HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GILENYA ® safely and effectively. See full prescribing information for GILENYA. GILENYA (fingolimod) capsules, for oral use Initial U.S. Approval: 2010 ----------------------------RECENT MAJOR CHANGES--------------------------------- Indications and Usage (1) 5/2018 Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5) 5/2018 Contraindications (4) 1/2019 Warnings and Precautions (5.1, 5.10) 5/2018 Warnings and Precautions (5.9) 10/2018 Warnings and Precautions (5.11) 1/2019 ----------------------------INDICATIONS AND USAGE---------------------------------- 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. (1) -------------------------DOSAGE AND ADMINISTRATION---------------------------- Assessments are required prior to initiating GILENYA (2.1) Recommended dosage for adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food (2.2, 2.3) Recommended dosage for pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: 0.25 mg orally once-daily, with or without food (2.2, 2.3). First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): o Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly. Electrocardiograms (ECGs) prior to dosing and at end of observation period required. (2.4) o Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, < 55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period. (2.4) o Monitor symptomatic bradycardia with ECG until resolved. Continue overnight if intervention is required; repeat first-dose monitoring for second dose. (2.4) o Observe patients overnight if at higher risk of symptomatic bradycardia, heart block, prolonged QTc interval, or if taking drugs with known risk of torsades de pointes. (2.4, 7.1) -------------------------DOSAGE FORMS AND STRENGTHS------------------------- 0.25 mg hard capsules (3) 0.5 mg hard capsules (3) ---------------------------------CONTRAINDICATIONS---------------------------------- Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure. (4) History of Mobitz Type II 2 nd degree or 3 rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. (4) Baseline QTc interval ≥ 500 msec. (4) Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs. (4) Hypersensitivity to fingolimod or its excipients. (4) ------------------------WARNINGS AND PRECAUTIONS-------------------- Infections: GILENYA may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 2 months after discontinuation. Do not start in patients with active infections. (5.2) Progressive Multifocal Leukoencephalopathy (PML): Withhold GILENYA at the first sign or symptom suggestive of PML. (5.3) Macular Edema: Examine the fundus before and 3-4 months after treatment start. Diabetes mellitus and uveitis increase the risk. (5.4) Posterior Reversible Encephalopathy Syndrome (PRES): If suspected, discontinue GILENYA. (5.5) Respiratory Effects: Evaluate when clinically indicated. (5.6) Liver Injury: Obtain liver enzyme results before initiation. Closely monitor patients with severe hepatic impairment. Discontinue if significant liver injury occurs. (5.7, 8.6, 12.3) Fetal Risk: Women of childbearing potential should use effective contraception during and for 2 months after stopping GILENYA. (5.8) Severe increase in disability after stopping GILENYA: Monitor for development of severe increase in disability following discontinuation and begin appropriate treatment as needed. (5.9) Increased Blood Pressure (BP): Monitor BP during treatment. (5.10) Malignancies: Suspicious skin lesions should be evaluated. (5.11) -------------------------------ADVERSE REACTIONS--------------------------- Most common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch. --------------------------------DRUG INTERACTIONS-------------------------- Systemic Ketoconazole: Monitor during concomitant use. (7.2, 12.3) Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping GILENYA treatment. (5.2, 7.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 1/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Assessment Prior to Initiating GILENYA 2.2 Important Administration Instructions 2.3 Recommended Dosage 2.4 First-Dose Monitoring 2.5 Monitoring After Reinitiation of Therapy Following Discontinuation 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Bradyarrhythmia and Atrioventricular Blocks 5.2 Infections 5.3 Progressive Multifocal Leukoencephalopathy 5.4 Macular Edema 5.5 Posterior Reversible Encephalopathy Syndrome 5.6 Respiratory Effects 5.7 Liver Injury 5.8 Fetal Risk 5.9 Severe Increase in Disability After Stopping GILENYA 5.10 Increased Blood Pressure 5.11 Malignancies 5.12 Immune System Effects Following GILENYA Discontinuation 5.13 Hypersensitivity Reactions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 QT Prolonging Drugs 7.2 Ketoconazole 7.3 Vaccines 7.4 Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies 7.5 Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem) 7.6 Laboratory Test Interaction 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Adults 14.2 Pediatric Patients (10 to less than 18 Years of Age) 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GILENYA®
safely and effectively. See full prescribing information for GILENYA.
