Gilenya Protocol

Unlocking the Gilenya Protocol: A comprehensive guide to navigating the administration, precautions, and monitoring procedures associated with Gilenya, a leading treatment for multiple sclerosis.

Preliminary Labs:

• CBC, Varicella Zoster Antibodies
• (If not immune to Varicella, vaccination required and patient has to wait for one month before we consider Gilenya)
• EKG QTc >450 ms in males or >470 msec in females is abnormal
• Pregnancy test
• JCV 

Precautions:

• No live vaccines while on Gilenya or for two months after terminating Gilenya
• Check for any medications that interfere with AV conduction. Check for heart failure.
• Inquire about any recent TIA / Stroke which increases risk of adverse effects.
• Avoid any meds that prolong QTc

Contradindications:

• Within the last 6 months: MI, unstable angina, stroke, TIA, decompensated Heart Failure
• Mobitz Type II second degree or third degree AV block
• Sick sinus Syndrome 
• QTc >500 msec 
• Cardiac arrhythmias that requred Class Ia or III antiarrhythmic
• Allergy to Gilenya
• Pregnancy

Admininstration protocol:

• Gilenya 0.5 mg one dose
• 6 hours of cardiac monitoring (specifically watch for third degree AV block and AV block with junctional escape)
• Hourly HR and BP for 6 hours

Cardiology consult and CONTINUE monitoring IF

• HR < 45 
• Second degree AV block or higher
• Continue Monitoring longer IF
• If heart rate post dose at 6 hours is the lowest dose post dose 
• Pharmacological treatment required for bradycardia

Outpatient dosing of Gilenya after first dose:

0.5 mg daily

Outpatient monitoring and adverse effects while on Gilenya:

• CBC (Lymphocyte count expected to reach 30% of baseline in 2 weeks)
• JCV titer: risk of PML
• Opthalmology followup for Macular edema
• Headache and altered mental status: consider PRES
• Increased BP
• Liver dysfunction
• Malignancies
• Shortness of breath