THE FIRST AND ONLY HEMOPHILIA A
TREATMENT THAT DELIVERS
chart-1
EXPLORE THE DATA
THE FIRST AND ONLY HEMOPHILIA A
TREATMENT THAT DELIVERS
chart-1
EXPLORE THE DATA

Once-weekly ALTUVIIIO is a first-in-class, high-sustained
Factor VIII replacement therapy that provides normal to
near-normal levels (>40%) for most of the week.2,3

ACHIEVE HIGHER
FACTOR VIII LEVELS
WITH ALTUVIIIO

Factor Level icon
Normal to near-normal
Factor VIII levels
for most of the week2

  •  ~4 days of Factor VIII levels above 40% (normal to near-normal range)2*
  •  Factor VIII trough levels of 18%2†
  • Factor VIII clearance has been demonstrated to be higher in patients <18 years, resulting in lower trough levels2

OBSERVE PHARMACOKINETICS
Shield icon
Improved bleed
protection with
once-weekly dosing2

  • Routine prophylaxis (n=128) resulted in a median ABR of 0.0 (Q1, Q3: 0.0-1.0) and a mean ABR of 0.7 (95% CI: 0.5-1.0)2‡
  • Significant improvement in bleed protection in the intrapatient comparison group (n=78): 77% reduction in mean ABR vs prestudy Factor VIII prophylaxis2‡

EXPLORE EFFICACY
Medal icon
Established
safety profile2

  • The most common adverse reactions (≥3%
    of patients) reported in XTEND-1 were headache (21%), arthralgia (16%), and
    back pain (6%)2
  • No Factor VIII inhibitors were detected
    in XTEND-1 and XTEND-Kids2§
  • Formation of inhibitors is possible
    following administration of ALTUVIIIO    2

EXAMINE SAFETY

*Data from the Phase 3 XTEND-1 study in 124 adults (aged 18 and older) receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO. At steady state (Week 26), ALTUVIIIO maintained normal to near-normal Factor VIII activity for a mean (SD) of 97.0 (20.2) hours with once-weekly prophylaxis. PK parameters shown are based on plasma Factor VIII activity measured by the aPTT-based one-stage clotting assay.  2

†Mean trough level observed at Week 52/end of study PK sampling visit for the adult population in the XTEND-1 study (n=124).  2

‡Based on treated bleeds.

§XTEND-Kids data based on an interim analysis.

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ALTUVIIIO has efficacy and safety data in prophylaxis, on-demand, and perioperative settings.

EXPLORE RESULTS

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 is 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.

See full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

ABR=annualized bleed rate; aPTT=activated partial thromboplastin time; IU=international unit; PK=pharmacokinetics; Q1=25th percentile; Q3=75th percentile.

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

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 is 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.

Please see full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

aPTT=activated partial thromboplastin time; PK=pharmacokinetics.

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