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Indication & Important Safety Information

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients...More

FOR YOUR PATIENTS

GILENYA^® Go Program^®

A comprehensive, personalized support program created by patients, for patients. Services include:

A GILENYA Patient Services Liaison to help answer questions about GILENYA and GILENYA support programs
An insurance coverage investigation More >

A GILENYA Patient Services Liaison

A dedicated GILENYA Patient Services Liaison supports you, your staff, and your patients.*

The Liaison—a key component of the GILENYA Support Team—is the primary contact for you and your patients. The main goal of the program is to get your patients started on GILENYA. More >

A dedicated Novartis GILENYA Patient Service Liaison

Co-Pay Assistance

Most eligible patients paid a $0 prescription co-pay for GILENYA.^† Two co-pay support programs that can help: More >

The GILENYA Prescription Co-Pay Support Program

To help ensure that treatment remains affordable, eligible patients can receive co-pay assistance for their GILENYA prescriptions. Payments are made directly to the patient’s pharmacy.^†

The GILENYA Medical Co-Pay Support Program

Baseline assessments and the first-dose observation (FDO) performed through the GILENYA Assessment Network (GAN)—whether in a medical facility or @Home—are provided free of charge to patients. The Medical Co-Pay Support Program may still help pay for most of these tests if conducted outside of the GAN.^‡

^† In 2016, most eligible patients paid a $0 co-pay. Call 1-800-GILENYA for details. People for whom GILENYA has been prescribed are required to report any benefits they receive through the GILENYA Prescription Co-Pay Support Program to their commercial insurance company. Limitations apply. Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid or any other federal or state program. Not valid for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the US and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. This program is subject to termination or modification at any time.

^‡ Medical co-pay support for covered initial assessments/examinations or for First-Dose Observations (FDO) is provided without regard to whether the patient continues on with GILENYA therapy. People for whom GILENYA has been prescribed are required to report any benefits they receive under the GILENYA Medical Co-Pay Support Program to their insurance company. This offer is not valid for prescriptions and medical assessments for which payment may be made in whole or in part under federal or state health programs, including but not limited to Medicare or Medicaid, or for residents of RI. Valid only for those with commercial insurance. This program is subject to termination or modification at any time.

Network of Digital and Social Properties

GILENYA has a network of social properties to help support your patients.

Service Request Form

Get patients started by submitting the GILENYA SRF online now. Download SRF

Get patients started by submitting the GILENYA SRF online. More >

DOWNLOAD SRF

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INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older.

Important Safety Information

Contraindications

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure (HF) requiring hospitalization or Class III/IV HF
History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker
Baseline QTc interval ≥500 msec
Concomitant treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who have had a hypersensitivity reaction to fingolimod or any of the excipients in GILENYA. Observed reactions include rash, urticaria, and angioedema upon treatment initiation

Bradyarrhythmia and Atrioventricular (AV) Block: Monitor patients during GILENYA initiation because of a risk of bradyarrhythmia and AV block. Prior to dosing and at the end of the observation period, obtain an electrocardiogram (ECG) in all patients (10 years of age and older). Monitor all patients for 6 hours after the first dose for signs and symptoms of bradycardia with hourly pulse and blood pressure (BP) measurement.
Continue monitoring until the abnormality resolves if any of the following is present after 6 hours: (1) The heart rate (HR) 6 hours postdose is <45 bpm in adults, <55 bpm in pediatric patients 12 years of age and older, or <60 bpm in pediatric patients 10 or 11 years of age. (2) The HR 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamic effect on the heart may not have occurred. (3) The ECG 6 hours postdose shows new onset second degree or higher atrioventricular (AV) block.

Begin continuous ECG monitoring in patients with symptomatic bradycardia until resolution. If pharmacological intervention is required, continue ECG monitoring overnight in a medical facility, and repeat 6-hour monitoring after the second dose. Some patients may experience a second decrease in HR within 24 hours after the first dose.

Patients with pre-existing ischemic heart disease, history of MI or cardiac arrest, CHF, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia or recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block, or on concomitant drugs that slow HR or AV conduction should be evaluated by a physician and, if treated with GILENYA, monitored overnight with continuous ECG in a medical facility after first dose due to higher risk of symptomatic bradycardia or heart block. Patients with or at risk for QT prolongation or on concomitant QT-prolonging drugs with a known risk of torsades de pointes should also be monitored overnight with continuous ECG.

