FREQUENTLY ASKED QUESTIONS ABOUT GILENYA
AND GENERIC FINGOLIMOD

Novartis is here to support you and your patients as generic fingolimod enters the market. If you are evaluating other treatment options, you can consider another Novartis treatment for adults with RMS. See the below FAQs for more information as you navigate through this time of change.

CAN GILENYA ADULT RMS PATIENTS BE CONSIDERED FOR ANOTHER NOVARTIS TREATMENT OPTION?

  • Yes, you can consider other available Novartis options for your adult RMS patients

  • Novartis is here for you and your patients. As you begin evaluating options, there are other Novartis treatments indicated for adults with RMS that may be appropriate for them

  • Once prescribed, Novartis offers services to help get started with another Novartis treatment

CAN MY PATIENTS WHO WANT TO REMAIN ON A BRANDED TREATMENT STILL BE COVERED AND SUPPORTED BY NOVARTIS?

  • Yes, let your adult patients know that there is another branded treatment from Novartis that may be appropriate for them and has patient support programs

  • The GILENYA Go Program®, which will end on March 31, 2023, continues to offer patient support services for eligible patients who are taking GILENYA. As generic fingolimod is available, insurance companies may no longer cover branded GILENYA, and specialty pharmacies may automatically switch to generic fingolimod based on state substitution laws

WHAT CONSIDERATIONS ARE IMPORTANT WHEN STOPPING GILENYA TREATMENT?

  • There is a possibility of severe increase in disability and multiple new lesions on MRI scans after discontinuation of GILENYA1

  • Risk for potential increase in disability generally occurred within 12-24 weeks after GILENYA discontinuation1

  • You should monitor your patients for development of severe increase in disability after discontinuation of GILENYA and begin appropriate treatment as needed1

WILL GILENYA STILL BE AVAILABLE? AND WHAT INFORMATION WILL MY PATIENTS FIND HELPFUL ABOUT GENERIC FINGOLIMOD?

Yes, GILENYA will still be available for your patients:

  • GILENYA remains available by prescription in 0.5 mg and 0.25 mg capsules

  • Through 2023, Novartis will continue to provide co-pay support for patients who remain on GILENYA, including the prescription and medical co-pay card support

You can guide your patients through possible considerations about generic fingolimod:

  • Specialty pharmacies may automatically switch your patients from branded GILENYA to generic fingolimod

  • If your patients are automatically switched to generic fingolimod, the medication they receive may look different or come in a different packaging

IS THE GILENYA GO PROGRAM STILL AVAILABLE?

  • Yes, Novartis is here for you and your patients. In states that permit it, the GILENYA Go Program will remain in place until March 31, 2023. After this date, your patients will start on GILENYA through their specialty pharmacy

  • For onboarding support, patients who have GILENYA Start Forms dated through December 31, 2022 will receive prior authorization support from the Hub, first-dose monitoring, and baseline assessments until March 31, 2023

  • Commercially insured patients who have been utilizing $0 co-pay support through the GILENYA Go Program may see their co-pay increase in the near future

  • After March 31, 2023, your patients and care partners may call the McKesson Co-Pay Support line for GILENYA at 1-855-443-1759. Further details and dates will be communicated when available

ARE RESOURCES STILL AVAILABLE FOR EXISTING GILENYA PATIENTS?

  • Yes, Novartis remains deeply committed to the MS community. We remain dedicated to providing patient support services until March 31, 2023

  • During this time frame, the GILENYA Go Program continues to offer support services, in states that permit it, for patients who are prescribed and staying on branded GILENYA, such as:

    • Onboarding support for both appropriate adult and pediatric patients, including in-home baseline assessments and first-dose observation (FDO)

    • Starter pack and Bridge free drug programs for eligible patients

    • Through 2023, co-pay support for eligible patients, including the prescription and medical co-pay card support

    • Referral to Novartis Patient Assistance Program (NPAF)

    • Adherence education for eligible patients

    • Patients and care partners with any questions about the program can call: 1-800-GILENYA (1-800-445-3692), 8:00AM – 9:00PM ET, Mon - Fri (excludes public holidays)

    • Additionally, Novartis is committed to maintaining the GILENYA supply chain for patients who currently take branded GILENYA. If you or your patients have any questions, please reach out to the GILENYA Go Program at (1-800-445-3692)

CAN I STILL PRESCRIBE GILENYA FOR MY PEDIATRIC PATIENTS?