GILENYA (fingolimod) capsules, for oral use
Initial U.S. Approval: 2010
----------------------------RECENT MAJOR CHANGES---------------------------------
Warnings and Precautions (5.9) 10/2018 Warnings and Precautions (5.11) 1/2019
----------------------------INDICATIONS AND USAGE----------------------------------
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. (1)
-------------------------DOSAGE AND ADMINISTRATION----------------------------
Assessments are required prior to initiating GILENYA (2.1)
Recommended dosage for adults and pediatric patients (10 years of age and
older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food
(2.2, 2.3)
Recommended dosage for pediatric patients (10 years of age and above)
weighing less than or equal to 40 kg: 0.25 mg orally once-daily, with or without
food (2.2, 2.3).
First-Dose Monitoring (including reinitiation after discontinuation greater than
14 days and dose increases): o Observe all patients for bradycardia for at least 6 hours; monitor pulse and
blood pressure hourly. Electrocardiograms (ECGs) prior to dosing and at end
of observation period required. (2.4) o Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, <
55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients
aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period. (2.4)
o Monitor symptomatic bradycardia with ECG until resolved. Continue
overnight if intervention is required; repeat first-dose monitoring for second dose. (2.4)
o Observe patients overnight if at higher risk of symptomatic bradycardia, heart
block, prolonged QTc interval, or if taking drugs with known risk of torsades de pointes. (2.4, 7.1)
-------------------------DOSAGE FORMS AND STRENGTHS-------------------------
0.25 mg hard capsules (3) 0.5 mg hard capsules (3)
Systemic Ketoconazole: Monitor during concomitant use. (7.2, 12.3)
Vaccines: Avoid live attenuated vaccines during, and for 2 months after
stopping GILENYA treatment. (5.2, 7.3)
See 17 for PATIENT COUNSELING INFORMATION and
Medication Guide.
Revised: 1/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION
2.1 Assessment Prior to Initiating GILENYA 2.2 Important Administration Instructions 2.3 Recommended Dosage 2.4 First-Dose Monitoring 2.5 Monitoring After Reinitiation of Therapy Following
Discontinuation 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
5.1 Bradyarrhythmia and Atrioventricular Blocks 5.2 Infections 5.3 Progressive Multifocal Leukoencephalopathy 5.4 Macular Edema 5.5 Posterior Reversible Encephalopathy Syndrome 5.6 Respiratory Effects 5.7 Liver Injury 5.8 Fetal Risk 5.9 Severe Increase in Disability After Stopping GILENYA 5.10 Increased Blood Pressure 5.11 Malignancies 5.12 Immune System Effects Following GILENYA Discontinuation 5.13 Hypersensitivity Reactions
7.4 Antineoplastic, Immunosuppressive, or Immune-Modulating
Therapies 7.5 Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g.,
beta blockers or diltiazem) 7.6 Laboratory Test Interaction
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment
Percentage of patients without relapse 70% 46% < 0.001
Hazard ratio‡ of disability progression
(95% CI) 0.70
(0.52, 0.96)
0.02
MRI Endpoint
Mean (median) number of new or newly
enlarging T2 lesions over 24 months
2.5 (0) 9.8 (5.0) < 0.001
Mean (median) number of T1 Gd-enhancing
lesions at Month 24
0.2 (0) 1.1 (0) < 0.001
All analyses of clinical endpoints were intent-to-treat. MRI analysis used evaluable dataset.
‡Hazard ratio is an estimate of the relative risk of having the event of disability progression on GILENYA as compared to placebo.
Figure 1: Time to 3-Month Confirmed Disability Progression – Study 1 (ITT population)
Study 2 was a 1-year randomized, double-blind, double-dummy, active-controlled study in patients with RRMS who
had not received any natalizumab in the previous 6 months. Prior therapy with interferon-beta or glatiramer acetate up
to the time of randomization was permitted.
Neurological evaluations were performed at screening, every 3 months, and at the time of suspected relapses. MRI
evaluations were performed at screening and at Month 12. The primary endpoint was the annualized relapse rate.
Median age was 36 years, median disease duration was 5.9 years, and median EDSS score at baseline was 2.0.
