Anti-retrovirals must be discontinued at least one month prior to stem cell mobilization and continued through apheresis completion, as they may interfere with SKYSONA manufacture.
Source: NLP:elivaldogene autotemcel
Elivaldogene Autotemcel Interactions
Brand names: Skysona
Route: Intravenous
FDA Black Box Warning
WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients treated with SKYSONA. Patients have been diagnosed between 14 months and 10 years after SKYSONA administration, and the cancers appear to be related to treatment with SKYSONA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 3 months. Monitor patients through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated [see Warnings and Precautions (5.1) ] . WARNING: HEMATOLOGIC MALIGNANCY See full prescribing information for complete boxed warning. Hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients treated with SKYSONA. The cancers appear to be the result of treatment with SKYSONA. Monitor patients closely for evidence of malignancy through complete blood counts at least every 3 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated. ( 5.1 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no available data with SKYSONA administration in pregnant women. Consider the risks associated with mobilization and conditioning agents on pregnancy and fertility. No animal reproductive and developmental toxicity studies have been conducted to assess whether SKYSONA can cause fetal harm when administered to a pregnant woman. No nonclinical germline transmission studies have been conducted with SKYSONA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
2 interactions on record
Vaccination is not recommended during the 6 weeks before myeloablative conditioning or until hematological recovery following SKYSONA treatment; safety and effectiveness have not been studied.
Source: NLP:elivaldogene autotemcel