Combivir Side Effects

Please note - some side effects for Combivir 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 Combivir - for the Consumer

Combivir

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 Combivir:

Appetite loss; changes in body fat; cough; diarrhea; dizziness; fatigue; headache; indigestion; nasal problems; sleeplessness or other sleep problems; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression; fast or irregular heartbeat; infection (fever, chills, sore throat); inflammation of the pancreas (severe stomach pain, nausea, vomiting); joint pain; mental or mood changes; muscle pain; nausea; numbness, tingling, or weakness in arms or legs; seizures; shortness of breath; stomach tenderness or pain; swelling or soreness of the mouth or tongue; unusual bleeding or bruising; unusual tiredness; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

Combivir Side Effects - for the Professional

Combivir

• The most commonly reported adverse reactions (incidence greater than or equal to 15%) in adult and pediatric HIV-1 clinical studies of combination lamivudine and zidovudine were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

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.

Gastrointestinal

Gastrointestinal side effects have included nausea (33%), diarrhea (18%), nausea and vomiting (13%), anorexia and/or decreased appetite (10%), abdominal pain (9%), abdominal cramps (6%), and dyspepsia (5%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Oral mucosal pigmentation, stomatitis, and pancreatitis have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Pancreatitis has been reported in 0.3% of patients receiving lamivudine during clinical studies. Taste perversion and flatulence have also been reported.

Hepatic

Hepatic side effects have included elevations in ALT (greater than 5 times ULN, 3.7%), AST (greater than 5 times ULN, 1.7%), bilirubin (greater than 2.5 times ULN, 0.8%), and amylase (greater than 2.0 ULN, 4.2%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, and posttreatment exacerbation of hepatitis B have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy.

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 HIV disease. If bone marrow toxicity occurs, an interruption or discontinuation of zidovudine therapy may be necessary.

Hematologic side effects have included neutropenia (7.2%), anemia (2.9%), and thrombocytopenia (0.4%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Anemia (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, and splenomegaly have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Exacerbation of anemia has been reported in HIV-1/HCV coinfected patients receiving ribavirin and zidovudine. Aplastic anemia, hemolytic anemia, leukopenia, and pancytopenia with marrow hypoplasia have been associated with zidovudine.

Nervous system

Nervous system side effects have included headache (35%), neuropathy (12%), insomnia and other sleep disorders (11%), and dizziness (10%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Paresthesia, peripheral neuropathy, and seizures have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Generalized seizures, status epilepticus, confusion, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine. Zidovudine has been associated with hearing loss.

Other

Other side effects have included malaise and fatigue (27%) and fever or chills (10%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Weakness and redistribution/accumulation of body fat have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Progressive subcutaneous fat wasting has been reported.

Respiratory

Respiratory side effects have included nasal signs and symptoms (20%) and cough (18%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Abnormal breath sounds/wheezing have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Dyspnea, rhinitis, and sinusitis have been reported.

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 have included musculoskeletal pain (12%), myalgia (8%), and arthralgia (5%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Muscle weakness, elevated CPK, and rhabdomyolysis have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Zidovudine-related myopathy may occur after prolonged use.

Dermatologic

Dermatologic side effects have included skin rashes (9%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Pruritus has also been reported. Skin and nailbed pigmentation changes, toxic epidermal necrolysis, increased sweating, urticaria, and leukocytoclastic vasculitis with eosinophilia and fever have been associated with zidovudine. Rarely, nail hyperpigmentation has been accompanied by mucocutaneous pigmentation or hypertrichosis.

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.

Psychiatric

Psychiatric side effects have included depressive disorders (9%) during clinical studies 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, confusion, loss of mental acuity, and grandiosity.

Cardiovascular

Cardiovascular side effects have included cardiomyopathy and vasculitis during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Syncope has been reported.

Hypersensitivity

Hypersensitivity side effects have included sensitization reactions (including anaphylaxis) and urticaria during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Genitourinary

Genitourinary side effects have included gynecomastia during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine. Urinary frequency and urinary hesitancy have been associated with zidovudine.

Ocular

Ocular side effects have included amblyopia, photophobia, and at least one case of macular edema.

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