Roferon-A Side Effects
Generic Name: interferon alfa-2a
Note: This document contains side effect information about interferon alfa-2a. Some of the dosage forms listed on this page may not apply to the brand name Roferon-A.
Applies to interferon alfa-2a: injectable powder for injection, injectable solution
Depression has been reported to have sometimes continued after decreases in dosage or discontinuation of therapy.
Results of a recent study (n=14) of patients affected by chronic hepatitis C who received interferon alfa-2b suggests that the development of the interferon alfa-induced depressive symptoms may arise through depletion of central and peripheral 5-HT and reduction of tryptophan plasma levels.[Ref]
Psychiatric side effects have included depression (16% to 28%) and suicidal behavior including suicidal ideation, suicide attempts, and suicides. Irritability (15%), insomnia (14%), anxiety (5% to 6%), and behavioral disturbances (3%) have also been reported. In a study of patients (n=25) with chronic myelogenous leukemia conducted to evaluate the neuropsychological symptoms related to the treatment with interferon alfa, a disproportionate number of these patients scored in the impaired range on tests of verbal memory, delayed visual memory, verbal fluency, visual scanning and sequencing, executive function, and motor dexterity for the preferred hand when compared to controls. Besides the mentioned cognitive deficits, the patients receiving interferon alfa also showed signs of personality and mood disturbances.[Ref]
Flu like symptoms may be especially prevalent during the first week of therapy.[Ref]
Other side effects have included flu like symptoms such as fatigue (58% to 95%), fever (25% to 92%), myalgia (68% to 71%), headache (44% to 66%), chills (23% to 64%), arthralgia/bone pain (25% to 47%), asthenia (6%), sweating (5%), leg cramps (3%), and malaise (1%). Weight loss (25% to 33%), change in taste or smell (3% to 25%), pain (24%), back pain (16%), night sweats (8%), menstrual irregularity (4%), reversible hearing loss, and tinnitus have also been reported.[Ref]
Gastrointestinal (GI) side effects have included anorexia (14% to 65%), diarrhea (20% to 42%), nausea/vomiting (33% to 39%), abdominal pain (12% to 15%), flatulence (3%), liver pain (3%), impaired digestion (2%), gingival bleeding (2%), and GI hemorrhage.[Ref]
Nervous system side effects have included headache (44% to 64%), dizziness (11% to 40%), decreased mental status (10% to 17%), paresthesias (7% to 12%), numbness (3% to 12%), sleep disturbances (10% to 11%), confusion (5% to 8%), involuntary movements (7%), lethargy (6%), sleep disturbances (5%), and impaired concentration (4%). At least one case of myorhythmia has also been reported, in addition to a case of encephalopathy.[Ref]
Most of the central nervous system adverse effects have been mild and reversible within a few days to 3 weeks after dose reduction or discontinuation of therapy.
A 49-year-old female with a history of chronic myeloid leukemia experienced myorhythmia coincident with interferon alfa-2a therapy. She was treated with increasing doses of subcutaneous interferon alfa-2a up to 6 megaunits daily, with good clinical and hematologic response. After 1.5 years on the interferon, she had a gradual onset of involuntary facial movements. Movements on her forehead and both sides of her lower face were noted by her family members. Brain magnetic resonance imaging (MRI) did not show any structural abnormality. The patient was asked to discontinue interferon. Within 2 weeks, she reported improvement of the facial movements, and at 1 month there was almost complete resolution of her symptoms.
A 44-year-old female with metastatic renal cell cancer experienced encephalopathy coincident with interferon alfa-2a therapy. She presented with progressive apathy and slight subjective memory loss as well as two seizures. Electroencephalogram showed multifocal epileptiform discharges. Lumbar puncture results were normal. MRI demonstrated hyperintensities in the basal ganglia and the adjacent white matter but no other significant lesions. After stopping interferon therapy, the patients clinical state normalized, as did MRI 3 weeks later.[Ref]
Dermatologic side effects have included skin rash (8% to 44%), injection site reaction (29%), diaphoresis (7% to 22%), partial alopecia (17% to 22%), dry skin (7% to 17%), pruritus (7% to 13%), hematoma (1%). Psoriasis, cutaneous eruptions, eczema, and seborrhea have also been reported in less than 1% of patients.[Ref]
Respiratory side effects have included cough (19% to 27%), throat irritation (21%), coughing (16%), rhinorrhea (12%), dyspnea (8% to 12%), pneumonia (11%), sinusitis (greater than 1% to 11%), dryness or inflammation of the oropharynx (6%), epistaxis (4%), and rhinitis (3%).[Ref]
Cardiovascular side effects have included hypertension (11%), edema (9% to 11%), chest pain (4% to 11%), dysrhythmia (7%), hypotension (4%), and arrhythmia (1%). Myocardial infarction has been reported rarely. Cases of cardiomyopathy have been reported rarely in patients treated with alpha interferons.[Ref]
Musculoskeletal side effects have included arthritis or polyarthritis (5%).[Ref]
Hepatic side effects have included transient increases of liver transaminase or alkaline phosphatase in up to 50% of studied patients diagnosed with chronic myelogenous leukemia receiving interferon alfa-2a (the active ingredient contained in Roferon-A) Other hepatic side effects rarely reported have included pancreatitis, hypertriglyceridemia, and hepatitis.[Ref]
The incidence of neutropenia (WHO grades III or IV) among chronic hepatitis C patients was over twice as high in those treated with 6 million international units thrice weekly (21%) as those treated with 3 million international units three times weekly (10%).[Ref]
Metabolic side effects have included hyperglycemia.[Ref]
1. "Product Information. Roferon-A Injection (interferon alfa-2a)." Roche Laboratories, Nutley, NJ.
2. Bonaccorso S, Marino V, Puzella A, et al. "Increased Depressive Ratings in Patients With Hepatitis C Receiving Interferon-alpha-Based Immunotherapy Are Related to Interferon-alpha-Induced Changes in the Serotonergic System." J Clin Psychopharmacol 22 (2002): 86-90
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9. Hamnvik OP, Larsen PR, Marqusee E "Thyroid dysfunction from antineoplastic agents." J Natl Cancer Inst 103 (2011): 1572-87
Some side effects may not be reported. You may report them to the FDA.