ALTUVIIIO® Safety | Sanofi

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.

See how ALTUVIIIO performed

ALTUVIIIO has efficacy data in the prophylaxis, on-demand, and perioperative settings for children.

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Safety from the pediatric study

Find out more about the trial with the ALTUVIIIO safety profile in pediatric patients.

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Indication

ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

Routine prophylaxis to reduce the frequency of bleeding episodes
On-demand treatment & control of bleeding episodes
Perioperative management of bleeding

Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

Important Safety Information

Contraindications

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

Warnings and Precautions

Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
Formation of neutralizing antibodies (inhibitors) to Factor VIII are possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.

Adverse Reactions

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

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IndicationImportant Safety Information

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.

Adult & Adolescent Study - Safety

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

Hypersensitivity reactions in XTEND-12

Adverse reactions with frequency of >10% reported2

Pooled safety data*: Adverse reactions with frequency of ≥3% reported for ALTUVIIIO in the Phase 3 trials2