Peginterferon alfa-2b Side Effects

It is possible that some side effects of peginterferon alfa-2b may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to peginterferon alfa-2b: subcutaneous kit, subcutaneous powder for solution

As well as its needed effects, peginterferon alfa-2b may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking peginterferon alfa-2b, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • anxiety
  • black, tarry stools
  • blood in the urine or stools
  • bloody diarrhea
  • chills
  • cloudy urine
  • cough or hoarseness
  • depression
  • difficult or labored breathing
  • fever
  • irritability
  • lower back or side pain
  • mood swings
  • nausea
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • tightness in the chest
  • trouble sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
Less common
  • Changes in menstrual cycle
  • constipation
  • drowsiness
  • dry hair and skin
  • sensitivity to cold
  • weight gain
Rare
  • Aching, pain, or stiffness in the joints
  • aggressive behavior
  • attempt to kill yourself
  • backache
  • chest pain (severe)
  • cool, pale skin
  • decrease in vision
  • diarrhea
  • difficulty with speaking
  • dizziness
  • drug addiction or overdose
  • eye pain
  • fast or irregular heartbeat
  • feeling of constant movement of self or surroundings
  • headache
  • loss of appetite
  • muscle weakness
  • nervousness
  • numbness or loss of feeling in one or both limbs on the same side of the body
  • palpitations
  • paralysis
  • possible decrease in the amount of urine
  • rash, hives, or itching
  • restlessness
  • sensation of spinning
  • sensitivity to heat
  • sensitivity to sunlight
  • sweating (excessive)
  • thick, scaly skin
  • thoughts of killing someone
  • thoughts of killing yourself
  • warm, smooth, or moist skin
  • weight loss

Some peginterferon alfa-2b side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Aching, fullness, or tension in the sinuses
  • bruising, irritation, or itching at the injection site
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • difficulty with moving
  • flushing of the skin
  • hair loss
  • indigestion
  • loss of taste
  • muscle pain or stiffness
  • pain in the bones or muscles
  • runny nose
  • sneezing
  • sore throat
  • thinning of the hair
Less common
  • Muscle rigidity or stiffness

For Healthcare Professionals

Applies to peginterferon alfa-2b: subcutaneous powder for injection

General

Nearly all study patients experienced one or more side effects. The most common side effects associated with PegIntron(R), peginterferon alfa-2b for the treatment of chronic hepatitis C (CHC), with or without ribavirin have included headache, myalgia, fatigue/asthenia, injection site inflammation/reaction, emotional lability/irritability, nausea, rigors, and fevers. Serious side effects associated with PegIntron(R) (with or without ribavirin) have been reported in about 12% of subjects during clinical trials. The most common serious side effects associated with PegIntron(R) and ribavirin were depression and suicidal ideation in less than 1% of subjects. The most common fatal side effects associated with PegIntron(R) and ribavirin were cardiac arrest, suicidal ideation, and suicide attempt in less than 1% of subjects. In most cases, side effects resolved upon discontinuation of therapy. During clinical trials, 10% to 15% of CHC patients discontinued therapy due to side effects.

The most common side effects associated with Sylatron(TM), peginterferon alfa-2b for adjuvant treatment of melanoma, have included fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reaction. The most common serious side effects were fatigue, increased ALT, increased AST, and pyrexia. During a clinical trial, 33% of melanoma patients discontinued therapy due to adverse events.

Hematologic

Hyperbilirubinemia (10% to 14%) and hyperuricemia (33% to 38%), in association with hemolysis, have been reported during combination therapy trials using peginterferon alfa-2b with ribavirin.

A 48-year-old patient with multiple myeloma experienced severe bone marrow hypoplasia coincident with peginterferon alfa-2b therapy. The patient had been receiving oral thalidomide during several months prior to adding peginterferon alfa-2b to her therapy, and she developed a severe bone marrow hypoplasia while she received these 2 drugs. Since she had received thalidomide therapy previously and this agent was never stopped, it would seem as if the peginterferon alfa-2b was responsible for the myelosuppression of the patient; however, the possibility of an interaction between thalidomide and interferon alfa-2b cannot be ruled out.

