Interim Results from Boceprevir Phase II Study in Genotype 1 Treatment-Naive Hepatitis C Patients Present...(ith hypersensitivity toPEGINTRON or any ...),Health

Date:4/26/2008

ith hypersensitivity to PEGINTRON or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON A (Interferon alfa-2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min.

Avoid Pregnancy

REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months post-treatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.

Incidence of Adverse Events

There are no new adverse events specific to PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may
'/>"/>

SOURCE Schering-Plough Corporation Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8 9
Related medicine technology :

1. Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
2. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
3. Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
4. NanoBio Corporation Completes Interim Analysis of Phase 2 Clinical Trial in Onychomycosis
5. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
6. Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer
7. NanoBio Corporation Presents Preclinical and Interim Clinical Data on Topical Treatments for Herpes Labialis and Onychomycosis at AAD 2008
8. Interim Analysis Supports Continuation of Cell Genesys VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
9. Interim Safety Analysis Supports Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
10. Novavax Announces Favorable Interim Results from Human Clinical Trial for Its Pandemic Influenza Vaccine Program
11. Grantees of the Avon Foundation Breast Cancer Prevention Research Initiative Gather in Houston to Report Interim Findings