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Trizivir

"Current prevention strategies have reduced the incidence of HIV worldwide, but that decline has slowed in recent years. We need new prevention strategies if we are to realize President Obama's goal of an AIDS-free generation. Targeting people who"...

Trizivir

Trizivir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Trizivir (abacavir sulfate, lamivudinc, and zidovudinc) is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS. It is a type of antiviral medication called a reverse transcriptase inhibitor. Common side effects include headache, tiredness, weakness, nausea, vomiting, loss of appetite, diarrhea, dizziness, or trouble sleeping.

The recommended oral dose of Trizivir is one tablet twice daily. Trizivir may interact with methadone, ribavirin, interferon, sulfa drugs, doxorubicin, ganciclovir, or other HIV medicines. Tell your doctor all medications and supplements you use. During pregnancy, Trizivir should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if abacavir passes into breast milk. Lamivudine and zidovudine pass into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Trizivir (abacavir sulfate, lamivudinc, and zidovudinc) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Trizivir in Detail - Patient Information: Side Effects

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 medication, 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 may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, 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.

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;
  • signs of a new infection such as flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
  • severe pain in your upper stomach spreading to your back;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (goiter);
  • problems with walking, breathing, speech, swallowing, or eye movement;
  • severe lower back pain, loss of bladder or bowel control; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder.

Less serious side effects may include:

  • headache, joint pain, depression, nervousness;
  • cold symptoms such as stuffy nose, sneezing, sinus pain;
  • mild nausea or diarrhea; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);

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.

Read the entire detailed patient monograph for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Trizivir Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and How to Use sections.

Headache, tiredness, weakness, nausea, vomiting, loss of appetite, diarrhea, dizziness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, skin/nail color changes.

Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Trizivir FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a frequency greater than or equal to 5% during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 1.

Table 1. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, ≥ 5% Frequency) in Therapy-Naive Adults (CNA3005) Through 48 Weeks of Treatment

Adverse Reaction ZIAGEN plus
Lamivudine/ Zidovudine
(n = 262)
Indinavir plus
Lamivudine/ Zidovudine
(n = 264)
Nausea 19% 17%
Headache 13% 9%
Malaise and fatigue 12% 12%
Nausea and vomiting 10% 10%
Hypersensitivity reaction 8% 2%
Diarrhea 7% 5%
Fever and/or chills 6% 3%
Depressive disorders 6% 4%
Musculoskeletal pain 5% 7%
Skin rashes 5% 4%
Ear/nose/throat infections 5% 4%
Viral respiratory infections 5% 5%
Anxiety 5% 3%
Renal signs/symptoms < 1% 5%
Pain (non-site-specific) < 1% 5%

Five subjects receiving abacavir in CNA3005 experienced worsening of pre-existing depression compared to none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.

Laboratory Abnormalities: Laboratory abnormalities in CNA3005 are listed in Table 2.

Table 2. Treatment-Emergent Laboratory Abnormalities (Grades 3/4) in CNA3005

Grade 3/4
Laboratory Abnormalities
Number of Subjects by Treatment Group
ZIAGEN plus
Lamivudine/ Zidovudine
(n = 262)
Indinavir plus
Lamivudine/ Zidovudine
(n = 264)
Elevated CPK ( > 4 x ULN) 18(7%) 18(7%)
ALT( > 5.0xULN) 16 (6%) 16 (6%)
Neutropenia ( < 750/mm3) 13 (5%) 13 (5%)
Hypertriglyceridemia ( > 750 mg/dL) 5 (2%) 3 (1%)
Hyperamylasemia ( > 2.0 x ULN) 5 (2%) 1 ( < 1%)
Hyperglycemia ( > 13.9 mmol/L) 2 ( < 1%) 2 ( < 1%)
Anemia (Hgb ≤ 6.9 g/dL) 0 (0%) 3 (1%)
ULN = Upper limit of normal,
n = Number of subjects assessed.

Other Adverse Events: In addition to adverse reactions in Tables 1 and 2, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GOT.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of abacavir, lamivudine, and/or zidovudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to abacavir, lamivudine and/or zidovudine.

Abacavir

Cardiovascular: Myocardial infarction.

Skin: 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. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.

There have also been reports of erythema multiforme with abacavir use.

Abacavir, Lamivudine, and/or Zidovudine:

Body as a Whole: Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Cardiovascular: Cardiomyopathy.

Digestive: Stomatitis.

Endocrine and Metabolic: Gynecomastia, hyperglycemia.

Gastrointestinal: Anorexia and/or decreased appetite, abdominal pain, dyspepsia, oral mucosal pigmentation.

General: Vasculitis, weakness.

Hemic and Lymphatic: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia.

Hepatic: Lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS], elevated bilirubin, elevated transaminases, posttreatment exacerbation of hepatitis B [see WARNINGS AND PRECAUTIONS].

Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal: Arthralgia, myalgia, muscle weakness, CPK elevation, rhabdomyolysis.

Nervous: Dizziness, paresthesia, peripheral neuropathy, seizures.

Psychiatric: Insomnia and other sleep disorders.

Respiratory: Abnormal breath sounds/wheezing.

Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.

Read the entire FDA prescribing information for Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine) »

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Trizivir - User Reviews

Trizivir User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trizivir sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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