TrumpRX Mayzent | Trump rx
Mayzent ® Details
Information sourced from the FDA label through OpenFDA. To see extended label information, visit www.novartis.com. Last updated August 29, 2025.
MAYZENT® may cause serious side effects, including:
1. 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 updosing 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 updosing. Call your healthcare provider if you miss a dose of MAYZENT®.
2. 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:
• fever
• vomiting
• tiredness
• headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis or encephalitis)
• body aches
• chills
• nausea
3. 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. Call your doctor 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
4. 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®. Your healthcare provider should test your vision around the time you start taking MAYZENT® and periodically during treatment. Call your healthcare provider right away if you have any of the following symptoms:
• blurriness or shadows in the center of your vision
• sensitivity to light
• a blind spot in the center of your vision
• unusually colored (tinted) vision
• 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 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 within 10 days after you stop taking MAYZENT®.
◦ If you are a woman who can become pregnant, you should use effective birth control during treatment and for at least 10 days after you stop taking MAYZENT®.
◦ Pregnancy Registry: If you become pregnant while taking MAYZENT®, contact MotherToBaby by calling 1-877-311-8972, emailing MotherToBaby@health.ucsd.edu, or visiting www.mothertobaby.org/join-study.
• are breastfeeding or plan to breastfeed. It is not known if MAYZENT® passes into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you:
• take medicines to control your heart rhythm (antiarrhythmics), 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
• 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.
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. Do not split, crush, or chew MAYZENT® tablets; take tablets whole.
Titration schedule for the 1 mg daily maintenance dose (7-tablet starter pack):
• Day 1: 1 x 0.25 mg tablet
• Day 2: 1 x 0.25 mg tablet
• Day 3: 2 x 0.25 mg tablet
• Day 4: 3 x 0.25 mg tablet
• Day 5 and every day after: 1 x 1 mg tablet
Titration schedule for the 2 mg daily maintenance dose (12-tablet starter pack):
• Day 1: 1 x 0.25 mg tablet
• Day 2: 1 x 0.25 mg tablet
• Day 3: 2 x 0.25 mg tablet
• Day 4: 3 x 0.25 mg tablet
• Day 5: 5 x 0.25 mg tablet
• Day 6 and every day after: 1 x 2 mg tablet
• 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 during the initial dose titration, you need to restart the medication.
• If you miss a dose after the initial dose titration, take it as soon as you remember.
• If MAYZENT® treatment is stopped for 4 days in a row, treatment has to be restarted with the titration.
• Do not stop taking MAYZENT® without talking with your healthcare provider first.
MAYZENT® may cause serious side effects, including:
• See “What is the most important information I should know about MAYZENT®?”
• Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with MAYZENT®.
• 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:
◦ nausea
◦ loss of appetite
◦ vomiting
◦ your skin or the whites of your eyes turn yellow
◦ stomach pain
◦ dark urine
◦ tiredness
• 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.
• Swelling and narrowing of blood vessels in your brain (PRES). A condition called Posterior Reversible Encephalopathy Syndrome has happened with drugs in the same class. Symptoms usually get better when you stop taking MAYZENT®, but if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have:
◦ sudden severe headache
◦ sudden loss of vision or other changes in your vision
◦ sudden confusion
◦ seizure
• Severe worsening of multiple sclerosis 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 doctor before you stop taking MAYZENT® for any reason.
• Types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma. Tell your doctor if you have any changes in the appearance of your skin. Your doctor should check your skin at the start of and during treatment. Limit time in sunlight and UV light. Wear protective clothing and use a sunscreen with a high sun protection factor.
The most common side effects of MAYZENT® include:
• headache
• high blood pressure (hypertension)
• abnormal liver tests
• May be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months.
• If storing for more than 3 months, keep containers unopened and refrigerated between 36°F to 46°F (2°C to 8°C) until use.Opened Containers:
• Bottles: May be stored at room temperature for up to 3 months. Do not refrigerate after opening.
• Starter Pack/Blister Card: May be stored at room temperature 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.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MAYZENT® for a condition for which it was not prescribed. Do not give MAYZENT® to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for more information about MAYZENT® that is written for health professionals.
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