PegIntron(R):
Very common (10% or more): Decreased neutrophil counts (alone: 70%; with ribavirin: 85%), decreased hemoglobin levels (up to 47%), decreased platelet counts (20%), hyperuricemia (with ribavirin: up to 38%), anemia (with ribavirin: up to 35%), neutropenia (with ribavirin: up to 31%), hyperbilirubinemia (with ribavirin: up to 14%)
Common (1% to 10%): Thrombocytopenia (alone: 7%; with ribavirin: 5%), neutropenia (alone: 6%), leukopenia (with ribavirin: up to 10%)
Uncommon (0.1% to 1%): Autoimmune thrombocytopenia with or without purpura (1% or less), severe potentially life-threatening neutropenia (1%), leukopenia (alone: less than 1%)
Rare (less than 0.1%): Severe bone marrow hypoplasia (at least 1 case)
Postmarketing reports: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura

Sylatron(TM):
Common (1% to 10%): Anemia (all grades: 6%)
Uncommon (0.1% to 1%): Anemia (Grade 3/4: less than 1%)

Nervous system

PegIntron(R):
Very common (10% or more): Headache (alone: 56%; with ribavirin: up to 62%), dizziness (alone: 12%; with ribavirin: up to 21%)
Common (1% to 10%): Hypertonia (5%), agitation (alone: 2%; with ribavirin: 8%)
Uncommon (0.1% to 1%): Nerve palsy (facial, oculomotor), transient ischemic attack, loss of consciousness
Postmarketing reports: Vertigo, seizures, memory loss, migraine headache, paresthesia, hearing impairment, hearing loss, encephalopathy, peripheral neuropathy

Sylatron(TM):
Very common (10% or more): Headache (all grades: 70%), dysgeusia (all grades: 38%), dizziness (all grades: 35%), olfactory nerve disorder (all grades: 23%), paresthesia (all grades: 21%)
Common (1% to 10%): Headache (Grade 3/4: 4%), dizziness (Grade 3/4: 2%)
Uncommon (0.1% to 1%): Paresthesia (Grade 3/4: less than 1%)

Psychiatric

Life-threatening or fatal neuropsychiatric events have been reported in CHC patients with and without a previous psychiatric disorder.

Psychosis and hallucinations have been reported in patients treated with alpha interferons.

PegIntron(R):
Very common (10% or more): Depression (alone: 29%; with ribavirin: up to 31%), anxiety/emotional lability/irritability (alone: 28%; with ribavirin: up to 47%), insomnia (alone: 23%; with ribavirin: up to 41%), impaired concentration (alone: 10%; with ribavirin: 17%)
Common (1% to 10%): Nervousness (alone: 4%; with ribavirin: 6%)
Uncommon (0.1% to 1%): Life-threatening or fatal neuropsychiatric events (including suicide, suicide attempt, suicidal and homicidal ideation, severe depression, psychosis, aggressive reaction, relapse of drug addiction/overdose)
Frequency not reported: Psychosis, hallucinations
Postmarketing reports: Homicidal ideation, aggressive behavior, psychoses, hallucinations, bipolar disorders, mania

Sylatron(TM):
Very common (10% or more): Depression (all grades: 59%)
Common (1% to 10%): Depression (Grade 3/4: 7%)

Other

Influenza-like symptoms may decrease in severity as treatment continues.

