Note: This document contains side effect information about peginterferon alfa-2b. Some dosage forms listed on this page may not apply to the brand name Sylatron.

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

Serious side effects of Sylatron

Along with its needed effects, peginterferon alfa-2b (the active ingredient contained in Sylatron) 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-2b:

More common

• Anxiety
• black, tarry stools
• blood in the urine or stools
• bloody diarrhea
• chills
• cloudy urine
• cough
• depression
• difficult or labored breathing
• fever
• hoarseness
• irritability
• lower back or side pain
• mood swings
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• stomach pain
• 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
• attempts 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, irregular, pounding, or racing heartbeat or pulse
• 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
• 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 or yourself
• warm, smooth, or moist skin
• weight loss

Other side effects of Sylatron

Some side effects of peginterferon alfa-2b 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

• 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
• feeling of warmth
• hair loss
• indigestion
• loss of taste
• muscle pain or stiffness
• pain in the bones or muscles
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• thinning of the hair

Less common

• Muscle rigidity or stiffness

For Healthcare Professionals

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

General

Nearly all study patients experienced at least 1 side effect. The most common side effects associated with the product used 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. Chills, insomnia, anemia, alopecia, anorexia, weight loss, and rash were also reported very commonly with peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin. Serious side effects associated with this drug (with or without ribavirin) have been reported in about 12% of subjects during clinical trials. The most common serious side effects associated with peginterferon alfa-2b/ribavirin were depression and suicidal ideation in less than 1% of subjects. The most common fatal side effects associated with this combination 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 the product used 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 side effects.^[Ref]

Hematologic

Decreased neutrophil counts (alone: 70%; with ribavirin: 85%), anemia (with ribavirin: up to 35%), neutropenia (alone: 6%; with ribavirin: up to 31%), thrombocytopenia (alone: 7%; with ribavirin: 5%), and leukopenia (alone: less than 1%; with ribavirin: up to 10%) have been reported in CHC patients.

WHO grade 3 (21%) and WHO grade 4 (7%) neutropenia and hemoglobin levels below 100 g/L (up to 14%) were reported with peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Granulocytopenia (less than 0.75 x 10[9]/L) was reported in 4% and 7% of patients using 0.5 and 1 mcg/kg of peginterferon alfa-2b, respectively. Thrombocytopenia (less than 70 x 10[9]/L) was reported in 1% and 3% of patients using 0.5 and 1 mcg/kg of peginterferon alfa-2b, respectively.

Neutropenia, thrombocytopenia, and anemia occurred more often in hepatitis C virus (HCV)/HIV-coinfected patients. Neutropenia (26%), decreased absolute neutrophil count levels (less than 500 cells/mm3: 4%), decreased platelets (less than 50,000/mm3: 4%), anemia (hemoglobin less than 9.4 g/dL: 12%), and decreased CD4 lymphocytes (8%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

Anemia (all grades: 6%; grade 3/4: less than 1%) has been reported in melanoma patients.

A 48-year-old patient with multiple myeloma experienced severe bone marrow hypoplasia coincident with peginterferon alfa-2b therapy. The patient was taking oral thalidomide for several months prior to adding peginterferon alfa-2b to her regimen; she developed a severe bone marrow hypoplasia while using both drugs. Since she used thalidomide previously and this agent was never stopped, it would appear the peginterferon alfa-2b was responsible for the myelosuppression; however, a possible interaction between thalidomide and interferon alfa-2b cannot be ruled out.^[Ref]

CHC Patients:

-Very common (10% or more): Decreased neutrophil counts (up to 85%), decreased hemoglobin levels (up to 47%), decreased platelet counts (20%), anemia (up to 35%), neutropenia (up to 31%)

-Common (1% to 10%): Granulocytopenia, thrombocytopenia, leukopenia, hemolytic anemia, lymphadenopathy, decreased CD4 lymphocytes

-Uncommon (0.1% to 1%): Autoimmune thrombocytopenia with or without purpura, severe potentially life-threatening neutropenia

-Very rare (less than 0.01%): Aplastic anemia

-Frequency not reported: Hemolysis

-Postmarketing reports: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura

Melanoma Patients:

-Common (1% to 10%): Anemia

-Frequency not reported: Severe bone marrow hypoplasia^[Ref]

Nervous system

Headache (alone: 56%; with ribavirin: up to 62%), dizziness (alone: 12%; with ribavirin: up to 21%), and taste perversion (alone: less than 1%; with ribavirin: 9%) have been reported in CHC patients.

