Trizivir

What Is Trizivir?

Trizivir (abacavir sulfate, lamivudine, and zidovudine) is a type of antiviral medication called a reverse transcriptase inhibitor used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Trizivir is not a cure for HIV or AIDS.

What Are Side Effects of Trizivir?

Common side effects of Trizivir include:

• headache,
• tiredness,
• weakness,
• nausea,
• vomiting,
• loss of appetite,
• diarrhea,
• dizziness,
• trouble sleeping,
• joint pain,
• depression,
• nervousness,
• cold symptoms (stuffy nose, sneezing, sinus pain), or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

Tell your doctor if you have serious side effects of Trizivir including:

• unexplained weight loss,
• persistent muscle aches or weakness,
• joint pain,
• numbness or tingling of the hands/feet/arms/legs,
• severe tiredness,
• vision changes,
• severe or 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),
• mental/mood changes (such as depression, anxiety),
• easy bruising or bleeding, or
• skin and nail color changes.

Dosage for Trizivir

The recommended oral dose of Trizivir is one tablet twice daily.

What Drugs, Substances, or Supplements Interact with Trizivir?

Trizivir may interact with methadone, ribavirin, interferon, sulfa drugs, doxorubicin, ganciclovir, or other HIV medicines. Tell your doctor all medications and supplements you use.

Trizivir During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or become pregnant before using Trizivir. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Trizivir 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.

Additional Information

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.

 

Trizivir Consumer Information

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.

Also call your doctor at once if you have:

• other signs of allergic reaction--skin blisters or peeling, eye redness, swelling in your face or throat, trouble breathing;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Abacavir, lamivudine, and zidovudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken 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;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• headache;
• weakness or tiredness;
• 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.

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

 

Trizivir Professional Information

SIDE EFFECTS

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

• Serious and sometimes fatal hypersensitivity reactions [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Symptomatic myopathy [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS].
• Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS].
• Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
• Lipoatrophy [see WARNINGS AND PRECAUTIONS].
• Myocardial infarction [see WARNINGS AND PRECAUTIONS].

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.

Serious And Fatal Abacavir-Associated Hypersensitivity Reactions

In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of TRIZIVIR [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. These reactions have been characterized by 2 or more of the following signs or symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, or achiness); (5) respiratory symptoms (including dyspnea, cough, or pharyngitis). Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome.

Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia, and abnormal chest x-ray findings (predominantly infiltrates, which were localized).

Additional Adverse Reactions With Use Of TRIZIVIR

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, Greater than or Equal to 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

Laboratory Parameter	ZIAGEN plus Lamivudine/ Zidovudine (n = 262)	Indinavir plus Lamivudine/ Zidovudine (n = 264)
Elevated CPK (>4 x ULN)	18 (7%)	18 (7%)
ALT (>5.0 x ULN)	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 GGT.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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 [see ADVERSE REACTIONS].

Abacavir, Lamivudine, And/Or Zidovudine

Body as a Whole: Redistribution/accumulation of body fat.

Cardiovascular: Cardiomyopathy.

Digestive: Stomatitis.

Endocrine and Metabolic: Gynecomastia.

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 exacerbations of hepatitis B [see WARNINGS AND PRECAUTIONS].

Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal: Arthralgia, myalgia, muscle weakness, 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)