Peginterferon Alpha-2b

Table of contents

  • Brand Names
  • Drug Combinations
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Inhibits
  • Induces
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Pegintron, Viraferonpeg; Belgium: Pegintron; Czech Republic: Pegintron, Viraferonpeg; Denmark: Pegintron; Estonia: Pegintron, Viraferonpeg; Finland: Pegintron; France: Pegintron, Viraferonpeg; Germany: Pegintron, Viraferonpeg; Greece: Pegintron, Viraferonpeg; Hungary: Pegintron, Viraferonpeg; Ireland: Pegintron, Viraferonpeg; Italy: Pegintron; Lithuania: Pegintron, Viraferonpeg; Luxembourg: Pegintron, Viraferonpeg; Netherlands: Pegintron, Viraferonpeg; Poland: Pegintron, Viraferonpeg; Portugal: Pegintron, Viraferonpeg; Romania: Pegintron; Slovakia: Pegintron, Viraferonpeg; Spain: Pegintron; Sweden: Pegintron, Viraferonpeg; UK: Viraferonpeg.

North America

Canada: Unitron Peg; USA: Pegintron.

Latin America

Argentina: Intron-A Peg; Brazil: Pegintron; Mexico: Pegtron.

Asia

Japan: Pegintron.

Drug combinations

Peginterferon Alpha-2b and Ribavirin

Chemistry

Peginterferon Alpha-2b: (1) Monocarboxyinterferon alpha-2b, diesters with polyethylene glycol monomethyl ether; (2) Pegylated, recombinant interferon alpha-2b. CAS-215647-85-1.

Pharmacologic Category

Antivirals; Interferons. (ATC-Code: L03AB10).

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 (as monotherapy or in combination with ribavirin) in adult patients who have never received alpha-interferons and have compensated liver disease.

Pregnancy and lactiation implications

Peginterferon alpha-2b monotherapy should only be used in pregnancy when potential benefit to mother justifies possible risk to fetus. Combination therapy with ribavirin contraindicated in pregnancy. Not recommended during lactation.

Unlabeled use

Treatment of advanced melanoma.

Contraindications

Hypersensitivity to peginterferon alpha-2b, or any component of the formulation. Autoimmune hepatitis. Decompensated liver disease in cirrhotic chronic hepatitis C. Combination therapy with peginterferon alpha-2b and ribavirin also contraindicated in pregnancy. Males with pregnant partners. Hemoglobinopathies (e.g. thalassemia major, sickle-cell anemia). Renal dysfunction (CrCl <50 mL/minute).

Warnings and precautions

Hazardous agent. Causes bone marrow suppression, including potentially severe cytopenias. alpha-interferons may (rarely) cause aplastic anemia (use with caution in chronically immunosuppressed patients, with low peripheral blood counts or myelosuppression, including concurrent use of myelosuppressive therapy). Ulcerative or hemorrhagic/ischemic colitis observed with alpha-interferons. Acute hypersensitivity reactions and cutaneous reactions reported (rarely) with alpha-interferons. Hypertriglyceridemia reported. May cause or aggravate severe psychiatric adverse events (e.g. addiction relapse, depression, psychosis, mania, suicidal behavior/ideation) in patients with and without history of psychiatric disorder (use with extreme caution in history of psychiatric disorders, including depression). Higher doses may be associated with development of encephalopathy (higher risk in elderly patients). Ophthalmologic disorders (including decreased/loss of vision, macular edema, retinal hemorrhages, optic neuritis, papilledema, cotton wool spots, and retinal artery or vein thrombosis) occurred with peginterferon alpha-2b and/or with other alpha-interferons. Pancreatitis observed with alpha-interferon therapy. May cause or aggravate dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, and sarcoidosis, which may result in respiratory failure. May cause or exacerbate autoimmune disorders (use with caution in autoimmune disorders). Use with caution in current or history of cardiovascular disease. Diabetes reported (use caution in history of diabetes mellitus, particularly if prone to DKA). Patients with chronic hepatitis C with cirrhosis, and patients coinfected with human immunodeficiency virus receiving highly-active antiretroviral therapy are at increased risk for hepatic decompensation. May cause or aggravate infectious disorders. May cause or aggravate ischemic disorders and hemorrhagic cerebrovascular events. Use with caution in renal impairment (CrCl <50 mL/minute), and in thyroid disorders (may cause or aggravate hyper- or hypothyroidism). 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. Combination therapy with ribavirin contraindicated in pregnancy.

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