Peginterferon alfa-2a Side Effects

Brand Names: Pegasys

Please note - some side effects for Peginterferon alfa-2a 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 of Peginterferon alfa-2a - for the Consumer

Peginterferon Alfa-2a

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 Peginterferon Alfa-2a:

Diarrhea; dizziness; drowsiness; dry mouth; dry or irritated skin; hair thinning; headache; loss of appetite; mild flu-like symptoms (fever, chills, muscle aches, or joint pain); nausea; pain, redness, itching, or swelling at the injection site; taste changes; temporary hair loss; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters or sores in the eyes, nose, or mouth; bloody or black, tarry stools; burning, numbness, or tingling in the arms, hands, legs, or feet; chest pain; confusion; coughing up yellow or pink mucus; dark urine, change in the amount of urine produced, or burning or painful urination; decreased coordination; difficulty hearing or hearing loss; eye pain or redness; fainting; fast, slow, or irregular heartbeat; new or worsening mental or mood problems (eg, anxiety, aggressive or unusual behavior, depression, hallucinations, irritability, suicidal thoughts or actions); numbness of an arm or leg; one-sided weakness; pale stools; persistent loss of appetite; persistent or severe diarrhea, nausea, stomach or back pain, or vomiting; persistent or severe fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe or unusual tiredness or weakness; slurred speech; stomach bloating; sudden leg pain; sudden, severe dizziness, headache, or vomiting; sudden shortness of breath; unusual bruising or bleeding; vision loss or other vision changes; vomit that looks like coffee grounds; weight loss; worsening psoriasis; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

During hepatitis C studies, one or more serious side effects were reported in 10% of chronic hepatitis C (CHC) patients and 19% of CHC patients coinfected with HIV. The most common serious side effect was bacterial infection, including sepsis, osteomyelitis, endocarditis, pyelonephritis, and pneumonia (3% CHC, 5% CHC/HIV). Other serious side effects have included suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination in less than 1% of patients.

The most common side effects have included psychiatric reactions, (including depression, insomnia, irritability, and anxiety), flu-like symptoms (such as fatigue, pyrexia, myalgia, headache, rigors), anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus. Psychiatric, flu-like syndrome, dermatologic, and gastrointestinal disorders and laboratory abnormalities (thrombocytopenia, neutropenia, and anemia) were the most common reasons for discontinuation of therapy.

Immunologic

Immunologic side effects have included bacterial infections (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia), autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), and the development of binding antibodies to peginterferon alfa-2a. Alpha interferons have been associated with the development or exacerbation of autoimmune disorders, including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus. The most common or important serious side effects reported during hepatitis B studies have included infections (sepsis, appendicitis, tuberculosis, influenza). Liver graft rejection and renal graft rejection have been reported during postmarketing experience with peginterferon alfa-2a alone or in combination with ribavirin.

Psychiatric

Psychiatric side effects are among the most common reasons given for discontinuation of therapy.

Psychiatric side effects have included irritability/anxiety/nervousness (19% monotherapy, 33% combination therapy), depression (18% monotherapy, 20% combination therapy), concentration impairment (8% monotherapy, 10% combination therapy), and mood alteration (3% monotherapy, 5% combination therapy). Suicidal ideation, suicide, psychosis, aggression, psychotic disorder, and relapse of drug abuse and drug overdose have been reported. Impairment of desire and the potential to affect sexual satisfaction have been reported with peginterferon alfa-2a plus ribavirin in male patients.

Hematologic

Laboratory abnormalities (thrombocytopenia, neutropenia, and anemia) are among the most common reasons given for discontinuation of therapy.

Hematologic side effects have included neutropenia (21% monotherapy, 27% combination therapy), thrombocytopenia (5% monotherapy, 5% combination therapy), lymphopenia (3% monotherapy, 14% combination therapy), anemia (2% monotherapy, 11% combination therapy), aplastic anemia, thrombotic thrombocytopenic purpura, and cerebral hemorrhage. Neutropenia (40%), anemia (14%), and thrombocytopenia (8%) have been reported during treatment with peginterferon alfa-2a plus ribavirin in CHC patients coinfected with HIV. The most common or important serious side effects reported during hepatitis B studies have included thrombotic thrombocytopenic purpura. Pure red cell aplasia has been reported during postmarketing experience with peginterferon alfa-2a alone or in combination with ribavirin.