Paresthesia was reported in 5% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Vertigo, migraine headache, paresthesia, hearing impairment, hearing loss, encephalopathy, and peripheral neuropathy have also been reported during postmarketing experience.

Headache (all grades: 70%; grade 3/4: 4%), dysgeusia (all grades: 38%), dizziness (all grades: 35%; grade 3/4: 2%), olfactory nerve disorder (all grades: 23%), and paresthesia (all grades: 21%; grade 3/4: less than 1%) have been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Headache (up to 64%), dizziness (up to 21%)

-Common (1% to 10%): Hypertonia, taste perversion, amnesia, memory impairment, syncope, migraine, ataxia, confusion, neuralgia, paresthesia, hypoesthesia, hyperesthesia, somnolence, disturbance in attention, tremor, dysgeusia, hearing impairment/loss, tinnitus, vertigo

-Uncommon (0.1% to 1%): Nerve palsy (facial, oculomotor), transient ischemic attack, loss of consciousness, neuropathy, peripheral neuropathy

-Rare (0.01% to 0.1%): Convulsion

-Very rare (less than 0.01%): Cerebrovascular hemorrhage, cerebrovascular ischemia, encephalopathy

-Frequency not reported: Mononeuropathies, hearing/vestibular disorders

-Postmarketing reports: Seizures, memory loss

Melanoma Patients:

-Very common (10% or more): Headache (up to 70%), dysgeusia (up to 38%), dizziness (up to 35%), olfactory nerve disorder (up to 23%), paresthesia (up to 21%)^[Ref]

Psychiatric

Anxiety/emotional lability/irritability (alone: 28%; with ribavirin: up to 47%), insomnia (alone: 23%; with ribavirin: up to 41%), depression (alone: 29%; with ribavirin: up to 31%), impaired concentration (alone: 10%; with ribavirin: 17%), agitation (alone: 2%; with ribavirin: 8%), and nervousness (alone: 4%; with ribavirin: 6%) have been reported in CHC patients.

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.

Psychoses, hallucinations, and bipolar disorders have also been reported during postmarketing experience.

Depression (all grades: 59%; grade 3/4: 7%) has been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Anxiety/emotional lability/irritability (up to 47%), insomnia (up to 41%), depression (up to 31%), impaired concentration (up to 17%)

-Common (1% to 10%): Nervousness, agitation, aggression, anger, altered mood, abnormal behavior, sleep disorder, decreased libido, apathy, abnormal dreams, crying

-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), hallucinations, panic attack

-Rare (0.01% to 0.1%): Bipolar disorders

-Postmarketing reports: Homicidal ideation, aggressive behavior (sometimes directed towards others), mania

Melanoma Patients:

-Very common (10% or more): Depression (up to 59%)^[Ref]

Other

Fatigue/asthenia (alone: 52%; with ribavirin: up to 68%), 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 (alone: 8%; with ribavirin: 12%), viral infections (alone: 11%; with ribavirin: 12%), malaise (alone: 7%; with ribavirin: 4%), chest pain (alone: 6%; with ribavirin: 8%), flushing (alone: 6%; with ribavirin: 4%), and fungal infections (alone: less than 1%; with ribavirin: 6%) have been reported in CHC patients.

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

Bacterial infection (including sepsis) has also been reported during postmarketing experience.

Fatigue (all grades: 94%; grade 3/4: 16%), pyrexia (all grades: 75%; grade 3/4: 4%), chills (all grades: 63%; grade 3/4: 1%), and decreased weight (all grades: 11%; grade 3/4: less than 1%) have been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Fatigue/asthenia (up to 68%), rigors (up to 48%), influenza-like symptoms/illness (up to 46%), fever/pyrexia (up to 46%), chills (up to 39%), weight decrease (up to 29%), unspecified pain (up to 13%), right upper quadrant pain (up to 12%), viral infections (up to 12%)

-Common (1% to 10%): Chest pain, malaise, flushing, bacterial infection (including sepsis), fungal infections, otitis media, breast pain, chest discomfort, face edema, peripheral edema, feeling abnormal, thirst

-Uncommon (0.1% to 1%): Infection (sepsis, pneumonia, abscess, cellulitis), ear pain

-Postmarketing reports: Asthenic conditions (including asthenia, malaise, fatigue)

Melanoma Patients:

-Very common (10% or more): Fatigue (up to 94%), pyrexia (up to 75%), chills (up to 63%), decreased weight (up to 11%)^[Ref]

Musculoskeletal

Myalgia (alone: 54%; with ribavirin: up to 56%), arthralgia (alone: 23%; with ribavirin: up to 34%), and musculoskeletal pain (alone: 28%; with ribavirin: 21%) have been reported in CHC patients.