Patients were randomized to receive GILENYA 0.5 mg (N = 431), 1.25 mg (N = 426), or interferon beta-1a, 30 mcg
via the intramuscular route (IM) once-weekly (N = 435) for up to 12 months. Median time on study drug was 365
days on GILENYA 0.5 mg, 354 days on 1.25 mg, and 361 days on interferon beta-1a IM.
The annualized relapse rate was significantly lower in patients treated with GILENYA 0.5 mg than in patients who
received interferon beta-1a IM. The key secondary endpoints were number of new and newly enlarging T2 lesions and
time to onset of 3-month confirmed disability progression as measured by at least a 1-point increase from baseline in
EDSS (0.5 point increase for those with baseline EDSS of 5.5) sustained for 3 months. The number of new and newly
enlarging T2 lesions was significantly lower in patients treated with GILENYA than in patients who received
interferon beta-1a IM. There was no significant difference in the time to 3-month confirmed disability progression
between GILENYA and interferon beta-1a-treated patients at 1 year. The 1.25 mg dose resulted in no additional
benefit over the GILENYA 0.5 mg dose. The results for this study are shown in Table 3.
Table 3: Clinical and MRI Results of Study 2
GILENYA
0.5 mg
N = 429
Interferon beta-1a
IM 30 mcg
N = 431
p-value
Clinical Endpoints
Annualized relapse rate (primary
endpoint)
0.16 0.33 < 0.001
Percentage of patients without relapse 83% 70% < 0.001
Hazard ratio‡ of disability progression
(95% CI)
0.71
(0.42, 1.21)
0.21
MRI Endpoint
Mean (median) number of new or
newly enlarging T2 lesions over 12
months
1.6 (0) 2.6 (1.0) 0.002
Mean (median) number of T1 Gd-
enhancing lesions at Month 12
0.2 (0) 0.5 (0) < 0.001
All analyses of clinical endpoints were intent-to-treat. MRI analysis used evaluable dataset. ‡ Hazard ratio is an estimate of the relative risk of having the event of disability progression on GILENYA as compared to control.
Pooled results of study 1 and study 2 showed a consistent and statistically significant reduction of annualized relapse
rate compared to comparator in subgroups defined by gender, age, prior MS therapy, and disease activity.
14.2 Pediatric Patients (10 to less than 18 Years of Age)
Study 4 (NCT 01892722) evaluated the efficacy of once-daily oral doses of GILENYA 0.25 mg or GILENYA 0.5 mg
in pediatric patients 10 to less than 18 years of age with relapsing-remitting multiple sclerosis. Study 4 was a 215-
patient, double-blind, randomized, clinical trial that compared GILENYA to intramuscular interferon beta-1a. Prior
therapy with interferon-beta, dimethyl fumarate, or glatiramer acetate up to the time of randomization was permitted.
The study included patients who had experienced at least 1 clinical relapse during the year prior or 2 relapses during
the 2 years prior to screening, or evidence of 1 or more Gd-enhancing lesions on MRI within 6 months prior to
randomization, and had an EDSS score from 0 to 5.5. Neurological evaluations were scheduled at screening, every 3
months, and at the time of suspected relapses. MRI evaluations were performed at screening and every 6 months
throughout the study. The primary endpoint was the annualized relapse rate.
At baseline, the median age was 16 years, median disease duration since first symptom was 1.5 years, and median
EDSS score was 1.5. One patient received no study drug and is excluded from the analysis of efficacy. Median
duration of exposure to study drug was 634 days in the GILENYA group (n = 107) and 547 days in the interferon
beta-1a group (n = 107). In the GILENYA group, 6.5% of patients did not complete the study, compared to 18.5% in
the interferon beta-1a group.
The primary endpoint, the annualized relapse rate (ARR), was significantly lower in patients treated with GILENYA
(0.122) than in patients who received interferon beta-1a (0.675). Relative reduction in ARR was 81.9%. The
annualized rate of the number of new or newly enlarged T2 lesions up to month 24 (key secondary endpoint) was
significantly lower in patients treated with GILENYA, as was the number of Gd-enhancing T1 lesions per scan up to
per scan up to Month 24 0.436 1.282 < 0.001* 66.0%
All analyses of clinical endpoints were on full analysis set. MRI analyses used the evaluable dataset.
