Generic Name: Reeflec v
What is Reeflec V?
Some subjects experienced ongoing or new serious adverse reactions during the 6-month follow-up period. In Study 2, many subjects continued to experience adverse reactions several months after discontinuation of therapy. By the end of the 6-month follow-up period, the incidence of ongoing adverse reactions by body class in the PegIntron 1. There have been 31 subject deaths that occurred during treatment or during follow-up in these clinical trials. In Study 3, there were 14 deaths, 2 of which were probable suicides and 1 was an unexplained death in a person with a relevant medical history of depression.
The most common reasons for discontinuation of therapy were related to known interferon effects of psychiatric, systemic e. Reduction of interferon was dose-related PegIntron 1.
Other common reasons included depression, fatigue, nausea, and thrombocytopenia.
The recommended dose of REBETOL capsules depends on the patient's body weight refer to Table 3. The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. After 24 weeks of treatment, virologic response should be assessed.
Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. Refer to Table 2 for Pediatric Dosing of REBETOL in combination with INTRON A.
Refer to adult dosing table for greater than 61 kg body weight. The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The following laboratory tests are recommended for all patients treated with REBETOL, prior to beginning treatment and then periodically thereafter.
If intolerance persists after dose adjustment, combination therapy should be discontinued. Refer to labeling for PegIntron for additional information regarding dose reduction of PegIntron. REBETOL should be administered with caution to patients with pre-existing cardiac disease.
How should I take Reeflec V?
Female sexual partners of male patients being treated with REBETOL must not become pregnant during treatment and for 6 months after treatment has stopped. Therefore, you must use 2 forms of birth control during this time. If you or a female sexual partner becomes pregnant, you should tell your health care provider.
There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes in female patients and female partners of male patients exposed to ribavirin.
You or your health care provider are encouraged to contact the Registry at 1-800-593-2214. Be assured that any information you tell the Registry will be kept confidential. See " What should I avoid while taking REBETOL Capsules and Oral Solution.
What should I avoid while taking Reeflec V?
It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Cardiac arrhythmias primarily supraventricular usually respond to conventional therapy but may require discontinuation of therapy. There are no data in children or adolescents with a history of cardiac disease. Teratogenic riskPrior to initiation of treatment with Rebetol the physician must comprehensively inform both male and female patients of the teratogenic risk of Rebetol, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with Rebetol see section 4.
For laboratory monitoring of pregnancy, please refer to Laboratory tests. Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for discontinuation or dose modification recommendations.
Renal impairmentThe pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Reeflec V side effects
How is Rebetol used. How does Rebetol work. How has Rebetol been studied. What benefit has Rebetol shown during the studies. What is the risk associated with Rebetol.
Common Reeflec V ide effects may include:
It is not known if treatment with REBETOL will cure hepatitis C virus infections or prevent cirrhosis, liver failure, or liver cancer that can be caused by hepatitis C virus infections.
The active ingredient, Ribavirin is a professional grade drug, which when metabolized resembles purine RNA nucleotides.
For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with Rebetol.
Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
The new stand-alone package of Rebetol capsules provides patients and physicians with the option of individualized ribavirin and interferon-based therapies. Individuals with a history of significant or unstable heart disease should not use Rebetol capsules, as fatal and non-fatal heart attacks have occurred in patients with anemia caused by the drug. Additionally, due to the possibility of severe adverse events, extreme care must be taken to prevent pregnancy in female patients receiving Rebetol and female partners of male patients.
Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with antiviral activity.
Where can I get more information?
It is not known whether the REBETOL product is excreted in human milk.
Ribavirin dient zur Behandlung bestimmter Virusinfektionen.