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The following is crucial safety and warning information regarding the use of Mayzent (siponimod). Please read this carefully and consult your healthcare provider if you have any questions or concerns.

• Infections: Mayzent (siponimod) may reduce your white blood cell count, impacting your immune system and increasing your risk of bacterial, viral, and fungal infections, which can be severe. Ensure all vaccinations are current before starting treatment. If you develop an infection, your healthcare provider may advise discontinuing the medication to allow your body to fight the infection. Notify your provider promptly if you experience symptoms such as fever, cough, breathing difficulties, diarrhea, or chills. Higher risk is associated with having active, chronic, or recurring infections, other conditions that increase infection risk, or taking immunosuppressive medications.

• Eye Problems: Some individuals have developed a condition known as macular edema while on Mayzent (siponimod), typically within the first four months of treatment. Your healthcare provider will conduct eye exams before and during treatment. Report any blurry vision or vision changes immediately. Increased risk factors include diabetes and a history of eye inflammation (uveitis).

• Slow Heart Rate: Mayzent (siponimod) may temporarily reduce your heart rate when beginning treatment, usually within 24 hours after a dose during the initial phase. Heart rate generally normalizes within 10 days. Inform your provider of any heart conditions or medications affecting heart rate. Monitoring for at least six hours after the first dose may be required. Seek medical attention if you experience dizziness, fatigue, weakness, fainting, breathing difficulties, or chest pain. Increased risk may occur with concurrent medications affecting heart rate, a history of heart issues, or when starting or restarting Mayzent (siponimod).

• Breathing Problems: This medication can cause respiratory issues, potentially as soon as three months after starting treatment. Inform your provider if you experience any breathing difficulties. Routine lung function tests may be necessary.

• Liver Damage: Mayzent (siponimod) can occasionally cause liver injury. Inform your provider about any pre-existing liver conditions. Blood tests to assess liver function are required before and during treatment. Discontinuation may be advised if liver test results are abnormal. Seek medical attention for symptoms like appetite loss, dark urine, stomach pain, or yellowing of the eyes or skin.

• Risk of Skin Cancer: There is a rare risk of certain types of skin cancer associated with Mayzent (siponimod). Regular skin exams are recommended. Use protective clothing and sunscreen outdoors. Report any new moles or skin changes to your provider.

• Harm to Unborn Babies: Animal studies suggest potential harm to unborn babies if Mayzent (siponimod) is taken during pregnancy. Women who can conceive should use effective contraception during treatment and for at least 10 days after the last dose. Notify your provider immediately if you become pregnant or suspect pregnancy.

• Posterior Reversible Encephalopathy Syndrome (PRES): Though no cases have been reported with Mayzent (siponimod), similar medications have been associated with this rare brain condition, which can lead to serious complications like stroke. Contact your provider immediately if you experience sudden headaches, seizures, loss of consciousness, or vision changes.

Contraindications: Mayzent (siponimod) is contraindicated in individuals with certain genetic profiles that prevent the medication's breakdown, recent heart attacks, chest pain, strokes, "mini-strokes," heart failure within the last six months, and specific heart rhythm issues unless a functional pacemaker is present. Discuss any of these conditions with your healthcare provider before starting treatment.

When taking this medication, some common side effects may include headaches, swelling in the arms or legs, dizziness, and nausea. These effects are generally mild and often temporary, but if they persist or worsen, it is important to inform your healthcare provider. Additionally, you might experience a slow heartbeat, particularly at the beginning of treatment, and regular monitoring may be necessary.

Other side effects reported include elevated blood pressure, increased liver enzyme levels, and instances of falling. There is also a potential risk for infections characterized by symptoms such as fever, cough, or difficulty breathing. Be vigilant about any persistent cold or flu-like symptoms, as this medication can weaken your immune system, increasing susceptibility to infections for a short period after stopping the drug.

More severe side effects, though rare, require immediate medical attention. These include signs of liver problems such as persistent nausea, abdominal pain, or yellowing of the skin or eyes. Skin changes could indicate an increased risk of skin cancer. Furthermore, the risk of a serious brain infection known as PML exists, with symptoms resembling a worsening MS attack, such as difficulty with balance, confusion, or changes in vision.

Serious heart-related issues like very slow or irregular heartbeat, severe dizziness, or fainting should not be ignored. Seek urgent medical care if you experience these symptoms. Allergic reactions, although very rare, may present as rash, swelling, or trouble breathing, and require immediate attention. Always keep your healthcare provider informed of any new or unusual symptoms you experience while on this medication.