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Hepatitis B/C, Cirrhosis

PEGSTAT

DESCRIPTION

Peginterferon alfa-2b  is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12 KDa. The average molecular weight of the Pegstat molecule is approximately 31 KDa. The specific activity of peginterferon alfa-2b is approximately 0.7 x 108 IU/mg protein.

Interferon alfa-2b is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon gene from human leukocytes.

COMPOSITION

Each lyophilized powder vial contains

Peginterferon alfa-2b                                            50 mcg/ 80mcg/ 120mcg/ 150mcg

Each vial of 1ml solvent contains:                          9mg Benzyl alcohol

Each vial of 1ml contains: Peginterferon alfa-2b      50 mcg/ 80mcg/ 120mcg/ 150mcg

Each prefilled syringe of 0.5 ml contains: Peginterferon alfa-2b     50 mcg/ 80mcg/120mcg/150mcg

THERAPEUTIC INDICATIONS

Chronic Hepatitis C

Combination therapy: Pegstat in combination with ribavirin is indicated for the treatment of chronic hepatitis C in patients age of 3  or older with compensated liver disease.

Monotherapy (for patients who are intolerant to ribavirin)

Pegstat is indicated for use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon alpha and who are at least 18 years old.

Administration route: SC injection

CONTRAINDICATIONS

Pegstat is contraindicated in patients with

  • Verified hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other component of the product
  • Autoimmune hepatitis
  • Hepatic decompensation (Child-Pugh score > 6 [class B and C]) in cirrhotic CHC patients before or during treatment

Pegstat/ribavirin combination therapy is additionally contraindicated in

  • Women who are pregnant or becoming pregnant
  • Men whose female partners are pregnant.
  • Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
  • Patients with creatinine clearance < 50 mL/min

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store at 2°C to 8°C. Do not freeze. Protect from light. The solution for injection should be inspected visually for particulate matter and discoloration before administration.

Shelf life:  24 months from manufacturing date.

Reconstituted solution is stable for 7 days at  2°C - 8°C.

Packing units:

Box of 01 vial of Pegstat lyophilized powder + 1 vial of solvent 1 mL.

Box of 01 or 05 vial(s) of Pegstat solution for injection (1 mL).

Box of  01 or 06 prefilled syringe(s) of Pegstat solution for injection (0.5 mL).


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