Trade Names:PEG-Intron- Injection, lyophilized, powder for solution 100 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 160 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 240 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 300 mcg/mL (reconstituted)
Trade Names:PEG-Intron Redipen- Injection, lyophilized, powder for solution 100 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 160 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 240 mcg/mL (reconstituted)- Injection, lyophilized, powder for solution 300 mcg/mL (reconstituted)Unitron PEG (Canada)
Binds to specific membrane receptors on cell surface and initiates a complex sequence of intracellular events (eg, suppression of cell proliferation, enhancement of phagocytic activity of macrophages).
T max is 15 to 44 h (postdose). Bioavailability increases with multiple dosing. Both AUC and C max increased 70% when administered with a high-fat meal.
Renal excretion is 30%. The half-life absorption is 4.6 h (subcutaneous) and elimination is approximately 40 h. Apparent Cl is 22 mL/h•kg.
Duration is 48 to 72 h.
Cl decreases by 17% in moderate renal impairment (CrCl 30 to 49 mL/min) and by 44% in severe renal impairment (CrCl 10 to 29 mL/min).Children
In children receiving peginterferon alfa-2b 60 mcg/m 2 /wk, exposure may be approximately 50% higher than observed in adults receiving 1.5 mcg/kg/wk.
For use alone (in patients 18 yr of age and older) or in combination with ribavirin (in patients 3 yr of age and older) for the treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease. For use in combination with ribavirin, see ribavirin package insert.
Treatment of renal cell carcinoma, chronic myelogenous leukemia, metastatic carcinoma.
Autoimmune hepatitis; decompensated liver disease; hypersensitivity to the drug.
Subcutaneous For patients weighing 45 kg or less, administer 40 mcg; 46 to 56 kg, administer 50 mcg; 57 to 72 kg, administer 64 mcg; 73 to 88 kg, administer 80 mcg; 89 to 106 kg, administer 96 mcg; 107 to 136 kg, administer 120 mcg; 137 to 160 kg, administer 150 mcg.Peginterferon Alfa-2b Dose in Combination Therapy With RibavirinAdults
Subcutaneous For patients weighing less than 40 kg, administer 50 mcg; 40 to 50 kg, administer 64 mcg; 51 to 60 kg, administer 80 mcg; 61 to 75 kg, administer 96 mcg; 76 to 85 kg, administer 120 mcg; greater than 86 kg, administer 150 mcg.Children 3 to 17 yr of age
Subcutaneous 60 mcg/m 2 /week.Dose ReductionAdults and Children 3 yr of age and older
Subcutaneous If a serious adverse reaction occurs during treatment, discontinue or modify the dosage until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events occur despite adequate dosage adjustments, discontinue treatment. See product information for guidelines for dosage modification or discontinuation in adults and children.Renal Function ImpairmentAdults and Children 3 yr of age and older
SubcutaneousModerate renal function impairment (CrCl 30 to 50 mL/min)
Decrease the peginterferon alfa-2b dose 25%.Severe renal function impairment (CrCl 10 to 29 mL/min), including patients on hemodialysis
Decrease the peginterferon alfa-2b dose 50%.
If renal function decreases during treatment, discontinue peginterferon alfa-2b. Do not use peginterferon alfa-2b/ribavirin in patients with CrCl less than 50 mL/min.
Store unopened vials at controlled room temperature (59° to 86°F). Store Redipen in refrigerator (36° to 46°F). Administer reconstituted solution immediately or store for up to 24 h in refrigerator. Do not freeze.
The therapeutic effects of these agents may be decreased by peginterferon alfa-2b.Methadone
Methadone plasma concentrations may be elevated, increasing the narcotic effect.
None well documented.
The incidences stated for the following adverse reactions were reported with peginterferon alfa-2b monotherapy
Headache (56%); asthenia/fatigue (52%); depression (29%); anxiety/emotional lability/irritability (28%); insomnia (23%); dizziness (12%); impaired concentration (10%); malaise (7%); nervousness (4%); agitation (2%).Children
Pyrexia (80%); headache (62%); fatigue (30%); decreased appetite (22%); asthenia (15%); dizziness, irritability (14%).Postmarketing
Memory loss; migraine headache; peripheral neuropathy; seizures.
Alopecia (22%); pruritus (12%); dry skin (11%); flushing, increased sweating, rash (6%).Children
Erythema multiforme; Stevens-Johnson syndrome; toxic epidermal necrolysis.
Pharyngitis (10%); conjunctivitis (4%); blurred vision, rhinitis (2%).Postmarketing
Hearing loss; impaired hearing; vertigo.
