Pegin 180 mcg/0.5 ml

INDICATIONS

Chronic Hepatitis C: Peginterferon alfa-2a, alone or in combination with Ribavirin, is indicated for the treatment of aadults with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.Chronic Hepatitis B ... Read moreChronic Hepatitis C: Peginterferon alfa-2a, alone or in combination with Ribavirin, is indicated for the treatment of aadults 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 infection who have compensated liver disease and evidence of viral replication and liver inflammation.

PHARMACOLOGY

Peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol chain. The Peginterferon alfa-2a 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.

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 thighChronic hepatitis B: The recommended dose of Peg interferon is 180 mcg once weekly for 48 weeks by subcutaneous administration on abdomen or thighHepatitis C Genotype 1 & 4:

Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
Pegylated Interferon alfa-2a dual therapy: 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:

Pegylated Interferon alfa-2a Monotherapy: 180 mcg once weekly for 48 weeks
Pegylated Interferon alfa-2a dual therapy: 180 mcg once weekly for 24 weeks; Celbarin: (400+0+400) mg.

Pediatric Use: The safety and effectiveness of Pegferon®, alone or in combination with Ribavirin in patients below the age of 5 years have not been established.

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.

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

PREGNANCY & LACTATION

Pregnancy Category C: Peginterferon alfa 2a Monotherapy has not been studied for its teratogenic effect. There are no adequate and well-controlled studies of in pregnant women. This is recommended for use in women of childbearing potential only when they are using effective contraception during therapy. Pregnancy Category X: Use with Ribavirin Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Combination therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnantNursing Mothers: The effect of orally ingested peginterferon or ribavirin from breast milk on the nursing infant has not been evaluated. 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.

PRECAUTIONS & WARNINGS

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

THERAPEUTIC CLASS

Hepatic viral infections (Hepatitis B), Hepatic viral infections (Hepatitis C)

STORAGE CONDITIONS

Store in refrigerator at 2-8° C; do not freeze or shake. Protect from light.