Interferon alfa-2b Side Effects

Some side effects of interferon alfa-2b 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-2b: injectable kit, injectable powder for injection, injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking interferon alfa-2b: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon alfa-2b and call your doctor at once if you have a serious side effect such as:

• severe depression, aggressive behavior, or thoughts of hurting yourself or others;

• fast, slow, or uneven heart rate, feeling like you might pass out;

• fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;

• vision or hearing problems;

• urinating less than usual or not at all;

• severe stomach pain, jaundice (yellowing of the skin or eyes);

• cough with yellow or green mucus, feeling short of breath;

• chest pain, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, headache, confusion, or problems with speech or balance; or

• a severe blistering, peeling, and red skin rash.

Less serious side effects of interferon alfa-2b may include:

• dizziness, spinning sensation;

• muscle pain, tired feeling;

• nausea, vomiting, diarrhea, loss of appetite;

• dry mouth, dry cough, sore throat, hair loss;

• mild itching or skin rash; or

• burning, bleeding, pain, itching, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to interferon alfa-2b: injectable kit, injectable powder for injection, injectable solution

General

Most side effects reported during clinical trials were mild to moderate in severity and manageable. Some side effects were transient and most diminished with continued treatment. "Influenza-like" symptoms (mainly fever, headache, chills, myalgia, and fatigue) were reported most often. In general, more severe toxicities were observed at higher doses.

Gastrointestinal

Gastrointestinal side effects have included anorexia (up to 69%), nausea (up to 66%), diarrhea (up to 45%), vomiting (up to 32%), altered taste (up to 24%), abdominal pain (up to 23%), constipation (up to 14%), gingivitis (up to 14%), loose stools (up to 10%), dyspepsia (up to 7%), and gastrointestinal disorder (up to 7%). Abdominal ascites, abdominal distension, colitis, dysphagia, eructation, esophagitis, flatulence, gallstones, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal mucosal discoloration, gingival bleeding, gum hyperplasia, halitosis, hemorrhoids, increased appetite, increased saliva, intestinal disorder, melena, mouth ulceration, mucositis, oral hemorrhage, oral leukoplakia, rectal bleeding after stool, rectal hemorrhage, stomatitis, stomatitis ulcerative, taste loss, tongue disorder, and tooth disorder have been reported in less than 5% of patients. Pancreatitis has also been reported during postmarketing experience.

Hepatic

Hepatic side effects have included elevated SGOT (up to 63%) and right upper quadrant pain (up to 15%). Abnormal hepatic function tests, biliary pain, bilirubinemia, hepatitis, increased lactate dehydrogenase, increased transaminases (SGOT/SGPT), and jaundice have been reported in less than 5% of patients. Hepatic encephalopathy, hepatic failure, and death have been reported very rarely.

Psychiatric

Psychiatric side effects have included depression (up to 40%), anxiety (up to 9%), and nervousness (up to 3%). Abnormal dreaming, aggravated depression, aggressive reaction, apathy, emotional lability, feeling of ebriety, manic depression, manic reaction, personality disorder, psychosis, suicidal ideation, and suicide attempt have been reported in less than 5% of patients. Frontal subcortical dementia and choreic movements mimicking Huntington's disease have been reported. Homicidal ideation and psychosis including hallucinations have been reported during postmarketing experience.

Frontal subcortical dysfunction and choreic movements of the limbs appeared in a 68-year-old woman almost 2 years after the initiation of interferon alfa-2b (3 x 10(6) units/day) for CML. She had no history of psychiatric disorders and no hereditary neurodegenerative disease with long term recombinant interferon therapy. Symptoms of personality changes, short memory loss, and choreic movements progressively worsened over a 4 months period until she became bedridden. One month after interferon alfa-2b therapy was discontinued patient's cognitive performance had improved and choreic movements had disappeared. Clinical examination of her cognitive performances at six and 12 months later were normal.

Dermatologic

Case reports of aseptic necrosis of the skin and ulceration have been described in patients with Kaposi's sarcoma associated with HIV infection treated with interferon alfa-2b.

