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FOR US HEALTHCARE PROFESSIONALS ONLY

 * PATIENT SITE
 * PRESCRIBING INFORMATION
 * MEDICAL INFORMATION

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 * DOSING CALCULATOR
 * CONTACT A REP

FOR US HEALTHCARE PROFESSIONALS ONLY

 * PATIENT SITE
 * PRESCRIBING INFORMATION
 * MEDICAL INFORMATION

sanofi

ABOUT HEMOPHILIA A
PK/MOE
EFFICACY & SAFETY
 * TRIAL DESIGN
 * EFFICACY
 * SAFETY
   

DOSING
 * DOSING REGIMEN
 * DOSING CALCULATOR
   

RESOURCES
 * RESOURCES FOR YOUR PATIENTS
 * HCP RESOURCES
 * CONTACT A REP
   

PRESCRIBING
INFORMATION
MEDICAL
INFORMATION
PATIENT SITE
 * ABOUT HEMOPHILIA A
 * PK/MOE
 * EFFICACY & SAFETY
    * TRIAL DESIGN
    * EFFICACY
    * SAFETY
      

 * DOSING
    * DOSING REGIMEN
    * DOSING CALCULATOR
      

 * RESOURCES
    * RESOURCES FOR YOUR PATIENTS
    * HCP RESOURCES
    * CONTACT A REP
      

 * DOSING CALCULATOR
 * CONTACT A REP

People being active across days of the week
NOW APPROVED

THE FIRST AND ONLY HEMOPHILIA A
TREATMENT THAT DELIVERS


EXPLORE THE DATA
NOW APPROVED

THE FIRST AND ONLY HEMOPHILIA A
TREATMENT THAT DELIVERS


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

NORMAL TO NEAR-NORMAL
FACTOR VIII LEVELS
FOR MOST OF THE WEEK2



 *  ~4 days with mean 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

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)2,4‡
 * Significant improvement in bleed protection in the intrapatient comparison
   group (n=78): 77% reduction in mean ABR vs prestudy Factor VIII prophylaxis2‡



EXPLORE EFFICACY

ESTABLISHED
SAFETY PROFILE2



 * The most common adverse reactions (≥3%
   of patients) reported in XTEND-1 were headache (21%), arthralgia (16%), and
   back pain (6%)2,5
 * No Factor VIII inhibitors were detected
   in XTEND-1 and XTEND-Kids2,5§

 * Formation of inhibitors is possible
   following administration of ALTUVIIIO2



EXAMINE SAFETY

*Data from the Phase 3 XTEND-1 study in 134 adults (aged 18 and older) receiving
a weekly IV infusion of 50 IU/kg ALTUVIIIO. PK parameters shown are based on
plasma Factor VIII activity measured by the aPTT-based one-stage clotting assay.
2,4,5

†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.


SEE HOW ALTUVIIIO PERFORMED IN XTEND -1

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

EXPLORE RESULTS

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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.

See full Prescribing Information.

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

ABR=annualized bleed rate; aPTT=activated partial thromboplastin time;
EHL=extended half-life; IU=International unit; PK=pharmacokinetics; Q=quartile;
SHL=standard half-life.

go to indication and important safety information


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 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.

Please see full Prescribing Information.

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

aPTT=activated partial thromboplastin time; PK=pharmacokinetics.


CONTACT
A REP
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Copay Savings
for ALTUVIIIO*

*Terms and restrictions apply.

References: 1. Data on file, March 2022. 2. ALTUVIIIO Prescribing Information.
Bioverativ Therapeutics Inc. Waltham, MA. 3. Chhabra ES, et al. Blood.
2020;135(17):1484-1496. 4. Data on file, June 2022. 5. von Drygalski A, et al. N
Engl J Med. 2023;388:310-318.

This site is intended for US healthcare
professionals only.

© 2023 Genzyme Corporation. All rights
reserved. ALTUVIIIO, MyALTUVIIIO, XTEN,
and Sanofi are trademarks of Sanofi or an
affiliate. All other trademarks are the
property of their respective owners.

MAT-US-2208594-v2.0-03/2023
Last Update: March 2023

This site is intended for US healthcare professionals only.

© 2023 Genzyme Corporation. All rights reserved. ALTUVIIIO, MyALTUVIIIO, XTEN,
and Sanofi are trademarks of Sanofi or an affiliate.
All other trademarks are the property of their respective owners.

MAT-US-2208594-v2.0-03/2023 Last Update: March 2023

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