Repeat first-dose monitoring if GILENYA is interrupted ≥1 day within first 2 weeks or >7 days during weeks 3 and 4, or >14 days after the first month of treatment because effects on HR and AV conduction may occur upon reinitiation. First-dose monitoring is also recommended when the dose is increased in pediatric patients switching from 0.25 mg to 0.5 mg.
Infections: GILENYA may increase risk of infections. Life threatening and fatal infections have occurred in association with GILENYA. A recent CBC should be available before initiating GILENYA. Consider suspending GILENYA if a patient develops a serious infection. Monitor for signs and symptoms of infection during treatment and up to 2 months after discontinuation. Do not start GILENYA in patients with active acute or chronic infections until infection is resolved. Two patients receiving a higher than recommended dose of GILENYA (1.25 mg) in conjunction with high-dose corticosteroid therapy died of herpetic infections. In the postmarketing setting with GILENYA, serious infections, some fatal, have been reported with opportunistic pathogens, including viruses (eg, John Cunningham virus [JCV], herpes simplex viruses 1 and 2, varicella zoster virus [VZV]), fungi (eg, cryptococci), bacteria (eg, atypical mycobacteria), and Kaposi’s sarcoma. Patients with signs and symptoms consistent with any of these infections should undergo prompt diagnostic evaluation and treatment. Concomitant use with antineoplastic, immunosuppressive, or immune-modulating therapies are expected to increase the risk of additive immunosuppression. When switching to GILENYA from these types of therapies, consider their duration of effect and mode of action to avoid this risk.
Before initiating GILENYA, patients should be tested for antibodies to VZV. VZV vaccination of antibody-negative patients is recommended prior to starting treatment. GILENYA initiation should be postponed for 1 month after vaccination. It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating GILENYA.
Progressive Multifocal Leukoencephalopathy (PML): Cases of PML occurred in patients with MS who received GILENYA in the postmarketing setting. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and usually leads to severe disability or death. PML has occurred in patients who had not been treated previously with natalizumab, which has a known association with PML, and who were not taking concomitant immunosuppressive or immunomodulatory medications.
Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, visual disturbances, and changes in thinking, memory, and orientation, leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms. PML, diagnosed based on MRI findings and detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, has been reported in patients treated with MS medications associated with PML, including GILENYA. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful. Any suspicious findings should lead to further investigation to allow for an early diagnosis of PML. Lower PML-related morbidity and mortality have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or differences in disease in these patients.

At the first sign or symptom suggestive of PML, withhold GILENYA and perform an appropriate diagnostic evaluation.
Macular Edema: Fingolimod increases the risk of macular edema, with or without visual symptoms. Perform an exam of the fundus, including the macula, before starting GILENYA, and 3 to 4 months after initiation. Monitor visual acuity at baseline, during routine patient evaluations, and if a patient reports visual disturbances while on GILENYA. Patients with diabetes mellitus or history of uveitis are at increased risk and should have regular ophthalmologic evaluations.
Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported with GILENYA. Symptoms reported include sudden onset of severe headache, altered mental status, visual disturbances, and seizure. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, GILENYA should be discontinued.
Respiratory Effects: Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and diffusion lung capacity for carbon monoxide (DLCO) were observed in GILENYA patients as early as 1 month after initiation. Changes in FEV1 appear to be reversible after discontinuing GILENYA; however, there is insufficient information to determine reversibility of DLCO. Obtain spirometry and DLCO when clinically indicated.
Liver Injury: Recent liver transaminase and bilirubin levels should be available before initiating GILENYA. Elevations 3- and 5-fold the upper limit of normal have occurred with GILENYA. The majority occurred within 6 to 9 months and returned to normal within 2 months after discontinuing GILENYA. Recurrence of liver transaminase elevations occurred with rechallenge in some patients. Assess liver enzymes and bilirubin if symptoms suggestive of hepatic injury develop. Discontinue GILENYA if significant liver injury is confirmed. Postmarketing cases of liver injury with hepatocellular and/or cholestatic hepatitis have been reported.
Fetal Risk: GILENYA may cause fetal harm. Women of childbearing potential should use effective contraception during and for 2 months after stopping GILENYA. A registry for women who become pregnant during GILENYA treatment is available. Contact the GILENYA Pregnancy Registry by calling 1-877-598-7237, sending an e-mail to gpr@quintiles.com, or visiting gilenyapregnancyregistry.com.
Severe Increase in Disability After Stopping GILENYA: Severe increase in disability accompanied by multiple new lesions on MRI has been reported following discontinuation of GILENYA in the postmarketing setting. Most of these reported cases did not return to the functional status they had before stopping GILENYA. The increase in disability generally occurred within 12 weeks after stopping GILENYA, but was reported up to 24 weeks after GILENYA discontinuation.
The possibility of severe increase in disability should be considered in patients who discontinue GILENYA, including those who are pregnant or planning for pregnancy.

