This webpage is intended for UK Healthcare Professionals only. Webpage contains promotional material.

Prescribing Information and Adverse Event Reporting can be found at the end of this webpage.

Initiated and funded by Sobi

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Choose ALPROLIX® for long-term protection from bleeds and target joint resolution†1-6

The efficacy of ALPROLIX® in adults and adolescents ≥12 years was proven in a large EHL FIX clinical trial programme in haemophilia B (B-LONG and B-YOND) over 5 years of prophylactic treatment1-4

The final results of the B-YOND extension study confirmed sustained low median ABRs in adults and adolescents receiving ALPROLIX® prophylaxis*1–4

A(s)BR, annualised (spontaneous) bleeding rate; IQR, interquartile range

100% (37/37) of adults and adolescents ≥12 years with target joints at baseline achieved resolution of target joints with long-term use of ALPROLIX® in B-LONG and B-YOND§5,6

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Choose ALPROLIX® for long-term protection from bleeds and joint damage1

The efficacy of ALPROLIX® in children aged <12 years was proven in a large EHL FIX clinical trial programme in haemophilia B (Kids B-LONG and B-YOND)1-3

Children aged <12 years in Kids B-LONG1

Children aged <6 years (n=15) and 6–11 years (n=15)

ABRs remained low across all age groups in subjects receiving 1–5 years of prophylactic treatment3

Median overall ABR

Children aged <6 years: 1.1 IQR 0.0-2.9

Children aged 6–11 years: 2.1 IQR 0.0-4.2

Subjects in Kids B-LONG received 50–60 IU/kg of ALPROLIX® once weekly, with dose or frequency adjusted*1

A(s)BR, annualised (spontaneous) bleeding rate; IQR, interquartile range

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Choose ALPROLIX® for flexible dosing1,2

ALPROLIX® offers two possible starting doses with the potential to extend dosing to 14 days and beyond in adults and adolescents aged ≥12 years1,2

In children aged <12 years, the recommended starting dose is 50–60 IU/kg every 7 days§2

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Choose ALPROLIX® for extensive experience1-6

Take confidence from a large EHL FIX clinical trial programme and more than 5 years of real-world experience1–6

ALPROLIX® has more than
5 years
of real-world experience5

ALPROLIX® was generally well-tolerated in patients of all ages in clinical studies1,3,7

Confidence for the long-term: The tolerability profile of ALPROLIX® was studied over 5 years in the B-YOND extension study4

  • No inhibitors detected on study**1
    • Patients using ALPROLIX® should be monitored for the development of neutralising antibodies (inhibitors)7
    • Inhibitors have been detected in the post-marketing setting7
  • No vascular thrombotic events†1
    • There is a potential risk of thromboembolic episodes following the administration of FIX products, with a higher risk for low-purity preparations7
  • No anaphylaxis or allergic reactions†1
    • No serious hypersensitivity or anaphylaxis events were reported in clinical studies1,4
    • Hypersensitivity or allergic reactions have been observed rarely in a post-marketing setting and may in some cases progress to severe anaphylaxis (including shock)7
    • Serious adverse events were uncommon and typical of the population studied1
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Treating beyond Troughs

FIX and volume of distribution

  • Trough levels only measure FIX in the plasma and do not account for the FIX that distributes into the extravascular space1
  • Volume of distribution may provide a new way of thinking about protection in haemophilia B by accounting for the distribution of FIX outside the plasma2

Data presented at the 2019 International Society on Thrombosis and Haemostasis (ISTH) conference, adds to the growing evidence of the clinical relevance and potential role of extravascular FIX in bleed control3

An electronic survey regarding centre-specific use of EHL FIX among patients with severe haemophilia B (SHB) at four US Haemophilia Treatment Centres (HTCs) was sent in Autumn 2018. Providers were asked if patients using EH FX had experienced spontaneous/minimally traumatic bleeding events at factor levels >10% or poorly controlled bleeding events requiring frequent/higher doses of EHL FIX than anticipated, in addition to patterns of EHL FIX product switching. The surveyed HTCs cared for 71 patients with SHB, including 55 (77%) who used EHL FIX, 24 (34%) recombinant factor IX (FIX) albumin fusion protein (rFIX-FP) and 31 (44%) recombinant factor IX Fc fusion protein. Unexpected spontaneous/minimally traumatic bleeding and poorly controlled bleeding was reported in 13 patients, all using rFIX-FP prophylaxis3

