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DELIVERING MORE DAYS NORMAL TO NEAR-NORMAL FVIII LEVELS*1,2

*ALTUVIIIO(efanesoctocog alfa) provided normal to near-normal FVIII levels (>40%) for most of the week in adults and for 3 days in children.†

Achieve higher sustained Factor VIII levels with ALTUVIIIO*1,2

Once-weekly ALTUVIIIO is a first-in-class, high-sustained Factor VIII (FVIII) replacement therapy, uniquely designed to extend FVIII half-life and deliver more days with near-normal (>40%) FVIII activity than standard FVIII therapy.*‡1–4

 

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ALTUVIIIO(efanesoctocog alfa) mechanism of action

Learn more about the mechanism of action of ALTUVIIIO

Explore how ALTUVIIIO is strategically designed to address the vWF ceiling and support extended FVIII half-life

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Clinical data of ALTUVIIIO (efanesoctocog alfa) in adults, adolescents and children

Learn more about the clinical data of ALTUVIIIO in adults, adolescents and children

Explore key trial outcomes in adults and adolescents (XTEND-1) and children (XTEND-Kids)

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Discover how ALTUVIIIO achieves high sustained Factor VIII levels*1

The half-life of most FVIII replacement therapies is limited by endogenous vWF binding, which imposes a half-life ceiling of ~15 hours.1

Indications4


ALTUVIIIO is a long-acting recombinant anti-haemophilic Factor (coagulation FVIII) indicated in adults, adolescents and children with haemophilia A for:

  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Treatment and control of bleeding episodes
  • Perioperative management of bleeding (surgical prophylaxis)

Currently, patient access is under discussion in Australia, now that it is registered by the Therapeutic Goods Authority
 

Contraindications4


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

Demonstrated safety profile1,2,4

  • No FVIII inhibitors, allergic-type hypersensitivity reactions, anaphylaxis or thrombolic events were reported in the XTEND-1 or XTEND-Kids clinical trials
  • Neutralising anti-Factor VIII antibodies (inhibitors) have been reported following administration of ALTUVIIIO in the postmarketing setting. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and  tests.§4
  • The most common adverse events (e5%) in a pooled analysis included arthralgia (17%), headache (16%), pyrexia (6%) and pain in extremity (6%)
     

To learn more about ALTUVIIIO please contact your local Haemophilia Account Executive
 

For TAS & VIC

Contact here

For NSW, QLD, NT, SA, & ACT

Contact here

For WA

Contact here


*ALTUVIIIO provided normal to near-normal levels (>40%) for most of the week in adults and for 3 days in children.1,2

†Adults: Data from the Phase 3 XTEND-1 study in 133 adults receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO.1 Children: Data from the Phase 3 XTEND-Kids study in 74 children receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO.2

‡Data from a Phase 1 trial in 133 previously treated adults with severe haemophilia A. Pharmacokinetic profiles of ALTUVIIIO, Advate® [octocogalfa], and Adynovate® [rurioctocogalfa pegol] were evaluated after sequential IV infusions. Primary objective: assess the elimination half-life for each product. Secondary objectives: characterisation of additional PK parameters; evaluation of safety and tolerability of ALTUVIIIO.3 Advate and Adynovate are registered trademarks of Baxalta Incorporated, a Takeda company.5,6

§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.4


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FVIII, factor VIII; IV, intravenous; vWF, von Willebrand factor.

  1. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318.
  2. Malec L, et al. N Engl J Med. 2024;391(3):236-246. 
  3. Lissitchkov T, et al. Res Pract Thromb Haemost. 2023;7(4):100176.
  4. Australian Approved Product Information for ALTUVIIIO (efanesoctocog alfa).
  5. Adynovate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA.
  6. Afstyla Prescribing Information. CSL Behring LLC. Kankakee, IL.

PBS Information:

This product is not listed on the PBS.

Please review full Product Information before prescribing. Full Product Information is available here or by calling 1800 818 806.

▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

MAT-AU-2601246 - 1.0 - 07/2026