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Betaferon is a brand name for Interferon Beta-1b. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Betaferon is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically…
Verbatim from this product's EMA label. Tap a section to expand.
The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease. 6), to be injected subcutaneously every other day. Paediatric population No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
0 million IU subcutaneously every other day is similar to that seen in adults. There is no information on the use of Betaferon in children under 12 years of age. Therefore Betaferon should not be used in this population. Generally, dose titration is recommended at the start of treatment.
0 ml) every other day (see Table A). The titration period may be adjusted, if any significant adverse reaction occurs. 0 ml) every other day should be reached. A titration pack composed of four triple packs is available for the titration period and the patient’s initial treatment with Betaferon.
This package meets the patient’s needs for the first 12 injections. 5). 75 ml 19, 21, 23 et seq. 0 ml * The titration period may be adjusted, if any significant adverse reaction occurs. The optimal dose has not been fully clarified. At the present time, it is not known how long the patient should be treated for.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years. For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period. In patients with a single clinical event suggestive of multiple sclerosis, the progression to clinically definite multiple sclerosis was significantly delayed over a period of five years.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of ACTH or corticosteroids during a one year period is required despite Betaferon therapy, treatment with Betaferon should be stopped.
Summary of the safety profile At the beginning of treatment adverse reactions are common but in general they subside with further treatment. The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Injection site reactions occurred frequently after administration of Betaferon. 0 million IU) Betaferon treatment. The most serious adverse reactions reported include thrombotic microangiopathy (TMA) and haemolytic anaemia (HA). 2). Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory drugs.
The incidence of injection site reactions may be reduced by the use of an autoinjector. Tabulated list of adverse reactions The following adverse event listing is based on reports from clinical trials and from the post-marketing surveillance (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)) of Betaferon use.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. 4). c Class label for interferon products, see below Pulmonary arterial hypertension. d life-threatening and/or fatal cases have been reported.
g. the following terms: injection site atrophy, injection site edema, injection site haemorrhage, injection site hypersensitivity, injection site infection, injection site inflammation, injection site mass, injection site pain and injection site reaction.
g Flu-like symptom complex’ denotes flu syndrome and/or a combination of at least two Adverse Events from fever, chills, myalgia, malaise, sweating. Pulmonary arterial hypertension Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 4 Immune system disorders The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Gastrointestinal disorders In rare cases, pancreatitis was observed with Betaferon use, often associated with hypertriglyceridemia. 3). Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Patients treated with Betaferon should be advised to report any symptoms of depression and/or suicidal ideation to their prescribing physician immediately. Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
8). 8). This product contains human albumin and hence carries a potential risk for transmission of viral diseases. A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded. Laboratory test Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
g. AST (SGOT), ALT (SGPT) and Gamma-GT), are recommended prior to initiation and at regular intervals following introduction of Betaferon therapy, and then periodically thereafter in the absence of clinical symptoms. Patients with anaemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Patients who develop neutropenia should be monitored closely for the development of fever or infection. There have been reports of thrombocytopenia, with profound decreases in platelet count. Hepatobiliary disorders Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaferon during clinical trials.
1. 8). 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Interferon Beta-1b in European Union.
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Method of administration For subcutaneous injection. 6.
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.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients treated with Betaferon. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse). Patients should be monitored for signs of hepatic injury.
The occurrence of elevations in serum transaminases should lead to close monitoring and investigation. Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions. 5 Renal and urinary disorders Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
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 Betaferon should be considered. Cardiac disorders Betaferon should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Betaferon.
While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease. During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
Rare cases of cardiomyopathy have been reported. If this occurs and a relationship to Betaferon is suspected, treatment should be discontinued. Thrombotic microangiopathy (TMA) and Haemolytic anaemia (HA) 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.
Early clinical features include thrombocytopenia, new onset hypertension, fever, […]