  • Yes, you can still prescribe GILENYA for your pediatric patients. However, since the GILENYA Go Program will end on March 31, 2023, patients newly prescribed will not receive the onboarding and adherence support after this date

  • Novartis remains committed to pediatric patients, and we will maintain production of 0.25 mg dose. Whether your patients receive generic fingolimod or branded GILENYA will depend on the availability of other generic forms of fingolimod 0.25 mg dose and your patient's health plan preferred drug

  • Novartis is dedicated to ensuring your pediatric patients can appropriately initiate therapy with GILENYA. If your patients want to stay on a branded treatment they know and trust, they can call the GILENYA Go Program to find out more: 1-800-GILENYA (1-800-445-3692)

WHO CAN I CONTACT IF I HAVE ADDITIONAL QUESTIONS?

Please reach out to your Novartis Sales Specialist if you have any questions or call 1-888-NOW-NOVA (1-888-669-6682) Mon - Fri, 8:30AM – 5:00PM ET.

WHO SHOULD MY PATIENTS CONTACT IF THEY HAVE ANY QUESTIONS?

Please have your patients contact the below if they have any questions:

  • For adult patients taking GILENYA, call 1-800-GILENYA (1-800-445-3692), 8:00AM – 9:00PM ET, Mon - Fri

  • For pediatric patients taking GILENYA, call 1-800-598-1410, 8:00AM – 9:00PM ET, Mon - Fri

MS=multiple sclerosis; RMS=relapsing multiple sclerosis.

GO PROGRAM is a registered trademark of Novartis AG.

Reference: 1. Gilenya [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.

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Indication and Important Safety
Information

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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

Indication

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

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.

Human papilloma virus (HPV) infections, including papilloma, dysplasia, warts, and HPV-related cancer, have been reported with GILENYA in the postmarketing setting. Vaccination against HPV should be considered prior to treatment initiation, taking into account vaccination recommendations. Cancer screening, including Papanicolaou (Pap) test, is recommended as per standard of care for patients using an immunosuppressive therapy.

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.

Liver Injury: Clinically significant liver injury has occurred in patients treated with GILENYA in the postmarketing setting. Signs and symptoms of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as 10 days after the first dose and also have been reported after prolonged use. Cases of acute liver failure requiring liver transplant have been reported.

Elevation of liver enzymes (ALT, AST, and GGT) 3- and 5-fold the upper limit of normal and greater has 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.

Prior to starting treatment with GILENYA (within 6 months), obtain serum transaminases (ALT and AST) and total bilirubin levels, and periodically until 2 months after GILENYA discontinuation. Patients should be monitored for signs and symptoms of any hepatic injury. Treatment with GILENYA should be interrupted if the patient is found to have an ALT greater than 3 times the reference range with serum total bilirubin greater than 2 times the reference range. Patients with severe hepatic impairment should be closely monitored, as their risk of adverse reactions is greater.

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.

Fetal Risk: GILENYA may cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Because it takes approximately 2 months to eliminate GILENYA from the body, advise females of reproductive potential to use effective contraception to avoid pregnancy during and for 2 months after stopping GILENYA treatment. 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.

Tumefactive Multiple Sclerosis: MS relapses with tumefactive demyelinating lesions on imaging have been observed during GILENYA therapy and after discontinuation in the postmarketing setting. Most reported cases occurred within the first 9 months after initiation, but may occur at any point during treatment. Cases have also been reported within the first 4 months after discontinuation of GILENYA. Tumefactive MS should be considered when a severe MS relapse occurs during treatment, especially during initiation, or after discontinuation, prompting imaging evaluation and initiation of appropriate treatment.

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.

Malignancies: The risk of basal cell carcinoma (BCC) and melanoma is increased in patients treated with GILENYA. Melanoma, squamous cell carcinoma, and Merkel cell carcinoma have been reported with GILENYA in the postmarketing setting. Monitor and evaluate suspicious skin lesions.

Cases of lymphoma, including both T-cell and B-cell types and CNS lymphoma, have occurred in patients receiving GILENYA. The reporting rate of non-Hodgkin lymphoma with GILENYA is greater than that expected in the general population. Cutaneous T-cell lymphoma (including mycosis fungoides) has also been reported in the postmarketing setting.

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.

Seizure: Cases of seizures, including status epilepticus, have been reported with the use of GILENYA in clinical trials and in the postmarketing setting in adults. In adult clinical trials, the rate of seizures was 0.9% in GILENYA-treated patients and 0.3% in placebo-treated patients.

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.

Indication

GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Click here for full Prescribing Information.