Mayzent Starter Pack 12s

Siponimod is a sphingosine 1-phosphate (S1P) receptor modulator. It binds with high affinity to S1P receptors 1 and 5 (S1P1 and S1P5). By binding to S1P1 receptors on lymphocytes, siponimod prevents the egress of lymphocytes from lymph nodes, thereby reducing the number of lymphocytes in peripheral blood. This reduction in circulating lymphocytes is thought to reduce the migration of these cells into the central nervous system (CNS), where they contribute to inflammation and nerve damage in multiple sclerosis.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Allergic Reaction: 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.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Meningitis: Headache with fever, stiff neck, upset stomach, confusion, or sensitivity to light.
Shingles: Pain, itching, or tingling; fever; muscle aches; or a rash with or without blisters.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Skin Cancer: New wart, lump, or skin growth; a sore that bleeds or doesn't heal; a shiny, white, pink, red, or skin-colored bump that bleeds or doesn't heal; or a change in the color or size of a mole.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath or worsening breathing difficulties.
Swelling: Swelling in the arms or legs.
Heart Problems: Slow or abnormal heartbeat, especially after the first dose. People with certain heart conditions will require close monitoring after the first dose.
Confusion or Dizziness: If you feel confused or experience dizziness, slow or abnormal heartbeat, fatigue, or chest pain, contact your doctor immediately.

Additional Warnings:

Macular Edema: An eye problem that can cause lasting vision loss, especially in people with diabetes or a history of uveitis. If you experience light sensitivity, abnormal colors, blurriness, shadows, or a blind spot in your vision, 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 immediately if you experience chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on one side of your body; trouble speaking or thinking; changes in balance or vision; shortness of breath; or swelling, warmth, or pain in the leg or arm.
Posterior Reversible Encephalopathy Syndrome (PRES): A rare and potentially life-threatening brain problem. Contact your doctor immediately if you experience confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headache.
Progressive Multifocal Leukoencephalopathy (PML): A severe brain problem that can cause disability or be life-threatening. If you experience confusion, memory problems, depression, changes in behavior, uneven strength, trouble speaking or thinking, changes in balance or vision, contact your doctor right away.

Common Side Effects:

Dizziness or headache
Upset stomach
Diarrhea
* Pain in arms or legs

If these side effects bother you or don't go away, contact your doctor. This is not a comprehensive list of all possible side effects. If you have questions or concerns, discuss them with your doctor.

Reporting Side Effects:

You can report side effects to the FDA at 1-800-332-1088 or online at 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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Your CYP2C9 gene type, specifically if you have the CYP2C93/3 gene variant. If you are unsure about your gene type, discuss this with your doctor, as testing may be required before starting the medication.
A history of certain heart conditions, including:
+ Abnormal heart rhythms (heart block, sick sinus syndrome, slow heartbeat, or long QT interval on an electrocardiogram)
+ Chest pain (angina)
+ Heart attack
+ Heart failure
+ Brain blood vessel disease (such as transient ischemic attack or stroke)
+ High blood pressure
+ Sleep apnea
The presence of an active infection
Recent vaccination with the varicella (chickenpox) vaccine within the past month
Recent administration of a live vaccine
Current light therapy treatment; consult your doctor to discuss potential interactions
Previous treatment with alemtuzumab, beta interferon, or glatiramer
Concurrent use of certain medications, including:
+ Carbamazepine
+ Efavirenz
+ Fluconazole
+ Modafinil
+ Rifampin
Use of medications that can cause a slow heartbeat, prolong the QT interval, or suppress the immune system. There are many medications with these effects; consult your doctor or pharmacist if you are unsure.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications
Natural products
Vitamins
Health problems

Do not start, stop, or change the dosage of any medication without first consulting your doctor to verify the safety of combining this medication with your other treatments and health conditions.

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 periodic eye and skin exams as directed by your doctor.

Monitoring your blood pressure is crucial while taking this drug, as it may cause high blood pressure. Your doctor will advise you on how often to have your blood pressure checked.

