Peginterferon Alpha-2a

Table of contents

  • Brand Names
  • Drug Combinations
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Inhibits
  • Induces
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Pegasys; Belgium: Pegasys; Czech Republic: Pegasys; Denmark: Pegasys; Estonia: Pegasys; Finland: Pegasys; France: Pegasys; Germany: Pegasys; Greece: Pegasys; Hungary: Pegasys; Ireland: Pegasys; Italy: Pegasys; Latvia: Pegasys; Lithuania: Pegasys; Luxembourg: Pegasys; Malta: Pegasys; Netherlands: Pegasys; Poland: Pegasys; Portugal: Pegasys; Romania: Pegasys; Slovakia: Pegasys; Slovenia: Pegasys; Spain: Pegasys; Sweden: Pegasys; UK: Pegasys.

North America

Canada: Pegasys; USA: Pegasys.

Latin America

Argentina: Pegasys.

Asia

Japan: Pegasys.

Drug combinations

Peginterferon Alpha-2a and Ribavirin

Chemistry

Peginterferon Alpha-2a: (1) Interferon αA (human leukocyte), mono(N^2^,N^6^-dicarboxyl-L-lysyl) derivative, diester with α-methyl-ω-hydroxypoly(oxy-1,2-ethanediyl); (2) Interferon αA (human leukocyte), mono(N^2^,N^6^-dicarboxyl-L-lysyl) derivative, diester with polyethylene glycol monomethyl ether. CAS-198153-51-4 (2003).

* pegylation sites

Pharmacologic Category

Antivirals; Interferons. (ATC-Code: L03AB11).

Mechanism of action

Inhibits cellular growth, alters state of cellular differentiation, interferes with oncogene expression, alters cell surface antigen expression, increases phagocytic activity of macrophages, and augments cytotoxicity of lymphocytes for target cells.

Therapeutic use

Treatment of chronic hepatitis C, alone or in combination with ribavirin, in compensated liver disease and histological evidence of cirrhosis and clinically-stable HIV disease. Treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease and evidence of viral replication and liver inflammation.

Pregnancy and lactiation implications

Peginterferon monotherapy should only be used in pregnancy when potential benefit to mother justifies possible risk to fetus. Not recommended during lactation.

Unlabeled use

Contraindications

Hypersensitivity to polyethylene glycol, interferon alpha, or any component of the formulation. Autoimmune hepatitis. Decompensated liver disease in cirrhotic patients. Decompensated liver disease in chronic hepatitis C coinfected with HIV. Neonates and infants.

Warnings and precautions

Hazardous agent. May cause myelosuppression (including neutropenia, thrombocytopenia, lymphopenia, aplastic anemia). CNS effects (dizziness, confusion, somnolence, or fatigue) might occur. Serious cutaneous reactions, including vesiculobullous eruptions, Stevens-Johnson syndrome, and exfoliative dermatitis, reported (rarely) with use, with or without ribavirin therapy. Commonly associated with flu-like symptoms, including fever. Gastrointestinal hemorrhage, ulcerative and hemorrhagic/ischemic colitis observed with interferon alpha treatment. Hepatic decompensation and death associated with use of alpha-interferons, in cirrhotic chronic hepatitis C. Severe acute hypersensitivity reactions occurred rarely. Serious and severe infections (bacterial, viral, and fungal) reported. Severe psychiatric adverse effects (including depression, suicidal ideation, and suicide attempt) may occur (avoid use in severe psychiatric disorders, and use with extreme caution in history of depression). Ocular effects, including retinal hemorrhages, cotton wool spots, and retinal artery or vein obstruction, can occur. Pancreatitis might develop. Pulmonary effects (dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonia, and sarcoidosis, resulting in potentially fatal respiratory failure) may occur (use with caution in pulmonary dysfunction or history of pulmonary disease). Use with caution in increased risk for severe anemia (e.g. spherocytosis, history of GI bleeding), in autoimmune disease, in prior cardiovascular disease, and in diabetes mellitus (hyper-/hypoglycemia reported). In hepatitis B, flares (transient and potentially severe increases in serum ALT) may occur. Infectious disorders, or ischemic disorders might occur. Use with caution in renal dysfunction (CrCl <50 mL/minute), and in pre-existing thyroid disease. Combination treatment with ribavirin may cause birth defects and/or fetal mortality, hemolytic anemia (may worsen cardiac disease), genotoxicity, mutagenicity, and may possibly be carcinogenic. Use with caution in the elderly.

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