Adult & Adolescent Study - Safety

ALTUVIIIO has an established safety profile¹

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its components.¹

Factor VIII inhibitors¹

• Inhibitor development is a known risk inherent of factor replacement therapies, including ALTUVIIIO
• Neutralizing anti-Factor VIll antibodies (inhibitors) have been reported following administration of ALTUVIIIO in the postmarketing setting*
• No inhibitors were reported in the XTEND-1 trial
• Monitor all patients for the development of Factor Vlll inhibitors by appropriate clinical observations and laboratory tests

Hypersensitivity reactions¹

• Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ALTUVIIIO in the postmarketing setting*
• No allergic-type hypersensitivity reactions were reported in the XTEND-1 trial
• Discontinue ALTUVIIIO if hypersensitivity reaction occurs and manage symptoms as appropriate

*In a postmarketing setting, reports are derived from a population of uncertain size; therefore, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure.

Safety findings in XTEND-1
Adverse reactions with frequency of >10% reported¹

Pooled safety data^†: Adverse reactions with frequency of ≥3% reported for ALTUVIIIO in the Phase 3 trials¹

^† 233 patients across the adult and adolescent, and pediatric studies.