A Framework for Fitness-for-Purpose and Reuse in Computational Phenotyping
November 17, 2025
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Brand Name :
N/A
Synonyms :
lovotibeglogene autotemcel
Class :
Gene Therapies, Hematologics
Brand Name :
N/A
Synonyms :
lovotibeglogene autotemcel
Class :
Gene Therapies, Hematologics
FDA Approval Pending as one-time gene therapy for sickle cell disease in patients aged ≥12 years
FDA Approval Pending as one-time gene therapy for sickle cell disease in patients aged ≥12 years
Refer to adult dosingÂ
Actions and Spectrum Â
None
None
Black Box Warning:Â
NoneÂ
Contraindication/Caution:Â Â Â
None
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excretion into human milk is unknown Â
Pregnancy Categories:        Â
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.Â
Category N: There is no data available for the drug under this category.
Pharmacology Â
Using gene therapy, a patient’s own hematopoietic stem cells (HSCs) will be transformed to contain functional copies of the beta-globin gene (A-T87Q-globin gene).Â
It lowers the percentage of sickle hemoglobin with the intention of lowering sickled RBCs and hemolysis.Â
PharmacodynamicsÂ
Limited information available Â
PharmacokineticsÂ
Limited information available on ADMEÂ Â
Administration Â
Not available
Patient information leafletÂ
Generic Name: lovotibeglogene autotemcel (FDA Approval Pending)Â
Why do we use lovotibeglogene autotemcel?Â
For the treatment of sickle cell disease patients having a history of vaso-occlusive episodes, the gene therapy lovotibeglogene autotemcel is being developed. Â
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