Discontinue 2 months prior to mobilization and 2 days prior to conditioning. Interaction with mobilization process and LYFGENIA manufacturing.
Source: NLP:lovotibeglogene autotemcel
Lovotibeglogene Autotemcel Interactions
Brand names: Lyfgenia
Route: Intravenous
FDA Black Box Warning
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 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. ( 5.1 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on LYFGENIA administration in pregnant women. Consider the risks associated with myeloablative conditioning agents on pregnancy and fertility. No reproductive and developmental toxicity studies in animals have been conducted with LYFGENIA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known whether LYFGENIA has the potential to be transferred to the fetus. Therefore, LYFGENIA should not be administered to women who are pregnant, and pregnancy after LYFGENIA infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
4 interactions on record
Drug-drug interactions must be considered with mobilization and myeloablative conditioning. Discontinue at least 7 days prior to mobilization or conditioning. Myelosuppressive iron chelators should not restart sooner than 6 months post-infusion.
Source: NLP:lovotibeglogene autotemcel
Anti-retroviral medications may interfere with manufacturing of LYFGENIA. Discontinue at least one month prior to mobilization and until all cycles of apheresis are completed. Some long-acting anti-retrovirals may require longer discontinuation.
Source: NLP:lovotibeglogene autotemcel
Safety of immunization with live viral vaccines during or following LYFGENIA treatment has not been studied. Follow institutional guidelines and post-transplant vaccination schedules.
Source: NLP:lovotibeglogene autotemcel