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Peginterferon alfa-2a

Class
Cytokines
Subclass
Interferons
Generic name
Peginterferon alfa-2a, pegylated interferon alfa-2a
Brand names
Pegasys®
Common formulations
Solution for injection
Dosage and administration
Adults patients
HBV infection • Chronic
•
180 mcg SC weekly for 48 weeks
HCV infection • Chronic
•
180 mcg SC weekly for 48 weeks for genotypes 1 and 4, and 24 weeks for genotypes 2 and 3, when combined with ribavirin without other antivirals; or 48 weeks when given as monotherapy
HDV infection • Chronic • Off-label
•
180 mcg SC weekly for 48 weeks
Indications for use
Labeled indications
Adults
•
Treatment of HBV infection (chronic)
•
Treatment of HCV infection (chronic)
Children
•
Treatment of HBV infection (in patients ≥ 3 years) (chronic)
•
Treatment of HCV infection (in patients ≥ 5 years) (chronic)
Off-label indications
Adults
•
Treatment of HDV infection (chronic)
Safety risks
Boxed warnings
Exacerbation of autoimmune disorders
•
Maintain a high level of suspicion, as peginterferon alfa-2a has been associated with an increased risk of autoimmune disorders, including myositis, hepatitis, TTP, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and SLE. Use with caution in patients with autoimmune disorders.
Exacerbation of cerebrovascular events
•
Maintain a high level of suspicion, as peginterferon alfa-2a has been associated with an increased risk of ischemic and hemorrhagic cerebrovascular events.
Infections
•
Maintain a high level of suspicion, as serious and severe infections have been reported with peginterferon alfa-2a treatment.
Neuropsychiatric adverse events
•
Maintain a high level of suspicion, as peginterferon alfa-2a may cause life-threatening or fatal neuropsychiatric reactions, including suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose. Use with extreme caution in patients with a history of depression.
Contraindications
Hypersensitivity to alpha interferons, including peginterferon alfa-2a, or its components
AIH
Warnings and precautions
Acute pancreatitis
•
Maintain a high level of suspicion, as peripheral neuropathy has been reported with peginterferon alfa-2a/ribavirin treatment.
Cardiovascular adverse events
•
Use caution in patients with cardiac disease, as peginterferon alfa-2a may cause hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction.
Colitis
•
Maintain a high level of suspicion, as ulcerative and hemorrhagic/ischemic colitis have been reported with peginterferon alfa-2a treatment.
Endocrine disorders
•
Maintain a high level of suspicion, as peginterferon alfa-2a can cause or aggravate hypothyroidism and hyperthyroidism, and has been associated with hyperglycemia, hypoglycemia, and diabetes mellitus. Do not initiate peginterferon alfa-2a in patients with these conditions who cannot be effectively treated by medications.
Growth suppression
•
Maintain a high level of suspicion, as peginterferon alfa-2a can impact growth in children.
Hepatitis exacerbation
•
Maintain a high level of suspicion, as peginterferon alfa-2a can cause serum ALT elevations, hepatitis exacerbations, and liver failure. Monitor biochemical tests, including LFTs, at 4 weeks after initiation and periodically thereafter. Reduce to 135 mcg SC once weekly if ALT elevations occur.
Myelosuppression
•
Maintain a high level of suspicion, as peginterferon alfa-2a suppresses bone marrow function and may result in severe cytopenias. Use with caution in patients with baseline neutrophil counts < 1,500 cells/mm³, platelet counts < 90,000 cells/mm³, or hemoglobin < 10 g/dL. Monitor hematological tests at 2 and 4 weeks after initiation and periodically therafter.
•
Reduce to 135 mcg SC once weekly if neutrophils fall to 500-750 cells/mm³. Discontinue if < 500 cells/mm³ until recovery to > 1,000 cells/mm³, then restart at 90 mcg SC once weekly with monitoring.
•
Reduce to 90 mcg SC once weekly if platelet counts fall to 25,000-50,000 cells/mm³. Discontinue if < 25,000 cells/mm³.
Peripheral neuropathy
•
Maintain a high level of suspicion, as pancreatitis, sometimes fatal, has been reported with peginterferon alfa-2a/telbivudine treatment.
Pulmonary disorders
•
Maintain a high level of suspicion, as peginterferon alfa-2a can cause dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, sarcoidosis, and respiratory failure.
Visual impairment
•
Maintain a high level of suspicion, as peginterferon alfa-2a can cause vision loss, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for anemia and adverse reactions.
CrCl < 30 mL/min
•
Maximal dose of 135 mcg weekly. Monitor renal function. Monitor for anemia and adverse reactions.
Renal replacement therapy
Continuous renal replacement
•
Dose as in CrCl < 30 mL/min. Maximal dose of 135 mcg. Maximal frequency of weekly.
Intermittent hemodialysis
•
Dose as in CrCl < 30 mL/min. Maximal dose of 135 mcg. Maximal frequency of weekly.
Peritoneal dialysis
•
Dose as in CrCl < 30 mL/min. Maximal dose of 135 mcg. Maximal frequency of weekly.
Hepatic impairment
Child-Pugh A (mild)
•
Use with caution. Monitor liver function tests.
Child-Pugh B (moderate)
•
Do not use.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Do not combine peginterferon alfa-2a with ribavirin during pregnancy or in men with pregnant partners. Exclude pregnancy before starting treatment. Advise using two effective contraceptive methods during treatment and for at least 6 months after the last dose, and obtain monthly pregnancy testing.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ blood neutrophil count, ↑ serum triglycerides, ↑ serum ALT, abdominal pain, arthralgia, depression, diarrhea, dizziness, fatigue, asthenia, fever, hair loss, headache, injection site reactions, irritability, nervousness, anxiety, insomnia, itching, loss of appetite, myalgia, nausea, vomiting, pain, rigors
Common 1-10%
•
Anemia, ↓ blood lymphocyte count, mood changes, ↓ platelet count, memory impairment, skin rash, dermatitis, eczema, hyperthyroidism, hypothyroidism, back pain, difficulty concentrating, dry mouth, sweating, dyspnea, cough, blurred vision, weight loss, dry skin patches
Uncommon < 1%
•
Dyspepsia
Unknown frequency
•
Pure red cell aplasia, skin abscess, transplant rejection, hearing loss, tongue pigmentation, dehydration, seizure
Interactions
Drug(s)
Check Interactions
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