Peginterferon alfa-2a Side Effects

Some side effects of 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.

For the Consumer

Applies to peginterferon alfa-2a: subcutaneous solution

Along with its needed effects, peginterferon alfa-2a may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking peginterferon alfa-2a:

More common
  • Black, tarry stools
  • chills
  • cough
  • discouragement
  • feeling sad or empty
  • fever
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • shortness of breath
  • sore throat
  • tiredness
  • trouble sleeping
  • trouble with concentrating
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Bone pain
  • chest pain or discomfort
  • confusion
  • constipation
  • depressed mood
  • dizziness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • hair loss
  • headache
  • heart murmur
  • hives
  • hoarseness or husky voice
  • lightheadedness
  • muscle cramps and stiffness
  • pale skin
  • rapid, shallow breathing
  • slowed heartbeat
  • sneezing
  • stomach pain
  • tightness in the chest
  • troubled breathing with exertion
  • weight gain

Some side effects of peginterferon alfa-2a may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, scaly skin
  • diarrhea
  • dry mouth
  • fear
  • feeling unusually cold, shivering
  • hair loss or thinning of the hair
  • muscle or joint pain
  • nervousness
  • numbness
  • pain
  • rash
  • redness
  • scarring
  • soreness
  • stinging
  • stomach pain
  • swelling
  • tenderness
  • tingling
  • ulceration
  • vomiting
  • warmth
Less common
  • Acid or sour stomach
  • belching
  • blurred vision
  • heartburn
  • indigestion
  • memory problems
  • stomach discomfort or upset
Incidence not known
  • Change of hearing
  • loss of hearing

For Healthcare Professionals

Applies to peginterferon alfa-2a: subcutaneous kit, subcutaneous solution

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, anxiety), influenza-like symptoms (such as fatigue, pyrexia, myalgia, headache, rigors), anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus. Psychiatric disorders, influenza-like syndrome (e.g., lethargy, fatigue, headache), dermatologic disorders, gastrointestinal disorders, and laboratory abnormalities (thrombocytopenia, neutropenia, anemia) were the most common reasons for discontinuation of therapy.

Immunologic

Frequency not reported: Bacterial infections (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia), infections (appendicitis, tuberculosis, influenza), autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), development of binding antibodies to peginterferon alfa-2a; Alpha interferons: Development or exacerbation of autoimmune disorders (including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, systemic lupus erythematosus)
Postmarketing reports: Liver graft rejection, renal graft rejection

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 with peginterferon alfa-2a alone or in combination with ribavirin.

Hematologic

Neutropenia (40%), anemia (14%), and thrombocytopenia (8%) have been reported during treatment with peginterferon alfa-2a plus ribavirin in CHC patients coinfected with HIV.

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

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 with peginterferon alfa-2a alone or in combination with ribavirin.

Very common (10% or more): Neutropenia (21% monotherapy, 27% to 40% combination therapy), lymphopenia (14% combination therapy), anemia (11% to 14% combination therapy)
Common (1% to 10%): Thrombocytopenia (5% monotherapy, 5% to 8% combination therapy), lymphopenia (3% monotherapy), anemia (2% monotherapy)
Frequency not reported: Aplastic anemia, thrombotic thrombocytopenic purpura, cerebral hemorrhage
Postmarketing reports: Pure red cell aplasia

Hepatic

Common (1% to 10%): Hepatic decompensation (2%)
Frequency not reported: Elevated ALT (occasionally associated with hyperbilirubinemia), hepatic dysfunction, fatty liver, cholangitis, exacerbations of hepatitis, hepatitis B flares

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.

Other

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.

Very common (10% or more): Influenza-like signs and symptoms: Fatigue/asthenia (56% monotherapy, 65% combination therapy), pyrexia (37% to 54% monotherapy, 41% combination therapy), rigors (35% monotherapy, 25% combination therapy), pain (11% monotherapy, 10% combination therapy); fatigue (24%); overall resistance mechanism disorders (10% monotherapy, 12% combination therapy)
Common (1% to 10%): Fever, chills
Rare (less than 0.1%): Mucosal hyperpigmentation, sarcoidosis (at least 1 case)

Nervous system

Very common (10% or more): Headache (27% to 54% monotherapy, 43% combination therapy), insomnia (19% monotherapy, 30% combination therapy), dizziness (excluding vertigo; 16% monotherapy, 14% combination therapy)
Common (1% to 10%): Concentration impairment (8%), memory impairment (5% monotherapy, 5% combination therapy)
Rare (less than 0.1%): Chorea and akathisia (at least 1 case)
Frequency not reported: Peripheral neuropathy, hallucination, coma
Postmarketing reports: Seizures, hearing impairment, hearing loss

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.

