NANOGEN | Solution for injection 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

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.

• 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: 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)