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Rebif is a brand name for Interferon Beta-1a. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rebif is indicated for the treatment of relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1). Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Rebif is available in two strengths: 22 micrograms and 44 micrograms. For patients initiating treatment with Rebif, Rebif 22 micrograms and Rebif 44 micrograms solution for injection in cartridge packs are available for use with the RebiSmart electronic injection device, allowing automatic dose titration tailored to the patient’s needs for the first month of therapy.
Posology The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection. A lower dose of 22 micrograms, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist.
When first starting treatment with Rebif, the dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions. 3 Paediatric population No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255). The results of this study suggest that the safety profile in children (2 to 11 years old) and in adolescents (12 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms subcutaneous three times per week is similar to that seen in adults.
The safety and efficacy of Rebif in children below 2 years of age have not yet been established. Rebif should not be used in this age group. Method of administration Rebif is administered by subcutaneous injection. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
At the present time, it is not known for how long patients should be treated. Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment. It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Summary of the safety profile The highest incidence of adverse reactions associated with Rebif therapy is related to flu-like syndrome. Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Approximately 70% of patients treated with Rebif can expect to experience the typical interferon flu-like syndrome within the first six months after starting treatment. Approximately 30% of patients will also experience reactions at the injection site, predominantly mild inflammation or erythema.
Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells are also common. The majority of adverse reactions observed with interferon beta-1a are usually mild and reversible, and respond well to dose reductions.
In case of severe or persistent undesirable effects, the dose of Rebif may be temporarily lowered or interrupted, at the discretion of the physician. List of adverse reactions The adverse reactions presented have been identified from clinical studies as well as from post- marketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
e. e. 4) General disorders and administration site conditions Very common: Injection site inflammation, injection site reaction, influenza-like symptoms Common: Injection site pain, fatigue, rigors, fever Uncommon: Injection site necrosis, injection site mass, injection site abscess, injection site infections*, increased sweating* Rare: Injection site cellulitis* Frequency not known: Panniculitis (occurred in the injection site) Paediatric population No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment.
Thrombotic microangiopathy (TMA) Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta. g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Rebif is recommended.
3). Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use. Patients treated with Rebif should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately. 8). 8). Cardiac disease Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation of therapy with interferon beta-1a.
1. 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Interferon Beta-1a in European Union.
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Limited safety data suggest that the safety profile in children and adolescents (2 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms three times weekly is similar to that seen in adults. Class effects The administration of interferons has been associated with anorexia, dizziness, anxiety, arrhythmias, vasodilation and palpitation, menorrhagia and metrorrhagia.
An increased formation of auto-antibodies may occur during treatment with interferon beta. 9 Pulmonary arterial hypertension Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products. Events were reported at various time points including up to several years after starting treatment with interferon beta.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions. 8). To minimise the risk of injection site necrosis patients should be advised to: • use an aseptic injection technique, • rotate the injection sites with each dose.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred. If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with their physician before continuing injections with Rebif.
If the patient has multiple lesions, Rebif should be discontinued until healing has occurred. Patients with single lesions may continue provided that the necrosis is not too extensive. Hepatic dysfunction In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter. Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
5 times ULN). Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear. 8). The majority of the cases of severe liver injury occurred within the first six months of treatment. The mechanism for the rare symptomatic hepatic dysfunction is not known.
No specific risk factors have been identified. 5 Renal and urinary disorders Nephrotic syndrome Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Rebif should be considered. Laboratory abnormalities Laboratory abnormalities are associated with the use of interferons. Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and […]