For US Health Care Professionals Only
GETTING PATIENTS STARTED

For your convenience, there are 3 ways to get patients started on GILENYA:

Getting Patients Started

Recommended Dosage

  • In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the recommended dosage of GILENYA is 0.5 mg orally once-daily
  • In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage of GILENYA is 0.25 mg orally once daily
  • Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit
Baseline Assessments
Baseline Assessments Confirm Patients Appropriate to Start GILENYA
Before starting treatment with GILENYA, baseline assessments should be established by the patient’s respective health care provider(s). Confirm these exams and review the results before initiation.
Cardiac Evaluation: Cardiac evaluation in patients with certain pre-existing conditions
  • Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular conduction
Complete Blood Count: Review results of a recent complete blood count (CBC) (ie, within 6 months or after discontinuation of prior therapy)
Prior Medications: If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with GILENYA
Vaccinations: Test patients for antibodies to varicella zoster virus (VZV) before initiating GILENYA; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with GILENYA
  • It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating GILENYA therapy
Eye Exam: Perform an examination of the fundus including the macula in all patients before starting treatment
Liver Enzymes: Prior to treatment (within 6 months), transaminase and bilirubin levels should be available before initiation of GILENYA therapy. Obtain transaminase levels and total bilirubin levels periodically until 2 months after GILENYA discontinuation
Discuss risk with pregnancy
First Dose
ECG prior to first dosing and at the end of observation period
Observe for at least 6 hours, with hourly pulse and blood pressure measurements.  More
Additional monitoring after 6 hours
  • Continue monitoring until resolution if:
    • The heart rate 6 hours postdose is less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age
    • The heart rate 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamics effect on the heart may not have occurred
    • The ECG 6 hours postdose shows new onset second degree or higher AV block
Overnight monitoring
  • Continuous overnight ECG monitoring should be instituted in patients:
    • That require pharmacologic intervention for symptomatic bradycardia. Repeat first-dose monitoring after the second dose of GILENYA
    • With some preexisting heart and cerebrovascular conditions
    • With a prolonged QTc interval before dosing or during 6-hour observation, or at additional risk for QT prolongation, or on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes
    • Receiving concurrent therapy with drugs that slow heart rate or AV conduction
Additional monitoring after 6 hours
  • Continue monitoring until resolution if:
    • The heart rate 6 hours postdose is less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age
    • The heart rate 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamics effect on the heart may not have occurred
    • The ECG 6 hours postdose shows new onset second degree or higher AV block
Overnight monitoring
  • Continuous overnight ECG monitoring should be instituted in patients:
    • That require pharmacologic intervention for symptomatic bradycardia. Repeat first-dose monitoring after the second dose of GILENYA
    • With some preexisting heart and cerebrovascular conditions
    • With a prolonged QTc interval before dosing or during 6-hour observation, or at additional risk for QT prolongation, or on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes
    • Receiving concurrent therapy with drugs that slow heart rate or AV conduction
Repeat first-dose monitoring if GILENYA treatment is reinitiated
  • In pediatric patients changing dose from 0.25 mg to 0.5 mg
  • In patients after discontinuation
    • for ≥1 day during the first 2 weeks of treatment
    • for >7 days during weeks 3 or 4 of treatment
    • for >14 days after the first month of treatment
During Treatment
*Heart rate less than 45 beats per minute in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age.
Within weeks 1 and 2 of treatment for interruptions ≥1 day, within weeks 3 and 4 for interruptions >7 days, and after 1 month of treatment for interruptions >14 days.
 
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