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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 dosing
Actions and Spectrum
None
None
Black Box Warning:
None
Contraindication/Caution:
None
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
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.
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.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
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).
It lowers the percentage of sickle hemoglobin with the intention of lowering sickled RBCs and hemolysis.
Pharmacodynamics
Limited information available
Pharmacokinetics
Limited information available on ADME
Administration
Not available
Patient information leaflet
Generic Name: lovotibeglogene autotemcel (FDA Approval Pending)
Why do we use lovotibeglogene autotemcel?
For the treatment of sickle cell disease patients having a history of vaso-occlusive episodes, the gene therapy lovotibeglogene autotemcel is being developed.
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