Gilenya

Gilenya

fingolimod

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Fingolimod
Indications/Uses
Relapsing forms of multiple sclerosis to reduce frequency of clinical exacerbation & delay accumulation of physical disability.
Dosage/Direction for Use
Adult & ped >10 yr, >40 kg 0.5 mg once daily, ≤40 kg 0.25 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not open cap.
Contraindications
Hypersensitivity. Experienced MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or class III/IV heart failure w/in last 6 mth. History or presence of Mobitz type II 2nd- or 3rd-degree AV block or sick sinus syndrome (unless w/ functioning pacemaker). Baseline QTc interval ≥500 msec. Concomitant use w/ class IA or III antiarrhythmic drugs.
Special Precautions
Discontinue use if progressive multifocal leukoencephalopathy, macular edema, significant liver injury or posterior reversible encephalopathy syndrome is suspected. Not to be used in patients w/ SA heart block, history of symptomatic bradycardia or recurrent syncope, or significant QT prolongation [QTc >470 msec (females), >460 msec (ped females) or >450 msec (adult & ped males)]; history of cardiac arrest, uncontrolled HTN, severe untreated sleep apnea; active acute or chronic infection. Avoid use patients w/ risk factors for QT prolongation eg, hypokalemia, hypomagnesemia or congenital QT prolongation. Cryptococcal meningitis; basal cell carcinoma & other cutaneous neoplasms; lymphoma; tumefactive lesions associated w/ relapse. Perform ECG prior to 1st dose & at end of 6-hr observation period; ophth exam prior to & regularly in patients w/ history of uveitis & DM. Monitor heart rate & BP regularly during 6-hr observation period. Consider HPV vaccination prior to initiation. Varicella zoster virus vaccination of Ab negative patients & postpone initiation for 1 mth. Perform recent complete blood count, transaminase & bilirubin levels; liver function test & periodic skin exam prior & during treatment. Avoid exposure to sunlight w/o protection. Severe exacerbation after discontinuation. Not to be initiated concurrently w/ β-blockers, heart rate lowering Ca-channel blockers or drugs decreasing heart rate. Concomitant use w/ antineoplastics, immune-modulating or immunosuppressives including corticosteroids. Switching from natalizumab or teriflunomide. Severe hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended during pregnancy & lactation.
Adverse Reactions
Influenza, sinusitis, headache, cough, nausea, diarrhea, abdominal & back pain, pain in extremity, increased hepatic enzymes. Bronchitis, herpes zoster, tinea versicolor, basal cell carcinoma, lymphopenia, leukopenia, bradycardia, migraine, asthenia, alopecia, actinic keratosis, increased blood triglycerides, dyspnea, blurred vision, HTN, skin papilloma.
Drug Interactions
Increased blood levels w/ ketoconazole. Reduced efficiency w/ live attenuated vaccines during & for 2 mth after treatment. Increased risk of immunosuppression w/ antineoplastics, immune-modulating or immunosuppressive therapies including corticosteroids. QT prolonging drugs w/ known risk of Torsade de pointes eg, citalopram, chlorpromazine, haloperidol, methadone, erythromycin; drugs slowing heart rate or AV conduction eg, β-blockers, digoxin or Ca-channel blockers eg, diltiazem or verapamil.
MIMS Class
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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