ALTUVIIIO has an established safety profile in the XTEND-1 trial1
ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its components.2
No Factor VIII inhibitors were detected2
All patients were monitored for neutralizing antibodies (inhibitors) to Factor VIII in the clinical programs.
- No patients developed neutralizing antibodies to Factor VIII
- Formation of neutralizing antibodies (inhibitors) to Factor VIII is possible following administration of ALTUVIIIO. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests
Hypersensitivity reactions in XTEND-12
- No adverse allergic-type hypersensitivity reactions, including anaphylaxis, were reported
- Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with ALTUVIIIO
Adverse reactions with frequency of >10% reported2
| Adverse Reactions | Percentage of Subjects (n) (N=159) |
| Headache | 20.1% (32) |
| Arthralgia | 16.4% (26) |
Pooled safety data*: Adverse reactions with frequency of ≥3% reported for ALTUVIIIO in the Phase 3 trials2
| Adverse Reactions | Percentage of Patients (n) (N=233*) |
| Headache | 15% (35) |
| Arthralgia | 13% (31) |
| Pain in extremity | 4% (10) |
| Pyrexia | 4% (10) |
| Back pain | 4% (9) |
| Vomiting | 3% (7) |
* 233 patients across the adult and adolescent, and pediatric studies.
Indication
References: 1. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318. 2. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA.
