Generic Name: Rebetol
What is Rebetol?
Table of Contents Prescribing information last updated December 21, 2015 provided by Kadmon Pharmaceuticals, LLC. ReferencesMcHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. The ribavirin was given as weight based dosing.
In addition, the investigators demonstrated the 12 week HCV RNA response clearly predicted a subsequent sustained virologic response.
This trial established the benefit of adding ribavirin to peginterferon: patients receiving peginterferon plus ribavirin had lower virologic relapse rates after end of treatment and greater SVR24 rates than patients who received peginterferon alone.
ReferencesFried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. Investigators enrolled 1311 patients, among whom 740 had genotype 1 infection.
For a full list of restrictions, see the package leaflet. The Committee noted that Rebetol in combination with other medicines, including peginterferon alfa and DAAs is effective against long-term hepatitis C virus infection in adults and children.
A risk management plan has been developed to ensure that Rebetol is used as safely as possible. The European Commission granted a marketing authorisation valid throughout the European Union for Rebetol on 7 May 1999. For more information about treatment with Rebetol, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C CHC for paediatric patients children 3 years of age and older and adolescents not previously treated and without liver decompensation.
What is Rebetol used for. The medicine can only be obtained with a prescription. How is Rebetol used. How does Rebetol work. How has Rebetol been studied.
How should I take Rebetol?
Dosage strength would be prescribed depending on age, severity of the condition and response to treatment. It should be taken regularly to get better effectiveness from the drug. The missed dose of Rebetol can be taken at the earliest unless it does not clash with the schedule of the next dose or else skip it.
Increasing the dosage strength to cope up with the missed one should be avoided. This would only result in drug overdose. Seek medical emergency in case of drug overdose. It is very essential to consult the doctor before taking Rebetol.
What should I avoid while taking Rebetol?
What are possible side effects. Psychiatric and Central Nervous System: Some people get depressed when taking Rebetol in combination treatment with an interferon, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour sometimes directed against others. Possible side effects listed below are grouped by frequency of occurrence Very common Common Uncommon Rare Very rare Not known affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available dataThe following side effects have been reported with the combination of Rebetol hard capsules and an alpha interferon product in adults:Very commonly reported side effects:decreases in the number of red blood cells that may cause fatigue, shortness of breath, dizzinessdecrease in neutrophils that make you more susceptible to different infections ,difficulty concentra ss of weight, stomach pain,dry skin, irritation, pain or redness at the site of injection, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Very rarely reported side effects:suicide. The following side effects have been reported with the combination of Rebetol and an interferon alfa-2b product in children and adolescents:Very commonly reported side effects:decreases in the number of red blood cells that may cause fatigue, shortness of breath, dizzinessdecrease in neutrophils that make you more susceptible to different infections ,decrease in thyroid gland activity which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms ,feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness,diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth height and weig n joints and muscles, rash.
The following other side effects have also been reported with the combination of Rebetol and an alpha interferon product:abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation,angioedema swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathingstroke cerebrovascular events ,Vogt-Koyanagi-Harada syndrome an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord ,bronchoconstriction and anaphylaxis a severe, whole-body allergic reactionconstant cough,eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots white deposits on the retina ,enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement,acute hypersensitivity reactions including urticaria hivesbruises, intense pain in a limb, Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b may also cause:dark, cloudy or abnormally coloured urine,difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain,loss of consciousness,loss of use, drooping or loss of power of facial muscles, loss of feeling sensation,loss of vision.
You or your caregiver should call your doctor immediately if you have any of these symptoms. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Rebetol side effects
Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. If needed, 2nd dose reduction of PegIntron is to 0. Refer to labeling for INTRON A or PegIntron for additional information about how to reduce an INTRON A or PegIntron dose.
Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered. Manufactured by: Schering-Plough Canada, Inc.
Common Rebetol ide effects may include:
MOST POPULAR 14 August 2008 Share Tweet Share Email Rebetol capsules contain the active ingredient ribavirin, which is a type of medicine called a nucleoside analogue.
I pazienti sono stati randomizzati a ricevere Rebetol 800-1.
REBETOL should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
What is Hepatitis C Hep C, HVC.
Dosage strength would be prescribed depending on age, severity of the condition and response to treatment. It should be taken regularly to get better effectiveness from the drug. The missed dose of Rebetol can be taken at the earliest unless it does not clash with the schedule of the next dose or else skip it. Increasing the dosage strength to cope up with the missed one should be avoided. This would only result in drug overdose.
Where can I get more information?
See full prescribing information for REBETOL.
The population enrolled mainly consisted in children with mild to moderate hepatitis C.