Nausea (26%); anorexia (20%); diarrhea (18%); abdominal pain (16%); vomiting (7%); dry mouth, dyspepsia (6%); constipation (1%).Children
Anorexia (29%); vomiting (27%); abdominal pain (21%); nausea (18%); upper abdominal pain (12%).Postmarketing
Menstrual disorder (4%).Postmarketing
Renal failure; renal insufficiency.
Decreased neutrophils (70%); decreased platelets (20%); thrombocytopenia (7%); neutropenia (6%).Children
Neutropenia (33%); anemia (11%); leukopenia (10%).Postmarketing
Pure red cell aplasia; thrombotic thrombocytopenic purpura.
Injection-site inflammation/reaction (47%).Children
Injection-site erythema (29%).
Weight loss (11%); hypothyroidism (5%).Children
Decreased weight (19%).
Myalgia (54%); musculoskeletal pain (28%); arthralgia, rigors (23%).Children
Arthralgia, myalgia (17%).Postmarketing
Coughing (8%); sinusitis (7%); dyspnea (4%).
Fever (22%); viral infection (11%); right upper quadrant pain (8%); chest pain (6%).Children
WarningsNeuropsychiatric, autoimmune, ischemic, and infectious disorders
Interferons may cause or aggravate fatal or life-threatening disorders of this nature. Persistent, severe, or worsening signs or symptoms may necessitate discontinuation of therapy. Closely monitor patients with periodic clinical and laboratory evaluations.Use with ribavirin
Ribavirin may cause birth defects and fetal death. Extreme care must be taken to avoid pregnancy. Ribavirin causes hemolytic anemia, which may result in worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
Closely monitor clinical status and hepatic function. Closely monitor patients with renal function impairment for peginterferon toxicity, including increases in serum creatinine. Hematology and blood chemistry should be evaluated before treatment and periodically thereafter. Patients with preexisting cardiac abnormalities should have ECG before treatment. Patients should have regular dental checkups.Hepatitis C virus levels
Determine hepatitis C virus levels before starting therapy and after 6 mo of therapy. Be prepared to discontinue therapy if viral levels remain high after 6 mo of therapy.
Category C .
Safety and efficacy not established in children younger than 3 yr of age.
Use with caution.
Use with caution and monitor for signs and symptoms of interferon toxicity. Reduce dose in patients with moderate or severe renal function impairment.
Because interferon alfa may cause or exacerbate autoimmune disorders (eg, thyroiditis, SLE), use with caution in patients with history of autoimmune disorders. Discontinue use in patients with persistently severe or worsening signs or symptoms.
Bone marrow function may be suppressed.
Use with caution in patients with CV disease, including hypotension, arrhythmia, tachycardia, cardiomyopathy, and MI.
Ischemic and hemorrhagic cerebrovascular events have been reported. Events have occurred in patients with few or no reported risk factors.
Fatal and nonfatal ulcerative and hemorrhagic colitis have been observed. Discontinue use immediately in patients who develop symptoms.
Dental and periodontal disorders have been reported.
Hypo- and hyperthyroidism may occur or be aggravated. Diabetes mellitus has been observed in treated patients.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation and death. Immediately discontinue treatment if decompensation occurs.
Serious, acute hypersensitivity reactions (eg, angioedema, anaphylaxis) may occur with alfa interferon therapy.
Because life-threatening infectious disorders may occur, use with caution and monitor with periodic clinical and laboratory evaluations. Discontinue use in patients with persistently severe or worsening signs or symptoms.
Because life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction, and aggressive behavior have occurred, use with caution, especially in patients with history of psychiatric disorder. Discontinue use in patients with persistently severe or worsening signs or symptoms.
Decrease in or loss of vision, retinal hemorrhages, cotton wool spots, and retinal artery or vein obstruction have been observed. Ensure that all patients have an ophthalmic examination prior to beginning therapy and that patients with preexisting ophthalmic disorders (eg, diabetic, hypertensive retinopathy) receive periodic ophthalmic examinations during therapy.
Fatal and nonfatal pancreatitis has been observed. Discontinue use in patients who develop symptoms.
Increases in serum creatinine have occurred in patients with renal insufficiency.
Weight and height gain in children treated with peginterferon alfa-2b plus ribavirin lags behind that compared with normative population data. After about 6 mo posttreatment, subjects have weight gain rebounds and regain their weight to the 53rd percentile. After about 6 mo posttreatment, height gain stabilizes and children have an average height percentile of 44th percentile, which is less than the average normative population.
Dyspnea, pulmonary infiltrates, pneumonia, pneumonitis, and sarcoidosis, some resulting in respiratory failure and/or patient deaths, have been associated with use.
Elevated triglyceride levels may occur.
Experience is limited. No serious reactions have been attributed to overdosage (ie, 10.5 times the intended dose).
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