Interferon Alphacon-1

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic 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
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Germany: Inferax.

North America

Canada: Infergen; USA: Infergen.

Asia

Japan: Advaferon.

Drug combinations

Chemistry

Interferon Alphacon-1: C~870~H~1366~N~236~O~259~S~9~. Mw: 19564.18. A non-naturally occurring type-1 interferon having 166 aa produced by recombinant technique using a synthetic DNA coding sequence. As expressed in E. coli, the product is nonglycosylated and has an N-terminal methionine. N-L-Methionyl-22-L-arginine-76-L-alanine-78-L-aspartic acid-79-L-glutamic acid-86-L-tyrosine-90-L-tyrosine-156-L-threonine-157-L-asparagine-158-L-leucineinterferonα~1~ (human lymphoblast reduced). CAS-118390-30-0 (1997).

Pharmacologic Category

Antivirals; Interferons. (ATC-Code: L03AB09).

Mechanism of action

Interferons induce gene transcription, inhibit cellular growth, alter state of cellular differentiation, interfere with oncogene expression, alter cell surface antigen expression, increase phagocytic activity of macrophages, and augment cytotoxicity of lymphocytes for target cells.

Therapeutic use

Treatment of chronic hepatitis C virus infection in patients ≥18 years of age with compensated liver disease and anti-HCV serum antibodies or HCV-RNA.

Pregnancy and lactiation implications

Animal studies have shown embryolethal or abortifacient effects. Use caution during pregnancy or lactation.

Unlabeled use

Contraindications

Hypersensitivity to interferon alphacon-1 or any component of the formulation, other alpha interferons, or E. coli-derived products. Decompensated liver disease. Autoimmune hepatitis.

Warnings and precautions

Hazardous agent. Causes bone marrow suppression, including potentially severe cytopenias. Cardiovascular events (hypertension, palpitations, tachycardia, and tachyarrhythmias) reported (use with caution in pre-existing cardiac disease). Flu-like symptoms, including fever, are common. Gastrointestinal effects (GI hemorrhage, ulcerative and hemorrhagic/ischemic colitis) observed. Acute hypersensitivity reactions reported (rarely) with alpha interferons. Increases in serum creatinine and (rarely) renal failure reported. May cause severe psychiatric adverse events (e.g. depression, psychosis, mania, suicidal behavior/ideation) in patients with and without previous psychiatric symptoms (use with extreme caution in history of depression). Use with caution in seizure disorders, brain metastases, or compromised CNS function. Ocular effects occurred in patients receiving other alpha interferons (use caution in pre-existing ophthalmic disorders). Pancreatitis observed (occasionally fatal). Pulmonary effects might occur (use caution in history of pulmonary disease). Avoid use in history of autoimmune disorders (possible development or exacerbation of autoimmune disorders). Use contraindicated in autoimmune hepatitis. Use with caution in diabetes mellitus (hyperglycemia reported). Use with caution in hepatic impairment (risk for hepatic decompensation with alpha interferon therapy). May cause or aggravate fatal or life-threatening infectious disorders, or ischemic disorders. Use with caution in renal impairment, pre-existing thyroid disease, or chronically-immunosuppressed patients, including transplantation recipients.

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