DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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



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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 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 >>


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)

PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer [Terminated]
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With CHC [Completed]
The purpose of this study is to see which of two doses of PEG (polyethylene glycol) interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at elimination of hepatitis C. The primary objective of this study is to compare the efficacy of Induction PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron) and Ribavirin (Rebetol) in patients with chronic hepatitis C.

Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON) [Active, not recruiting]

- Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic

malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease.

- High dose chemotherapy with autologous stem cell transplant has improved the response

rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant.

- To improve these results and sustain remission, various maintenance treatment have been

proposed as is the case of Interpheron alpha2b s. c. (Intron A) that has shown benefits in a meta-analysis.

- Intron A s. c. need administration of 3 days per week and is not well tolerated

- Recently a new formulation of Interpheron alpha2b is available. Conjugated with

polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM.

- The purpose of this study is to evaluate the role of Pegintron as maintenance after

autologous transplant in MM

PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron [Terminated]
The purpose of this study is to determine if PEG-Intron is better tolerated and more efficacious than standard interferons (Roferon, Intron) in patients with Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously received standard interferon therapy and have been intolerant, resistant, or have relapsed disease.

Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies [Completed]
Primary Objective:

- To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in

combination with IFN alpha2b in patients with advanced malignancies. Secondary Objectives:

- To correlate the AUC of SSG with clinical toxicity and efficacy.

- To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal

transduction pathways.

- To characterize the effects of SSG on PTPases SHP-1 and SHP-2.

- To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

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

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017