*Indicates statistical significance vs. Interferon beta-1a IM at two-sided 0.05 level.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
0.25 mg GILENYA capsules are supplied as follows:
hard gelatin capsules with an ivory opaque body and cap, with black radial imprint “FTY 0.25mg” on the cap and
a black radial band on the capsule body
Bottle of 30 capsules NDC 0078-0965-15
Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 0078-0965-89
0.5 mg GILENYA capsules are supplied as follows:
hard gelatin capsules with a white opaque body and bright yellow cap imprinted with “FTY 0.5 mg” on the cap
and 2 radial bands imprinted on the capsule body with yellow ink.
Bottle of 30 capsules NDC 0078-0607-15
Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 0078-0607-89
16.2 Storage and Handling
GILENYA capsules should be stored at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Protect from
moisture.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Tell patients not to discontinue GILENYA without first discussing this with the prescribing physician. Advise patients
to contact their physician if they accidently take more GILENYA than prescribed.
Cardiac Effects
Advise patients that initiation of GILENYA treatment results in a transient decrease in heart rate. Inform patients that
they will need to be observed in the doctor's office or other facility for at least 6 hours after the first dose, after
reinitiation if treatment is interrupted or discontinued for certain periods, and after the dosage is increased [see
Dosage and Administration (2.4), Warnings and Precautions (5.1)].
Risk of Infections
Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when
taking GILENYA, and that they should contact their physician if they develop symptoms of infection. Advise patients
that the use of some vaccines should be avoided during treatment with GILENYA and for 2 months after
discontinuation. Recommend to patients that they delay treatment with GILENYA until after VZV vaccination if they
have not had chickenpox or a previous VZV vaccination. Inform patients that prior or concomitant use of drugs that
suppress the immune system may increase the risk of infection [see Warnings and Precautions (5.2)].
Progressive Multifocal Leukoencephalopathy
Inform patients that cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients who
received GILENYA. Inform the patient that PML is characterized by a progression of deficits and usually leads to
death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if
they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are
diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of
limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality
changes [see Warnings and Precautions (5.3)].
Macular Edema
Advise patients that GILENYA may cause macular edema, and that they should contact their physician if they
experience any changes in their vision. Inform patients with diabetes mellitus or a history of uveitis that their risk of
macular edema is increased [see Warnings and Precautions (5.4)].
Posterior Reversible Encephalopathy Syndrome
Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe
headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to
permanent neurological sequelae [see Warnings and Precautions (5.5)].
Respiratory Effects
Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea [see
Warnings and Precautions (5.6)].
Hepatic Effects
Inform patients that GILENYA may increase liver enzymes. Advise patients that they should contact their physician if
they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see
Warnings and Precautions (5.7)].
Fetal Risk
Inform patients that, based on animal studies, GILENYA may cause fetal harm. Discuss with women of childbearing
age whether they are pregnant, might be pregnant or are trying to become pregnant. Advise women of childbearing
age of the need for effective contraception during GILENYA treatment and for 2 months after stopping GILENYA.
Advise the patient that if she should nevertheless become pregnant, she should immediately inform her physician [see
Warnings and Precautions (5.8)].
Severe Increase in Disability After Stopping GILENYA
Inform patients that severe increase in disability has been reported after discontinuation of GILENYA. Advise
patients to contact their physician if they develop worsening symptoms of MS following discontinuation of
GILENYA [see Warnings and Precautions (5.9)].
Malignancies
Advise patients that basal cell carcinoma and melanoma are associated with use of GILENYA. Advise patients that
any suspicious skin lesions should be promptly evaluated. Advise patients to limit exposure to sunlight and ultraviolet
light by wearing protective clothing and using a sunscreen with a high protection factor. Inform patients that
lymphoma has also occurred in patients receiving GILENYA [see Warnings and Precautions (5.11)].
Persistence of GILENYA Effects After Drug Discontinuation
Advise patients that GILENYA remains in the blood and continues to have effects, including decreased blood
lymphocyte counts, for up to 2 months following the last dose [see Warnings and Precautions (5.12)].
Hypersensitivity Reactions
Advise patients that GILENYA may cause hypersensitivity reactions including rash, urticaria, and angioedema.
Advise patients to contact their physician if they have any symptoms associated with hypersensitivity [see Warnings
and Precautions (5.13)].
Pregnancy and Pregnancy Registry
Instruct patients that if they are pregnant or plan to become pregnant while taking GILENYA they should inform their
physician. Encourage patients to enroll in the GILENYA Pregnancy Registry if they become pregnant while taking
GILENYA [see Use in Specific Populations (8.1)].
