Trizivir Side Effects

Please note - some side effects for Trizivir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trizivir - for the Consumer

Trizivir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trizivir:

Decreased appetite; diarrhea; headache; joint or muscle pain; nausea; nervousness; tiredness; vomiting; weakness.

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression; excess hunger, thirst, or urination; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mouth ulcers; severe or persistent muscle pain, weakness, or cramping; numbness, tingling, or pain in the hands and feet; pale stools; red, swollen, blistered, or peeling skin; swollen lymph nodes; unusual tiredness or weakness; yellowing of the skin or eyes.

Trizivir Side Effects - for the Professional

Trizivir

Hypersensitivity Reaction:

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of Trizivir.

Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency 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 5.

Five patients receiving abacavir in study 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 in study CNA3005 are listed in Table 6.

In addition to adverse reactions in Tables 5 and 6, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.

Observed During Clinical Practice:

The following events have been identified during post-approval 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 events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine and/or zidovudine.

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.

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

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 and Pancreatic: Lactic acidosis and hepatic steatosis, elevated bilirubin, elevated transaminases, pancreatitis, posttreatment exacerbation of hepatitis B.

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. 

Side Effects by Body System

Hypersensitivity

Because abacavir/lamivudine/zidovudine combination tablets contain abacavir, the combination tablet should not be restarted following a hypersensitivity reaction because more severe symptoms will occur within hours and may include life-threatening hypotension and death. It should be permanently discontinued if hypersensitivity can not be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.

Fatal hypersensitivity reactions have been associated with abacavir therapy. Frequently observed signs and symptoms include, but are not limited to, fever, skin rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, abnormal chest X-ray findings, adult respiratory distress syndrome, respiratory failure and erythema multiforme. 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. Sensitization reactions including anaphylaxis have rarely occurred with the use of lamivudine plus zidovudine administered as separate formulations.

Gastrointestinal

Gastrointestinal side effects have included nausea (47%), nausea and vomiting (16%), diarrhea (12%), and loss of appetite/anorexia (11%) when abacavir was administered with lamivudine and zidovudine. Abdominal pain, abdominal cramps, pancreatitis, oral mucosal pigmentation, and dyspepsia have also been reported. Oral ulcerations and lesions have been observed with the use of lamivudine and flatulence has been reported with the use of zidovudine.

Dermatologic

Bluish or brownish-black discoloration of nails may develop during the first month or two of zidovudine therapy and usually disappears within 2 months if the drug is discontinued. Discoloration may occur as longitudinal streaks or transverse bands.

Dermatologic side effects have included hair loss 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. Dermatologic side effects associated with abacavir have included rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Sweet's syndrome.

Hematologic

Zidovudine should be used with extreme caution in patients with bone marrow suppression indicated by a granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Routine blood counts are recommended, and generally should occur more frequently in patients with advanced disease. If bone marrow toxicity occurs, an interruption or discontinuation of zidovudine therapy may be necessary.

Hematologic side effects have included anemia, neutropenia and CPK elevations when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Hematologic side effects observed with the use of lamivudine plus zidovudine have included neutropenia (7.2%), anemia (2.9%), and thrombocytopenia (0.4%). Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, and splenomegaly have also been reported during postmarketing experience.

Musculoskeletal

In one zidovudine study, myalgias and elevated CK 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.

Musculoskeletal side effects observed with the use of lamivudine plus zidovudine administered as separate formulations have included musculoskeletal pain (12%), myalgia (8%), arthralgia (5%), muscle weakness, CPK elevation, and rhabdomyolysis. Zidovudine-related myopathy may occur after several weeks of therapy and may be difficult to distinguish from that associated with the natural progression of HIV disease.

Nervous system

Nervous system side effects have included insomnia and other sleep disorders (7%) when abacavir was administered with lamivudine and zidovudine. Other nervous system side effects observed with the use of lamivudine plus zidovudine administered as separate formulations have included neuropathy (12%) and dizziness (10%). Generalized seizures, status epilepticus, confusion, paresthesia, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine.

Hepatic

Hepatic side effects associated with the use of nucleoside analogs alone or in combination with other antiretroviral agents have included lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Liver function test abnormalities were seen in clinical trials 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.

Patients with a history of liver disease should be monitored for further deterioration in liver function.

Cardiovascular

Cardiovascular side effects have included rare cases of reversible congestive heart failure, syncope, and vasodilation with the use of zidovudine. Myocardial infarction has been reported during postmarketing experience with the use of abacavir.

Endocrine

Endocrine side effects have included hyperglycemia associated with the use of lamivudine plus zidovudine.

General

The adverse effects of lamivudine plus zidovudine 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.

Ocular

Ocular side effects including a case of macular edema deemed definitively associated with zidovudine occurred in a patient with a history of anterior uveitis secondary to syphilis.

Other

Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome 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.

Psychiatric

Psychiatric side effects have included depressive disorders with the use of lamivudine plus zidovudine administered as separate formulations. Other psychiatric side effects reported with the use of zidovudine have included isolated cases of mania, anxiety, and grandiosity.

Respiratory

Respiratory side effects have included nasal symptoms and cough (20%) in patients treated with lamivudine and zidovudine simultaneously.

Metabolic

Metabolic side effects have included the redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement and cushingoid appearance.

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