Lyfgenia (LOVOTIBEGLOGENE AUTOTEMCEL)
Lyfgenia (LOVOTIBEGLOGENE AUTOTEMCEL) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Lyfgenia; Generic name: LOVOTIBEGLOGENE AUTOTEMCEL; Manufacturer: Genetix Biotherapeutics Inc..
| Brand name | Lyfgenia |
|---|---|
| Generic name | LOVOTIBEGLOGENE AUTOTEMCEL |
| Manufacturer | Genetix Biotherapeutics Inc. |
| Used for | 1 INDICATIONS AND USAGE LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. LYFGENIA is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. ( 1 ) Limitations of Use Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions. ( 1 ) Limitations of Use Following treat |
| Dosage | 2 DOSAGE AND ADMINISTRATION For autologous use only. For one-time single-dose intravenous use only. For autologous use only. For intravenous use only. Patients are required to undergo hematopoietic stem cell (HSC) mobilization followed by apheresis to obtain CD34+ cells for LYFGENIA manufacturing. ( 2.2 ) Dosing of LYFGENIA is based on the number of CD34+ cells in the infusion bag(s) per kg of body weight. ( 2.1 ) The minimum recommended dose is 3 × 10 6 CD34+ cells/kg. ( 2.1 ) Myeloablative con |
| Warnings | WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted [see Warnings and Precautions (5.1) ]. WARNING: HEMATOLOGIC MALIGNANCY See full prescribing information for complete boxed warning. Hematologic malignancy has occurred in patients treated with LYFGENIA. Monitor patients |
| Active ingredient(s) | LOVOTIBEGLOGENE AUTOTEMCEL |
| Route | INTRAVENOUS |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d1b475e-5781-2bd1-e063-6294a90a7311 |