PEGNANO (Peginterferon alfa 2a)

Each glass vial of 1 mL contains

Peginterferon alfa-2a ..... 180mg

Each prefilled syringe of 0.5 mL contains

Peginterferon alfa-2a ..... 180mg

Peginterferon alfa-2a is a covalent conjugate of the recombinant protein, interferon alfa-2a, (approximate molecular weight 19.2 kDa), which is branched with a 40kDa-polyethylene glycol chain. Peginterferon alfa-2a has an approximate molecular weight of 59 KDa. Interferon alfa-2a is produced by recom binant DNA technology in which a cloned human leukocyte interferon gene is transferred and expressed in Escherichia coli.

Pharmacotherapeutic group:

Immunostimulating Agent /Cytokine

INDICATION

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 with compensated and/or co-infected with 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 alpha (PEGylated or non-PEGylated) alone or in combination with Ribavirin.

Monotherapy is indicated in the case of intolerance or contradication to Ribavarin.

CONTRAINDICATION

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 Pegnano 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 at 2°C 8°C. Don't freeze.

Protect from light. The solution for injection should be inspected apparently for particulates and discoloration before administration.

Shelf life: 24 months from manufacturing date.

Packing units:

Box of 01 prefilled syringe (0.5 mL)

Box of 01 vial of solution for injection (1 mL)

PEGNANO (Peginterferon alfa 2a)