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| (peg-IN-ter-FEER-ahn AL-fuh-2a) |
| Pegasys |
| Injection: 180 mcg/mL |
| Class: Interferon, Immunomodulator |
Action Binds to specific receptors on cell surface and initiates a complex sequence of intracellular events (eg, inhibition of viral replication and inhibition of cell proliferation).
Absorption: Tmax is 72 to 96 hr. Steady-state is reached within 5 to 8 wk.
Elimination: Cl is approximately 94 mL/hr; t½ is approximately 80 hr.
Elderly: AUC increased but Cmax did not.
Renal function impairment: Cl decreased 25% to 45% in those with end-stage renal disease undergoing hemodialysis.
Indications Treatment of chronic hepatitis C in patients with compensated liver disease and not treated previously with interferon alfa.
Contraindications Autoimmune hepatitis; decompensated hepatic disease prior to or during treatment with interferon alfa-2a; hypersensitivity to any component of the product.
Adults: SC 180 mcg (1 mL) once weekly for 48 wk.
Dose reduction
Adverse reactions: When dose reduction is required for moderate to severe adverse reactions, initial dose reduction to 135 mcg is generally adequate; however, in some cases, a dose reduction to 90 mcg may be needed. The dose may be re-escalated following improvement of the adverse reaction. Hematologic toxicity: Dose reduction to 135 mcg of peginterferon alfa-2a is recommended if the neutrophil count is less than 750 cells/mm3. Suspend treatment in patients with an absolute neutrophil count below 500 cells/mm3 until the count returns to more than 1000 cells/mm3. Reinstitute therapy at 90 mcg of peginterferon alfa-2a and monitor the neutrophil count.
A dose reduction to 90 mcg of peginterferon alfa-2a is recommended if the platelet count is less than 50,000 cells/mm3. Cessation of therapy is recommended when the platelet count is below 25,000 cells/mm3. Renal function impairment: A dose reduction to 135 mcg of peginterferon alfa-2a is recommended in patients with end-stage renal disease requiring hemodialysis. Hepatic function impairment: A dose reduction to 90 mcg of peginterferon alfa-2a is recommended in patients with progressive ALT increases above baseline values. Discontinue peginterferon alfa-2a immediately if ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation.
Theophylline: Plasma concentrations of theophylline may be elevated, increasing the risk of side effects.
Lab Test Interferences None well documented.
CARDIOVASCULAR: Arrhythmia; endocarditis. CNS: Depression, irritability, anxiety; headache; insomnia; dizziness; concentration impairment; memory impairment; suicidal ideation. DERMATOLOGIC: Alopecia; pruritus; sweating; dermatitis; rash. EENT: Corneal ulcer. GI: Nausea; anorexia; diarrhea; abdominal pain; dry mouth; vomiting; peptic ulcer; GI bleeding; pancreatitis; colitis. HEMATOLOGIC: Neutropenia; thrombocytopenia. HEPATIC: Hepatic dysfunction; fatty liver; cholangitis. METABOLIC: Diabetes mellitus. RESPIRATORY: Pneumonia; interstitial pneumonitis; pulmonary embolism. OTHER: Flu-like symptoms; myalgia; arthralgia; back pain; fatigue; pyrexia; rigors; injection-site reaction; pain; asthenia; suicide; autoimmune phenomena; peripheral neuropathy; coma; myositis; cerebral hemorrhage.
Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly patients: Use with caution because of increased likelihood of decreased renal function. Autoimmune disorders: Use with caution. Bone marrow toxicity: Bone marrow function may be suppressed. Cardiovascular disorders: Use with caution in patients with preexisting cardiac disease, including hypertension, supraventricular arrhythmias, chest pain, and MI. Colitis: Fatal and nonfatal ischemic and hemorrhagic colitis have been observed. Discontinue use immediately in patients who develop symptoms. Endocrine disorders: May cause or aggravate hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia, and diabetes mellitus have occurred during treatment with peginterferon alfa-2a; therefore, patients with these conditions at baseline, who cannot be effectively treated by medication, should not begin peginterferon alfa-2a therapy. Patients who develop these conditions during treatment and cannot be controlled by medication may require discontinuation of peginterferon alfa-2a therapy. Ophthalmologic disorders: Decreased or loss of vision, retinopathy including macular edema, retinal hemorrhage, cotton wool spots, and retinal artery or vein obstruction have been observed. Pancreatitis: Fatal and nonfatal pancreatitis has been observed. Discontinue use in patients who develop symptoms. Pulmonary disorders: Dyspnea, pulmonary infiltrates; pneumonia, bronchiolitis obliterans, interstitial pneumonitis, and sarcodosis have been associated with use. Renal impairment: Use with caution and adjust dose accordingly. Special risk patients: May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.
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