Alpha interferons, including PEG-Intron, may 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 PEG-Intron therapy. See WARNINGS, ADVERSE REACTIONS.
Use with Ribavirin. Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. (See REBETOL package insert for additional information and other warnings).
PEG-Intron® , peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant alfa-2b interferon with monomethoxypolyethylene glycol (PEG).
PEG-Intron, peginterferon alfa-2b, is indicated for use alone or in combination with REBETOL (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.
Published Studies Related to PEG-Intron (Peginterferon Alfa-2B)
The combination of MK-5172, peginterferon, and ribavirin is effective in
treatment-naive patients with hepatitis C virus genotype 1 infection without
without cirrhosis... CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly
A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for
HCV genotype 1 infection. 
infection... CONCLUSIONS: Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin
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.
Seizures during pegylated interferon and ribavirin therapy for chronic Hepatitis C: observations from the WIN-R trial. [2011.03]
BACKGROUND: Seizures are reported as an uncommon side effect of interferon therapy. AIM: To determine the frequency and presentation of seizures occurring during pegylated interferon-alpha (PEG-IFNalpha) and ribavirin therapy for chronic hepatitis C... CONCLUSIONS: Seizures occur infrequently in patients receiving PEG-IFNalpha-2b plus ribavirin, and appear to be associated with other risk factors including antidepressant use.
Clinical Trials Related to PEG-Intron (Peginterferon Alfa-2B)
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer [Terminated]
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib
may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving
PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon
alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.
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
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252) [Completed]
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles,
anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur
during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue
their treatment early. The goal of this study is to assess whether a psychotherapy support
program may contribute to a better adherence rate.
BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C [Recruiting]
The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon
alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in
naive patients with chronic hepatitis C.
PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma [Active, not recruiting]
RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping
blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating
patients who have stage IV melanoma.
Reports of Suspected PEG-Intron (Peginterferon Alfa-2B) Side Effects
Decreased Appetite (127),
Weight Decreased (121),
Haemoglobin Decreased (112),
Malaise (104), more >>
Page last updated: 2015-08-10