PegIntron(R):
Very common (10% or more): Fatigue/asthenia (alone: 52%; with ribavirin: up to 68%), influenza-like symptoms (up to 46%), rigors (alone: 23%; with ribavirin: 48%), fever (alone: 22%; with ribavirin: up to 46%), chills (with ribavirin: up to 39%), weight decrease (alone: 11%; with ribavirin: up to 29%), unspecified pain (with ribavirin: up to 13%), right upper quadrant pain (with ribavirin: 12%)
Common (1% to 10%): Right upper quadrant pain (alone: 8%), malaise (alone: 7%; with ribavirin: 4%), flushing (alone: 6%; with ribavirin: 4%), taste perversion (with ribavirin: 9%)
Uncommon (0.1% to 1%): Taste perversion (alone: less than 1%)
Postmarketing reports: Asthenic conditions (including asthenia, malaise, fatigue)

Sylatron(TM):
Very common (10% or more): Fatigue (all grades: 94%; Grade 3/4: 16%), pyrexia (all grades: 75%), chills (all grades: 63%), decreased weight (all grades: 11%)
Common (1% to 10%): Pyrexia (Grade 3/4: 4%), chills (Grade 3/4: 1%)
Uncommon (0.1% to 1%): Decreased weight (Grade 3/4: less than 1%)

Musculoskeletal

PegIntron(R):
Very common (10% or more): Myalgia (alone: 54%; with ribavirin: up to 56%), arthralgia (alone: 23%; with ribavirin: up to 34%), musculoskeletal pain (alone: 28%; with ribavirin: 21%)
Uncommon (0.1% to 1%): Gout, rheumatoid arthritis
Postmarketing reports: Rhabdomyolysis, myositis, rheumatoid arthritis

Sylatron(TM):
Very common (10% or more): Myalgia (all grades: 68%), arthralgia (all grades: 51%)
Common (1% to 10%): Myalgia (Grade 3/4: 4%), arthralgia (Grade 3/4: 3%)

A small number of patients developed mild to moderate gout.

Local

PegIntron(R):
Very common (10% or more): Injection site inflammation/reaction, including bruise, itchiness, and irritation (alone: 47%; with ribavirin: up to 75%)
Common (1% to 10%): Injection site pain (up to 3%)
Uncommon (0.1% to 1%): Injection site necrosis
Frequency not reported: Localized skin ulcerations (after subcutaneous and IM injection)

Sylatron(TM):
Very common (10% or more): Injection site reaction (all grades: 62%)
Common (1% to 10%): Injection site reaction (Grade 3/4: 1.8%)

Gastrointestinal

Both fatal and nonfatal ulcerative or hemorrhagic/ischemic colitis have been reported within the first 3 months of alpha interferon therapy. Pancreatitis, fatal and nonfatal, has also been reported with the use of alpha interferon therapy.

PegIntron(R):
Very common (10% or more): Nausea (alone: 26%; with ribavirin: up to 43%), diarrhea (alone: 18%; with ribavirin: up to 22%), abdominal pain (alone: 15%; with ribavirin: up to 13%), vomiting (with ribavirin: up to 14%), dry mouth (with ribavirin: 12%)
Common (1% to 10%): Vomiting (alone: 7%), dyspepsia (alone: 6%; with ribavirin: 9%), dry mouth (alone: 6%), constipation (alone: 1%; with ribavirin: 5%)
Uncommon (0.1% to 1%): Gastroenteritis, pancreatitis
Frequency not reported: Ulcerative or hemorrhagic/ischemic colitis (fatal and nonfatal), pancreatitis (fatal and nonfatal)
Postmarketing reports: Aphthous stomatitis, pancreatitis, colitis

Sylatron(TM):
Very common (10% or more): Nausea (all grades: 64%), diarrhea (all grades: 37%), vomiting (all grades: 26%)
Common (1% to 10%): Nausea (Grade 3/4: 3%), diarrhea (Grade 3/4: 1%), vomiting (Grade 3/4: 1%)

