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ZYN-UK-00029 v2.0 Last updated: July 2020

This site is developed, sponsored, and funded by bluebird bio (UK) Ltd. and is only intended for UK healthcare professionals.

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How ZYNTEGLO Works

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ADVERSE EVENTS REPORTING

▼Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to bluebird bio at safety.reporting@bluebirdbio.com, or by telephone to 0207 660 0754.

MEDICAL INFORMATION REQUEST

If you have any additional enquiries about gene therapy with ZYNTEGLO, or would like copies of the educational materials, please contact the bluebird bio Medical Information department at medinfo@bluebirdbio.com or by calling 0800 069 8046.

REIMBURSEMENT INFORMATION

This product is currently not reimbursed by the NHS in the UK. The NICE technology appraisal is currently in development. The appraisal has been paused by NICE in response to the COVID-19 pandemic. For more information and updates to the appraisal timelines, please visit: https://www.nice.org.uk/guidance/indevelopment/gid-ta10334

Before prescribing ZYNTEGLO, please refer to the Summary of Product Characteristics and view the Prescribing Information.

References
1. ZYNTEGLO [summary of product characteristics]. bluebird bio; 2020.
2. European Medicines Agency. Zynteglo. European Medicines Agency website. https://www.ema.europa.eu/en/medicines/human/EPAR/zynteglo. June 3, 2020.
3. Guidelines for the Management of Transfusion Dependent Thalassaemia (TDT). 3rd ed. Thalassaemia International Federation. 2014. ISBN-13:978-9963-717-06-4.
4. Baronciani D, Angelucci E, Potschger U, et al. Hematopoietic stem cell transplantation in thalassemia: a report from the European Society for Blood and Bone Marrow Transplantation Hemoglobinopathy Registry 2000–2010. Bone Marrow Transplant. 2016;51(4):536-541.
5. Ladis V, Chouliaras G, Berdoukas V, et al. Survival in a large cohort of Greek patients with transfusion-dependent beta thalassaemia and mortality ratios compared to the general population. Eur J Haematol. 2011;86(4):332-338.
6. Locatelli F, Walters MC, Kwiatkowski JL, et al. Lentiglobin Gene Therapy for Patients with Transfusion-Dependent β-Thalassemia (TDT): Results from the Phase 3 Northstar-2 and Northstar-3 Studies. Blood. 2018;132(suppl 1):1025.
7. National Institutes of Health. Longterm follow-up of subjects with hemoglobinopathies treated ex vivo with gene therapy. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02633943. Published December 17, 2015. Accessed June, 2020.
8. Cavazzana M, Hacein-Bey-Abina S, Payen E, et al. Longer Term Follow-up on the First Patients with Severe Hemoglobinopathies Treated with Lentiglobin Gene Therapy. Blood. 2017;130(suppl 1):4609.
9. Walters MC, Kwiatkowski JL, Rasko JEJ, et al. Clinical outcomes of LentiGlobin gene therapy for transfusion-dependent β-thalassemia (TDT) following completion of the NORTHSTAR (HGB-204) study: S141. HemaSphere. 2019;3(22). doi: 10.1097/01.HS9.0000558784.71127.f8
10. Locatelli F, Thompson AA, Hongeng SJ, et al. Safety and efficacy of LentiGlobin gene therapy in patients with transfusion-dependent β‑thalassemia and non-β⁰/β⁰ genotypes in the phase 3 NORTHSTAR-2 study: S1632. HemaSphere. 2019;3(754). doi: 10.1097/01.HS9.0000564776.92239.40
11. National Institutes of Health. A study evaluating the efficacy and safety of LentiGlobin^® BB305 drug product in beta-thalassemia major and sickle cell disease. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02151526. Accessed June, 2020.
12. National Institutes of Health. A study evaluating the safety and efficacy of the LentiGlobin^® BB305 drug product in β‑thalassemia major participants. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01745120. Accessed June, 2020.
13. National Institutes of Health. A study evaluating the efficacy and safety of the LentiGlobin^® BB305 drug product in subjects with transfusion-dependent β‑thalassemia, who do not have a β⁰/β⁰ genotype. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02906202. Accessed June, 2020.
14. National Institutes of Health. A study evaluating the efficacy and safety of the LentiGlobin^® BB305 drug product in subjects with transfusion-dependent β‑thalassemia. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03207009. Accessed June, 2020.

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This site is developed, sponsored, and funded by bluebird bio (UK) Ltd. and is only intended for UK healthcare professionals.

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