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Extavia is a brand name for Interferon Beta-1b. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Extavia 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 Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease. 6), to be injected subcutaneously every other day. 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. 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 for how long the patient should be treated. There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
For relapsing-remitting multiple sclerosis, 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 Extavia over the whole time period.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three 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 adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.
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. No data are available on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
Method of administration The reconstituted solution is to be injected subcutaneously every other day. 6.
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 Extavia. 0 million IU) Extavia 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 medicinal products.
The incidence of injection site reactions may be reduced by the use of an auto-injector. Tabulated list of adverse reactions The following adverse event listings are based on reports from clinical trials and from 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 Extavia use.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. 4)a, b Medicinal product no longer authorised 10 Reproductive system and breast disorders Menorrhagia, Impotence, Metrorrhagia Menstrual disorder General disorders and administration site conditions Injection site reaction (various kindsf), Flu-like symptoms (complexg), Pain, Fever, Chills, Peripheral oedema, Asthenia Injection site necrosis, Chest pain, Malaise Sweating a ADRs derived only during post-marketing.
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 oedema, injection site haemorrhage, injection site hypersensitivity, injection site infection, injection site inflammation, injection site mass, injection site pain and injection site reaction.
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. 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 Cases of pancreatitis were observed with Extavia use, often associated with hypertriglyceridaemia. 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 Extavia 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 Extavia and treated appropriately.
8). 8). This medicinal 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 tests Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Patients with anaemia, thrombocytopenia or 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.
1. 8). 8). Medicinal product no longer authorised 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
There have been reports of thrombocytopenia, with profound decreases in platelet count. Medicinal product no longer authorised 5 Hepatobiliary disorders Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
As for other beta interferons, cases of severe hepatic injury, including hepatic failure, have been reported in patients treated with Extavia. 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 Extavia 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. 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.
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. Additionally, cases of HA not associated with TMA, including immune HA, have been reported with interferon beta products.
Life-threatening and fatal cases have been reported. Cases of TMA and/or HA have been reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta. If TMA and/or HA is diagnosed, and a relationship to Extavia is suspected, prompt treatment is required (in case of TMA considering plasma exchange) and immediate discontinuation of Extavia is recommended.
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 […]