Interferon alpha-2b

Compound Name:Interferon alpha-2bMolecular Target:Type I interferon receptorsMolecular Structure:recombinant, humanLicensed Indication:hairy cell leukemia; malignant melanoma; follicular lymphoma; condylomata acuminata; AIDS-related Kaposi's sarcoma; chronic hepatitis B; chronic hepatitis CManufacturer and/or Distributor:ScheringInitial FDA Approval1986SummaryInterferon alpha-2b (Intron A) is a recombinant human physiological Type I interferon (MW 19.3 kDa) that is produced in E. coli. It has the broad spectrum of activities characteristic of Type I interferons, including anti-viral, anti-proliferative, anti-tumor and immunomodulatory effects. It is administered as a subcutaneous or intramuscular injection 3-5 times per week, depending on the indication. For treatment of condylomata, it is injected directly into the lesions. Patients self-administering Intron A should follow certain proper instructions. Interferon alpha-2b was first FDA approved in 1986. It currently has indications for seven different diseases: Hairy cell leukemia, Malignant melanoma, Follicular lymphoma, Condylomata acuminata, AIDS-related Kaposi's sarcoma, Chronic hepatitis B, and Chronic hepatitis C. It is approved for use in children only for chronic hepatitis B. Interferon alpha-2b maybe useful in controlling recalcitrant viral infections in patients with immunodeficiencies. It is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, or hypersensitivity to the product. Should not be used during pregnancy. Administration of interferon alpha-2b often causes a flu-like syndrome. Tolerance to the flu-like syndrome develops over several months on continued dosing. Serious safety concerns include neuropsychiatric, autoimmune, ischemic, cerebrovascular, cardiac, pulmonary, GI, hematologic, ophthalmologic, endocrine and infectious disorders. Because the toxicity of high-dose interferon can be severely debilitating in patients with AIDS-related Kaposi's sarcoma, it is advisable to escalate dose levels slowly in 3 MU/m2 increments over several weeks and to immediately reduce doses by 50% when serious toxicity is encountered.References

Package Insert: Updated 02/2016

European Medicines Agency: updated 08/01/2016.

1. Perrillo RP, Schiff ER, Davis GL, Bodenheimer HC, Jr., Lindsay K, Payne J, et al. A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. The Hepatitis Interventional Therapy Group. N Engl J Med. 1990 Aug 2;323(5):295-301.

2. Smalley RV, Andersen JW, Hawkins MJ, Bhide V, O'Connell MJ, Oken MM, et al. Interferon alfa combined with cytotoxic chemotherapy for patients with non-Hodgkin's lymphoma. N Engl J Med. 1992 Nov 5;327(19):1336-1341.

3. Poynard T, Bedossa P, Chevallier M, Mathurin P, Lemonnier C, Trepo C, et al. A comparison of three interferon alfa-2b regimens for the long-term treatment of chronic non-A, non-B hepatitis. Multicenter Study Group. N Engl J Med. 1995 Jun 1;332(22):1457-1462.

4. Al-Zahrani D, Raddadi A, Massaad M, Keles S, Jabara HH, Chatila TA, Geha R. Successful interferon-alpha 2b therapy for unremitting warts in a patient with DOCK8 deficiency. Clin Immunol. 2014 Jul;153(1):104-8. doi: 10.1016/j.clim.2014.04.005.

5. Mohr P, Hauschild A, Trefzer U, Enk A, Tilgen W, Loquai C et al. Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial. J Clin Oncol. 2015 Dec 1;33(34):4077-84.

6. Neff BA, Voss SG, Carlson ML, O'Brien EK, Butterfield JH. Treatment of eosinophilic otitis media with pegylated interferon-α 2a and 2b. Laryngoscope. 2016 Sep 26 [Epub aead of print]