PEGNANO (Peginterferon alfa 2a)

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PEGNANO

Each glass vial of 1 mL contains:

Active ingredient: Peginterferon alfa-2a ..... 180mcg

Excipients: Sodium Chloride, Sodium Acetate Trihydrate, Benzyl Alcohol, Acetic Acid, Polysorbate 80 (Tween 80), Water for Injection.

Each prefilled syringe of 0.5 mL contains:

Active ingredient: Peginterferon alfa-2a ..... 180mcg
Excipients: Sodium Chloride, Sodium Acetate Trihydrate, Benzyl Alcohol, Acetic Acid, Polysorbate 80 (Tween 80), Water for Injection.

DESCRIPTION

Peginterferon alfa-2a is a covalent conjugate of the protein recombinant interferon alfa-2a, (approximate molecular weight 20,000 daltons), with a bis-monomethoxy polyethylene glycol (PEG) chain (approximate molecular weight MW 40,000 daltons). Peginterferon alfa-2a has an approximate molecular weight of 60 KDa. 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.

Pegnano is supplied as an injectable solution in prefilled syringes or vials. Injectable solution is sterile, clear and colorless.

Pharmacotherapeutic group: Immunostimulating Agent /Cytokine

INDICATIONS

Chronic hepatitis B

Pegnano is indicated for the treatment of HBeAg positive or HBeAg-negative-chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis.

Chronic hepatitis C

Pegnano is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.

The optimal way to use Pegnano in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegnano and ribavirin is indicated in naive patients and patients who have failed previous treatments with interferon alfa (PEGylated or non-PEGylated) alone or in combination therapy with ribavirin.

Monotherapy is indicated in the case of intolerance or contraindication to ribavarin.

Administration route: SC injection

Treatnebr should be initiated only by a physician experienced in the treatment of patients with hepatitis B or C.

CONTRAINDICATIONS

Hypersensitivity to the active substance, to interferon alfa, or to any of the excipients
Autoimmune hepatitis
Severe hepatic dysfunction or decompensated cirrhosis of the liver
Neonates and young children up to 3 years old, because of the excipient benzyl alcohol
A history of severe pre-existing cardiac diseases, including unstable or uncontrolled cardiac diseases in the previous six months
Initiation of Peginterferon alfa-2a is contraindicated in HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by drugs such as atazanavir and indinavir
Combination of Peginterferon alfa-2a with telbivudine.

STORAGE, SHELF LIFE, PACKING UNITS

Storage: Store in the refrigerator at 2°C - 8°C. Do not freeze. Protect from light.

Shelf life: Expiry 24 months from manufacturing date.

Packing units:

Box of 1 prefilled syringe of solution for injection PEGNANO 180 mcg (0.5 mL)

Box of 1 vial of solution for injection PEGNANO 180 mcg (1 mL)

PEGNANO (Peginterferon alfa 2a)