Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: bluebird bio (Netherlands) B.V., Stadsplateau 7, WTC Utrecht, 3521AZ Utrecht, The Netherlands
Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion. A clear to slightly cloudy, colourless to yellow or pink dispersion. |
Zynteglo (betibeglogene autotemcel) is a genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells (HSC) transduced with lentiviral vector (LVV) encoding the βA-T87Q-globin gene.
The finished product is composed of one or more infusion bags which contain a dispersion of 1.2-20 × 106 cells/mL suspended in cryopreservative solution. Each infusion bag contains approximately 20 mL of Zynteglo.
The quantitative information regarding strength, CD34+ cells, and dose for the medicinal product is provided in the Lot Information Sheet. The Lot Information Sheet is included inside the lid of the cryoshipper used to transport Zynteglo.
Excipient with known effect: Each dose contains 391-1564 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Betibeglogene autotemcel |
Betibeglogene autotemcel adds functional copies of a modified β-globin gene into the patients' HSCs through transduction of autologous CD34+ cells with BB305 LVV, thereby addressing the underlying genetic cause of the disease. After betibeglogene autotemcel infusion, transduced CD34+ HSCs engraft in the bone marrow and differentiate to produce RBCs containing biologically active βA-T87Q-globin (a modified β-globin protein) that will combine with α-globin to produce functional Hb containing βA-T87Q-globin (HbAT87Q). |
| List of Excipients |
|---|
|
Cryostor CS5 |
20 mL fluorinated ethylene propylene infusion bag(s), each packed in a transparent pouch inside a metal cassette.
Zynteglo is shipped from the manufacturing facility to the infusion centre storage facility in a cryoshipper, which may contain multiple metal cassettes intended for a single patient. Each metal cassette contains one infusion bag with Zynteglo. A patient may have multiple infusion bags.
bluebird bio (Netherlands) B.V., Stadsplateau 7, WTC Utrecht, 3521AZ Utrecht, The Netherlands
EU/1/19/1367/001
Date of first authorisation: 29 May 2019
Date of latest renewal: 16 September 2021
| Drug | Countries | |
|---|---|---|
| ZYNTEGLO | Austria, Cyprus, Estonia, France, Ireland, Italy, Lithuania, Poland |
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