T2019-18
MEDICATION GUIDE GILENYA® (je-LEN-yah)
(fingolimod) capsules
Read this Medication Guide before you start taking GILENYA and each time you get a refill. There may be new information. If you are the parent of a child who is being treated with GILENYA, the following information applies to your child. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about GILENYA?
GILENYA may cause serious side effects, including: 1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA. GILENYA can cause
your heart rate to slow down, especially after you take your first dose. You will have a test, called an electrocardiogram (ECG), to check the electrical activity of your heart before you take your first dose of GILENYA.
All adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of GILENYA. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of GILENYA when switching from the 0.25 mg dose.
After you take your first dose of GILENYA, and after a child takes their first dose of 0.5 mg of GILENYA when switching from the 0.25 mg dose:
Your pulse and blood pressure should be checked every hour.
You should be observed by a healthcare professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms such as:
o dizziness o tiredness o feeling like your heart is beating slowly or skipping beats o chest pain
If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of GILENYA. Symptoms can happen up to 24 hours after you take your first GILENYA dose.
6 hours after you take your first dose of GILENYA you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed.
If you have any serious side effects after your first dose of GILENYA, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. You will also be observed for any serious side effects for at least 6 hours after you take your second dose of GILENYA the next day.
If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be observed overnight after you take your first dose of GILENYA.
Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA. Call your doctor or go to the nearest hospital emergency room right away if you have any symptoms of a slow heart rate.
If you miss 1 or more doses of GILENYA, you may need to be observed by a healthcare professional when you take your next dose. Call your doctor if you miss a dose of GILENYA. See “How should I take GILENYA?”
2. Infections. GILENYA can increase your risk of serious infections that can be life-threatening and cause death. You should not receive live vaccines during treatment with GILENYA and for 2 months after you stop taking GILENYA. Talk to your doctor before you receive a vaccine during treatment and for 2 months after treatment with GILENYA. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with GILENYA.
GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment. Your doctor may do a blood test to check your white blood cells before you start taking GILENYA. Call your doctor right away if you have any of these symptoms of an infection during treatment with GILENYA, and for 2 months after your last dose of GILENYA:
fever
tiredness
body aches
chills
nausea
vomiting
headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)
3. Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML, that have lasted several days, including:
weakness on 1 side of your body
loss of coordination in your arms and legs
decreased strength
problems with balance
changes in your vision
changes in your thinking or memory
confusion
changes in your personality
4. A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 3 to 4 months after you start taking GILENYA. Your doctor should test your vision before you start taking GILENYA and 3 to 4 months after you start taking GILENYA, or any time you notice vision changes during treatment with GILENYA. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.
Call your doctor right away if you have any of the following:
blurriness or shadows in the center of your vision
a blind spot in the center of your vision
sensitivity to light
unusually colored (tinted) vision
What is GILENYA?
GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults and children 10 years of age and older.
It is not known if GILENYA is safe and effective in children under 10 years of age.
Who should not take GILENYA?
Do not take GILENYA if you:
have had a heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA) or certain types of heart failure in the last 6 months.
have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom a heart finding called prolonged QT is seen on ECG before starting GILENYA.
have a heart rhythm problem that needs treatment with certain medicines.
are allergic to fingolimod or any of the ingredients in GILENYA. See the end of this leaflet for a complete list of ingredients in GILENYA. Symptoms of an allergic reaction may include: rash, itchy hives, or swelling of the lips, tongue or face.
Talk to your doctor before taking GILENYA if you have any of these conditions, or do not know if you have any of these conditions.
What should I tell my doctor before taking GILENYA?
Before you take GILENYA, tell your doctor about all your medical conditions, including if you had or now have:
an irregular or abnormal heartbeat (arrhythmia).
a history of stroke or mini-stroke.
heart problems, including heart attack or angina.
a history of repeated fainting (syncope).
a fever or infection, or you are unable to fight infections due to a disease or take or have taken medicines that lower your immune system.
recently received a vaccine or are scheduled to receive a vaccine.
chickenpox or have received the vaccine for chickenpox. Your doctor may do a blood test for chickenpox virus. You may need to get the full course of the vaccine for chickenpox and then wait 1 month before you start taking GILENYA.
your child has completed their vaccination schedule. Your child needs to have completed their vaccination schedule before starting treatment with GILENYA.
eye problems, especially an inflammation of the eye called uveitis.
diabetes.
breathing problems, including during your sleep.
liver problems.
high blood pressure.
types of skin cancer called basal cell carcinoma (BCC) or melanoma.
are pregnant or plan to become pregnant. GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or are planning to become pregnant. Tell your doctor right away if you become pregnant while taking GILENYA or if you become pregnant within 2 months after you stop taking GILENYA. o If you are a female who can become pregnant, you should use effective birth control during your treatment
with GILENYA and for at least 2 months after you stop taking GILENYA.
