Prescribing Information

PRESCRIBING INFORMATION: IDELVION® (albutrepenonacog alfa)
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentation: 250 IU, 500 IU, 1000 IU and 2000 IU packs of powder and solvent for solution for injection. Indications: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). IDELVION can be used for all age groups. Dosage and Administration: On demand treatment: For patients <12 years of age; Dose (IU) = body weight (kg) x desired factor IX rise (IU/dl) x 1 dl/kg. For patients ≥12 years of age; Dose (IU) = body weight (kg) x desired factor IX rise (IU/dl) x 0.77 dl/kg. See SPC for example calculations and further dosing guidance in bleeding episodes and surgery. Prophylaxis Treatment: The usual doses are 35 to 50 IU/kg once weekly. Patients who are well-controlled on a once-weekly regimen might be treated with up to 75 IU/kg every 10 or 14 days. For patients >18 years, further extension of the treatment interval may be considered. In some cases, e.g. younger patients, shorter dose intervals or higher doses may be necessary. After a bleeding episode during prophylaxis, the prophylaxis regimen should be maintained as closely as possible, with two doses being administered at least 24 hours apart but longer as deemed suitable. Paediatric population; For long term prophylaxis the recommended regimen is 35 to 50 IU/kg once weekly. For adolescents of 12 years of age and above, the dose recommendations are the same as for adults. Method of administration: The reconstituted preparation should be injected slowly intravenously at a comfortable rate up to a maximum of 5 ml/min. Contraindications: Hypersensitivity to the active or to any of the excipients (see SPC for list). Known allergic reaction to hamster protein. Special warnings and precautions for use: Hypersensitivity: Allergic type hypersensitivity reactions are possible. If symptoms occur, patients should be advised to discontinue use immediately and contact their physician. Patients should be informed of early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. Initial administrations should be performed under medical observation where proper medical care for allergic reactions could be provided. In case of shock, standard medical treatment should be implemented. Inhibitors: Formation of inhibitor to factor IX has been reported with IDELVION in the treatment of haemophilia B. Patients should be monitored for the development of neutralising antibodies (inhibitors) after repeated treatment. Patients experiencing allergic reactions should be evaluated for presence of an inhibitor. Patients with inhibitors may be at an increased risk of anaphylaxis with subsequent administration.

Thromboembolism: Due to a potential risk of thrombotic complications, patients with liver disease, post-operatively, newborn infants, patients at risk of thrombotic phenomena or DIC should be monitored for early signs of thrombotic and consumptive coagulopathy. The benefit of treatment should outweigh the risk of these complications. Cardiovascular events: Patients with existing cardiovascular risk factors, FIX therapy may increase cardiovascular risk. Catheter-related complications: 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. Paediatric population: Listed warnings and precautions apply both to adults and children. Elderly population: Clinical studies did not include subjects aged 65 and over. It is not known whether they respond differently from younger subjects. Immune tolerance induction: Safety and efficacy for immune tolerance induction has not been established. Sodium content: Idelvion contains up to 25.8 mg (1.13 mmol) sodium per dose (bodyweight 70 kg) if the maximal dose (15 ml = 6000 IU) is applied (up to 8.6 mg sodium per vial). Traceability: Name and batch number of the product administered should be recorded. Pregnancy and Lactation: IDELVION should only be used during pregnancy and lactation if clearly indicated. There is no information on the effects on fertility. Undesirable effects: Common (≥1/100 to <1/10): Dizziness, Injection site reactions, Headache. Uncommon (≥1/1,000 to <1/100): Hypersensitivity, Rash, Eczema. Frequency not known (cannot be estimated from the available data): FIX inhibition/Inhibitor development. Hypersensitivity/allergic reactions have been observed rarely and may progress to severe anaphylaxis. Nephrotic syndrome has been reported following attempted immune tolerance induction. Refer to the SPC for details on full side effect profile and interactions. Marketing authorisation Number: Idelvion 250: PLGB 15036/0143 (EU/1/16/1095/001), Idelvion 500: PLGB 15036/0144 (EU/1/16/1095/002), Idelvion 1000: PLGB 15036/0141 (EU/1/16/1095/003), Idelvion 2000: PLGB 15036/0142 (EU/1/16/1095/004). NHS Maximum Price: 250 IU: £522.50; 500 IU: £1045.00; 1000 IU: £2090.00; 2000 IU: £4180.00. Further information is available from:CSL Behring UK Limited, 4 Milton Road, Haywards Heath, West Sussex, RH16 1AH. Legal Category: POM. Date Prepared: March 2021. PI Approval Code: GBR-IDL-0145.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk.
Adverse events should also be reported to CSL Behring UK Ltd. on 01444 447 405