Pain in limb (6%) and back pain (5%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

A small number of patients developed mild to moderate gout.

Rhabdomyolysis, myositis, and rheumatoid arthritis have also been reported during postmarketing experience.

Myalgia (all grades: 68%; grade 3/4: 4%) and arthralgia (all grades: 51%; grade 3/4: 3%) have been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Myalgia (up to 56%), arthralgia (up to 34%), musculoskeletal pain (up to 28%)

-Common (1% to 10%): Arthritis, back pain, muscle spasms, pain in extremity, pain in limb

-Uncommon (0.1% to 1%): Gout, rheumatoid arthritis, bone pain, muscle weakness

-Rare (0.01% to 0.1%): Rhabdomyolysis, myositis

Melanoma Patients:

-Very common (10% or more): Myalgia (up to 68%), arthralgia (up to 51%)^[Ref]

Local

Injection site inflammation/reaction (including bruise, itchiness, irritation; alone: 47%; with ribavirin: up to 75%) has been reported in CHC patients.

Injection site reaction (all grades: 62%; grade 3/4: 1.8%) has been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Injection site inflammation/reaction (including bruise, itchiness, irritation; up to 75%)

-Common (1% to 10%): Injection site pain

-Uncommon (0.1% to 1%): Injection site necrosis, injection site infection

-Frequency not reported: Localized skin ulcerations (after subcutaneous and IM injection)

Melanoma Patients:

-Very common (10% or more): Injection site reaction (up to 62%)^[Ref]

Gastrointestinal

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 (alone: 7%; with ribavirin: up to 14%), dry mouth (alone: 6%; with ribavirin: 12%), dyspepsia (alone: 6%; with ribavirin: 9%), and constipation (alone: 1%; with ribavirin: 5%) have been reported in CHC patients.

Oral candidiasis (14%), increased blood amylase (6%), and increased lipase (6%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

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.

Pancreatitis has also been reported during postmarketing experience.

Nausea (all grades: 64%; grade 3/4: 3%), diarrhea (all grades: 37%; grade 3/4: 1%), and vomiting (all grades: 26%; grade 3/4: 1%) have been reported in melanoma patients.^[Ref]

CHC Patients:

-Very common (10% or more): Nausea (up to 43%), diarrhea (up to 22%), abdominal pain (up to 15%), vomiting (up to 14%), oral candidiasis (14%), dry mouth (up to 12%)

-Common (1% to 10%): Dyspepsia, constipation, gastroesophageal reflux disease, stomatitis, mouth ulceration, glossodynia, gingival bleeding, flatulence, hemorrhoids, cheilitis, abdominal distension, gingivitis, glossitis, tooth disorder, increased blood amylase, increased lipase, loose stools, ulcerative stomatitis

-Uncommon (0.1% to 1%): Gastroenteritis, pancreatitis, oral pain

-Rare (0.01% to 0.1%): Ischemic colitis

-Very rare (less than 0.01%): Ulcerative colitis

-Frequency not reported: Hemorrhagic colitis, tongue pigmentation, tooth disorder, tooth fracture

-Postmarketing reports: Aphthous stomatitis, colitis

Melanoma Patients:

-Very common (10% or more): Nausea (up to 64%), diarrhea (up to 37%), vomiting (up to 26%)^[Ref]

Metabolic

CHC Patients:

-Very common (10% or more): Hyperuricemia (up to 38%), anorexia (up to 32%)

-Common (1% to 10%): Hypocalcemia, dehydration, increased appetite, decreased appetite, increased blood lactic acid

-Uncommon (0.1% to 1%): Hyperglycemia, diabetes mellitus (new onset or worsening), hypertriglyceridemia

-Rare (0.01% to 0.1%): Diabetic ketoacidosis

-Frequency not reported: Elevated triglyceride levels

-Postmarketing reports: Diabetes

Melanoma Patients:

-Very common (10% or more): Anorexia (up to 69%), increased blood alkaline phosphatase (23%)^[Ref]

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

Anorexia (alone: 20%; with ribavirin: up to 32%) has been reported in CHC patients.