Pregnancy Registry: There is a registry for women who become pregnant during treatment with GILENYA. If you become pregnant while taking GILENYA, talk to your doctor about registering with the GILENYA Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health.
For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by sending an email to [email protected], or go to www.gilenyapregnancyregistry.com.
are breastfeeding or plan to breastfeed. It is not known if GILENYA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take GILENYA.
Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take medicines that affect your immune system, including corticosteroids, or have taken them in the past.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
Using GILENYA and other medicines together may affect each other causing serious side effects.
How should I take GILENYA?
Adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of GILENYA. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of GILENYA when switching from the 0.25 mg dose. See “What is the most important information I should know about GILENYA?”
Take GILENYA exactly as your doctor tells you to take it.
Take GILENYA 1 time each day.
If you take too much GILENYA, call your doctor or go to the nearest hospital emergency room right away.
Take GILENYA with or without food.
Do not stop taking GILENYA without talking with your doctor first.
Call your doctor right away if you miss a dose of GILENYA. You may need to be observed by a healthcare professional for at least 6 hours when you take your next dose. If you need to be observed by a healthcare professional when you take your next dose of GILENYA you will have:
o an ECG before you take your dose o hourly pulse and blood pressure measurements after you take the dose o an ECG 6 hours after your dose
If you have certain types of heart problems, or if you are taking certain types of medicines that can affect your heart, you will be observed overnight by a healthcare professional in a medical facility after you take your dose of GILENYA.
If you have serious side effects after taking a dose of GILENYA, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. If you were observed overnight, you will also be observed for any serious side effects for at least 6 hours after you take your second dose of GILENYA.
See “What is the most important information I should know about GILENYA?”
What are possible side effects of GILENYA?
GILENYA can cause serious side effects, including:
See “What is the most important information I should know about GILENYA?”
swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened rarely in adults taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated, it may lead to a stroke. Call your doctor right away if you have any of the following symptoms:
o sudden severe headache o sudden confusion
o sudden loss of vision or other changes in your vision
o seizure
breathing problems. Some people who take GILENYA have shortness of breath. Call your doctor right away if you have new or worsening breathing problems.
liver problems. GILENYA may cause liver problems. Your doctor should do blood tests to check your liver
before you start taking GILENYA. Call your doctor right away if you have any of the following symptoms of liver problems:
o nausea o vomiting o stomach pain o tiredness
o loss of appetite o your skin or the whites of your eyes turn yellow o dark urine
severe worsening of multiple sclerosis after stopping GILENYA. When GILENYA is stopped, symptoms of MS can return and become worse compared to before or during treatment. Many people who have worsening of MS symptoms after stopping GILENYA do not return to the level of function that they had before stopping GILENYA. This worsening happens most often within 12 weeks after stopping GILENYA, but can happen later. Always talk to your doctor before you stop taking GILENYA for any reason. Tell your doctor if you have worsening symptoms of MS after stopping GILENYA.
increased blood pressure. Your doctor should check your blood pressure during treatment with GILENYA.
types of skin cancer called basal cell carcinoma (BCC) and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with GILENYA. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
allergic reactions. Call your doctor if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue or face.
The most common side effects of GILENYA include:
headache
abnormal liver tests
diarrhea
cough
flu
inflammation of the sinuses (sinusitis)
back pain
stomach-area (abdominal) pain
pain in arms or legs
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of GILENYA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GILENYA?
Store GILENYA in the original bottle or blister pack in a dry place.
Store GILENYA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep GILENYA and all medicines out of the reach of children.
General information about the safe and effective use of GILENYA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GILENYA for a condition for which it was not prescribed. Do not give GILENYA to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about GILENYA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about GILENYA that is written for health professionals.