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Ribasphere (Ribavirin) - Summary

 
 



BOXED WARNING

RIBASPHERE (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (seeWARNINGS).
The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin (seeWARNINGS,ADVERSE REACTIONS, andDOSAGE AND ADMINISTRATION).
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period (seeCONTRAINDICATIONS,WARNINGS, andPRECAUTIONS: Information for Patients, and Pregnancy: Category X).


 

RIBASPHERE SUMMARY

RIBASPHERE (ribavirin, USP), is a nucleoside analogue with antiviral activity.

RIBASPHERE (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).


See all Ribasphere indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ribasphere (Ribavirin)

The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis. [2014]
without cirrhosis... CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly

[Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease]. [Article in Chinese] [2014]
with hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol can be effectively and safely used for treating

[Effects of ribavirin aerosol on viral exclusion of patients with hand-foot-mouth disease]. [Article in Chinese] [2014]
treatment of hand-foot-mouth disease (HFMD)... CONCLUSIONS: Ribavirin aerosol has multiple advantages of lower dose, quicker

Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1. [2014]
infection... CONCLUSIONS: Daclatasvir combined with alfa-2a/ribavirin in treatment-naive

A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for HCV genotype 1 infection. [2014]
infection... CONCLUSIONS: Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin

more studies >>

Clinical Trials Related to Ribasphere (Ribavirin)

In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia [Recruiting]
The standard treatment of chronic hepatitis C infection is pegylated interferon alpha combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, reducing the likelihood of sustained viral response. Recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. In this study, we will evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.

Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma [Active, not recruiting]
Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in many patients. It is likely that treatment for many patients with tonsil and/or base of tongue cancer could be improved if effective therapy to control HPV-16 is developed. The investigators in this study want to learn if ribavirin shows evidence of activity against HPV-16. Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin has not yet been tested against head and neck cancer in patients. The purpose of this study is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients. The main purpose of this study is to see if ribavirin changes the expression of certain proteins related to HPV infection in the tumor. The study will also find out if ribavirin changes how the tumor appears in a PET/CT scan (positron emission tomography/computed tomography scan).

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.

Intermittent Use of Aerosolized Ribavirin for Treatment of RSV [Completed]
Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034) [Withdrawn]
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment na´ves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment na´ve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.

more trials >>

Reports of Suspected Ribasphere (Ribavirin) Side Effects

Fatigue (47)Anaemia (44)Nausea (25)Headache (18)Dyspnoea (16)White Blood Cell Count Decreased (15)Rash (15)Depression (14)Vomiting (14)Decreased Appetite (12)more >>


Page last updated: 2015-08-10

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