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Gilenya is a brand name for Fingolimod. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease…
Verbatim from this product's EMA label. Tap a section to expand.
The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. 5 mg capsule taken orally once daily. 25 mg capsule taken orally once daily. 5 mg capsule taken orally once daily. 5 mg capsules. 5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.
The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for: - 1 day or more during the first 2 weeks of treatment. - more than 7 days during weeks 3 and 4 of treatment. - more than 2 weeks after one month of treatment.
4). 2). Renal impairment Fingolimod was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to severe renal impairment.
3). 2). Paediatric population The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. No data are available. 1). Method of administration This medicinal product is for oral use. 2). The capsules should always be swallowed intact, without opening them.
0%). 14 Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from post-marketing experience via spontaneous case reports or literature cases are shown below. Frequencies were defined using the following convention: 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); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Infections and infestations Very common:
Influenza Sinusitis Common: Herpes viral infections Bronchitis Tinea versicolor Uncommon: Pneumonia Not known: Progressive multifocal leukoencephalopathy (PML)** Cryptococcal infections** Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common: Basal cell carcinoma Uncommon: Malignant melanoma**** Rare: Lymphoma*** Squamous cell carcinoma**** Very rare: Kaposi’s sarcoma**** Not known Merkel cell carcinoma*** Blood and lymphatic system disorders Common: Lymphopenia Leucopenia Uncommon: Thrombocytopenia Not known: Autoimmune haemolytic anaemia*** Peripheral oedema*** Immune system disorders Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation*** Immune reconstitution inflammatory syndrome (IRIS)** Psychiatric disorders Common: Depression Uncommon: Depressed mood Nervous system disorders Very common: Headache Common: Dizziness Migraine Uncommon: Seizure Rare: Posterior reversible encephalopathy syndrome (PRES)* Not known: Severe exacerbation of disease after fingolimod discontinuation*** Eye disorders Common: Vision blurred Uncommon: Macular oedema Cardiac disorders Common: Bradycardia Atrioventricular block Very rare: T-wave inversion*** Vascular disorders Common: Hypertension 15 Respiratory, thoracic and mediastinal disorders Very common: Cough Common: Dyspnoea Gastrointestinal disorders Very common: Diarrhoea Uncommon: Nausea*** Hepatobiliary disorders Not known: Acute hepatic failure*** Skin and subcutaneous tissue disorders Common: Eczema Alopecia Pruritus Musculoskeletal and connective tissue disorders Very common: Back pain Common: Myalgia Arthralgia General disorders and administration site conditions Common: Asthenia Investigations Very common: Hepatic enzyme increased (increased alanine transaminase, gamma glutamyltransferase, aspartate transaminase) Common: Weight decreased*** Blood triglycerides increased Uncommon: Neutrophil count decreased * The frequency category was based on an estimated exposure of approximately 10 000 patients to fingolimod in all clinical trials.
1). After the first dose, the decline in heart rate starts within one hour, and is maximal within 6 hours. This post-dose effect persists over the following days, although usually to a milder extent, and usually abates over the next weeks.
With continued administration, the average heart rate returns towards baseline within one month. However individual patients may not return to baseline heart rate by the end of the first month. Conduction abnormalities were typically transient and asymptomatic.
They usually did not require treatment and resolved within the first 24 hours on treatment. If necessary, the decrease in heart rate induced by fingolimod can be reversed by parenteral doses of atropine or isoprenaline. All patients should have an ECG and blood pressure measurement performed prior to and 6 hours after the first dose of Gilenya.
All patients should be monitored for a period of 6 hours for signs and symptoms of bradycardia with hourly heart rate and blood pressure measurement. Continuous (real time) ECG monitoring during this 6 hour period is recommended. 5 mg daily dose.
Should post-dose bradyarrhythmia-related symptoms occur, appropriate clinical management should be initiated and monitoring should be continued until the symptoms have resolved. Should a patient require pharmacological intervention during the first-dose monitoring, overnight monitoring in a medical facility should be instituted and the first-dose monitoring should be repeated after the second dose of Gilenya.
If the heart rate at 6 hours is the lowest since the first dose was administered (suggesting that the maximum pharmacodynamic effect on the heart may not yet be manifest), monitoring should be extended by at least 2 hours and until heart rate increases again.
Additionally, if after 6 hours, the heart rate is <45 bpm in adults, <55 bpm in paediatric patients aged 12 years and above, or <60 bpm in paediatric patients aged 10 to below 12 years, or the ECG shows new onset second degree or higher grade AV block or a QTc interval ≥500 msec, extended monitoring (at least overnight monitoring), should be performed, and until the findings have resolved.
Immunodeficiency syndrome. - Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
4). 4 - Severe active infections, active chronic infections (hepatitis, tuberculosis). - Active malignancies. - Severe liver impairment (Child-Pugh class C). 4). 4). 4). 4). 6). 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fingolimod in European Union.
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4). 5 mg in all clinical trials. 5 mg dose was similar to placebo. However, lower respiratory tract infections, primarily bronchitis and to a lesser extent herpes infection and pneumonia were more common in fingolimod-treated patients.
5 mg dose. g. g. g. 4). 4). Due to the immunosuppressive properties of fingolimod, vaccination against HPV should be considered prior to treatment initiation with fingolimod taking into account vaccination recommendations. Cancer screening, including Pap test, is recommended as per standard of care.
25 mg. The majority of cases occurred within the first 3-4 months of therapy. Some patients presented with blurred 16 vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination.
The macular oedema generally improved or resolved spontaneously after discontinuation of treatment. The risk of recurrence after re-challenge has not been evaluated. Macular oedema incidence is increased in multiple sclerosis patients with a history of uveitis (17% with a history of uveitis vs.
6% without a history of uveitis). 4). 5 mg and 5 mg resulted in a 2-fold increase in the incidence of macular oedema. Bradyarrhythmia Initiation of treatment results in a transient decrease in heart rate and may also be associated with atrioventricular conduction delays.
In multiple sclerosis clinical studies the maximal decline in heart […]
The occurrence at any time of third degree AV block should also lead to extended monitoring (at least overnight monitoring). 5 The effects on heart rate and atrioventricular conduction may recur on re-introduction of fingolimod treatment depending on duration of the interruption and time since start of treatment.
2). Very rare cases of T-wave inversion have been reported in adult patients treated with fingolimod. In case of T-wave inversion, the prescriber should ensure that there are no associated myocardial ischaemia signs or symptoms. If myocardial ischaemia is suspected, it is recommended to seek advice from a cardiologist.
3). In such patients, treatment with Gilenya should be considered only if the anticipated benefits outweigh the potential risks, and advice from a cardiologist sought prior to initiation of treatment in order to determine the most appropriate monitoring.
5). g. g. amiodarone, sotalol) antiarrhythmic medicinal products. 3). g. ivabradine, digoxin, anticholinesteratic agents or pilocarpine). 8, Bradyarrhythmia), concomitant use of these substances during treatment initiation may be associated with severe bradycardia and heart block.
5). In such patients, treatment with Gilenya should be considered only if the anticipated benefits outweigh the potential risks. If treatment with Gilenya is considered, advice from a cardiologist should be sought regarding the switch to non heart-rate lowering medicinal products prior to initiation of treatment.
5). 5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still present, fingolimod treatment resulted in a prolongation of QTcI, with the upper limit of […]