Mayzent 2mg Tablets

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 lymphoid organs, leading to a reduction in the number of lymphocytes in peripheral blood. This reduction in circulating lymphocytes is thought to prevent their migration into the central nervous system (CNS), thereby reducing inflammation and neurodegeneration associated with multiple sclerosis.

Serious Side Effects: Seek Medical Attention 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 help 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 Problems: 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. If you experience confusion, dizziness, slow or abnormal heartbeat, fatigue, or chest pain, contact your doctor immediately.

Additional Serious Side Effects:

Macular Edema: An eye problem that can lead to permanent vision loss over time, especially in people with diabetes or a history of uveitis. If you experience sensitivity to light, 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, which can be fatal. Seek medical attention 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. If you experience confusion, decreased alertness, changes in vision, loss of vision, seizures, or a severe headache, contact your doctor right away.
Progressive Multifocal Leukoencephalopathy (PML): A rare and potentially disabling or fatal brain problem that can occur with long-term use of this medication. If you experience confusion, memory problems, depression, changes in behavior, weakness on one side of the body, 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 you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. Not all side effects are listed here. If you have questions about side effects, 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, its components, or other substances. Describe the allergic reaction and its symptoms.
If you have been tested for the CYP2C93/3 gene type, as this may affect your treatment. If you are unsure about your gene type, consult your doctor.
A history of certain heart conditions, including:
+ Abnormal heart rhythms (heart block, sick sinus syndrome, slow heartbeat, or long QT interval on an electrocardiogram [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
Current or recent infections
Receipt of the varicella (chickenpox) vaccine within the past month
Recent administration of a live vaccine
Use of light therapy; 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, prolonged QT interval, or immune system suppression. There are many medications with these effects; consult your doctor or pharmacist if you are unsure.

To ensure your safety, it is crucial to disclose all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

As well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health conditions to determine the safety of this treatment for you.

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 to monitor your health.

Monitor your blood pressure as directed by your doctor, as this medication can cause high blood pressure. 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 medication 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 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 this medication, contact your doctor immediately. Do not discontinue this medication without 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 rare 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 pregnant or plan to become pregnant, 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, consult with your doctor to discuss any potential risks to your baby.

• Strong CYP2C9 and CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort)
• CYP2C9 *3/*3 genotype
• Moderate to severe hepatic impairment (Child-Pugh B or C)
• Patients who have experienced MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure in the last 6 months
• Patients with Mobitz Type II second-degree AV block, third-degree AV block, or sick sinus syndrome (unless patient has a functioning pacemaker)
• Patients with severe untreated sleep apnea
• Concomitant use of strong CYP2C9 inhibitors (e.g., fluconazole) in patients with CYP2C9 *1/*1, *1/*2, or *2/*2 genotype

• Class IA (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs (due to risk of bradycardia and QT prolongation)
• Drugs that prolong the QT interval (e.g., antipsychotics, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones) in patients with risk factors for QT prolongation
• Beta-blockers and other heart rate lowering drugs (e.g., calcium channel blockers like diltiazem, verapamil; ivabradine) - use with caution, monitor heart rate
• Live attenuated vaccines (e.g., MMR, varicella, yellow fever) - avoid during and for 4 weeks after treatment due to increased risk of infection
• Immunosuppressants (e.g., methotrexate, azathioprine, corticosteroids) - increased risk of infection and additive immunosuppressive effects
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) when co-administered with moderate CYP2C9 inhibitors (e.g., amiodarone, fluconazole) in patients with CYP2C9 *1/*1, *1/*2, or *2/*2 genotype

• Moderate CYP2C9 inhibitors (e.g., amiodarone, fluconazole) - may increase siponimod exposure, especially in certain genotypes. Consider dose reduction or alternative.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil) - may increase siponimod exposure.
• CYP2C9 inducers (e.g., modafinil, bosentan) - may decrease siponimod exposure.

• Not specifically listed as minor interactions with clinical significance requiring specific action beyond general caution.

• Signs of infection (fever, chills, sore throat, unusual fatigue)
• Symptoms of progressive multifocal leukoencephalopathy (PML) (new or worsening neurological symptoms, cognitive or behavioral changes)
• Symptoms of macular edema (blurred vision, shadowed vision, central vision loss)
• Symptoms of bradycardia or AV block (dizziness, lightheadedness, palpitations, syncope)
• Symptoms of liver injury (unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice)
• Symptoms of posterior reversible encephalopathy syndrome (PRES) (sudden severe headache, altered mental status, visual disturbances, seizures)
• New or worsening hypertension

Mayzent is contraindicated in pregnancy due to potential for fetal harm based on animal studies. Women of childbearing potential must use effective contraception during treatment and for at least 10 days after the last dose.

Siponimod is excreted in breast milk in animals. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with Mayzent and for 10 days after the last dose.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is not recommended.

Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Use with caution in elderly patients due to potential for increased susceptibility to adverse effects, particularly cardiac effects and infections. No specific dose adjustment is recommended based on age alone, but consider overall health status and comorbidities.

• Always confirm CYP2C9 genotype before initiating siponimod to determine the correct starting and maintenance dose, and to identify patients for whom it is contraindicated (CYP2C9 *3/*3).
• The initial 5-day titration is crucial to mitigate first-dose cardiac effects (bradycardia, AV block). First-dose observation (FDO) for at least 6 hours is required for patients with certain pre-existing cardiac conditions or those at higher risk.
• Patients should be vaccinated against VZV if seronegative prior to starting siponimod, as there is an increased risk of herpes zoster infection.
• Monitor for signs and symptoms of infection, especially serious infections, as siponimod causes a dose-dependent reduction in peripheral lymphocyte count.
• Be vigilant for symptoms of Progressive Multifocal Leukoencephalopathy (PML), a rare but serious brain infection. Any new or worsening neurological symptoms should prompt immediate investigation.
• Macular edema is a known side effect, especially in patients with diabetes or a history of uveitis. Regular ophthalmologic exams are important.
• Rebound disease activity, which can be severe and disabling, has been reported rarely after discontinuation of S1P modulators. Patients should not stop treatment without consulting their physician.
• Siponimod can cause dose-dependent increases in blood pressure; monitor regularly.
• Increased risk of skin malignancies (basal cell carcinoma, squamous cell carcinoma) has been observed with S1P modulators; advise patients on sun protection and regular skin checks.

• Other S1P receptor modulators: Fingolimod (Gilenya), Ozanimod (Zeposia), Ponesimod (Ponvory)
• Injectable DMTs: Interferon beta (e.g., Avonex, Betaseron, Rebif), Glatiramer acetate (e.g., Copaxone, Glatopa)
• Oral DMTs: Dimethyl fumarate (Tecfidera), Diroximel fumarate (Vumerity), Teriflunomide (Aubagio), Cladribine (Mavenclad)
• Infusion DMTs: Natalizumab (Tysabri), Ocrelizumab (Ocrevus), Alemtuzumab (Lemtrada)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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.