IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about ITVISMA?<ul><li>ITVISMA can increase liver enzyme levels and cause hepatotoxicity.</li><li>Patients will receive an oral corticosteroid medication before and after ITVISMA injection and will undergo regular blood tests to monitor liver function.</li><li>Patients and caregivers should contact the patient’s doctor immediately if the patient’s skin and/or whites of the eyes become yellowish, if the patient misses a dose of corticosteroid or vomits it up, or if the patient experiences a decrease in alertness.</li></ul>What should I watch for before and after injection with ITVISMA?<ul><li>Infections before or after ITVISMA injection can lead to more serious complications. Patients, caregivers, and close contacts of the patient should follow infection prevention procedures. Patients and caregivers should contact the patient’s doctor immediately if the patient experiences any signs of a possible infection such as coughing, wheezing, sneezing, runny nose, sore throat, or fever.</li><li>Decreased platelet counts could occur following injection with ITVISMA. Seek immediate medical attention if the patient experiences unexpected bleeding or bruising.</li><li>Peripheral sensory neuropathy has occurred with ITVISMA administration. Patients and caregivers should contact the patient’s doctor right away if the patient experiences numbness, tingling, prickling, or pain in the arms, hands, legs, and/or feet.</li><li>Decreased blood platelet and red blood cell counts, sudden kidney change, and increased bruising or bleeding, which could be signs of thrombotic microangiopathy (TMA), can occur. Patients and caregivers should seek immediate medical attention if the patient experiences unexpected bruising or bleeding, seizures, or decreased urine output.</li><li>There is a theoretical risk of tumor development with gene therapies such as ITVISMA. Patients and caregivers should contact the patient’s doctor and Novartis Gene Therapies, Inc. at 1-833-828-3947 if a tumor develops.</li></ul>What do I need to know about vaccinations and ITVISMA?<ul><li>Patients and caregivers should consult the patient’s doctor about vaccinations and ITVISMA.</li><li>Patients and caregivers should talk with the patient’s doctor to determine if adjustments to the patient’s vaccination schedule are necessary during corticosteroid use.</li><li>Protection against influenza and respiratory syncytial virus (RSV) is recommended, and vaccination status should be up-to-date prior to ITVISMA administration.</li></ul>What do I need to know about contraception and egg or sperm donation and ITVISMA?<ul><li>Women of childbearing potential should use an effective method of contraception and refrain from egg donation for 6 months following ITVISMA injection.</li><li>Men capable of fathering a child should use a barrier method of contraception and refrain from sperm donation for 3 months following ITVISMA injection.</li></ul>What are the possible or likely side effects of ITVISMA?<ul><li>The most common adverse reactions that occurred in patients treated with ITVISMA were upper respiratory tract infection, fever, upper gastrointestinal symptoms, increased liver enzymes, headache, dizziness, pain in extremity, low platelet counts, and sensory disturbance.</li></ul>The safety information provided here is not comprehensive. Talk to the patient’s doctor about any side effects that bother the patient or that don’t go away.You are encouraged to report suspected side effects by contacting the FDA at <a href="tel:1-800-FDA-1088">1-800-FDA-1088</a> or <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program" target="_blank">www.fda.gov/medwatch</a>, or Novartis Gene Therapies, Inc. at <a href="tel:1-833-828-3947">1-833-828-3947</a>.Please see the Full <a href="https://www.novartis.com/us-en/sites/novartis_us/files/Itvisma.pdf" target="_blank">Prescribing Information</a>.

What is ITVISMA?ITVISMA is a prescription gene therapy used to treat adults and children 2 years of age and older with spinal muscular atrophy (SMA). ITVISMA is given as a one-time intrathecal injection.

INDICATION

What is the most important safety information I should know about ITVISMA?<ul><li>ITVISMA can increase liver enzyme levels and cause hepatotoxicity.</li><li>Patients will receive an oral corticosteroid medication before and after ITVISMA injection and will undergo regular blood tests to monitor liver function.</li><li>Patients and caregivers should contact the patient’s doctor immediately if the patient’s skin and/or whites of the eyes become yellowish, if the patient misses a dose of corticosteroid or vomits it up, or if the patient experiences a decrease in alertness.</li></ul>

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