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The following information outlines crucial safety considerations and warnings for the use of Ponvory (ponesimod). Please review these points carefully and consult your healthcare provider with any questions or concerns.

• Infection Risk: Ponvory (ponesimod) may lower lymphocyte levels, increasing susceptibility to infections such as herpes, chickenpox, meningitis, and progressive multifocal leukoencephalopathy. A blood test will be conducted to check lymphocyte levels before starting treatment. If you have an existing infection, it is advisable to delay starting Ponvory (ponesimod) until it resolves. Notify your healthcare provider immediately if you develop any infections during treatment. Lymphocyte levels typically return to normal 1 to 2 weeks after stopping the medication. This risk is heightened for individuals with a weakened immune system or those taking immunosuppressive drugs.

• Cardiovascular Concerns: Ponvory (ponesimod) can temporarily reduce heart rate and affect the heart's electrical system, with a higher risk when beginning treatment. A cardiac evaluation will be performed before initiating the medication. A starter pack is available to gradually increase dosage and minimize heart-related risks. If you have pre-existing heart conditions, your first dose may be administered in a healthcare setting for monitoring. Discuss any heart issues with your provider to weigh the benefits and risks. The risk is increased for those with heart conditions or on heart-affecting drugs.

• Respiratory Issues: Ponvory (ponesimod) may cause lung-related problems affecting breathing, typically within the first month of use. Inform your provider of any history of lung or breathing issues so they can monitor your condition. Report any respiratory difficulties promptly. Individuals with pulmonary fibrosis, asthma, or COPD are at greater risk.

• Liver Function: Liver issues may arise within three months of starting Ponvory (ponesimod). Liver function tests will be performed prior to beginning treatment if not done in the last six months. Discontinuation may be necessary if liver damage occurs. Report symptoms such as nausea, vomiting, abdominal pain, fatigue, anorexia, rash, jaundice, or dark urine to your provider.

• Hypertension: Elevated blood pressure can occur as early as one month into treatment and persist throughout. Regularly monitor your blood pressure and inform your provider of any significant changes.

• Skin Cancer Risk: There may be an increased risk of skin cancer. Regular skin exams are recommended, especially for individuals at higher risk. Notify your provider of any concerning skin lesions. Minimize exposure to sunlight and use protective measures like clothing and sunscreen.

• Pregnancy Risks: Ponvory (ponesimod) can harm an unborn baby. Effective contraception should be used during treatment and for one week after discontinuation.

• Ocular Complications: There is a risk of fluid buildup in the eye's macula, potentially leading to vision changes. An eye exam may be conducted before starting treatment. Report any visual disturbances to your provider, particularly if you have a history of uveitis or diabetes.

• Brain Vessel Concerns: Although rare, similar medications have been associated with posterior reversible encephalopathy syndrome (PRES), which can reverse upon stopping the medication. While not reported with Ponvory (ponesimod), seek immediate medical attention if symptoms such as severe headache, behavioral changes, visual disturbances, confusion, or seizures occur. Cease use if these symptoms arise to prevent more severe complications like stroke or cerebral bleeding.

• Post-Treatment Effects: In rare instances, symptoms may worsen after stopping Ponvory (ponesimod). Maintain regular follow-ups with your provider and report any exacerbation of multiple sclerosis symptoms.

Contraindications for Ponvory (ponesimod) include recent heart attack, chest pain, stroke, or heart failure within the last six months, as well as certain heart rhythm disorders unless a pacemaker is present. Consult your healthcare provider if these conditions apply to you.

Ponesimod is a medication that may cause various side effects, which can range from mild to severe. Common side effects include drowsiness, dizziness, upper respiratory infections, and abnormal liver tests. Some individuals might also experience high blood pressure, urinary tract infections, difficulty breathing, cough, arm and leg pain, sleepiness, fever, elevated C-reactive protein levels indicating inflammation, high cholesterol, and feelings of being off balance or lightheaded.

While these effects are generally mild, it's important to monitor them and consult a healthcare provider if they persist or worsen. Ponesimod can also lead to viral infections, herpes zoster, high potassium levels, low white blood cell count, and eye swelling. These side effects should be discussed with your healthcare provider if they occur.

Serious side effects, though rare, demand immediate medical attention. These include signs of infection such as fever, chills, body aches, nausea, vomiting, and headache with fever. Slow heart rate may manifest as dizziness, shortness of breath, confusion, or chest pain. Breathing difficulties, liver problems characterized by yellowing skin or eyes, dark urine, and stomach pain, as well as vision changes like blurry or unusually colored vision, also require urgent care.

Additionally, there is a very rare risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML), which can present as clumsiness, balance issues, weakness, or sudden changes in thinking. Allergic reactions, although rare, may include rash, itching, swelling, severe dizziness, or trouble breathing. Always seek immediate medical help if these severe symptoms arise.