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.
Some side effects of Roferon-A may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to interferon alfa-2a: injectable powder for injection, injectable solution
Call your doctor or seek emergency medical attention if you develop symptoms of depression or are contemplating suicide; become unusually irritable, anxious (nervous), or aggressive; or experience other mood or behavior changes. In some cases, interferon alfa-2a (the active ingredient contained in Roferon-A) has caused serious mood or behavioral problems.
Problems with body organs such as the heart, lungs, and eyes have been experienced by people taking interferon alfa-2a or other similar drugs. Contact your doctor immediately if you develop difficulty breathing, chest pain, blurred vision, or loss of vision.
Some patients taking interferon alfa-2a have developed a drop in the number of white blood cells and platelets. If the number of these blood cells are too low, there is an increased risk of infection or bleeding. Contact your doctor immediately if you develop a fever, symptoms of an infection, or unusual bleeding or bruising.
If you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives), stop using interferon alfa-2a and seek emergency medical attention.
Flu-like symptoms are likely to occur. They are most common at the start of therapy and may decrease with continued use. Over-the-counter fever reducers such as acetaminophen (Tylenol, others), ibuprofen (Motrin, Advil, others), and naproxen (Aleve), plenty of fluids, and taking the medication at bedtime may help to alleviate these symptoms. Continue to use interferon alfa-2a and notify your doctor if you experience
fever or chills;
muscle aches or sore joints;
numbness or tingling;
nausea, vomiting, or loss of appetite;
dizziness or drowsiness;
nervousness or anxiety;
loss or thinning of hair;
itching or a rash; or
pain, redness, or bruising at the injection site.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
For Healthcare Professionals
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.
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.
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.
Flu like symptoms may be especially prevalent during the first week of therapy.
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.
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.
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.
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.
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%).
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.
Ocular side effects have included visual disturbance (5% to 6%) and conjunctivitis (4%).
Musculoskeletal side effects have included arthritis or polyarthritis (5%).
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.
Severe chronic active hepatitis has been reported in a patient post completion of interferon alfa-2a therapy and successful treatment of chronic active hepatitis B.
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%).
Hematologic side effects have included decreases in WBC (including neutropenia), hematocrit, and platelet counts.
Endocrine side effects have included thyroid disorders (hyperthyroidism or hypothyroidism).
Metabolic side effects have included hyperglycemia.
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