Dermatologic side effects have included alopecia (up to 38%), rash (up to 25%), pruritus (up to 11%), dry skin (up to 10%), dermatitis (up to 8%), and hair discoloration. Abnormal hair texture, acne, cellulitis, dermatitis lichenoides, eczema, epidermal necrolysis, erythema, erythema nodosum, folliculitis, furunculosis, increased hair growth, lipoma, maculopapular rash, melanosis, nail disorders, nonherpetic cold sores, pallor, photosensitivity, psoriasis, aggravated psoriasis, erythematous rash, sebaceous cyst, skin depigmentation, skin discoloration, skin nodule, urticaria, and vitiligo have been reported in less than 5% of patients. Trichomegaly following treatment with interferon alfa-2b has been reported in a few cases, but mechanism is unknown. Radiation recall dermatitis manifested as an erythematous macular rash in the region of irradiation has been reported after a high-dose of interferon alfa-2b. Aseptic necrosis of the skin and ulceration have been reported. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria have been reported during postmarketing experience.

Respiratory

Severe asthma developed in two patients as soon as 8 weeks after the start of interferon alfa-2b therapy in patients diagnosed with chronic hepatitis C and mild asthma.

Respiratory side effects have included dyspnea (up to 34%), coughing (up to 31%), pharyngitis (up to 31%), sinusitis (up to 21%), nonproductive cough (up to 14%), nasal congestion (up to 10%), and bronchitis (up to 10%). Asthma, bronchospasm, cyanosis, epistaxis, hemoptysis, hypoventilation, laryngitis, lung fibrosis, pleural effusion, orthopnea, pleural pain, pneumonia, pneumonitis, pneumothorax, rales, respiratory disorder, respiratory insufficiency, sneezing, tonsillitis, tracheitis, and wheezing have been reported in up to 5% of patients. Rhinitis and rhinorrhea have been reported in less than 5% of patients. Pulmonary hypertension and at least two cases of severe asthma have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 62%), somnolence (up to 33%), dizziness (up to 24%), irritability (up to 22%), paresthesia (up to 21%), impaired concentration (up to 14%), amnesia (up to 14%), confusion (up to 12%), insomnia (up to 12%), hypoesthesia (up to 10%), vertigo (up to 8%), and decreased libido (up to 5%). Abnormal coordination, abnormal gait, abnormal thinking, agitation, alcohol intolerance, aphasia, ataxia, Bell's palsy, central nervous system dysfunction, coma, convulsions, delirium, dysphonia, extrapyramidal disorder, hearing impairment, hyperesthesia, hyperkinesias, hypertonia, hypokinesia, impaired consciousness, labyrinthine disorder, loss of consciousness, migraine, neuralgia, neuritis, neuropathy, neurosis, paresis, paroniria, parosmia, polyneuropathy, speech disorder, stroke, syncope, tinnitus, tremor, and twitching have been reported in less than 5% of patients. Peripheral neuropathy and hearing loss have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 75%), musculoskeletal pain (up to 21%), and arthralgia (up to 19%). Arteritis, arthritis, aggravated arthritis, arthrosis, bone disorder, bone pain, carpal tunnel syndrome, hyporeflexia, leg cramps, muscle atrophy, muscle weakness, polyarteritis nodosa, tendinitis, rheumatoid arthritis, and spondylitis have been reported in less than 5% of patients. Myositis has been reported during postmarketing experience.

