Rebetron Side Effects

Please note - some side effects for Rebetron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

General

Interferon alfa-2b-ribavirin therapy was discontinued in 19% and 6% of previously untreated and relapse patients, respectively, during clinical trials. In comparison, 13% of previously untreated patients and 3% of relapse patients discontinued therapy in the interferon arms.

Alpha interferons, including interferon alfa-2b, have caused or aggravated fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. In many but not all cases these disorders resolved after stopping interferon alfa-2b.

Hematologic

Hemolytic anemia is the primary toxicity of ribavirin therapy. Hemoglobin levels generally declined within the first 1 to 2 weeks of ribavirin therapy. Cardiac and pulmonary events associated with anemia have been reported in about 10% of patients.

The mean maximum decrease from baseline hemoglobin levels observed in US and international studies ranged from 2.6 g/dL to 3.1 g/dL. Hemoglobin values returned to pretreatment levels within 4 to 8 weeks of cessation of therapy in most patients. Neutrophil and platelet values returned to pretreatment levels within 4 weeks after treatment discontinuation.

Hematologic side effects have included decreased hemoglobin (9.5 to 10.9 g/dL: up to 32%; 8 to 9.4 g/dL: up to 5%), leukocytes [2 to 2.9 x 10(9)/L: up to 45%; 1.5 to 1.9 x 10(9)/L: up to 9%; 1 to 1.4 x 10(9)/L: up to 2%], neutrophils [1 to 1.49 x 10(9)/L: up to 42%; 0.75 to 0.99 x 10(9)/L: up to 16%; 0.5 to 0.74 x 10(9)/L: up to 14%; less than 0.5 x 10(9)/L: up to 11%], and platelets [70 to 99 x 10(9)/L: up to 11%; 50 to 69 x 10(9)/L: up to 2%; less than 30 x 10(9)/L: up to 1%]. Bone marrow function suppression, which may result in severe cytopenias, has been reported with interferon alfa-2b therapy. Hemolytic anemia (hemoglobin less than 10 g/dL) was observed in approximately 10% of patients on combination therapy in clinical trials. Aplastic anemia has been rarely reported with interferon alfa-2b-ribavirin therapy.

Respiratory

Cardiac and pulmonary events associated with anemia have been reported in about 10% of patients.

Respiratory side effects have included dyspnea (up to 19%) and sinusitis (up to 12%). Pulmonary symptoms (including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and fatal pneumonia), sarcoidosis, and exacerbation of sarcoidosis have been reported.

Cardiovascular

Cardiovascular side effects have included deterioration of cardiac function and/or exacerbation of the symptoms of coronary disease due to the anemia associated with interferon alfa-2b-ribavirin therapy.

Cardiac and pulmonary events associated with anemia have been reported in about 10% of patients.

Psychiatric

Psychiatric side effects have included insomnia (up to 39%), depression (up to 36%), irritability (up to 32%), impaired concentration (up to 14%), emotional lability (up to 12%), and nervousness (up to 5%). Suicidal behavior (including ideation, attempts, and suicides) has been reported in 1% of patients. Severe psychiatric side effects, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides), and rare cases of homicidal ideation, have been reported in patients with and without previous psychiatric disorder.

Nervous system

Nervous system side effects have included headache (up to 66%), dizziness (up to 26%), and taste perversion (up to 8%). Hearing disorders (including tinnitus and hearing loss) and vertigo have been reported in postmarketing studies.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 47%), anorexia (up to 27%), dyspepsia (up to 16%), and vomiting (up to 12%). Pancreatitis, including fatal and nonfatal, has been observed.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 64%), arthralgia (up to 33%), and musculoskeletal pain (up to 28%).

Ocular

Ocular side effects induced or aggravated by alpha interferon therapy have included decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment.

Hypersensitivity

Hypersensitivity side effects have included acute serious hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) in patients treated with interferon alfa-2b.

Dermatologic

Dermatologic side effects have included alopecia (up to 32%), rash (up to 28%), and pruritus (up to 21%). Exacerbation of preexisting psoriasis has been reported. Transient rashes have been reported in some patients following interferon alfa-2b injection.

Endocrine

A case report of hyperthyroidism, manifested in the form of thyroiditis, in a 28-year-old woman responding well to interferon alfa-2b-ribavirin therapy, suggested that temporary interferon alfa-2b dose reduction and symptomatic treatment may be all that is needed in destructive thyroiditis.

Endocrine side effects have included thyroid abnormalities, including hypothyroidism and hyperthyroidism. Thyroiditis has been reported.

Local

Local side effects have included injection site inflammation (up to 13%) and injection site reaction (up to 8%).

Other

Other side effects have included fatigue (up to 70%), rigors (up to 43%), fever (up to 41%), influenza-like symptoms (up to 18%), asthenia (up to 10%), and chest pain (up to 9%). Increases in both bilirubin and uric acid, associated with hemolysis, have been reported in clinical trials. Elevated total bilirubin (1.5 to 3 mg/dL: up to 32%; 3.1 to 6 mg/dL: up to 3%; 6.1 to 12 mg/dL: up to 0.4%) has been reported.

Most cases of increased bilirubin and uric acid were moderate biochemical changes, reversed within 4 weeks after treatment discontinuation, and were not associated with hepatic dysfunction or clinical morbidity.

Immunologic

Immunologic side effects have included exacerbation of autoimmune disease in patients receiving interferon alfa-2b.

Metabolic

Diabetic ketoacidosis was reported in a 53-year-old white female after week 24 of treatment, who had in the first 12 weeks of treatment normal random blood glucose limits (less than 110 mg/dL), and required insulin. Interferon alfa-2b-ribavirin was stopped.

Metabolic side effects have included elevated triglycerides, hyperglycemia, new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and diabetic ketoacidosis.

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