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This site is developed and hosted by bluebird bio (Switzerland) GmbH and is not intended for US and UK healthcare professionals.

This product has received European Medicines Agency approval. The registration status and approved product labels of ZYNTEGLO may vary from country to country. The information on this website is not country-specific and may not be applicable to your country. For more information, please refer to your local Prescribing Information.

IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC)

This site is not intended for US and UK healthcare professionals. If you are a UK healthcare professional, please click here.

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▼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. See section 4.8 for how to report adverse reactions.

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

This site is developed and hosted by bluebird bio (Switzerland) GmbH and is not intended for US and UK healthcare professionals.

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MEDICAL INFORMATION REQUEST

For medical information questions and requests, please email us at medinfo@bluebirdbio.com.

To report adverse events, please email us at safety.reporting@bluebirdbio.com.

Reimbursement approval timing for ZYNTEGLO may vary by country. Please check with your local authorities regarding the status of reimbursement in your specific country or contact your local bluebird bio representative for additional information.

▼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. See section 4.8 for how to report adverse reactions.

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

References
1. ZYNTEGLO [summary of product characteristics]. bluebird bio; 2019.
2. European Medicines Agency. Zynteglo. European Medicines Agency website. https://www.ema.europa.eu/en/medicines/human/EPAR/zynteglo. June 3, 2019.
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. Updated January 31, 2019. Accessed May 31, 2019.
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 B-thalassemia and non-B0/B0 genotypes in the phase 3 NORTHSTAR-2 study: S1632. HemaSphere. 2019;3(754). doi: 10.1097/01.HS9.0000564776.92239.40

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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

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