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Intron A (Interferon Alfa-2B (Recombinant)) - Summary

 
 



WARNING

Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. See WARNINGS and ADVERSE REACTIONS.

 

INTRON A SUMMARY

INTRON A Interferon alfa-2b, recombinant for intramuscular, subcutaneous, intralesional, or intravenous Injection is a purified sterile recombinant interferon product.

INTRON A Interferon alfa-2b is indicated or the following:

  • Hairy Cell Leukemia
  • Malignant Melanoma
  • Follicular Lymphoma
  • Condylomata Acuminata
  • AIDS-Related Kaposi's Sarcoma
  • Chronic Hepatitis C
  • Chronic Hepatitis B

See all Intron A indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Intron A (Interferon Alfa-2B)

Long-Term Results of a Randomized, Observation-Controlled, Phase III Trial of Adjuvant Interferon Alfa-2b in Hepatocellular Carcinoma Underwent Curative Resection. [2011.11.19]
OBJECTIVE:: To investigate the clinical efficacy of adjuvant interferon alfa-2b (IFNalpha-2b) therapy on recurrence-free survival (RFS) of patients with postoperative viral hepatitis-related hepatocellular carcinoma (HCC). BACKGROUND:: Despite most individual trials have failed to meet their primary endpoint, recent pooled-data meta-analyses suggest that adjuvant IFN therapy may significantly reduce the incidence of recurrence in curatively ablated HCC... CONCLUSIONS: In this study, adjuvant IFNalpha-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. More potent antiviral therapy deserves to be explored for this patient population. This study is registered at ClinicalTrials.gov and carries the identifier NCT00149565.

A phase 2 trial of bevacizumab and high-dose interferon alpha 2B in metastatic melanoma. [2011.07]
Bevacizumab is a humanized recombinant monoclonal antibody that neutralizes vascular endothelial growth factor, an agent with proangiogenic effects in melanoma. Interferon alpha (IFN-alpha) has antiangiogenic properties through its ability to downregulate basic-fibroblast growth factor levels...

Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. [2011.06]
BACKGROUND & AIMS: Several studies have reported that low doses of interferon can delay the development of hepatocellular carcinoma (HCC) and progression of chronic hepatitis C. We investigated the incidence of clinical events among participants of the Evaluation of PegIntron in Control of Hepatitis C Cirrhosis (EPIC)3 program... CONCLUSIONS: Maintenance therapy with peginterferon alfa-2b is not warranted in all patients and does not prevent HCC. However, there is a potential clinical benefit of long-term suppressive therapy in patients with preexisting portal hypertension. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Combination therapy of intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma. [2011.06]
BACKGROUND: This study evaluated the efficacy of combined 5-fluorouracil (5-FU) and pegylated interferon (PEG-IFN) alpha-2b in patients with advanced hepatocellular carcinoma (HCC)... CONCLUSION: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-FU and PEG-IFNalpha-2b, this new combination therapy may be useful for patients with advanced HCC.

Controlled release recombinant human interferon-alpha2b for treating patients with chronic hepatitis C genotype 1: a phase 2a clinical trial. [2011.04]
Better convenience and tolerability and sustained therapeutic concentrations might improve interferon (IFN) treatment for chronic hepatitis C virus (HCV) infection. In an open-label, randomized study, controlled release free (chemically unmodified) recombinant human IFN-alpha(2b) in poly(ether-ester) microspheres (CR-rhIFN-alpha(2b)), was injected at doses of 160, 320, 480 or 640 mug every 2 weeks for 12 weeks with concomitant weight-based oral ribavirin in 32 treatment-naive patients with chronic HCV genotype 1...

more studies >>

Clinical Trials Related to Intron A (Interferon Alfa-2B)

Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma [Recruiting]
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep the cancer cell from growing.

PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic virus type 1-associated adult T-cell leukemia/lymphoma.

A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma [Recruiting]
The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute« Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron«) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute«-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron┬«, its side effects and the potential benefits, if any.

Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600 AM2) [Recruiting]
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.

Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients [Recruiting]
The goal of this clinical research study is to learn if temozolomide alone or given with pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want to study the safety of these 2 treatments.

Objectives:

1. To determine the anti-tumor activity [pathological response Complete Response (CR)+ Partial Response (PR)] and toxicity of temozolomide (TMZ) alone or in combination with pegylated interferon alpha-2b (PGI) in patients with resectable stage IIIC or stage IV (M1a) metastatic melanoma prior to definitive surgical resection.

2. To determine the relapse-free survival, overall survival and the impact of tumor response to chemotherapy in these patients.

3. To differentiate the in vivo treatment effects of TMZ alone versus TMZ plus PGI and correlate with clinical outcome by analysis the pre- and post-treatment tumors and peripheral blood mononuclear cells with respect to:

1. Known cellular and molecular markers of apoptosis and cell proliferation,

2. Promotor methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT),

3. DNA sequence variability of tumor suppressor genes and DNA repair enzymes,

4. Tumor genomic expression profiles analysis by cDNA microarray and protein array

Study Comparing Reduction and Viral Safety of IFN Alfa-2b XL + Ribavirin Versus PEG IFN Alfa-2b + Ribavirin in Patients With Chronic Hepatitis C Genotype 1 [Recruiting]
The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

more trials >>

Reports of Suspected Intron A (Interferon Alfa-2B) Side Effects

Nausea (32)Fatigue (20)Asthenia (16)Headache (15)Neutropenia (13)Chills (12)Vomiting (12)Drug Ineffective (11)Dehydration (11)Neutrophil Count Decreased (11)more >>


Page last updated: 2011-12-09

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