Optipeg-A(Pegylated Interferon alfa-2a)
Therapeutic Group: Bio Tech
Presentation
Optipeg-A 180 prefilled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Pegylated Interferon alfa-2a BP 180 microgram
Optipeg-A 135 prefilled syringe injection: Each pre-filled syringe contains 0.5 ml sterile solution which contains Pegylated Interferon alfa-2a BP 135 microgram.
Description
Peginterferon alfa-2a is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol (PEG) chain . The PEG 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.
Indications
Chronic Hepatitis C : Peginterferon alfa-2a alone or in combination with Ribavirin, is indicated for the treatment of adults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
Chronic Hepatitis B : Peginterferon alfa-2a is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B 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
Optipeg-A Monotherapy: 180 mcg once weekly for 48 weeks
Optipeg-A dual therapy: Optipeg-A: 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
Optipeg-A Monotherapy: 180 mcg once weekly for 48 weeks
Optipeg-A dual therapy: Optipeg-A: 180 mcg once weekly for 24 weeks; Celbarin: (400+0+400) mg.
Side Effects
• 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
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.
Use in Pregnancy & Lactation
Pregnancy Category C: Peginterferon alfa-2a monotherapy
There are no adequate and well controlled trial on pregnant women & developing fetus due to teratogenic effects. Peginterferon alfa-2a is recommended for use in women of childbearing potential only when they are using effective contraception during therapy.
Pregnancy Category X: Use with Ribavirin
It is not known whether peginterferon or ribavirin or its components are excreted in human milk. Because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue peginterferon and ribavirin treatment.
Drug Interaction
• Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly
• Methadone: monitor for signs and symptoms of methadone toxicity
• Nucleoside analogues: closely monitor for toxicities and dose reduce or discontinue Peginterferon alfa 2a/ Ribavirin or both should event worsen
• Zidovudine: monitor for worsening neutropenia and/or anemia with peginterferon alfa/rifavirin
• Azathioprine.
Over Dose
There are limited experiences of overdose. There were no serious reactions attributed to overdose. There is no specific antidote. Dialysis is not effective.
Storage
Peginterferon should be stored at 2° to 8 °C and shaking should be avoided. Protect from light.
Commercial Pack
Optipeg-A 180 prefilled syringe injection: Each box contains 1 pre-filled syringe containing 0.5 ml sterile solution of peginterferon alfa-2a INN 180 mg
Optipeg-A 135 prefilled syringe injection: Each box contains 1 pre-filled syringe containing 0.5 ml sterile solution of peginterferon alfa-2a INN 135 mg.