BOXED WARNING: Serious Liver Injury

Acute serious liver injury can occur with ITVISMA. Hepatotoxicity, with elevated alanine transaminase (ALT) and/or aspartate transaminase (AST) levels, has occurred with ITVISMA. Patients with preexisting hepatic impairment or acute hepatic viral infection may be at higher risk of liver injury. To mitigate potential aminotransferase elevations, administer systemic corticosteroid before and after ITVISMA injection. Prior to ITVISMA injection, assess liver function by clinical examination and laboratory testing. Continue to monitor liver function for at least 3 months after ITVISMA administration, and at other times as clinically indicated. In case hepatic injury is suspected, further testing is recommended. Promptly consult with a gastroenterologist or hepatologist, as necessary.

WARNINGS AND PRECAUTIONS

Thrombocytopenia

Transient decreases in platelet counts were observed within the first week after ITVISMA administration. Monitor platelet counts before ITVISMA injection and on a regular basis afterwards until platelet counts return to baseline.

Peripheral Sensory Neuropathy

Peripheral sensory neuropathy has occurred with ITVISMA administration with onset seen at approximately 3 weeks post-injection in clinical studies. Consider complete neurologic evaluation and other testing and/or symptom management based on the patient’s clinical presentation.

Thrombotic Microangiopathy

Thrombotic microangiopathy (TMA) may occur with ITVISMA administration and can result in life-threatening or fatal outcomes. Monitor platelet counts on a regular basis following ITVISMA injection, as well as signs and symptoms of TMA. Consult a hematologist and/or nephrologist immediately to manage TMA as clinically indicated.

Elevated Cardiac Troponin I

Increases in cardiac troponin I levels have occurred following ITVISMA administration. Consider cardiac evaluation after ITVISMA administration and consult a cardiologist as needed.

AAV Vector Integration and Risk of Tumorigenicity

There is a theoretical risk of tumorigenicity due to integration of AAV vector DNA into the genome. The clinical relevance of individual integration events is unknown, but it is acknowledged that individual integration events could potentially contribute to a risk of tumorigenicity. Report cases of tumor development in patients who received ITVISMA to Novartis Gene Therapies, Inc. at 1-833-828-3947.

ADVERSE EVENTS

The most common adverse reactions that occurred in ≥2% of patients treated with ITVISMA were upper respiratory tract infection, pyrexia, upper gastrointestinal symptoms, hepatic enzymes increased, headache, dizziness, pain in extremity, thrombocytopenia, and sensory disturbance.

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