Mayzent 1mg Tablets

Siponimod is a sphingosine 1-phosphate (S1P) receptor modulator. It binds with high affinity to S1P receptor subtypes 1 (S1P1) and 5 (S1P5). By acting as a functional antagonist at S1P1 receptors on lymphocytes, siponimod prevents the egress of lymphocytes from lymphoid organs (e.g., lymph nodes, thymus), leading to a reduction in the number of lymphocytes in peripheral blood. This reduction in circulating lymphocytes, particularly T and B cells, is thought to reduce the inflammatory response and subsequent damage to the central nervous system (CNS) in multiple sclerosis.

Urgent Side Effects: Seek Medical Help Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or wounds that won't heal.
Meningitis: Headache with fever, stiff neck, nausea, confusion, or sensitivity to light.
Shingles: Pain, itching, or tingling; fever; muscle aches; or rash (with or without blisters).
Liver problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellow skin and eyes.
Skin cancer: New warts, lumps, or skin growths; bleeding or non-healing sores; shiny, white, pink, red, or skin-colored bumps that bleed or don't heal; or changes in mole color or size.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Breathing difficulties: Shortness of breath or worsening breathing problems.
Swelling: Swelling in the arms or legs.
Heart problems: Slow or abnormal heartbeat, especially after the first dose. People with pre-existing heart conditions will require close monitoring.
Confusion or dizziness: If you experience confusion, dizziness, slow or abnormal heartbeat, fatigue, or chest pain, contact your doctor immediately.

Additional Warnings

Macular edema: An eye problem that can lead to permanent vision loss, especially in people with diabetes or a history of uveitis. If you notice light sensitivity, abnormal colors, blurriness, shadows, or blind spots, contact your doctor right away.
Blood vessel problems: Rarely, this medication can cause strokes, blood clots in the lungs, or heart attacks. Seek medical help if you experience chest, arm, back, neck, or jaw pain; coughing up blood; numbness or weakness on one side of the body; speech or thinking difficulties; balance changes; vision changes; shortness of breath; or swelling, warmth, or pain in the legs or arms.
Posterior reversible encephalopathy syndrome (PRES): A rare but potentially life-threatening brain problem. Contact your doctor if you experience confusion, decreased alertness, vision changes, seizures, or severe headaches.
Progressive multifocal leukoencephalopathy (PML): A severe brain problem that can cause disability or death. If you notice confusion, memory problems, depression, changes in behavior, uneven strength, speech or thinking difficulties, balance changes, or vision changes, contact your doctor immediately.

Common Side Effects

While many people don't experience side effects or only have mild ones, some common side effects include:

Dizziness or headache
Upset stomach
Diarrhea
* Arm or leg pain

If these or any other side effects bother you or persist, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, other drugs, foods, or substances. Describe the allergic reaction and its symptoms.
If you have been tested for the CYP2C93/3 gene type. This test is required before starting the medication. If you are unsure about your gene type, consult your doctor.
A history of certain health problems, including:
+ Abnormal heart rhythms (heart block, sick sinus syndrome, slow heartbeat, long QT on ECG)
+ Chest pain (angina)
+ Heart attack
+ Heart failure
+ Brain blood vessel disease (such as transient ischemic attack [TIA] or stroke)
+ High blood pressure
+ Sleep apnea
If you currently have an infection
If you have received the varicella (chickenpox) vaccine within the past month
If you have recently received a live vaccine
If you are undergoing light therapy, discuss this with your doctor
If you have taken alemtuzumab, beta interferon, or glatiramer
If you are taking any of the following medications: carbamazepine, efavirenz, fluconazole, modafinil, or rifampin
If you are taking or have recently taken medications that can cause a slow heartbeat, prolonged QT interval, or suppress your immune system. There are many medications that can interact with this drug, so it is crucial to ask your doctor or pharmacist if you are unsure.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Your medical history, including any health problems

Do not start, stop, or change the dosage of any medication without consulting your doctor to verify that it is safe to take this medication with your other medications and health conditions. This list is not exhaustive, and it is essential to discuss all potential interactions with your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will require you to undergo regular blood tests and heart function checks. Additionally, you will need to have eye and skin exams as directed by your doctor.

Monitor your blood pressure as instructed by your doctor, as this medication can cause high blood pressure. Before starting treatment, your doctor may order an MRI scan. If you have not had chickenpox or received the chickenpox vaccine, discuss this with your doctor.

While taking this medication and for 3 to 4 weeks after your last dose, you may be at a higher risk of developing infections, some of which can be severe or life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.

Before receiving any vaccinations while taking this medication and for at least 4 weeks after stopping it, consult with your doctor. The use of this medication may increase the risk of infection or reduce the effectiveness of the vaccine.

