There are no available data with prademagene zamikeracel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with prademagene zamikeracel.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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.
There is no information regarding the presence of prademagene zamikeracel in human milk, its effect on the breastfed infant, or its effects on milk production. Animal lactation studies have not been conducted with prademagene zamikeracel.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prademagene zamikeracel and any potential adverse effects on the breast-fed infant from prademagene zamikeracel or from the underlying maternal condition.
No carcinogenicity studies have been conducted with prademagene zamikeracel. Integration site analysis in RDEB keratinocytes transduced with LZRSE-Col7A1 showed a low level of integration distributed throughout the host genome with no predilection to specific integration sites, including in genes associated with malignant transformation in humans. No studies have been conducted to evaluate the effects of prademagene zamikeracel on fertility.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to the rates in the clinical trials of another product and may not reflect the rates observed in practice.
The safety data described in this section reflects exposure of 11 patients to prademagene zamikeracel in the VIITAL study.
The median number of sheets patients received was 6 (range 3-6), and the total exposure time was 6 months following prademagene zamikeracel application.
The most common adverse reactions occurring in ≥5% of patients were procedural pain (n=3; 27%) and pruritus (n=1; 9%).
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