What to know about the symptoms of slow heart rate
When your child takes his or her first dose of GILENYA®, it's expected that his or her heart rate will slow down temporarily.
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 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 your child starts on GILENYA. If these symptoms occur after your child has taken his or her first dose, you should call your child's doctor or go to the nearest emergency room right away if your child feels any of the symptoms of slow heart rate listed above.
A slow heart rate right after the first dose is linked to how GILENYA is thought to work in the body. Here's why it happens.
If your child experiences symptoms of 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.
If your child who takes GILENYA weighs 88.2 lb or less, he or she will start with a 0.25 mg dosage. After exceeding that weight, his or her health care professional may recommend that your child move up to the 0.5 mg dose, and he or she will be monitored again.
What to know about infections
GILENYA lowers the number of white blood cells (lymphocytes) in your child's blood. As a result, GILENYA can increase your child's risk of serious infections, some of which could be life threatening and cause death.
The reduction in the number of lymphocytes is expected—in 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 child's doctor may do a blood test before your child starts taking GILENYA to check how many white blood cells your child has and to make sure that GILENYA is right for him or her.
GILENYA may also decrease the way vaccines work in your child's body, especially the chicken pox vaccine. Increased risk of infection was seen with doses higher than the approved dose (0.5 mg).
Your child needs to have completed his or her vaccination schedule before starting treatment with GILENYA.
Call your child's doctor right away if he or she has 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 the 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 child's doctor right away if your child has any new or worsening medical problems that have lasted several days, including weakness on one side of the body, loss of coordination in the arms and legs, decreased strength, problems with balance, confusion, or changes in 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. Your child may not notice any symptoms, but if macular edema occurs, it usually begins within the first 3 to 4 months after your child starts taking GILENYA. Your child's risk of macular edema is higher if he or she has diabetes or has had an inflammation of the eye called uveitis.
Call your child's doctor right away if he or she has blurriness or shadows in the center of his or her vision, a blind spot in the center of his or her vision, sensitivity to light, or unusually colored (tinted) vision.
Your child should get his or her vision tested before starting GILENYA, as well as 3 to 4 months after starting GILENYA, and again any time your child notices vision changes during treatment. The GILENYA Support Team can help you schedule these tests.