Optipeg-A
Cheaper & Alternative Brands
Same generic (Peginterferon alfa-2a [Pegylated Interferon alfa-2a]), same form (SC Injection)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Chronic Hepatitis C
: Optipeg-A, alone or in combination with Ribavirin, is indicated for the treatment of aadults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Chronic Hepatitis B
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Chronic Hepatitis C
: Optipeg-A, alone or in combination with Ribavirin, is indicated for the treatment of aadults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Chronic Hepatitis B
: Optipeg-A, is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.
Dosage & Administration
Chronic hepatitis C
: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
Chronic hepatitis B
: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thigh
Hepatitis C Genotype 1 & 4:
Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
Pegylated Interferon alfa-2a dual therapy: 180 mcg once weekly for 48 weeks; Celbarin: <75 kg= (400+0+600) mg, >75 kg= (600+0+600) mg.
Hepatitis C Genotype 2 & 3:
Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
Pegylated Interferon alfa-2a dual therapy: 180 mcg once weekly for 24 weeks; Celbarin: (400+0+400) mg.
Pediatric Use
: The safety and effectiveness of Pegferon®, alone or in combination with Ribavirin in patients below the age of 5 years have not been established.
Contraindications
Hypersensitivity to any component of the product
Autoimmune hepatitis
Hepatic decompensation in cirrhotic patients before or during treatment
Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients co infected with HIV during or before treatment
Neonate or infants.
Side Effects & Adverse Reactions
Depression, suicide, relapse of drug abuse and bacterial infection
Flu like symptoms: Fatigue, pyrexia,
Gastrointestinal: Nausea/Vomiting, diarrhea, abdominal pain
Metabolic and Nutritional: Anorexia
Musculoskeletal: Myalgia, arthralgia
Neurological: Headache, dizziness, insomnia
Psychiatric reactions: Irritability, anxiety
Injection site reaction, skin problems, hair loss
Endocrine: Hypothyroidism
Warnings & Precautions
Patients who have failed alpha interferon treatment with or without ribavirin
Liver or other organ transplant recipients
Hepatitis B patients coinfected with HCV or HIV
Hepatitis C patients coinfected with HBV or coinfected with HIV with a CD4+ cell count < 100 cells/µL
Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia
Pharmacology & Mechanism of Action
Peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol chain. The Peginterferon alfa-2a moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.