In a sequential PK study, a single-dose of ALTUVOCT resulted in a three- to four-fold longer half-life than other FVIII products*7
Phase 1 intra-patient comparison of 13 patients, assessing the PK and safety of SHL (octocog alfa), EHL (rurioctocog alfa pegol) FVIIIs and ALTUVOCT in adult males with severe haemophilia A7
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ALTUVOCT in adults AlTUVOCT in CHILDREN
A monotherapy that can be used for prophylaxis, for the treatment of acute bleeds and in a surgical setting4,5
As an ultra-long half-life FVIII,1,2 ALTUVOCT offers once-weekly dosing for prophylaxis. ALTUVOCT offers the same fixed dose across surgery and on-demand treatment.4,5
*For minor and moderate bleeding episodes occurring within 2 to 3 days after a prophylactic dose, a lower dose of 30 IU/kg dose may be used. Additional doses of 30 or 50 IU/kg after 2 to 3 days may be considered. For major bleeding, additional doses of 30 or 50 IU/kg every 2 to 3 days may be considered until bleeding is resolved.4,5 †For minor surgery, an additional dose of 30 or 50 IU/kg after 2 to 3 days may be considered. For major surgery, additional doses of 30 or 50 IU/kg every 2 to 3 days may be administered as clinically needed until adequate wound healing is achieved.4,5
ALTUVOCT dosing for acute bleeds
| Degree of haemorrhage4,5 | Recommended dose4,5 | Additional information4,5 |
| Early haemarthrosis, muscle bleeding or oral bleeding | Single dose of 50 IU/kg | For minor and moderate bleeding episodes occurring within 2 to 3 days after a prophylactic dose, a lower dose of 30 IU/kg may be used. An additional dose of 30 or 50 IU/kg after 2 to 3 days may be considered |
| More extensive haemarthrosis, muscle bleeding or haematoma | Single dose of 50 IU/kg | Additional doses of 30 or 50 IU/kg every 2 to 3 days may be considered until bleeding is resolved |
| Life-threatening haemorrhages | Single dose of 50 IU/kg | Additional doses of 30 or 50 IU/kg every 2 to 3 days may be administered until the threat is resolved |
For resumption of prophylaxis (if applicable) after treatment of a bleed, it is recommended to allow an interval of at least 72 hours between the last 50 IU/kg dose for treatment of a bleed and resuming prophylaxis dosing. Thereafter, prophylaxis can be continued as usual on the patient’s regular dosing schedule.4,5
ALTUVOCT dosing for perioperative management
| Type of surgery4,5 | Recommended dose4,5 | Additional information4,5 |
| Minor surgery including tooth extraction | Single dose of 50 IU/kg | An additional dose of 30 or 50 IU/kg after 2 to 3 days may be considered |
| Major surgery | Single dose of 50 IU/kg | Additional doses of 30 or 50 IU/kg every 2 to 3 days may be administered as clinically needed until adequate wound healing is achieve |
For resumption of prophylaxis (if applicable) after treatment of a bleed, it is recommended to allow an interval of at least 72 hours between the last 50 IU/kg dose for treatment of a bleed and resuming prophylaxis dosing. Thereafter, prophylaxis can be continued as usual on the patient’s regular dosing schedule.4,5
AE, adverse event; AUC0-inf, area under the activity time curve extrapolated to infinity; Cmax, maximum activity; EHL, extended half-life; Fc, crystallisable fragment; FVIII, factor VIII; PK, pharmacokinetic; rFVIII, recombinant factor VIII; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SD, standard deviation; SHL, standard half-life; t1/2, half-life; TEAE, treatment-emergent adverse event; VODss, volume of distribution at steady state; vWF, von Willebrand factor.
1. Hermans C, Pierce GF. Journal of Thrombosis and Haemostasis. 2024;22(7):1844–1846. 2. Burke T, et al. Expert Rev Hematol. 2026;19(1):55–61. 3. von Drygalski A, et al. N Engl J Med. 2023;388(4):310–318. 4. ALTUVOCT UK Summary of Product Characteristics. 5. ALTUVOCT EU Summary of Product Characteristics. 6. Malec L, Matino D. Haemophilia. 2023;29(6):1419–1429. 7. Lissitchkov T, et al. Res Pract Thromb Haemost. 2023;7(4):100176.
In the UK, ALTUVOCT (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients 2 years and above with severe or moderate haemophilia A (≤5% endogenous plasma factor VIII activity). There are limited data in paediatric patients <2 years of age.4
In Ireland, ALTUVOCT (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ALTUVOCT can be used for all age groups.5
| ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found, for United Kingdom: via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. For Ireland: via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events should also be reported to Swedish Orphan Biovitrum Ltd by email at [email protected] or by calling +44 (0) 800 111 4754. |