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.
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 Phase 3 trials
- Monitor all patients for the development of Factor VIII 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 Phase 3 trials
- Discontinue ALTUVIIIO if hypersensitivity reaction occurs and manage symptoms as appropriate
*In the 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.
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.
