Interferon alfa-2B, recombinant

Capsules/Tablets/Oral solution - Ribavirin monotherapy is not effective for the treatment of chronic HCV infection. The safety and efficacy of ribavirin capsules and oral solution have only been established when used together with interferon alfa-2b, recombinant as interferon alfa-2b/ribavirin capsule combination therapy or with peginterferon alfa-2b injection. [Pg.1778]

A. General description Intron A (interferon alfa-2b recombinant) is a recombi-nantly derived water-soluble protein with a molecular weight of 19.3 kDa. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. [Pg.192]

Interferon Alfa-2b. Recombinant. Interferon alfa-2b. recombinant (Intron A). also contains a single. subtype of a-interferon. It is a glycoprotein containing 165 amino acid... [Pg.861]

INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRIN (Rebetron injection/capsules)... [Pg.356]

Interferon alfa-2b (Intron A) is a recombinant DNA product derived from the interferon alfa-2b gene of human white blood cells. Its mechanism of antitumor action involves binding to a plasma membrane receptor but is otherwise poorly understood. Its serum half-life is 2 to 3 hours after parenteral administration. [Pg.652]

Rx Interferon alfa-2b with ribavirin (Rebetron Combination Therapy) Chemical Class Recombinant interferon... [Pg.631]

Interferons and cytokines Interferon alfa-2b, human recombinant product produced in E. coli Intron A Lyophilized 5, 10,18,25, or 50MIUvial IM,SC, IV, intralesional... [Pg.461]

Interferon alfa-2b, Intron A human recombinant product produced in E. coli... [Pg.487]

REBETOL (Ribavirin) and INTRON A (interferon alfa-2b) [E. coli-expressed recombinant protein]... [Pg.326]

Therapeutic formulations contain a recombinant form of IFN-a (either interferon alfa-2a or interferon alfa-2b). These are available as powders for reconstitution or as prefilled injection pens. The drug is administered by subcutaneous injection (or intravenous for reconstituted powder formulations) and intramuscular injection. The dosage is usually stated as units per millilitre (refer to BNF for various preparations and dosages). Powder formulations of interferon alfa-2b also contain glycine, sodium phosphate (mono- and dibasic) and human albumin prefilled pens contain sodium chloride, edetate disodium, polysorbate 80 and m-cresol as a preservative. [Pg.333]

Recombinant aldesleukin-binding antibodies were detected in the half of 205 patients with metastatic cancer but there were neutralizing antibodies in only 7% (113). No significant difference in incidence was found between subcutaneous and continuous intravenous administration. In another study, none of the patients receiving aldesleukin alone developed neutralizing antibodies, whereas 18% of patients treated with aldesleukin and interferon alfa-2b had antibodies (114). Whatsoever, the clinical relevance of recombinant aldesleukin-neutralizing antibodies has not been accurately evaluated and a loss of response was apparently documented in only one patient (115). [Pg.65]

In a randomized comparison of recombinant interferon alfa-2b and interferon alfa n-3 (9 MU/week for 1 year) in 168 naive patients with chronic hepatitis C, there was no significant difference in clinical outcomes and the incidence or type of adverse effects between the groups (9). There was a non-significant trend toward more severe leukopenia and a higher incidence of severe thyroid disorders in patients who received recombinant interferon alfa-2b. [Pg.1793]

The FDA has expanded the indications for a combination product to include patients with chronic hepatitis C who have not been treated with interferon alfa. This product, Rebetron Combination Therapy (Schering), contains recombinant interferon alfa-2b for injection (Intron A) plus ribavirin (Rebetol) in capsules, and was previously only approved for patients who had relapsed after treatment with interferon alone (401). Serious adverse effects, such as depression, suicidal ideation, and suicide, have occurred with this regimen and patients should be closely monitored. [Pg.1817]

Recombinant interferon alfa-2b (rlFN alfa-2b Intron A)... [Pg.1841]

Interfemn Alfa-2b (Recombinant). Interferon alfa-2b. Inlrnn A. a watcr-.soluble protein of 165 amino acids and an approximate molecular mass of 19.200 Da. is expressed from a recombinant strain of E. colt. Tliis inicrferao molecule possesses an arginine at position 21 and a histidine at position 14. [Pg.180]

Interferon alfa 2b (interferon alfa-2b [usan] Alferon Intron A Viraferon Sch 30500) is a recombinant (rbe) version, and is extensively used by injection as an anticancer agent to treat hairy cell leukaemia, condylomata acuminata, AIDS-related Kaposi s sarcoma, follicular lymphoma, chronic myelogenous leukaemia, lymph or liver metastases of carcinoid tumour, as an anticancer adjunct in malignant melanoma also, in the maintenance of remission in multiple myeloma chronic active hepatitis B, chronic hepatitis C. [Pg.155]

Patt YZ, Hoque A, Lozano R, et al. Phase II trial of hepatic arterial infusion of fluorouracil and recombinant human interferon alfa-2b for liver metastases of colorectal cancer refractory to systemic fluorouracil and leucovorin. J Clin Oncol 1997 15 1432-1438. [Pg.2418]

USA interferon alfa-2b interferon I ntron A Alfatronol, Depo Interferon alpha, Viraferon Recombinant IFN-alpha2b from the clone Hif-SN206 with substitution at 23 (Arg) and 34 (His) from an E. coli expression system Cancer, hepatitis... [Pg.472]

EU peginterferon alfa-2b interferon Pegintron ViraferonPeg, Virtron Recombinant interferon alfa-2b from an E. coli expression system linked to polyethylene glycol Hepatitis... [Pg.472]

Danhauser LL, Freimann JH, Gilchrist TL, Gutterman JU, Hunter CY, Yeomans AC, Markowitz AB. Phase I and plasma pharmacokinetic study of infusional fluorouracil combined with recombinant interferon alfa-2b in patients with advanced cancer. J Clin Oncol 0993) 11,751-61. [Pg.634]

Interferons and cytokines Peginterferon aha-2b, PEG-modified human recombinant inteferon alfa-2b (Intron A, produced in E. coh) PEG-Intron Lyophilized 74,118,177, or 222 ig in 2 ml vial sc... [Pg.462]

Covalent conjugate of recombinant alfa-2b interferon with monomethoxyl polyethylene glycol (PEG) (type 1 interferon)... [Pg.439]

Liver In a 38-year-old man who took peginterferon alfa-2b plus ribavirin for hepatitis C, the aminotransferase activities normalized [50" ]. However, repeated treatment resulted in both a low hepatitis C RNA titer and an increase in aminotransferases. Immunostaining of the liver showed accumulation of peginterferon alfa-2b and when it was withdrawn and recombinant interferon alfa-2a was used instead, the aminotransferases normalized within about 2 months. The authors suggested that the rise in aminotransferase activities was related to polyethylene glycol. [Pg.775]

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