Mayzent
Generic name: Siponimod
Drug class:
Selective immunosuppressants
Usage of Mayzent
Mayzent (siponimod) belongs to a class of medications called sphingosine l-phosphate receptor modulators.
Mayzent is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS); a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control).
Mayzent works by decreasing the action of immune cells that may cause nerve damage.
Mayzent is used only if you have a specific genotype. Your doctor will test you for this genotype.
Mayzent side effects
Get emergency medical help if you have signs of an allergic reaction to Mayzent: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Siponimod may cause serious side effects. Call your doctor at once if you have:
Common Mayzent side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking Mayzent
You should not use Mayzent if you are allergic to siponimod or any of the ingredients in Mayzent tablets, or if you have:
Some heart rhythm medications can cause unwanted or dangerous effects when used with Mayzent. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, Flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.
Before you take Mayzent, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine. You may need to receive the vaccine and then wait 1 month before taking Mayzent.
To make sure this medicine is safe for you, tell your doctor if you have ever had::
Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.
Siponimod may harm an unborn baby. Use effective birth control while using Mayzent and for at least 10 days after your last dose. Tell your doctor if you become pregnant .
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of siponimod on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
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How to use Mayzent
Usual Adult Dose for Multiple Sclerosis:
CYP450 2C9 Genotype *1/*1, *1/*2, or *2/*2: -Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4, then 1.25 mg orally once daily on Day 5 -Maintenance dose: 2 mg orally once daily beginning on Day 6 NOTE: Use a starter pack for patients who will be titrated to the 2 mg maintenance dose. CYP450 2C9 Genotype *1/*3 or *2/*3: -Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4 -Maintenance dose: 1 mg orally once daily beginning on Day 5 NOTE: Do not use the starter pack for patients who will be titrated to the 1 mg maintenance dose. -If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen. Comments: -If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen. -First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree atrioventricular (AV) block, or a history of myocardial infarction or heart failure. -Administer the first dose in a setting equipped to manage symptomatic bradycardia. -Monitor patients for 6 hours after the first dose for bradycardia with hourly pulse and blood pressure measurements. Obtain an ECG in these patients at the end of Day 1. -If any of the following abnormalities are present after 6 hours (even in the absence of symptoms), continue monitoring until the abnormality resolves: the heart rate 6 hours post dose is less than 45 bpm; the heart rate 6 hours post dose is at the lowest value post dose, suggesting that the maximum pharmacodynamic effect on the heart may not have occurred; the ECG 6 hours post dose shows new onset second-degree or higher AV block. -If post dose symptomatic bradycardia, bradyarrhythmia, or conduction related symptoms occur, or if ECG 6 hours post dose shows new onset second degree or higher AV block or QTc greater than or equal to 500 msec, initiate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no treatment is required. If treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose. -After the initial titration is complete, if treatment is interrupted for 4 or more consecutive daily doses, reinitiate therapy with Day 1 of the titration regimen; also complete first-dose monitoring in patients for whom it is recommended. Use: For relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults
Warnings
You should not use Mayzent if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), or if you've recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.
Mayzent can slow your heart rate when you start taking it. You may receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may need to restart taking this medicine under medical observation.
You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, or problems with coordination, thought, vision, or muscle movement. Your risk of infection could last for 3 to 4 weeks after you stop taking this medicine.
You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking Mayzent, which may occur 1 to 4 months after your first dose.
You should not use Mayzent if you have a specific genotype. Your doctor will perform tests to make sure this medicine is the right treatment for you.
What other drugs will affect Mayzent
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Siponimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Siponimod can have long lasting effects on your body, especially on your immune system. For 3 or 4 weeks after your last dose, tell any doctor who treats you that you have used Mayzent.
Tell your doctor about all your current medicines. Many drugs can interact with siponimod, especially:
This list is not complete and many other drugs may interact with siponimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Disclaimer
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