Decreased appetite (8%) and increased blood lactic acid (5%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

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

Elevated triglyceride levels have been associated with interferon alphas.

Dehydration, hypertriglyceridemia, and diabetic ketoacidosis have also been reported during postmarketing experience.

Anorexia (all grades: 69%; grade 3/4: 3%) and increased blood alkaline phosphatase (all grades: 23%) have been reported in melanoma patients.^[Ref]

Dermatologic

CHC Patients:

-Very common (10% or more): Alopecia (up to 36%), rash (up to 34%), pruritus (up to 29%), dry skin (up to 24%), acquired lipodystrophy (13%), increased sweating (up to 11%)

-Common (1% to 10%): Herpes simplex, psoriasis, photosensitivity reaction, maculopapular rash, dermatitis, erythematous rash, eczema, night sweats, hyperhidrosis, acne, furuncle, erythema, urticaria, abnormal hair texture, nail disorder

-Uncommon (0.1% to 1%): Aggravated psoriasis, phototoxicity

-Rare (0.01% to 0.1%): Cutaneous sarcoidosis

-Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

-Frequency not reported: Generalized exfoliative dermatitis, cutaneous desquamation, seborrhea, pigmentation disorder

Melanoma Patients:

-Very common (10% or more): Exfoliative rash (up to 36%), alopecia (34%)^[Ref]

Alopecia (alone: 22%; with ribavirin: up to 36%), rash (alone: 6%; with ribavirin: up to 34%), pruritus (alone: 12%; with ribavirin: up to 29%), dry skin (alone: 11%; with ribavirin: up to 24%), and increased sweating (alone: 6%; with ribavirin: 11%) have been reported in CHC patients.

Acquired lipodystrophy was reported in 13% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

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 therapy with peginterferon alfa-2b/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.

Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, and psoriasis have also been reported during postmarketing experience.

Exfoliative rash (all grades: 36%; grade 3/4: 1%) and alopecia (all grades: 34%) have been reported in melanoma patients.^[Ref]

Respiratory

CHC Patients:

-Very common (10% or more): Dyspnea (up to 26%), cough (up to 23%), pharyngitis (up to 12%)

-Common (1% to 10%): Sinusitis, rhinitis, influenza, upper respiratory tract infection, bronchitis, dysphonia, epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain, nonproductive cough

-Uncommon (0.1% to 1%): Emphysema, bronchiolitis obliterans, pleural effusion, lower respiratory tract infection

-Frequency not reported: Pulmonary infiltrates, pneumonitis, pneumonia (sometimes fatal)

-Postmarketing reports: Interstitial pneumonitis, pulmonary hypertension

Melanoma Patients:

-Common (1% to 10%): Dyspnea, cough^[Ref]

Dyspnea (alone: 4%; with ribavirin: up to 26%), coughing (alone: 8%; with ribavirin: up to 23%), pharyngitis (alone: 10%; with ribavirin: 12%), sinusitis (alone: 7%; with ribavirin: 6%), and rhinitis (alone: 2%; with ribavirin: 8%) have been reported in CHC patients.

Rhinitis was reported in 5% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

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

Dyspnea, pulmonary infiltrates, pneumonia, and bronchiolitis obliterans have also been reported during postmarketing experience.

Dyspnea (all grades: 6%; grade 3/4: 1%) and cough (all grades: 5%; grade 3/4: less than 1%) have been reported in melanoma patients.^[Ref]

Hepatic

CHC Patients:

-Very common (10% or more): Hyperbilirubinemia (up to 14%)

-Common (1% to 10%): Hepatomegaly, increased GGT

-Frequency not reported: Increased risk of hepatic decompensation and death, hepatic decompensation (including fatalities), cirrhosis

Melanoma Patients:

-Very common (10% or more): Increased ALT or AST (up to 77%)

-Common (1% to 10%): Increased GGT^[Ref]

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

Hepatomegaly (alone: 6%; with ribavirin: 4%) has been reported in CHC patients.

Increased GGT (9%) and cytolytic hepatitis (6%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin. Hepatic decompensation (including fatalities) and cirrhosis were reported in a study in HCV/HIV coinfection.