Dermatologic

PegIntron(R):
Very common (10% or more): Alopecia (alone: 22%; with ribavirin: up to 36%), pruritus (alone: 12%; with ribavirin: up to 29%), dry skin (alone: 11%; with ribavirin: up to 24%), rash (with ribavirin: up to 34%), increased sweating (with ribavirin: 11%)
Common (1% to 10%): Rash (alone: 6%), increased sweating (alone: 6%)
Uncommon (0.1% to 1%): Aggravated psoriasis, urticaria, phototoxicity
Rare (less than 0.1%): Generalized exfoliative dermatitis (at least 1 case)
Postmarketing reports: Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, psoriasis

Sylatron(TM):
Very common (10% or more): Exfoliative rash (all grades: 36%), alopecia (all grades: 34%)
Common (1% to 10%): Exfoliative rash (Grade 3/4: 1%)

Urticaria and cutaneous desquamation of all of the patient's body except his face have been reported in a 41-year-old man with chronic hepatitis C infection after 3 months of combination antiviral treatment with peginterferon alfa-2b plus ribavirin. Initially, ribavirin was stopped and topical corticosteroid therapy started without significant improvement. Two weeks later peginterferon alfa-2b was discontinued and significant improvement (decrease in cutaneous lesions) was observed during the following week. Rechallenge with interferon alfa-2b confirmed the development of systemic cutaneous lesions and pruritus.

Metabolic

Elevated triglyceride levels have been associated with interferon alphas.

A 48-year-old man experienced sudden onset of diabetic ketoacidosis 7 months after the start of treatment for hepatitis C.

PegIntron(R):
Very common (10% or more): Anorexia (alone: 20%; with ribavirin: up to 32%)
Uncommon (0.1% to 1%): Hyperglycemia
Frequency not reported: Diabetes mellitus (new onset or worsening), elevated triglyceride levels
Postmarketing reports: Dehydration, hypertriglyceridemia, diabetic ketoacidosis, diabetes

Sylatron(TM):
Very common (10% or more): Anorexia (all grades: 69%), increased blood alkaline phosphatase (all grades: 23%)
Common (1% to 10%): Anorexia (Grade 3/4: 3%)

Immunologic

PegIntron(R):
Very common (10% or more): Viral infections (alone: 11%; with ribavirin: 12%)
Common (1% to 10%): Fungal infections (with ribavirin: 6%)
Uncommon (0.1% to 1%): Lupus-like syndrome, sarcoidosis, infection (sepsis, pneumonia, abscess, cellulitis), fungal infections (alone: less than 1%)
Rare (less than 0.1%): Hashimoto encephalopathy (at least 1 case)
Frequency not reported: Exacerbation of autoimmune disorders, autoimmune hepatitis, development of binding antibodies (including neutralizing antibodies) to peginterferon alfa-2b, autoimmune thrombocytopenia
Postmarketing reports: Bacterial infection (including sepsis), systemic lupus erythematosus

A case report of Hashimoto encephalopathy has been associated with the use of peginterferon alfa-2b with ribavirin for chronic hepatitis C infection in a 36-year-old woman with a 10-year history of autoimmune thyroiditis. Following discontinuation of the drugs, corticosteroid therapy was started and the patient experienced full recovery.

Autoimmune thrombocytopenia has been reported 4 weeks after the start of treatment for hepatitis C.

Cardiovascular

PegIntron(R):
Common (1% to 10%): Chest pain (alone: 6%; with ribavirin: 8%)
Uncommon (0.1% to 1%): Cardiomyopathy, angina pectoris, pericardial effusion, supraventricular arrhythmias, vasculitis, myocardial infarction
Frequency not reported: Hypotension, arrhythmia, tachycardia
Postmarketing reports: Palpitations, stroke, cardiomyopathy, angina pectoris, hypertension, hypotension

Sylatron(TM):
Common (1% to 10%): Myocardial infarction (4%), bundle-branch block (4%), ventricular tachycardia (4%), supraventricular arrhythmia (4%)

Hepatic

PegIntron(R):
Common (1% to 10%): Hepatomegaly (alone: 6%; with ribavirin: 4%)
Frequency not reported: Increased risks of hepatic decompensation and death

Sylatron(TM):
Very common (10% or more): Increased ALT or AST (all grades: 77%; Grade 3/4: 11%)
Common (1% to 10%): Increased gamma glutamyltransferase (all grades: 8%; Grade 3/4: 4%)

Increased risks of hepatic decompensation and death have been reported in patients with cirrhosis.