If you stop taking this medication, your multiple sclerosis (MS) symptoms may return and could be more severe than before or during treatment. If you experience worsening MS symptoms after stopping the medication, contact your doctor immediately. Do not discontinue this medication without first consulting the doctor who prescribed it for you.

There is an increased risk of skin cancer associated with this type of medication. To reduce this risk, limit your exposure to sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing when spending time outdoors.

A specific type of testicular cancer has been reported in patients taking this medication. If you have concerns, discuss them with your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you are of childbearing potential, use effective birth control while taking this medication and for 10 days after your last dose. If you become pregnant, notify your doctor immediately.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.

• Strong CYP2C9 and moderate/strong CYP3A4 inducers (e.g., carbamazepine, rifampin, phenobarbital, phenytoin, St. John's Wort)
• Strong CYP2C9 inhibitors (e.g., fluconazole) in patients with CYP2C9*1/*1 or *1/*3 genotypes (not contraindicated for *2/*2, *2/*3, *3/*3 genotypes, but dose adjustment may be needed for *2/*2 or *1/*2 with fluconazole)
• Live attenuated vaccines (during and for 4 weeks after treatment)

• Antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol) - increased risk of bradycardia and AV block
• QT-prolonging drugs (e.g., Class IA and Class III antiarrhythmics, antipsychotics, macrolide antibiotics) - increased risk of QT prolongation
• Beta-blockers (e.g., atenolol, metoprolol, propranolol) - increased risk of bradycardia and AV block
• Calcium channel blockers that decrease heart rate (e.g., diltiazem, verapamil) - increased risk of bradycardia and AV block
• Other immunosuppressants (e.g., methotrexate, azathioprine, corticosteroids) - increased risk of additive immunosuppression and infection

• Moderate CYP2C9 inhibitors (e.g., amiodarone, fluoxetine, fluvoxamine, miconazole) - may increase siponimod exposure, monitor for adverse effects.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice) - may increase siponimod exposure, monitor for adverse effects.

• Not specifically categorized as minor, but general caution with drugs affecting heart rate or immune system.

• Signs and symptoms of infection (e.g., fever, chills, sore throat, unusual fatigue)
• Bradycardia or symptoms of bradycardia (e.g., dizziness, lightheadedness, syncope, chest pain, shortness of breath)
• Symptoms of liver injury (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice)
• Visual disturbances (e.g., blurred vision, decreased visual acuity, scotoma)
• Symptoms of Posterior Reversible Encephalopathy Syndrome (PRES) (e.g., sudden onset of severe headache, altered mental status, visual disturbances, seizures)
• Symptoms of Progressive Multifocal Leukoencephalopathy (PML) (e.g., progressive weakness, clumsiness, vision changes, cognitive decline)

Siponimod is contraindicated in pregnant women. Based on animal studies, siponimod may cause fetal harm. Women of childbearing potential must have a negative pregnancy test prior to initiating treatment and use effective contraception during treatment and for at least 10 days after the last dose.

It is not known whether siponimod is excreted in human milk. However, siponimod is excreted in the milk of treated animals. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with siponimod and for 10 days after the last dose.

Safety and effectiveness in pediatric patients have not been established. Use is not recommended.

Use with caution in patients 65 years of age and older due to limited clinical experience and potentially increased risk of adverse reactions (e.g., infections, cardiovascular events). Dose adjustment is generally not needed based on age alone, but individual patient factors should be considered.

• Siponimod requires CYP2C9 genotyping prior to initiation to determine the appropriate maintenance dose and identify potential drug interactions.
• First-dose cardiac monitoring (6 hours post-dose) is crucial due to the risk of bradycardia and AV block, especially for patients with pre-existing cardiac conditions or on concomitant medications that lower heart rate.
• Patients should be vaccinated against Varicella Zoster Virus (VZV) if seronegative prior to starting siponimod, as there is an increased risk of herpes zoster infection.
• Macular edema is a known side effect; baseline and routine ophthalmologic exams are recommended, especially for patients with diabetes or a history of uveitis.
• Siponimod can cause a modest increase in blood pressure; monitor regularly.
• Risk of Progressive Multifocal Leukoencephalopathy (PML) and Posterior Reversible Encephalopathy Syndrome (PRES) should be considered if new neurological symptoms arise.
• Rebound disease activity can occur if siponimod is discontinued abruptly, especially if the drug is stopped for reasons other than adverse events.

• Other S1P receptor modulators (e.g., fingolimod, ozanimod, ponesimod)
• Injectable disease-modifying therapies (e.g., interferon beta preparations, glatiramer acetate)
• Oral disease-modifying therapies (e.g., dimethyl fumarate, teriflunomide, cladribine)
• Infusion therapies (e.g., natalizumab, ocrelizumab, alemtuzumab)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.