Lovotibeglogene Autotemcel
Lovotibeglogene Autotemcel (LYFGENIA) is an autologous gene therapy approved for the treatment of sickle cell disease in patients 12 years and older. The therapy involves harvesting a patient's own hematopoietic stem cells (CD34+ cells) and genetically modifying them using a lentiviral vector (BB305) to add functional copies of a modified βA-globin gene that produces anti-sickling hemoglobin. After the modified cells are infused back into the patient following myeloablative conditioning, these cells engraft in the bone marrow and produce the therapeutic hemoglobin, reducing or eliminating vaso-occlusive events.
An autologous gene therapy for sickle cell disease that modifies a patient's own stem cells to produce anti-sickling hemoglobin.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- B06AX06
- RxNorm
- 2671958
- Generic
- Lovotibeglogene Autotemcel
- Class
- atc-b06
- Brands
- Lyfgenia
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; women of childbearing potential should use effective contraception for at least 12 months after treatment
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
avoid breastfeeding during treatment and for at least 12 months after administration
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17no adjustment
indicated for patients 12 years and older with sickle cell disease; requires successful mobilization and collection of autologous CD34+ cells
regular monitoring for engraftment, vector integration, and potential insertional mutagenesis
geriatric
elderly 65 plusindividualize
use with caution; limited clinical trial data in patients over 65; assess overall health status and comorbidities
enhanced monitoring for cardiovascular and renal function
Use with caution and monitor for adverse effects.
renal_impairment
moderate renal impairmentindividualize
assess renal function before conditioning regimen; adjust conditioning if needed
monitor renal function closely during and after treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentindividualize
assess hepatic function before treatment; contraindicated in severe hepatic impairment
monitor hepatic function closely during and after treatment
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for sickle cell disease
Therapeutic class
Classification of Lyfgenia as cell-based gene therapy
Indication
Approved indication for Lovotibeglogene Autotemcel
Mechanism of action
Gene therapy mechanism for treating sickle cell disease
Lovotibeglogene Autotemcel is indicated for the treatment of sickle cell disease in adult and pediatric patients 12 years of age and older with a history of vaso-occlusive events.
LYFGENIA works by adding functional copies of a modified βA-globin gene (βA-T87Q) into the patient's own hematopoietic stem cells via transduction with the BB305 lentiviral vector. These modified cells produce anti-sickling hemoglobin that helps prevent the red blood cell sickling and vaso-occlusive events characteristic of sickle cell disease.
This is an autologous therapy using the patient's own cells; it requires myeloablative conditioning prior to infusion. Potential risks include hematologic malignancy (observed in some gene therapies for hemoglobinopathies), prolonged cytopenias, and engraftment failure. Patients should be monitored for hematologic malignancies long-term. BB305 LVV contains a functional copy of the βA-T87Q-globin gene, and integration analysis should be conducted per prescribing information.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy