Mayzent

Mayzent is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Mayzent prevents symptoms and slows worsening disability and is an oral tablet taken once a day.

• It is not known if Mayzent is safe and effective in children.

Mayzent (siponimod) works by attaching tightly to two specific targets on cells, known as S1P receptors 1 and 5. By acting on these receptors, siponimod keeps certain white blood cells (lymphocytes) trapped in the lymph nodes, so fewer of them circulate in the bloodstream. It is not fully understood how siponimod helps in multiple sclerosis, but the benefit may come from reducing the number of these immune cells that reach the brain and spinal cord (the central nervous system), where they can otherwise cause inflammation and damage. Mayzent belongs to the drug class called sphingosine 1-phosphate (S1P) receptor modulators. It is only used if you have a specific genotype. Your doctor will test you for this genotype.

Mayzent was FDA-approved on March 26, 2019. There is no generic.

Mayzent may cause serious side effects, including:

• Infections. Mayzent can increase your risk of serious infections that can be life-threatening and cause death. Mayzent lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 to 4 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking Mayzent.

Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with Mayzent and for 3 to 4 weeks after your last dose of Mayzent:

• fever tiredness body aches chills nausea vomiting headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine, or encephalitis, an infection of the brain)
• Progressive multifocal leukoencephalopathy (PML). Mayzent can increase your risk for PML, which 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. Call your healthcare provider right away if you have any new or worsening neurologic symptoms that have lasted several days, including:

• weakness on 1 side of your body loss of coordination in your arms and legs decreased strength problems with balance changes in your vision changes in your thinking or memory confusion changes in your personality.
• A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 1 to 4 months after you start taking Mayzent but can happen at any time. Your healthcare provider should test your vision around the time you start taking Mayzent, periodically while taking Mayzent, and any time you notice vision changes during treatment with Mayzent. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.

Call your healthcare provider right away if you have any of the following symptoms:

• blurriness or shadows in the center of your vision a blind spot in the center of your vision sensitivity to light unusually colored (tinted) vision.
• Slow heart rate (bradycardia or bradyarrhythmia) when you start taking Mayzent. Mayzent can cause your heart rate to slow down, especially after you take your first dose. You should have a test called an electrocardiogram (ECG) to check the electrical activity of your heart before you take your first dose of Mayzent. During the initial titration period (4 days for the 1 mg daily dose or 5 days for the 2 mg daily dose), if you miss 1 or more doses of Mayzent, you need to restart the titration. Call your healthcare provider if you miss a dose of Mayzent. See "How should I take Mayzent?"
• See "What are the possible side effects of Mayzent?" for more information about side effects.

The daily maintenance dose of Mayzent is either 1 mg or 2 mg, depending on your CYP2C9 genotype. Ask your healthcare provider if you are not sure about your daily maintenance dose.

• Take Mayzent tablets whole. Do not split, crush, or chew Mayzent tablets.
• Start your treatment with Mayzent using the following titration schedule with your starter pack:

For the 1 mg daily maintenance dose, use a 7-tablet starter pack:

For the 2 mg daily maintenance dose, use a 12-tablet starter pack:

• Take Mayzent exactly as your healthcare provider tells you. Do not change your dose or stop taking Mayzent unless your healthcare provider tells you to.
• Take Mayzent 1 time each day.
• Take Mayzent with or without food.
• If you miss 1 or more doses of Mayzent during the initial dose-titration, you need to restart with Day 1 of the titration schedule.
• If you miss a dose of Mayzent after the initial dose-titration, take it as soon as you remember.
• After the initial dose-titration is complete, if Mayzent treatment is stopped for 4 or more days in a row, treatment has to be restarted with Day 1 of the titration schedule. Contact your healthcare provider if you stop Mayzent for 4 or more days in a row.
• Do not stop taking Mayzent without talking with your healthcare provider first.

Do not take Mayzent if you:

• have a CYP2C9*3/*3 genotype. Before starting treatment with Mayzent, your CYP2C9 genotype should be determined by your healthcare provider. Ask your healthcare provider if you are not sure.
• have had a heart attack, chest pain called unstable angina, stroke or mini stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months
• have certain types of heart block or irregular or abnormal heartbeat (arrhythmia), unless you have a pacemaker
• are allergic to siponimod or any of the ingredients in Mayzent. See the end of this leaflet for a complete list of ingredients in Mayzent. Symptoms of an allergic reaction may include: rash, itchy hives, or swelling of the lips, tongue or face.

