zerit, or Ziagen.
This list is not complete. Other drugs may interact with Trizivir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Copyright 1996-2012 Cerner Multum, Inc. Version: 6.02. Revision Date: 2014-08-12, 4:55:50 PM.
Not all side effects for abacavir / lamivudine / zidovudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to abacavir / lamivudine / zidovudine: oral tablet
In addition to its needed effects, some unwanted effects may be caused by abacavir / lamivudine / zidovudine. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking abacavir / lamivudine / zidovudine:More common
Some of the side effects that can occur with abacavir / lamivudine / zidovudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to abacavir / lamivudine / zidovudine: oral tablet
The adverse effects are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.[Ref]
Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)
A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.
Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.[Ref]
Hypersensitivity side effects associated with abacavir have included serious and sometimes fatal hypersensitivity reactions. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, achiness, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia. Hypersensitivity reaction (Grades 2 to 4; 8%) has been reported when abacavir was administered with lamivudine and zidovudine. Sensitization reactions (including anaphylaxis) and urticaria have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Gastrointestinal side effects of at least moderate intensity have included nausea (19%), nausea and vomiting (10%), and diarrhea (7%) when abacavir was administered with lamivudine and zidovudine. Abdominal cramps have been reported. Oral ulcerations and lesions have been observed with the use of lamivudine and flatulence has been reported with the use of zidovudine. Pancreatitis was observed in the expanded access program. Abdominal pain, anorexia and/or decreased appetite, pancreatitis, oral mucosal pigmentation, stomatitis, and dyspepsia have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients coinfected with hepatitis B virus and HIV-1 who have discontinued antihepatitis B therapy, including lamivudine. The causal relationship to stopping lamivudine treatment is unknown.[Ref]
Hepatic side effects have included elevated ALT (greater than 5 times ULN; 6%) and liver function test abnormalities when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy. Increased gamma-glutamyltransferase was observed in the expanded access program. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Hepatic decompensation, sometimes fatal, has been reported in patients coinfected with HIV-1 and hepatitis C virus who were receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Lactic acidosis and hepatic steatosis, elevated bilirubin, elevated transaminases, and posttreatment exacerbations of hepatitis B have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Nervous system side effects of at least moderate intensity have included headache (13%) when abacavir was administered with lamivudine and zidovudine. Generalized seizures, status epilepticus, confusion, paresthesia, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine. Insomnia and other sleep disorders, paresthesia, peripheral neuropathy, seizures, and dizziness have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Other side effects of at least moderate intensity have included malaise and fatigue (12%), fever and/or chills (6%), and non-site-specific pain (less than 1%) when abacavir was administered with lamivudine and zidovudine. Weakness has been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Metabolic side effects have included elevated creatine phosphokinase (greater than 4 times ULN; 7%), hypertriglyceridemia (greater than 750 mg/dL; 2%), hyperamylasemia (greater than 2 times ULN; 2%), and hyperglycemia (greater than 13.9 mmol/L; less than 1%). Redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Progressive subcutaneous fat wasting has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.[Ref]
Bluish or brownish-black discoloration of nails has developed during the first month or two of zidovudine therapy and usually disappeared within 2 months if the drug was discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.
Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.[Ref]
Dermatologic side effects of at least moderate intensity have included skin rashes (5%) when abacavir was administered with lamivudine and zidovudine. Hair loss has been associated with lamivudine therapy in a few patients. Several cases of nailbed hyperpigmentation have been associated with zidovudine. Leukocytoclastic vasculitis with eosinophilia and fever has also been reported with the use of zidovudine. Rash and Sweet's syndrome have been reported with abacavir. Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported during postmarketing experience with abacavir. Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Hematologic side effects have included neutropenia (less than 750/mm3; 5%) when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen. Hematologic toxicity (including neutropenia and severe anemia) has been reported with zidovudine. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, thrombocytopenia, and splenomegaly have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. Abacavir / lamivudine / zidovudine should be used with caution in patients with bone marrow suppression indicated by granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease treated with abacavir / lamivudine / zidovudine. Periodic blood counts are recommended for HIV-1-infected individuals and patients with asymptomatic or early HIV-1 disease.[Ref]
In one zidovudine study, myalgias and elevated creatine phosphokinase occurred in 8% of treated patients with a CD4 cell count less than 200/mm3, and in none of the patients with higher CD4 cell counts. Dosage reduction has not affected the course of myopathy, although drug discontinuation sometimes resulted in improvement of symptoms, generally within a month. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions.[Ref]
Musculoskeletal side effects of at least moderate intensity have included musculoskeletal pain (5%) when abacavir was administered with lamivudine and zidovudine. Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine. Myalgia, arthralgia, muscle weakness, creatine phosphokinase elevation, and rhabdomyolysis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Psychiatric side effects of at least moderate intensity have included depressive disorders (6%), anxiety (5%), and worsening of preexisting depression when abacavir was administered with lamivudine and zidovudine. Other psychiatric side effects reported with the use of zidovudine have included isolated cases of mania, anxiety, and grandiosity.[Ref]
Immunologic side effects of at least moderate intensity have included ear/nose/throat infections (5%) and viral respiratory infections (5%) when abacavir was administered with lamivudine and zidovudine. Immune reconstitution syndrome has been reported. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. The emergence of lamivudine-resistant hepatitis B virus (HBV) has been reported in HIV-1-infected patients who were treated with lamivudine-containing regimens in the presence of coinfection with HBV.
Cardiovascular side effects have included rare cases of reversible congestive heart failure, syncope, and vasodilation with zidovudine. Myocardial infarction has been reported during postmarketing experience with abacavir. Cardiomyopathy and vasculitis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.[Ref]
Respiratory side effects have included nasal symptoms and cough in patients treated with lamivudine and zidovudine simultaneously. Abnormal breath sounds/wheezing have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]
Genitourinary side effects have included gynecomastia during postmarketing experience with abacavir, lamivudine, and/or zidovudine.
Renal side effects of at least moderate intensity have included renal signs/symptoms (not specified) in less than 1% of patients when abacavir was administered with lamivudine and zidovudine.
Ocular side effects have included a case of macular edema deemed definitively associated with zidovudine in a patient with a history of anterior uveitis secondary to syphilis.[Ref]
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