In some cases, your doctor may order an MRI scan before starting this medication. If you have not had chickenpox or received the chickenpox vaccine, discuss this with your doctor.

While taking this drug and for 3 to 4 weeks after your last dose, you may be more susceptible to 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 vaccines while taking this medication and for at least 4 weeks after stopping it, consult with your doctor. The use of this drug 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 drug, contact your doctor immediately. Do not discontinue taking 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 outdoors.

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

This medication may harm an unborn baby if taken during pregnancy. If you may become pregnant, use effective birth control while taking this drug 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., rifampin, carbamazepine, phenytoin, phenobarbital)
• CYP2C9 *3/*3 genotype

• Strong CYP2C9 inhibitors (e.g., fluconazole, amiodarone, miconazole)
• Moderate/strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
• Antiarrhythmics (Class IA and III, e.g., quinidine, procainamide, amiodarone, sotalol)
• Beta-blockers (e.g., atenolol, metoprolol, propranolol)
• Calcium channel blockers that slow heart rate (e.g., diltiazem, verapamil)
• Other immunosuppressants (e.g., natalizumab, alemtuzumab, ocrelizumab, interferon beta, glatiramer acetate, mitoxantrone, teriflunomide, dimethyl fumarate, corticosteroids)
• Live attenuated vaccines

• CYP2C9 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - dose adjustment may be needed for CYP2C9 *1/*1, *1/*2, *2/*2 genotypes
• CYP3A4 inducers (e.g., efavirenz, etravirine, modafinil)

• Not specifically listed as minor, but caution with any drug affecting heart rate or immune system.

• Signs/symptoms of infection (fever, chills, body aches, fatigue)
• Bradycardia or symptoms of bradycardia (dizziness, lightheadedness, syncope)
• Symptoms of macular edema (blurred vision, shadows, central vision loss)
• Symptoms of liver injury (unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice)
• Symptoms of Posterior Reversible Encephalopathy Syndrome (PRES) (sudden severe headache, confusion, seizures, visual disturbances)
• Symptoms of Progressive Multifocal Leukoencephalopathy (PML) (new or worsening neurological symptoms, cognitive or behavioral changes)
• Symptoms of respiratory issues (dyspnea, cough)

Contraindicated in pregnancy. Based on animal studies, siponimod can cause fetal harm. A negative pregnancy test is required before initiation, and effective contraception must be used during treatment and for at least 10 days after the last dose.

Contraindicated during breastfeeding. Siponimod is excreted in animal milk, and due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for 10 days after the last dose.

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

Use with caution in patients 65 years of age and older due to increased risk of adverse reactions, particularly infections. Dose adjustment is not generally needed based on age alone, but individual patient factors should be considered.

• CYP2C9 genotyping is mandatory before initiating siponimod to determine the appropriate dose and identify patients for whom it is contraindicated (CYP2C9 *3/*3 genotype).
• The starter pack is crucial for gradual dose escalation to mitigate the risk of first-dose bradycardia and AV block. First-dose cardiac monitoring is required for certain patients.
• Patients must be vaccinated against VZV if seronegative prior to initiation, and live attenuated vaccines should be avoided during and for 4 weeks after treatment.
• Siponimod has a long half-life; its effects on lymphocyte counts and potential for adverse events can persist for up to 10 days after discontinuation.
• Educate patients thoroughly on the importance of contraception and the risks of pregnancy.
• Monitor for signs of infection, macular edema, and liver injury throughout treatment.

• Fingolimod (Gilenya)
• Ozanimod (Zeposia)
• Ponesimod (Ponvory)
• Natalizumab (Tysabri)
• Ocrelizumab (Ocrevus)
• Alemtuzumab (Lemtrada)
• Dimethyl fumarate (Tecfidera)
• Teriflunomide (Aubagio)
• Glatiramer acetate (Copaxone)
• Interferon beta preparations (e.g., Avonex, Betaseron, Rebif)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, 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, we encourage you to discuss them with 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 quantity, and the time it occurred.