Before taking Mayzent, tell your healthcare provider about all of your medical conditions, including if you:

• have an irregular or abnormal heartbeat.
• have a history of stroke or other diseases related to blood vessels in the brain.
• have breathing problems, including during your sleep.
• have a fever or infection, or you are unable to fight infections due to a disease or taking medicines that lower your immune system. Tell your healthcare provider if you have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for chickenpox virus. You may need to get the full course of vaccine for chickenpox and then wait 1 month before you start taking Mayzent.
• have a slow heart rate.
• have liver problems.
• have diabetes.
• have eye problems, especially an inflammation of the eye called uveitis.
• had or now have any types of skin cancer, including basal cell carcinoma (BCC), melanoma, or squamous cell carcinoma (SCC).
• have high blood pressure.
• are pregnant or plan to become pregnant. Mayzent may harm your unborn baby. Talk to your healthcare provider right away if you become pregnant while taking Mayzent or if you become pregnant within 10 days after you stop taking Mayzent. If you are a woman who can become pregnant, you should use effective birth control during your treatment with Mayzent and for at least 10 days after you stop taking Mayzent. There is a pregnancy safety study for women who take Mayzent during pregnancy. The purpose of this study is to collect information about the health of you and your baby. Pregnant women or healthcare providers are encouraged to report pregnancies to Novartis by emailing [email protected], calling 1-888-669-6682, or visiting the website at https://www.novartis.com/report.
• are breastfeeding or plan to breastfeed. It is not known if Mayzent passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mayzent.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Serious side effects

Mayzent may cause serious side effects, including:

• See "What is the most important information I should know about Mayzent?"
• Breathing problems. Some people who take Mayzent have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
• Liver problems. Mayzent may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking Mayzent. Call your healthcare provider right away if you have any of the following symptoms of liver problems: nausea vomiting stomach pain tiredness loss of appetite your skin or the whites of your eyes turn yellow dark urine
• Types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or any growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your healthcare provider should check your skin for any changes at the start of and during treatment with Mayzent. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
• Allergic reactions. Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue, or face.
• Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with Mayzent.
• Swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened with medicines that work like Mayzent. Symptoms of PRES usually get better when you stop taking Mayzent. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms: sudden severe headache sudden confusion sudden loss of vision or other changes in your vision seizure
• Severe worsening of MS after stopping Mayzent. When Mayzent is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking Mayzent for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping Mayzent.

Common side effects

The most common side effects of Mayzent include:

• headache
• high blood pressure (hypertension)
• abnormal liver tests.

Tell your healthcare provider if you have any side effects that bother you or that do not go away.

These are not all of the possible side effects of Mayzent. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Mayzent and other medicines together may affect each other, causing serious side effects. Especially tell your healthcare provider if you:

• take medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heartbeat (such as calcium channel blockers or beta-blockers)
• take medicines that affect your immune system, such as beta-interferon or glatiramer acetate, or any of these medicines that you took in the past
• have recently received a live vaccine. You should avoid receiving live vaccines during treatment with Mayzent. Mayzent should be stopped 1 week before and for 4 weeks after receiving a live vaccine. If you receive a live vaccine, you may get the infection that the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with Mayzent.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

Unopened containers

• Mayzent 0.25 mg, 1 mg, and 2 mg tablets may be stored at room temperature between 68°F and 77°F (20°C and 25°C) for up to 3 months.
• If you need to store Mayzent tablets for more than 3 months, containers should remain unopened and stored in a refrigerator between 36°F and 46°F (2°C and 8°C) until use.

Opened containers

• Bottles Mayzent 0.25 mg, 1 mg, and 2 mg tablets may be stored at room temperature between 68°F and 77°F (20°C and 25°C) for up to 3 months. Do not refrigerate after opening.
• Starter Pack/Blister Card Mayzent 0.25 mg tablets may be stored at room temperature between 68°F and 77°F (20°C and 25°C) for up to 3 months. Do not refrigerate after opening. Store in original calendarized blister-wallet container.

Keep Mayzent and all medicines out of the reach of children.

Active ingredient: siponimod

Inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose, with a film coating containing iron oxides (black and red iron oxides for the 0.25 mg and 1 mg strengths and red and yellow iron oxides for the 2 mg strength), lecithin (soy), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.

Mayzent (siponimod) is distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. For more information, go to www.Mayzent.com or call 1-888-669-6682.