Interferon Alfa n1

What is Interferon Alfa n1

NOTE: This drug is discontinued in the US.

Interferon alfa n1 lymphoblastoid, is a formulation of purified, natural, human interferon (IFN) alpha proteins derived from a human lymphoblastoid cell line following induction with murine parainfluenza virus type 1 (Sendai strain).

Alpha IFNs and beta interferons are structurally and functionally related. The alpha IFNs include more than 25 subtypes; interferon alfa-n1 consists of predominantly 9 IFN alpha subtypes comprising 165 or 166 amino acids.

The manufacturing process includes two immunoaffinity chromotography steps using bovine and ovine antibodies.

In addition, the manufacturing process contains steps that have been shown to inactivate viruses and microorganisms, and there has been no evidence of infection transmission during clinical trials.

The leukocyte nutrient medium contains neomycin and polymyxin B; however, neither product is detectable in the final product. Interferon alfa-n1 is used in the treatment of chronic hepatitis C.

In a comparison with interferon alfa-2b, sustained response rates were 10.3% and 6.7% for interferon alfa-n1 and interferon alfa-2b, respectively, following 6 months of treatment. Longer treatment duration is associated with an increased response.

The FDA approved interferon alfa-n1 in March 1999 for the treatment of chronic hepatitis C; however, the product was never launched in the United States.

In August 1999 the manufacturer discontinued all production and supply of interferon alfa-n1; this product is no longer available.

Indications

  1. adenovirus
  2. encephalomyocarditis virus
  3. hepatitis B virus
  4. hepatitis C infection
  5. hepatitis C virus
  6. hepatitis D virus
  7. herpes simplex virus type 1
  8. herpes simplex virus type 2
  9. human immunodeficiency virus (HIV)
  10. human papillomavirus (HPV)
  11. human T-lymphotropic virus type I (HTLV-I)
  12. poliovirus
  13. rhinovirus
  14. varicella-zoster virus
  15. variola virus (smallpox)
  16. vesicular stomatitis virus

Side Effects

  1. abdominal pain
  2. alopecia
  3. angioedema
  4. anorexia
  5. anxiety
  6. arthralgia
  7. ascites
  8. asthenia
  9. cardiomyopathy
  10. chest pain (unspecified)
  11. chills
  12. coma
  13. confusion
  14. cough
  15. depression
  16. diaphoresis
  17. diarrhea
  18. dizziness
  19. dyspnea
  20. edema
  21. elevated hepatic enzymes
  22. emotional lability
  23. fatigue
  24. fever
  25. GI bleeding
  26. headache
  27. hepatic failure
  28. hyperglycemia
  29. hypertension
  30. hyperthyroidism
  31. hypothyroidism
  32. infection
  33. injection site reaction
  34. insomnia
  35. leukopenia
  36. myalgia
  37. myocardial infarction
  38. nausea
  39. neutropenia
  40. paresthesias
  41. pneumonitis
  42. proteinuria
  43. pruritus
  44. rash
  45. renal failure (unspecified)
  46. retinal hemorrhage
  47. rhabdomyolysis
  48. rhinorrhea
  49. seizures
  50. suicidal ideation
  51. supraventricular tachycardia (SVT)
  52. thrombocytopenia
  53. urticaria
  54. visual impairment
  55. vomiting
  56. weight loss

Monitoring Parameters

  • (drug no longer available)
  • CBC with differential
  • chest x-ray
  • ECG
  • LFTs
  • thyroid function tests (TFTs)

Contraindications

  • alcoholism
  • ascites
  • autoimmune disease
  • bone marrow suppression
  • bovine protein hypersensitivity
  • breast-feeding
  • cardiac arrhythmias
  • cardiac disease
  • children
  • chronic obstructive pulmonary disease (COPD)
  • coagulopathy
  • coronary artery disease
  • dental disease
  • dental work
  • depression
  • diabetes mellitus
  • driving or operating machinery
  • egg hypersensitivity
  • geriatric
  • Graves’ disease
  • hepatic disease
  • hepatitis
  • hyperlipidemia
  • hypertension
  • hyperthyroidism
  • hypothyroidism
  • immunosuppression
  • intramuscular administration
  • intramuscular injections
  • jaundice
  • myocardial infarction
  • neomycin hypersensitivity
  • non-arteritic anterior ischemic optic neuropathy
  • organ transplant
  • ovine protein hypersensitivity
  • pregnancy
  • psoriasis
  • pulmonary disease
  • radiation therapy
  • renal impairment
  • seizure disorder
  • suicidal ideation
  • thyroid disease

Interactions

No information is available regarding drug interactions associated with Interferon Alfa n1 

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