Other

Other side effects commonly reported have included fever and chills. Flu-like signs and symptoms have been reported and have included fatigue/asthenia (56% monotherapy, 65% combination therapy), pyrexia (37% to 54% monotherapy, 41% combination therapy), rigors (35% monotherapy, 25% combination therapy), and pain (11% monotherapy, 10% combination therapy). Anorexia (16% to 17% monotherapy, 24% combination therapy) and overall resistance mechanism disorders (10% monotherapy, 12% combination therapy) have been reported. Fatigue has been reported in 24% of patients during hepatitis B studies. Sarcoidosis has been reported in a 65-year-old man at the seventh month of therapy. Most of the symptoms improved over the next three months following discontinuation of therapy.

Gastrointestinal

Gastrointestinal side effects are among the most common reasons given for discontinuation of therapy.

Gastrointestinal side effects have included nausea and vomiting (24% monotherapy, 25% combination therapy), diarrhea (16% monotherapy, 11% combination therapy), abdominal pain (15% monotherapy, 8% combination therapy), dry mouth (6% monotherapy, 4% combination therapy), dyspepsia (less than 1% monotherapy, 6% combination therapy), peptic ulcer, gastrointestinal bleeding, pancreatitis, and colitis.

Nervous system

Nervous system side effects have included headache (27% to 54% monotherapy, 43% combination therapy), insomnia (19% monotherapy, 30% combination therapy), dizziness (excluding vertigo; 16% monotherapy, 14% combination therapy), concentration impairment (8%), memory impairment (5% monotherapy, 5% combination therapy), peripheral neuropathy, hallucination, and coma. At least one case of chorea and akathisia has been reported. Seizures, hearing impairment, and hearing loss have been reported during postmarketing experience.

A 40-year-old male coinfected with hepatitis C virus and HIV experienced chorea and akathisia coincident with peginterferon alfa-2a therapy. He was administered subcutaneous peginterferon alfa-2a 180 mcg weekly and oral ribavirin 1 g daily. At week 20 of therapy, the patient presented to the clinic complaining of irritability, difficulty in sleeping and prominent choreiform involuntary movements with myoclonic activity of the upper and lower extremities. He was diagnosed with chorea and akathisia. He was treated with ropinirole, propranolol, and clonazepam. Peginterferon alfa-2a and ribavirin were discontinued with complete resolution of symptoms after 5 days.

Dermatologic

Dermatologic side effects are among the most common reasons given for discontinuation of therapy.

Dermatologic side effects have included alopecia (18% to 23% monotherapy, 28% combination therapy), pruritus (12% monotherapy, 19% combination therapy), dermatitis (8% monotherapy, 16% combination therapy), increased sweating (6% monotherapy, 6% combination therapy), rash (5% monotherapy, 8% combination therapy), dry skin (4% monotherapy, 10% combination therapy), and eczema (1% monotherapy, 5% combination therapy). Skin disorders associated with combination therapy have included lichenoid eruptions and maculopapular rashes. At least one case of drug-induced Sweet's syndrome has been reported. Serious skin reactions have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included elevated ALT (occasionally associated with hyperbilirubinemia), hepatic dysfunction, fatty liver, cholangitis, and exacerbations of hepatitis. Hepatic decompensation has been reported in 2% of CHC patients coinfected with HIV. The most common or important serious side effects reported during hepatitis B studies have included hepatitis B flares.

Cardiovascular

Cardiovascular side effects have included angina, arrhythmia, and endocarditis.

Metabolic

Elevated triglyceride levels have been reported in patients receiving alfa interferons, including peginterferon alfa-2a.

Metabolic side effects have included weight decrease (4% monotherapy, 10% combination therapy), elevated triglycerides, and diabetes mellitus. Dehydration has been reported during postmarketing experience.

Ocular

Ocular side effects have included blurred vision (4% monotherapy, 5% combination therapy) and corneal ulcers. Serous retinal detachment has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea (4% monotherapy, 13% combination therapy), cough (4% monotherapy, 10% combination therapy), and exertional dyspnea (less than 1% monotherapy, 4% combination therapy). Pneumonia, interstitial pneumonitis, and pulmonary embolism have been reported.

Endocrine

Endocrine side effects have included hypothyroidism (3% monotherapy, 4% combination therapy) and hyperthyroidism.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic shock during hepatitis B studies.

Musculoskeletal

Musculoskeletal side effects have included myalgia (26% to 37% monotherapy, 40% combination therapy), arthralgia (28% monotherapy, 22% combination therapy), back pain (9% monotherapy, 5% combination therapy), and myositis.

Genitourinary

Genitourinary side effects associated with peginterferon alfa-2a plus ribavirin have included sexual dysfunction in male patients.

Local

Local side effects have included injection site reactions (22% monotherapy, 23% combination therapy). Skin disorders associated with combination therapy have included cutaneous necrosis at peginterferon alfa-2a injection sites. Hyperpigmentation around/over the injection sites has been reported.

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