Betibeglogene autotemcel is a prescription medicine indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. It is available as injectable suspension for intravenous use. MedsAcross supplies Betibeglogene autotemcel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZYNTEGLO is indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. ZYNTEGLO is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions.
Source: US FDA prescribing information
ZYNTEGLO adds functional copies of a modified β-globin gene into patients' hematopoietic stem cells (HSCs) through transduction of autologous CD34+ cells with BB305 LVV. After ZYNTEGLO infusion, transduced CD34+ HSCs engraft in the bone marrow and differentiate to produce RBCs containing biologically active β A-T87Q -globin (a modified β-globin protein) that will combine with α-globin to produce functional adult Hb containing β A-T87Q -globin (HbA T87Q ). β A-T87Q -globin can be quantified relative to other globin species in peripheral blood using high-performance liquid chromatography. β A-T87Q -globin expression is designed to correct the β/α-globin imbalance in erythroid cells of patients with β-thalassemia and has the potential to increase functional adult HbA and total Hb to normal levels and eliminate dependence on regular pRBC transfusions.
Source: US FDA prescribing information
For autologous use only. For one-time single-dose intravenous use only. For intravenous use only. Patients are required to undergo hematopoietic stem cell (HSC) mobilization followed by apheresis to obtain CD34+ cells for ZYNTEGLO manufacturing. Dosing of ZYNTEGLO is based on the number of CD34+ cells in the infusion bag(s) per kg of body weight. The minimum recommended dose is 5.0 × 10 6 CD34+ cells/kg. Full myeloablative conditioning must be administered before infusion of ZYNTEGLO. Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended. Prophylaxis for seizures should be considered. Verify that the patient's identity matches the unique patient identification information on the ZYNTEGLO infusion bag(s) prior to infusion. Do not sample, alter, or irradiate ZYNTEGLO. Do not use an in-line blood filter or an infusion pump.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Delayed Platelet Engraftment: Monitor platelet counts until platelet engraftment and recovery are achieved. Patients should be monitored for thrombocytopenia and bleeding. Risk of Neutrophil Engraftment Failure: Monitor absolute neutrophil counts (ANC) after ZYNTEGLO infusion. If neutrophil engraftment does not occur administer rescue cells. Risk of Insertional Oncogenesis: Monitor patients at least annually for hematologic malignancies for at least 15 years after ZYNTEGLO infusion. Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion.
Source: US FDA prescribing information
The following adverse reactions are described elsewhere in the labeling: Delayed Platelet Engraftment Risk of Neutrophil Engraftment Failure Risk of Insertional Oncogenesis Hypersensitivity Reactions The most common non-laboratory adverse reactions (incidence ≥ 20%) were mucositis, febrile neutropenia, vomiting, pyrexia (fever), alopecia (hair loss), epistaxis (nose bleed), abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus (itch). The most common Grade 3 or 4 laboratory abnormalities (> 50%) include neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.
Source: US FDA prescribing information
No formal drug interaction studies have been performed. ZYNTEGLO is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters. Anti-retrovirals and Hydroxyurea: Do not take anti-retroviral medications or hydroxyurea for one month prior to mobilization, or for the expected duration for elimination of the medications, and until all cycles of apheresis are completed. Iron Chelation: Discontinue iron chelators 7 days prior to initiation of myeloablative conditioning. Avoid use of myelosuppressive iron chelators for 6 months after ZYNTEGLO infusion.
Source: US FDA prescribing information
Keep the infusion bag(s) in the metal cassette(s) and store in the vapor phase of liquid nitrogen at less than or equal to -140°C (≤ -220°F) until ready for thaw and administration. Do not re-freeze after thawing.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Betibeglogene autotemcel, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zynteglo 20000000 injectable suspensionIntravenous | Genetix Biotherapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Betibeglogene autotemcel and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Betibeglogene autotemcel, including Zynteglo.
No listed presentation of Betibeglogene autotemcel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Betibeglogene autotemcel is classified under ATC code B06AX02 (Betibeglogene autotemcel).
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