LENYA, 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. Advise patients who have not had chickenpox or vaccination to consider VZV vaccination prior to commencing treatment with GILENYA.
17.4 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.
17.5 Respiratory Effects
Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea.
17.6 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.
17.7 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 two months after stopping GILENYA. Advise the patient that if she should nevertheless become pregnant, she should immediately inform her physician.
17.8 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 two months following the last dose.
MEDICATION GUIDE
GILENYA™ (je-LEN-yah)
(fingolimod)
capsules
Read this Medication Guide before you start using GILENYA and each time you get a refill. There may be new information. This information does not take the place of talking with 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 to check the electrical activity of your heart (ECG) before you take your first dose of GILENYA.
You should stay in a medical facility for at least 6 hours after you take your first dose of GILENYA.
After you take your first dose of GILENYA:
•Your pulse and blood pressure should be checked every hour.
•You should be watched 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:
◦dizziness
◦tiredness
◦feeling like your heart is beating slowly or skipping beats
•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 watched.
•If you have any serious side effects after your first dose of GI |