Immunologic

Immunologic side effects have included moniliasis (up to 17%), nonspecific infection (up to 7%), viral infection (up to 7%), and herpes simplex (up to 5%). Other resistance mechanism disorders have been reported in less than 5% of patients and have included abscess, conjunctivitis, fungal infection, hemophilus, herpes zoster, infection, bacterial infection, parasitic infection, otitis media, sepsis, stye, trichomonas, and upper respiratory tract infection. Systemic lupus erythematosus has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included neutropenia (up to 92%), anemia (up to 22%), thrombocytopenia (up to 10%), bleeding (up to 8%), and purpura (up to 5%). Hypochromic anemia, granulocytopenia, hemolytic anemia, leukopenia, lymphadenitis, lymphadenopathy, lymphocytosis, poor peripheral circulation, and thrombocytopenia purpura have been reported in less than 5% of patients. Aplastic anemia, pure red cell aplasia, pancytopenia (concurrent anemia, leukopenia, thrombocytopenia), sarcoidosis or exacerbation of sarcoidosis, idiopathic thrombocytopenia purpura, and thrombotic thrombocytopenic purpura have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included amenorrhea (up to 12%) and polyuria (up to 10%). Mastitis, scrotal/penile edema, and urinary tract infections have been reported in up to 5% of patients. Albumin/protein in urine, cystitis, dysmenorrhea, dysuria, hematuria, impotence, incontinence, leukorrhea, menorrhagia, menstrual irregularity, micturition disorder, micturition frequency, nocturia, pelvic pain, penis disorder, sexual dysfunction, uterine bleeding, vaginal dryness, and gynecomastia have been reported in less than 5% of patients.

Cardiovascular

Cardiovascular side effects have included hypertension (up to 9%). Angina, arrhythmia, atrial fibrillation, bradycardia, cardiac failure, cardiomegaly, cardiomyopathy, coronary artery disorder, extrasystoles, heart valve disorder, hematoma, hypotension, palpitations, phlebitis, postural hypotension, pulmonary embolism, Raynaud's disease, tachycardia, thrombosis, and varicose vein have been reported in less than 5% of patients.

Endocrine

Endocrine side effects have included aggravation of diabetes mellitus, goiter, hyperthyroidism, and hypothyroidism in less than 5% of patients. Hypopituitarism has been reported during postmarketing experience.

Metabolic

Elevated triglyceride levels should be managed as clinically appropriate. Severe hypertriglyceridemia (greater than 1000 mg/dL) may result in pancreatitis.

Metabolic side effects have included dehydration, hypercalcemia, hyperglycemia, and hypertriglyceridemia in up to 5% of patients. Lipoatrophy has been reported in at least one patient.

Ocular

Ocular side effects have included abnormal vision, blurred vision, diplopia, dry eyes, eye pain, lacrimal gland disorder, lacrimation, nystagmus, and photophobia in less than 5% of patients. At least seven cases of retinopathy in patients receiving high dose interferon alfa-2b have been reported. Vogt-Koyanagi-Harada syndrome and serous retinal detachment have been reported during postmarketing experience.

Renal

Renal side effects have included increased BUN and renal insufficiency in less than 5% of patients. Nephrotic syndrome, renal failure, and renal insufficiency have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (up to 5%). Cases of acute hypersensitivity reactions (including anaphylaxis and angioedema) have been reported during postmarketing experience.

Local

Local side effects have included injection site inflammation (up to 20%). Other application site disorders have been reported in up to 5% of patients and have included burning, injection site bleeding, injection site pain, injection site reaction, and itching. Injection site necrosis has been reported during postmarketing experience.

Other

Other side effects have included fatigue (up to 96%), fever (up to 94%), influenza-like symptoms (up to 79%), asthenia (up to 63%), chills (up to 54%), rigors (up to 42%), dry mouth (up to 28%), chest pain (up to 28%), increased sweating (up to 21%), back pain (up to 19%), unspecified pain (up to 18%), malaise (up to 14%), facial edema (up to 10%), decreased weight (up to 13%), and peripheral edema (up to 6%). Cachexia, earache, hernia, edema, hypothermia, nonspecific inflammation, periorbital edema, superficial phlebitis, thirst, weakness, and increased weight have been reported in up to 5% of patients. Substernal chest pain, cyanosis of the hand, cold and clammy skin, flushing, hot flashes, hyperthermia, peripheral ischemia, and virilism have been reported in less than 5% of patients. Asthenic conditions (including asthenia, malaise, fatigue) have been reported during postmarketing experience.

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