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Rebetol is a brand name for Ribavirin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). 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…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C. 1. Please refer to the corresponding Summary of Product Characteristics (SmPC) of medicinal products used in combination with Rebetol for additional prescribing information particular to that product and for further dosage recommendations on co-administration with Rebetol.
Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food. Adults The recommended dose and duration of Rebetol depends on patient’s weight and on the medicinal product that is used in combination.
Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol. In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
Medicinal product no longer authorised 3 Paediatric population No data are available in children below 3 years of age.
Note:
For patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SmPC for Rebetol 40 mg/mL oral solution. Dosing of Rebetol for children and adolescent patients is determined by the patient body weight. For example, the body weight dosing used in conjunction with interferon alfa-2b or peginterferon alfa-2b is shown in Table 1.
Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol as some combination regimens do not adhere to the Rebetol dosing guidance provided in Table 1. Table 1 Rebetol dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in paediatric patients Patient weight (kg) Daily Rebetol dose Number of 200 mg capsules 47 - 49 600 mg 3 capsules a 50 - 65 800 mg 4 capsules b > 65 Refer to adult dose recommendations a1 morning, 2 evening b2 morning, 2 evening Dose modification for adverse reactions Dose modification for adults Dose reduction of Rebetol depends on the initial Rebetol posology which depends on the medicinal product that is used in combination with Rebetol.
If a patient has a serious adverse reaction potentially related to Rebetol, the Rebetol dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient’s haemoglobin concentration, cardiac status and indirect bilirubin concentration.
Summary of the safety profile The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy. The haemolytic anaemia associated with Rebetol therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients. The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when Rebetol was used in combination with interferon alfa-2b or peginterferon alfa-2b.
Use of Ribavirin in combination with direct antiviral agents (DAA) Based on the review of safety data derived from clinical studies in adults with DAA in combination with ribavirin, the most frequent adverse reactions identified as associated with ribavirin were anaemia, nausea, vomiting, asthenia, fatigue, insomnia, cough, dyspnoea, pruritus and rash.
Except anaemia, the majority of these adverse reactions were not serious and resolved without treatment discontinuation. Please refer to the corresponding SmPC of medicinal products that are used in combination with Rebetol for additional undesirable effects reported with these products.
Adults Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of Rebetol capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, two trials studied Rebetol in combination with peginterferon alfa-2b.
Patients who are treated with interferon alfa-2b and Rebetol after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below. Tabulated list of adverse reactions for adults The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
1). Please refer to the SmPC of (peg)interferon alfa for details on the recommendations of monitoring and management regarding the adverse reactions listed below before initiating therapy and other precautions associated with (peg)interferon alfa.
There are several serious adverse reactions associated with the combination therapy of Rebetol with (peg)interferon alfa. ) - Growth inhibition in children and adolescents that may be irreversible in some patients - Increased thyroid stimulating hormone (TSH) in children and adolescents - Severe ocular disorders - Dental and periodontal disorders.
Paediatric population When deciding not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to consider that this combination therapy induced a growth inhibition that may be irreversible in some patients.
The decision to treat should be made on a case by case. Haemolysis A decrease in haemoglobin levels to < 10 g/dL was observed in up to 14 % of adult patients and 7 % of children and adolescents treated with Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Although Rebetol has no direct cardiovascular effects, anaemia associated with Rebetol may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both. 3). 2). Medicinal product no longer authorised 6 Cardiovascular Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
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.
1. 3). In females of childbearing potential, Rebetol must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. - Breast-feeding. 4). , thalassemia, sickle-cell anaemia).
Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for contraindications specific to these products.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ribavirin in European Union.
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5 g/dL Haemoglobin: Patients with History of Stable Cardiac Disease 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction) < 12 g/dL despite 4 weeks at reduced dose Bilirubin – Indirect > 5 mg/dL > 4 mg/dL (adults) * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, Rebetol dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
If the abnormality is reversed, Rebetol may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician. However, a return to higher doses is not recommended. For patients receiving a 800 mg (< 65 kg)-1,000 mg (65-80 kg)-1,200 mg (81-105 kg) or 1,400 mg (> 105 kg) dose, 1st dose reduction of Rebetol is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
If needed, 2nd dose reduction of Rebetol is by an additional 200 mg/day. Patients whose dose of Rebetol is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. Medicinal product no longer authorised 4 In case of serious adverse reaction potentially related to medicinal products used in combination with Rebetol, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the Rebetol dose modification and/or discontinuation guidelines as described in Table 2.
Dose modification for paediatric patients Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2). 4). Table 3 provides guidelines for discontinuation based on the patient’s indirect bilirubin concentration.
Table 3 Management of Adverse Reactions Laboratory values Discontinue Rebetol if:
Bilirubin – Indirect > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b), or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b) Special populations Elderly ( 65 years of age) There does not appear to be a significant age-related effect on the pharmacokinetics of Rebetol.
2). 4). The selection of Rebetol formulation is based on individual characteristics of the patient. The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established. No data are available.
Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for further dosage recommendations on co-administration. 2). Therefore, it is recommended that renal function be evaluated in all […]
A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with Rebetol) are also listed for reference in Table
There are no data in children or adolescents with a history of cardiac disease. 6). For laboratory monitoring of pregnancy, please refer to Laboratory tests. , urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Transient rashes do not necessitate interruption of treatment. Liver function Any patient developing significant liver function abnormalities during treatment must be monitored closely. Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for discontinuation or dose modification recommendations.
Renal impairment The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients. Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol.
Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, Rebetol dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute. 2). 2). Potential to exacerbate immunosuppression Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and Rebetol concomitantly with azathioprine.
5).
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa/ribavirin treatment. In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when Rebetol is administered.
For additional details see section