Out of 55 patients with severe haemophilia B treated with either ALPROLIX® or rFIX-FP, no ALPROLIX® patients reported poorly controlled bleeding compared with 54% of those treated with rFIX-FP3

Proportions of patients with uncontrolled bleeding

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Prescribing Information

ALPROLIX®(eftrenonacog alfa)
Abbreviated Prescribing Information

For further prescribing information, please refer to the ALPROLIX® Summary of Product Characteristics (SPC)
Composition: The active substance is eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion protein). Each vial of ALPROLIX® contains nominally 250, 500, 1000, 2000 or 3000 IU eftrenonacog alfa. The other ingredients are sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide and hydrochloric acid. Diluent: Sodium chloride and water for injection.
Indications: Indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). ALPROLIX® can be used for all age groups. Dosage and Administration: On-demand treatment: The calculation of the required dose of recombinant factor IX Fc is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1% of normal activity (IU/dL). The required dose is determined using the following formula: Required units = body weight (kg) x desired factor IX rise (%) (IU/dL) x {reciprocal of observed recovery (IU/kg per IU/dL)}. Please refer to the SmPC for further information, including Table 1: Guide to ALPROLIX® dosing for treatment of bleeding episodes and surgery. Prophylaxis: For long-term prophylaxis, the recommended dose is either 50 IU/kg once weekly, dose adjusted based on individual response, or 100 IU/kg once every 10 days, interval adjusted based on individual response. Some patients who are well-controlled on a once every 10 days regimen, might be treated on an interval of 14 days or longer. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. The highest recommended dose for prophylaxis is 100 IU/kg. Treatment monitoring: Please refer to the SmPC for further information on treatment monitoring. Elderly population: There is limited experience in patient’s ≥65 years old. Previously untreated patients (PUPs): The safety and efficacy of ALPROLIX® in PUPs have not yet been established. Paediatric population: For children <12 years old, more frequent or higher doses may be required and the recommended starting dose is 50-60 IU/kg every 7 days. For adolescents (≥12 years old), the dose recommendations are the same as for adults. Refer to the SmPC for instructions on reconstitution. Contraindications: Hypersensitivity to eftrenonacog alfa (recombinant human coagulation factor IX, and/or Fc domain) or to any of the excipients. Precautions and Warnings: Allergic type hypersensitivity reactions have been reported. Patients should be informed of the signs of hypersensitivity reactions. Patients should be advised to discontinue use of the product immediately and contact their physician if such signs occur. Implement standard treatment in cases of anaphylactic shock. All patients treated with coagulation factor IX products should be carefully monitored for the development of inhibitors. Patients with liver disease, post-operative patients, newborn infants, and patients at risk of thrombotic phenomena or coagulopathy should be monitored for early signs of thrombotic complications. In patients with existing cardiovascular risk factors, substitution therapy with factor IX may increase the cardiovascular risk. If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered. Recording of batch number is recommended in order to maintain a link between the patient and the batch of the medicinal product. The listed warnings and precautions apply both to adults and children. ALPROLIX® contains 0.3 mmol (6.4 mg) sodium per vial. This should be taken into consideration by patients on a controlled sodium diet. Interactions: No interactions of human coagulation factor IX (rDNA) with other medicinal products have been reported. No interaction studies with ALPROLIX® have been performed. Undesirable Effects: Hypersensitivity or allergic reactions (swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock). Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction. In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed. Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with thromboembolic complications. Consult the SmPC for further information about adverse events. Legal Category: POM Marketing Authorisation Nos.: EU/5/16/1098/001-005. Pack size: 1 glass vial of powder plus materials for reconstitution and infusion. NHS List Price: £1.20/IU. Eire List Price: Available on request. Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden. Further information is available from Swedish Orphan Biovitrum (UK) Ltd, Suite 2, Riverside 3, Granta Park, Great Abington, Cambridgeshire, CB21 6AD Date of Revision: June 2018 Company Reference: PP-4359

This medicinal product 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. For reporting within the UK, forms and information can be found at www.mhra.gov.uk/yellowcard and for Republic of Ireland at www.hpra.ie. Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at drugsafety@sobi.com