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

Increased ALT or AST (all grades: 77%; grade 3/4: 11%) and increased GGT (all grades: 8%; grade 3/4: 4%) have been reported in melanoma patients.^[Ref]

Cardiovascular

CHC Patients:

-Common (1% to 10%): Palpitations, tachycardia, hypertension, hypotension

-Uncommon (0.1% to 1%): Cardiomyopathy, angina pectoris, pericardial effusion, supraventricular arrhythmias, vasculitis, myocardial infarction

-Rare (0.01% to 0.1%): Congestive heart failure, arrhythmia, pericarditis

-Very rare (less than 0.01%): Cardiac ischemia

-Postmarketing reports: Stroke, angina pectoris

Melanoma Patients:

-Common (1% to 10%): Myocardial infarction, bundle-branch block, ventricular tachycardia, supraventricular arrhythmia^[Ref]

Palpitations, cardiomyopathy, hypertension, and hypotension have also been reported during postmarketing experience.^[Ref]

Endocrine

Hypothyroidism (with or without ribavirin: 5%) and hyperthyroidism (with or without ribavirin: 3%) have been reported in CHC patients.

TSH abnormalities, with and without clinical manifestations, have been associated with interferon therapies.^[Ref]

CHC Patients:

-Common (1% to 10%): Hypothyroidism (new onset or worsening), hyperthyroidism (new onset or worsening)

-Frequency not reported: Thyroid-stimulating hormone (TSH) abnormalities, thyroid disorders

-Postmarketing reports: Thyroiditis

Melanoma Patients:

-Common (1% to 10%): Endocrine disorders, hypothyroidism^[Ref]

Ocular

Conjunctivitis (alone: 4%; with ribavirin: 4%) and blurred vision (alone: 2%; with ribavirin: 5%) have been reported in CHC patients.

Retinal and ocular changes induced or aggravated by treatment with this 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.^[Ref]

CHC Patients:

-Common (1% to 10%): Conjunctivitis, blurred vision, visual disturbance, photophobia, eye irritation, lacrimal gland disorder, eye pain, dry eye, abnormal vision

-Uncommon (0.1% to 1%): Retinal ischemia, retinal artery or vein thrombosis/occlusion, blindness, decreased visual acuity, optic neuritis, retinal exudates

-Rare (0.01% to 0.1%): Loss of visual acuity or visual fields, retinal hemorrhages, retinopathy, papilledema, macular edema

-Frequency not reported: Retinal and ocular changes, decreased or loss of vision, cotton wool spots, serous retinal detachment

Melanoma Patients:

-Uncommon (0.1% to 1%): Serious retinal disorders, visual disturbances, blurred vision, reduction in visual acuity

-Frequency not reported: Partial loss of vision due to retinal thrombosis or retinopathy^[Ref]

Genitourinary

CHC Patients:

-Common (1% to 10%): Menstrual disorder, frequent micturition, polyuria, urine abnormality, amenorrhea, menorrhagia, ovarian disorder, vaginal disorder, sexual dysfunction, prostatitis, erectile dysfunction/impotence

Melanoma Patients:

-Common (1% to 10%): Proteinuria

Menstrual disorder (alone: 4%; with ribavirin: 7%) has been reported in CHC patients.

Proteinuria (all grades: 7%) has been reported in melanoma patients.

Immunologic

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

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

Sarcoidosis has also been reported during postmarketing experience.^[Ref]

CHC Patients:

-Uncommon (0.1% to 1%): Lupus-like syndrome, sarcoidosis

-Very rare (less than 0.01%): Exacerbation of sarcoidosis

-Frequency not reported: Exacerbation of autoimmune disorders, autoimmune hepatitis, development of binding antibodies (including neutralizing antibodies) to peginterferon alfa-2b, autoimmune thrombocytopenia, Hashimoto encephalopathy

-Postmarketing reports: Systemic lupus erythematosus, Vogt-Koyanagi-Harada syndrome^[Ref]

Hypersensitivity

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

CHC Patients:

-Uncommon (0.1% to 1%): Drug hypersensitivity

-Rare (0.01% to 0.1%): Serious acute hypersensitivity reactions

-Postmarketing reports: Acute hypersensitivity reactions (including anaphylaxis, angioedema, bronchoconstriction, urticaria), anaphylactic reactions (including anaphylactic shock)^[Ref]

Renal

Renal insufficiency, renal failure, and interstitial nephritis have also been reported during postmarketing experience.^[Ref]

CHC Patients:

-Uncommon (0.1% to 1%): Interstitial nephritis

-Rare (0.01% to 0.1%): Renal insufficiency, renal failure^[Ref]