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The following information outlines important safety warnings associated with the use of Zeposia (ozanimod). It is essential to review these details and discuss any concerns with your healthcare provider.

• Risk of Serious Infections: Zeposia may weaken your immune system, increasing the risk of severe infections. Ensure your vaccinations are current before starting treatment. Contact your healthcare provider if you experience infection symptoms like fever, chills, cough, breathing difficulties, or diarrhea. You may need to pause the medication to allow your body to combat the infection. This risk is higher if you have chronic or recurrent infections, are over 65, have other conditions that elevate infection risk, or are on immune-suppressing medications.

• Progressive Multifocal Leukoencephalopathy (PML): There is a risk of developing PML, a potentially fatal brain infection caused by the JC virus. Seek immediate medical attention and testing for PML if you experience weakness, clumsiness, personality changes, vision issues, or memory problems. The risk is higher in individuals with weakened immune systems or those taking immunosuppressants.

• Slow Heart Rate: Zeposia can cause a temporary decrease in heart rate, particularly with the first dose. Although serious heart block has not been reported in studies, caution is advised. This risk is increased if you take other medications affecting heart rate, have a history of heart issues, or are restarting Zeposia after a break.

• High Blood Pressure: The medication may raise blood pressure, even at standard doses. Consult your provider to determine if Zeposia is appropriate for you, especially if you have heart conditions or uncontrolled hypertension.

• Liver Damage: Zeposia can elevate liver enzyme levels, signaling potential liver damage. Your provider will conduct regular liver function tests. Report symptoms like nausea, stomach pain, or jaundice to your healthcare provider.

• Pregnancy Risks: Animal studies suggest a risk of harm to unborn babies. Those capable of becoming pregnant should use contraception during treatment and for at least three months after the last dose. Inform your provider immediately if you become or suspect you are pregnant.

• Breathing Issues: Some individuals may experience breathing difficulties within three months of starting treatment. Notify your provider if you experience such symptoms, as routine lung function tests may be necessary.

• Eye Problems: There is a risk of developing macular edema. Regular eye exams are recommended before and during treatment, especially if you have diabetes or a history of uveitis. Report any changes in vision to your provider promptly.

• Posterior Reversible Encephalopathy Syndrome (PRES): Although rare, PRES has been associated with medications like Zeposia. Be vigilant for symptoms such as sudden headaches, seizures, unconsciousness, or vision/behavior changes, and contact your provider immediately.

Contraindications: Do not use Zeposia if you have had a recent heart attack, unexpected chest pain, stroke, mini-stroke, or severe heart failure within the last six months. Avoid use if you have certain heart rate or rhythm disorders unless you have a pacemaker, have untreated severe sleep apnea, or are taking monoamine oxidase inhibitors (MAOIs). Always consult your healthcare provider if any of these conditions apply to you.

When taking this medication, some individuals may experience mild side effects such as back pain, dizziness, or lightheadedness. These symptoms are often manageable, but if they persist or worsen, consult your healthcare provider. To minimize dizziness or lightheadedness, rise slowly from sitting or lying down. Be aware that this medication can also cause an increase in blood pressure, so regular monitoring is advised.

In some cases, more concerning side effects may occur, including serious infections, marked by symptoms like a persistent sore throat, cough, fever, or difficulty breathing. Additionally, there is a risk of a rare brain infection known as progressive multifocal leukoencephalopathy (PML), which may present as clumsiness, confusion, or seizures. If any of these symptoms appear, seek immediate medical attention.

Other serious side effects include significant liver problems, characterized by ongoing nausea, loss of appetite, or yellowing of the skin or eyes. The drug may also lead to a dangerously slow heart rate, severe high blood pressure, or a potentially fatal condition called posterior reversible encephalopathy syndrome (PRES), with symptoms such as sudden severe headaches or vision changes. Lastly, although rare, allergic reactions like rash or difficulty breathing require urgent medical care. Always inform your healthcare provider of any side effects experienced.