Mayzent

What is Mayzent?

Mayzent (siponimod), also known as sphingosine-l-phosphate receptor moderators, belongs to this class of drugs. Mayzent helps to slow down the progression of disability and prevent episodes of symptoms in adults with relapsing-remitting MS (a disease where the nerves are not functioning properly, causing weakness, numbness, and loss of muscle coordination, as well as problems with vision, bladder control, and speech). Mayzent reduces the activity of immune cells, which may cause nerve damage. Mayzent can only be used if you possess a certain genotype. This genotype will be tested by your doctor.

Warnings

Do not use Mayzent for a serious heart condition like "sick sinus" syndrome or "AV block" or if a recent heart rhythm disorder or heart attack has occurred. Mayzent may slow down your heart rate as soon as you begin taking it. Your first dose may be administered in an environment where your heart rate can be monitored. You may have to start taking this medication again under medical supervision if you miss a dose. You could get more infections, including serious or deadly infections. Contact your doctor immediately if you experience a high fever or other symptoms such as chills, aches, fatigue, nausea, or confusion. You may experience a risk of infection for up to four weeks after stopping this medication. Mayzent may cause increased sensitivity to light, blurred or clouded vision, eye pain, or a blind spot in the middle of your vision. You may also experience an unusual color or vision while taking Mayzent. These symptoms may appear 1 to 4 months after your initial dose. Mayzent should not be used if you have a certain genotype. Your doctor will run tests to ensure that this medication is right for you.

Before you take this drug

Mayzent should not be used if:

• A specific genotype;
• "Av block" (second or third degree);
• If you have an abnormal or irregular heart rhythm (unless your pacemaker is installed),
• Recent heart problems (within 6 months) include heart failure, heart attacks, strokes,mini-strokes' or tias, chest pain (unstable angina), and other serious heart conditions.

Mayzent can interact with some heart rhythm medicines that may cause dangerous or unwanted effects. If you are also taking amiodarone or disopyramide (or any of the following), your doctor may alter your treatment plan. Tell your doctor before taking mayzent if this is the first time you've had chickenpox or if it's been a while since you received the varicella vaccination. It may be necessary to get the varicella vaccine, then wait a month before taking mayzent.

Tell your doctor about any of the following to ensure that this medicine will be safe for you:

• Weak immune system (caused either by illness or certain medications);
• Fever, active, or chronic infection
• High blood pressure
• Slow or irregular heartbeats
• Heart problems, heart attacks, strokes, or chest pains;
• Asthma or sleep apnea (breathing stops while sleeping) or other breathing disorders;
• Skin cancer (melanoma);
• Uveitis is a condition of the eye.
• Diabetes;
• Liver disease

Tell your doctor whether you've recently received a vaccination or are scheduled to get one. Siponimod can harm an unborn child. Use effective contraception during the use of Mayzent and for 10 days following your last dose. Inform your doctor immediately if you fall pregnant. You may find your name on a registry if you're pregnant to track siponimod's effects on the baby. Ask your doctor if you can safely breastfeed while taking this medication.

How to take Mayzent?

Follow all instructions listed on your prescription label, as well as read any medication guides or instruction sheets provided with it.Please read the instructions on your prescription label. You will gradually increase your dose during the first five to six days of taking Mayzent. Mayzent may require medical testing before you begin taking it, including blood tests, ECGs, eye tests, liver and heart function tests, as well as a skin examination. Siponimod may slow down your heart rate as soon as you begin taking it. Your first dose may be administered in a medical environment. You may need to have your blood pressure and heartbeat constantly monitored for 6 hours following the first Mayzent dose. Siponimod can affect your immune system. Your body could fall prey to further infections, even potentially life-threatening ones. You will be examined by your doctor on a regular schedule. You may be at risk for infection up to four weeks after stopping this medication. Your MS symptoms can return if you stop taking Mayzent. Some people have experienced worse MS symptoms after stopping Mayzent. Do not restart taking Mayzent without consulting your doctor. If you are restarting this medication, you may be required to undergo medical supervision. Mayzen tablets should not be crushed, broken, or split. Swallow the entire tablet. Mayzent can be taken with or without food. Do not freeze unopened tablets. Store Mayzent at room temperature, away from moisture or heat, after opening. When you stop taking the medicine, be on the lookout for symptoms of MS worsening. Call your doctor immediately if new or worsening signs and symptoms occur.

