What to know about the symptoms of slow heart rate
When you take your first dose of GILENYA®, it's expected that your heart rate will slow down temporarily. In clinical studies, less than 1% of adults experienced symptoms due to slow heart rate.
For most people, slow heart rate begins to return to normal after 6 hours and usually fully returns to normal within 1 month.
When symptoms of slow heart rate did occur, it was usually during the first 6 hours after the first dose of GILENYA (although they can occur up to 24 hours after). Symptoms of slow heart rate include dizziness, tiredness, feeling like the heart is beating slowly or skipping beats, and chest pain.
All adults and children will be observed by a health care professional for at least 6 hours after taking their first dose of GILENYA. Children should also be observed by a health care 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.
Remember, symptoms of slow heart rate typically happen when you start on GILENYA. If these symptoms occur after you've taken your first dose, you should call your doctor or go to the nearest emergency room right away if you feel any of the symptoms of slow heart rate listed above.
A slow heart rate right after your first dose is linked to how GILENYA is thought to work in the body. Here's why it happens.
If you experience symptoms from slow heart rate, a health care professional will be there to help, if needed. That's because GILENYA has a plan in place to help monitor slow heart rate during your first day on GILENYA.
What to know about infections
GILENYA lowers the number of white blood cells (lymphocytes) in your blood. As a result, GILENYA can increase your risk of serious infections, some of which could be life threatening and cause death.
The reduction in the number of lymphocytes is expectedin fact, it's thought to be a big part of how GILENYA works.
Because GILENYA does not destroy lymphocytes, this effect is reversible. Lymphocytes typically return to normal levels within 2 months after stopping GILENYA. Your doctor may do a blood test before you start taking GILENYA to check how many white blood cells you have and to make sure that GILENYA is right for you.
GILENYA may also decrease the way vaccines work in your body, especially the chicken pox vaccine. Increased risk of infection was seen with doses higher than the approved dose (0.5 mg).
Call your doctor right away if you have fever, tiredness, body aches, chills, nausea, vomiting, or headache accompanied by fever, neck stiffness, sensitivity to light, nausea, and/or confusion. These may be symptoms of meningitis, an infection of the lining around your brain and spine.
What to know about PML
Progressive multifocal leukoencephalopathy 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. It is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days, including weakness on one side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, confusion, or changes in your vision, thinking, memory, or personality.
What to know about GILENYA and possible effects on vision
Macular edema is swelling or thickening of the part of the eye responsible for detailed, central vision and can appear to be the same vision symptoms as an MS relapse. You may not notice any symptoms, but if macular edema occurs, it usually begins within the first 3 to 4 months after you start taking GILENYA. Your risk of macular edema is higher if you have diabetes or have had an inflammation of the eye called uveitis.
In clinical studies, less than 1% of adults taking GILENYA experienced macular edema. And for those who did, macular edema usually improved or went away after stopping GILENYA.
Call your doctor right away if you have blurriness or shadows in the center of your vision, a blind spot in the center of your vision, sensitivity to light, or unusually colored (tinted) vision.
You should get your vision tested before you start taking GILENYA, as well as 3 to 4 months after you start taking GILENYA, and again any time you notice vision changes during treatment. The GILENYA Support Team can help you schedule these tests.
Is GILENYA right for me?
All medicines for relapsing MS have side effects, and GILENYA is no exception. Make sure you talk to your health care professional about any questions you have and find out if GILENYA is right for you.