Fingolimod Mylan

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.

25 mg strength. For this dosage, other medicinal products containing fingolimod, available on the market, should be used. The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:  One 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). 1). The safety and efficacy of fingolimod in children aged below 10 years have not yet been established. No data are available. Method of administration This medicinal product is for oral use. 2). The capsules should always be swallowed intact, without opening them.

0%). 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. 14 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 Respiratory, thoracic and mediastinal disorders Very common Cough Common Dyspnoea 15 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 electrocardiogram (ECG) and blood pressure measurement performed prior to and 6 hours after the first dose of Fingolimod Mylan.

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 Fingolimod Mylan.

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.

1.  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).  Severe active infections, active chronic infections (hepatitis, tuberculosis).  Active malignancies.  Severe liver impairment (Child-Pugh class C). 4). 4). 4). 4). 6).