Endocrine

PegIntron(R):
Common (1% to 10%): Hypothyroidism (with or without ribavirin: 5%), hyperthyroidism (with or without ribavirin: 3%)
Frequency not reported: Hypothyroidism (new onset or worsening), hyperthyroidism (new onset or worsening), TSH abnormalities
Postmarketing reports: Thyroiditis

Sylatron(TM):
Common (1% to 10%): Endocrine disorders (2%), hypothyroidism (1%)

TSH abnormalities, with and without clinical manifestations, have been associated with interferon therapies.

Respiratory

PegIntron(R):
Very common (10% or more): Pharyngitis (alone: 10%; with ribavirin: 12%), dyspnea (with ribavirin: up to 26%), coughing (with ribavirin: up to 23%)
Common (1% to 10%): Coughing (alone: 8%), sinusitis (alone: 7%; with ribavirin: 6%), dyspnea (alone: 4%), rhinitis (alone: 2%; with ribavirin: 8%)
Uncommon (0.1% to 1%): Emphysema, bronchiolitis obliterans, pleural effusion
Frequency not reported: Pulmonary infiltrates, pneumonitis, pneumonia (sometimes fatal)
Postmarketing reports: Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, sarcoidosis, pulmonary hypertension

Sylatron(TM):
Common (1% to 10%): Dyspnea (all grades: 6%; Grade 3/4: 1%), cough (all grades: 5%)
Uncommon (0.1% to 1%): Cough (Grade 3/4: less than 1%)

Pulmonary infiltrates, pneumonitis, and pneumonia (sometimes fatal) have been reported with the use of peginterferon alfa-2b or alpha interferon therapy in general.

Ocular

Retinal and ocular changes induced or aggravated by treatment with peginterferon alfa-2b or other alpha interferons have included decreased or loss of vision, retinopathy including macular edema, retinal hemorrhages and cotton wool spots, retinal artery or vein thrombosis, optic neuritis, papilledema, and serous retinal detachment.

PegIntron(R):
Common (1% to 10%): Conjunctivitis (alone: 4%; with ribavirin: 4%), blurred vision (alone: 2%; with ribavirin: 5%)
Uncommon (0.1% to 1%): Retinal ischemia, retinal artery or vein thrombosis, blindness, decreased visual acuity, optic neuritis
Frequency not reported: Retinal and ocular changes (including decreased or loss of vision, retinopathy including macular edema, retinal hemorrhages and cotton wool spots, retinal artery or vein thrombosis, optic neuritis, papilledema, serous retinal detachment)
Postmarketing reports: Vogt-Koyanagi-Harada syndrome

Sylatron(TM):
Uncommon (0.1% to 1%): Serious retinal disorders, visual disturbances, blurred vision, reduction in visual acuity
Rare (less than 0.1%): Partial loss of vision due to retinal thrombosis or retinopathy (at least 2 cases)

Hypersensitivity

Serious acute hypersensitivity reactions have been reported rarely with the use of alpha interferon therapy.

PegIntron(R):
Rare (less than 0.1%): Serious acute hypersensitivity reactions
Postmarketing reports: Acute hypersensitivity reactions (including anaphylaxis, angioedema, bronchoconstriction, urticaria)

Renal

PegIntron(R):
Uncommon (0.1% to 1%): Interstitial nephritis (1% or less)
Postmarketing reports: Renal insufficiency, renal failure, interstitial nephritis

Genitourinary

PegIntron(R):
Common (1% to 10%): Menstrual disorder (alone: 4%; with ribavirin: 7%)

Sylatron(TM):
Common (1% to 10%): Proteinuria (all grades: 7%)

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