ALTUVIIIO: Demonstrated safety profile in XTEND-Kids trial1
ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its components.
No Factor VIII inhibitors were detected
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
- 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% reported for ALTUVIIIO in the XTEND-Kids trial1
| Adverse Reactions | Percentage of Patients (n) (N=74) |
|---|---|
| Pyrexia | 12.2% (9) |
Pooled safety data: Adverse reactions with frequency of ≥3% reported for ALTUVIIIO in the Phase 3 trials1*
| 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) |
* Phase 3 clinical trials include XTEND-1 and XTEND-Kids.
† 233 subjects across the adult and adolescent and pediatric studies.1
Indication
Reference: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA.
