Gilenya

Gilenya

fingolimod

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Fingolimod HCl
Indications/Uses
Single disease modifying therapy in highly active relapsing-remitting multiple sclerosis for adult patients & paed patients ≥10 yr w/ highly active disease despite full & adequate course of treatment w/ at least 1 disease modifying therapy; or patients w/ rapidly evolving severe relapsing-remitting multiple sclerosis defined by ≥2 disabling relapses in 1 yr, & w/ ≥1 Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Dosage/Direction for Use
Adult 0.5 mg once daily. Paed patient ≥10 yr weighing >40 kg 0.5 mg once daily, weighing ≤40 kg 0.25 mg once daily. Paed patients who start on 0.25 mg cap & subsequently reach a stable body wt >40 kg should be switched to 0.5 mg cap.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Immunodeficiency syndrome; increased risk for opportunistic infections including immunocompromised patients; severe active infections, active chronic infections eg, hepatitis, TB; active malignancies; severe liver impairment (Child-Pugh class C). Patients who in the previous 6 mth had MI, unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or NYHA class III/IV heart failure. Patients w/ severe cardiac arrhythmias requiring anti-arrhythmic treatment w/ class Ia or class III anti-arrhythmic medicinal products; 2nd-degree Mobitz type II AV block or 3rd-degree AV block, or sick-sinus syndrome, w/o pacemaker; baseline QTc interval ≥500 msec. Women of childbearing potential not using effective contraception. Pregnancy.
Special Precautions
Risk of bradyarrhythmia; QTc interval prolongation; BP effects. Measure ECG & BP prior to & 6 hr after the 1st dose of Gilenya. Should not be used in patients w/ SA heart block, history of symptomatic bradycardia, recurrent syncope or cardiac arrest, or in patients w/ significant QT prolongation, uncontrolled HTN or severe sleep apnoea. Monitor BP regularly during treatment. Infection risk & increased risk of developing lymphomas & other malignancies; basal cell carcinoma & other cutaneous neoplasms. Assess complete blood count before initiating treatment, periodically during treatment, at mth 3 & at least yrly thereafter, & in case of signs of infection. Delay initiation of treatment in patients w/ severe active infection or active viral hepatitis until resolution. A full course of vaccination for Ab-negative patients w/ varicella vaccine is recommended prior to commencing treatment; postpone treatment initiation for 1 mth to allow full effect of vaccination to occur. Risk of cryptococcal meningitis; progressive multifocal leukoencephalopathy (PML); human papilloma virus (HPV) infection, including papilloma, dysplasia, warts & HPV-related cancer; macular oedema w/ or w/o visual symptoms. Increased risk of macular oedema in patients w/ history of uveitis & patients w/ DM. Increased hepatic enzymes. In the absence of clinical symptoms, monitor liver transaminases at mth 1, 3, 6, 9 & 12 on therapy & periodically thereafter. Interference w/ laboratory tests involving the use of circulating mononuclear cells. Patients w/ severe resp disease, pulmonary fibrosis & COPD. Rare cases of posterior reversible encephalopathy syndrome (PRES). Rare cases of tumefactive lesions associated w/ MS relapse. Prior treatment w/ immunosuppressive or immunomodulatory therapies. Concomitant use w/ potent CYP450 inducers. Not recommended w/ St. John's wort. Caution against exposure to sunlight w/o protection. Patients should not receive concomitant phototherapy w/ UV-B-radiation or PUVA-photochemotherapy. Caution when stopping therapy due to risk of rebound. If stopping Gilenya treatment, allow a 6-wk interval w/o therapy to clear fingolimod from circulation. Patients w/ mild to moderate hepatic impairment or history of significant liver disease. Women of childbearing potential must use effective contraception during treatment & for 2 mth after treatment discontinuation. Women receiving Gilenya should not breastfeed. Elderly ≥65 yr. Paed population: Childn 10-12 yr, <40 kg or at Tanner stage <2. Reports of seizures, anxiety, depressed mood & depression. Mild isolated bilirubin increases. Recommended to complete all immunisations before starting Gilenya therapy.
Adverse Reactions
Influenza, sinusitis; headache; cough; diarrhoea; back pain; increased hepatic enzyme (increased ALT, γ-glutamyltransferase & AST). Herpes viral infections, bronchitis, tinea versicolor; basal cell carcinoma; lymphopenia, leucopenia; depression; dizziness, migraine; blurred vision; bradycardia, AV block; HTN; dyspnoea; eczema, alopecia, pruritus; myalgia, arthralgia; asthenia, increased blood triglycerides.
Drug Interactions
Risk of additive immune system effects w/ antineoplastic, immunomodulatory or immunosuppressive therapies. Exercise caution when switching patients from long-acting therapies w/ immune effects eg, natalizumab, teriflunomide or mitoxantrone. Vaccination may be less effective during & for up to 2 mth after Gilenya treatment. Risk of infections w/ live attenuated vaccines. Potential additive effects on heart rate w/ β-blockers, class Ia & III antiarrhythmics, Ca-channel blockers, ivabradine, digoxin, anticholinesteratic agents or pilocarpine. Increased AUC w/ CYP3A4 inhibitors eg, PIs, azole antifungals, clarithromycin or telithromycin. Reduced AUC w/ strong CYP3A4 inducers eg, carbamazepine, rifampicin, phenobarb, phenytoin, efavirenz, St. John's wort.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AA27 - fingolimod ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Gilenya hard cap 0.25 mg
Packing/Price
28's
Form
Gilenya hard cap 0.5 mg
Packing/Price
28's
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