Monitor patients for development of severe increase in disability following discontinuation of GILENYA and begin appropriate treatment as needed.
Increased Blood Pressure (BP): Monitor BP during treatment with GILENYA. An average increase of 3 mm Hg in systolic and 2 mm Hg in diastolic BP was observed in clinical trials versus placebo.
Cutaneous Malignancies: The risk of basal cell carcinoma (BCC) and melanoma is increased in patients treated with GILENYA. Melanoma and Merkel cell carcinoma have been reported with GILENYA in the postmarketing setting. Monitor and evaluate suspicious skin lesions.
Immune System Effects Following Discontinuation: Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose. Lymphocyte counts generally return to normal range within 1 to 2 months of stopping therapy. Initiating other drugs during this period warrants the same considerations needed for concomitant administration.
Hypersensitivity Reactions: Hypersensitivity reactions including rash, urticaria, and angioedema have been reported with GILENYA.
Drug Interactions: Closely monitor patients receiving systemic ketoconazole. The use of live attenuated vaccines should be avoided during, and for 2 months after stopping GILENYA.
Common Adverse Reactions: The most common adverse reactions with GILENYA 0.5 mg (incidence ≥10% and >placebo) were headache, liver transaminase elevations, diarrhea, nausea, cough, influenza, sinusitis, abdominal pain, back pain, and pain in extremity.
Pediatric Patients 10 Years of Age and Older: In the pediatric study, the safety profile in pediatric patients receiving GILENYA 0.25 mg or 0.5 mg daily was similar to that seen in adult patients. Cases of seizures were reported in 5.6% of GILENYA-treated patients and 0.9% of interferon beta-1a-treated patients.

Please click here for full Prescribing Information for GILENYA.

Indication

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older.

References: 1. Gilenya [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; October 2018. 2. Kappos L, Radue E-W, O’Connor P, et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401. 3. Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-415. 4. Data on file. Summary of Clinical Efficacy in Multiple Sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2009. 5. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability scale (EDSS). Neurology. 1983;33(11):1444-1452. 6. Data on file. CSR 2302. Novartis Pharmaceuticals Corp; East Hanover, NJ. July 2009. 7. Data on file. CSR 2301. Novartis Pharmaceuticals Corp; East Hanover, NJ. July 2009. 8. Ge Y. Multiple sclerosis: the role of MR imaging. AJNR Am J Neuroradiol. 2006;27(6):1165-1176. 9. Hauser SL, Goodin DS. Multiple sclerosis and other demyelinating diseases. In: Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine. 17th ed. New York, NY: The McGraw-Hill Companies, Inc; 2008:2611-2621. 10. Data on file. Briefing document. Novartis Pharmaceuticals Corp; East Hanover, NJ. May 2010. 11. Data on file. GILENYA exposure: August 2018 cutoff. Novartis Pharmaceuticals Corp; September 2018. 12. Data on file. Hub SRF and Sales Table. Novartis Pharmaceuticals Corp. Q4 2017. 13. Data on file. CSR 2309. Novartis Pharmaceuticals Corp; East Hanover, NJ. July 2009. 14. Chun J, Hartung H-P. Mechanism of action of oral fingolimod (FTY720) in multiple sclerosis. Clin Neuropharmacol. 2010;33(2):91-101. 15. Takabe K, Paugh SW, Milstien S, Spiegel S. “Inside out” signaling of sphingosine-1-phosphate: therapeutic targets. Pharmacol Rev. 2008;60(2):181-195. 16. Data on file. GILENYA exposure: August 2018 cutoff. Novartis Pharmaceuticals Corp; September 2018. 17. DiMarco JP, O’Connor P, Cohen JA, et al. First-dose effects of fingolimod: pooled safety data from three phase 3 studies. Mult Relat Disord. 2014;3(5):629-638. 18. Degaute JP, van de Borne P, Linkowski P, et al. Quantitative analysis of the 24-hour blood pressure and heart rate patterns in young men. Hypertension. 1991;18(2):199-210. 19. Zdanowicz MM, Lynch LM. Teaching the pharmacology of antiarrhythmic drugs. Am J Pharm Educ. 2011;75(7):139. 20. Ganusov VV, De Boer RJ. Do most lymphocytes in humans reside in the gut? Trends Immunol. 2007;28(12):514-518. 21. Zhang ZQ, Notemans DQ, Sedgewick G, et al. Kinetics of CD4+ T cell repopulation of lymphoid tissues after treatment of HIV-1 infection. Proc Natl Acad Sci U S A. 1998;95(3):1154-1159. 22. Haynes BF, Soderberg KA, Fauci AS. Introduction to the immune system. In: Fauci AS, ed. Harrison’s Rheumatology. 2nd edition. New York, NY: The McGraw-Hill Companies; 2010:2-43. 23. Aubagio [prescribing information]. Cambridge, MA: Genzyme Corp; November 2016.

Please click here for full Prescribing Information for GILENYA.

GILENYA® Go Program®

GILENYA^® Go Program^®