← Search & browse all drugs
BLOOD AND BLOOD FORMING ORGANS › OTHER HEMATOLOGICAL AGENTS › OTHER HEMATOLOGICAL AGENTS › Other hematological agents
lovotibeglogene autotemcel
B06AX06
Forms & Strengths
- Autologous CD34+ cell suspension for intravenous infusion
- Single-dose infusion bag containing minimum 3.0 x 10^6 CD34+ cells/kg
Adult Dosing
- One-time single intravenous infusion
- Target dose: 3.0 x 10^6 to 20.0 x 10^6 CD34+ cells/kg
- Preceded by myeloablative conditioning with busulfan
Pediatric Dosing
- Patients 12 years and older: One-time single intravenous infusion
- Target dose: 3.0 x 10^6 to 20.0 x 10^6 CD34+ cells/kg
- Preceded by weight-based myeloablative conditioning with busulfan
Indications
- Treatment of sickle cell disease in patients 12 years and older with a history of vaso-occlusive events
Mechanism of Action
- Autologous CD34+ hematopoietic stem cells transduced with lentiviral vector encoding the beta-T87Q-globin gene
- Enables production of anti-sickling hemoglobin (HbAT87Q) to inhibit red blood cell sickling
Contraindications
- Hypersensitivity to the active substance or any excipients including dimethyl sulfoxide (DMSO)
- Patients for whom myeloablative conditioning is contraindicated
Adverse Reactions
- Myelosuppression and prolonged cytopenias
- Febrile neutropenia
- Abdominal pain
- Vomiting
- Nausea
- Pyrexia
- Alloimmunization
- Risk of insertional oncogenesis (hematologic malignancy)
Drug Interactions
- Avoid administration of anti-retroviral medications for HIV prophylaxis prior to collection and for at least 1 month after infusion
- Live vaccines should not be given for at least 6 weeks prior to myeloablative conditioning, during treatment, and until immune recovery
Curated Content: Needs Vetting Before Put to Clinical Use