Musculoskeletal

Very common (10% or more): Myalgia (26% to 37% monotherapy, 40% combination therapy), arthralgia (28% monotherapy, 22% combination therapy)
Common (1% to 10%): Back pain (9% monotherapy, 5% combination therapy)
Frequency not reported: Myositis

Psychiatric

Very common (10% or more): Irritability/anxiety/nervousness (19% monotherapy, 33% combination therapy), depression (18% monotherapy, 20% combination therapy), concentration impairment (10% combination therapy)
Common (1% to 10%): Concentration impairment (8% monotherapy), mood alteration (3% monotherapy, 5% combination therapy)
Frequency not reported: Suicidal ideation, suicide, psychosis, aggression, psychotic disorder, relapse of drug abuse, drug overdose, impairment of desire, sexual satisfaction affected (potentially), sexual dysfunction

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

Impairment of desire, sexual satisfaction affected (potentially), and sexual dysfunction have been reported with peginterferon alfa-2a plus ribavirin in male patients.

Dermatologic

Very common (10% or more): Alopecia (18% to 23% monotherapy, 28% combination therapy), pruritus (12% monotherapy, 19% combination therapy), dermatitis (16% combination therapy), dry skin (10% combination therapy)
Common (1% to 10%): Dermatitis (8% monotherapy), increased sweating (6% monotherapy, 6% combination therapy), rash (5% monotherapy, 8% combination therapy), dry skin (4% monotherapy), eczema (1% monotherapy, 5% combination therapy)
Rare (less than 0.1%): Drug-induced Sweet's syndrome (at least 1 case)
Frequency not reported: Lichenoid eruptions, maculopapular rashes
Postmarketing reports: Serious skin reactions

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

Skin disorders associated with combination therapy have included lichenoid eruptions and maculopapular rashes.

Gastrointestinal

Very common (10% or more): Nausea and vomiting (24% monotherapy, 25% combination therapy), diarrhea (16% monotherapy, 11% combination therapy), abdominal pain (15% monotherapy)
Common (1% to 10%): Abdominal pain (8% combination therapy), dry mouth (6% monotherapy, 4% combination therapy), dyspepsia (6% combination therapy)
Uncommon (0.1% to 1%): Dyspepsia (less than 1% monotherapy)
Rare (less than 0.1%): Tongue hyperpigmentation
Frequency not reported: Peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis

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

Metabolic

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

Very common (10% or more): Anorexia (16% to 17% monotherapy, 24% combination therapy), weight decrease (10% combination therapy)
Common (1% to 10%): Weight decrease (4% monotherapy)
Frequency not reported: Elevated triglycerides, diabetes mellitus
Postmarketing reports: Dehydration

Local

Very common (10% or more): Injection site reactions (22% monotherapy, 23% combination therapy)
Frequency not reported: Cutaneous necrosis at injection sites, hyperpigmentation around/over injection sites

Skin disorders associated with combination therapy have included cutaneous necrosis at peginterferon alfa-2a injection sites.

Hypersensitivity

Anaphylactic shock has been reported during hepatitis B studies.

Frequency not reported: Anaphylactic shock

Respiratory

Very common (10% or more): Dyspnea (13% combination therapy), cough (10% combination therapy)
Common (1% to 10%): Dyspnea (4% monotherapy), cough (4% monotherapy), exertional dyspnea (4% combination therapy)
Uncommon (0.1% to 1%): Exertional dyspnea (less than 1% monotherapy)
Frequency not reported: Pneumonia, interstitial pneumonitis, pulmonary embolism

Cardiovascular

Frequency not reported: Angina, arrhythmia, endocarditis

Ocular

Common (1% to 10%): Blurred vision (4% monotherapy, 5% combination therapy)
Frequency not reported: Corneal ulcers
Postmarketing reports: Serous retinal detachment

Endocrine

Common (1% to 10%): Hypothyroidism (3% monotherapy, 4% combination therapy)
Frequency not reported: Hyperthyroidism

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