Details on dosage

Adult dose for multiple sclerosis:
CYP450 Genotype *1/*1, or *2/*2
-Titration regimen: 0.25 mg oral once daily for the first two days, then 0.5mg orally daily for day 3, 0.75mg orally daily on day 4, and 1.25mg orally daily on day 5.
Maintenance dosage: 2 mg once daily orally, starting on day 6.
NOTE: A starter pack is recommended for patients who are titrating to the maintenance dose of 2 mg.
CYP450 Genotype *1/*3 and *2/*3
-Titration regimen: 0.25 mg once daily orally on days 1 and 2. Then 0.5 mg once daily orally on day 3. Finally, 0.75 mg once daily, orally, on day 4.
Maintenance dosage: 1 mg once daily orally, starting on day 5.
Note: Do not give the starter pack to patients who are going to be titrated up to the maintenance dose of 1 mg.
If a titration dosage is missed for longer than 24 hours, the therapy must be restarted on Day 1 of titration.
Comments:
If a titration dosage is missed for longer than 24 hours, the therapy must be restarted on Day 1 of titration.
Patients with a history of myocardial ischemia or heart failure, as well as sinus bradycardia or first- or second-degree atrioventricular block, are recommended to monitor their dose.
administer the first dose to a patient in an environment equipped to treat bradycardia symptoms.
Monitor patients 6 hours after the first dose with blood pressure and pulse measurements every hour. At the end of day 1, obtain an ECG from these patients.
If any of the following abnormalities occur after 6 hours, even in the absence of symptoms, continue monitoring until the abnormality resolves. The heart rate is less than 45 bpm 6 hours after the dose; the heart is at its lowest value. 6 hours after the dose, suggesting that maximum pharmacodynamic effects on the heart have not occurred; ECG is 6 hours.
The dose indicates a new onset of AV block at the second or higher degree.
If symptoms persist after the dose, start management. Start continuous ECG monitoring. Continue monitoring until symptoms resolve, if treatment is not required. If treatment is needed, continue monitoring over night and repeat the 6-hour monitoring following the second dose.
After the initial titration, if the treatment has been interrupted for four or more consecutive doses per day, restart the therapy on Day 1 of the regimen. Complete the first-dose monitoring for patients who are recommended.
Use: relapsing forms, including the clinically isolated syndrome (CIS), relapsing remitting disease, and secondary progressive active disease in adults.

What happens if I miss the dose?

For instructions, call your doctor. You may be required to take the next dose in a medical environment if you missed one or more doses of your first or maintenance doses. Refill your prescription before you run out.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Do not receive a vaccination without consulting your doctor. Mayzent may affect the effectiveness of the vaccine. You may develop an infection if you receive a "live vaccine" while taking Mayzent. Live vaccines are measles (MMR), rubella, typhoid (chickenpox), varicella, zoster, shingles (shingles), nasal flu (influenza), and rotavirus (typhoid). You should stop taking Mayzent at least one week before you receive the vaccine. You should wait 4 weeks after receiving the vaccination before taking Mayzent. Do not stop taking Mayzent without consulting your doctor. Ask your doctor before stopping or starting this medication for any reason.

Side effects of Mayzent

If you experience any of the following symptoms of an allergic reaction: difficulty breathing, hives, swelling of the face, lips, throat, or tongue,

Siponimod may cause serious side effects. If you experience:

• Slow or irregular heartbeats
• Vision problems, such as blurred vision, eye discomfort, a blind spot in the middle of your vision, or a strange color (these problems can occur between 1 and 4 months after starting Mayzent);
• Headache confusion, mental state change;
• A seizure;
• Sores in the mouth or throat; cold sores Sores on the genital area
• Skin changes include moles that have changed in size or color.
• Shortness of breath
• Liver disease: nausea, vomiting, upper stomach discomfort, fatigue, loss of appetite, and dark urine; jaundice
• Meningitis symptoms include fever, body aches, and a feeling of tiredness. Other symptoms include nausea, vomiting, neck stiffness, and increased sensitivity to light.

Common Mayzent Side Effects

• Headache;
• Increased blood pressure
• Abnormal liver function tests

There may be other side effects.Call your physician if experiencing side effects. For guidance or medical advice regarding adverse reactions. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

At times it can be dangerous to take certain medicines together. Certain drugs could interfere with one another and alter blood levels causing side effects or less effectiveness of certain treatments. Siponimod may cause serious heart problems. You may have a higher risk if you use other medications for HIV, cancer, depression,  or mental illness. Siponimod has a long-lasting effect on your body and your immune system. Tell any doctor you see for 3 to 4 weeks that you used Mayzent.

Inform your doctor of all the medications you are taking. Siponimod can be affected by many drugs, including:

• Drugs that suppress the immune system, such as steroids, cancer medicines, and drugs to prevent transplant rejection,
• Other medicines to treat MS symptoms
• Heart medications are available in many different forms.

This list does not include all the drugs that may interact with siponimod. These include prescription and over-the-counter medicines, vitamins, and herbal products; this list does not represent all possible drug interactions.