Source: FDA, National Drug Code (US) Revision Year: 2025
None.
Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Monitor for signs and symptoms of hypersensitivity reactions such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis and treat according to standard clinical practice.
RVV-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN [see Nonclinical Toxicology (13)]. Monitor patients lifelong after treatment with ZEVASKYN for the development of malignancies. In the event that a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236 to obtain instructions on collecting patient samples for testing.
Transmission of infectious disease or agents may occur with ZEVASKYN administration because it is manufactured using human and bovine-derived reagents, which are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.
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 ZEVASKYN in the VIITAL study [see Clinical Studies (14)].
The median number of sheets patients received was 6 (range 3-6), and the total exposure time was 6 months following ZEVASKYN application.
The most common adverse reactions occurring in ≥5% of patients were procedural pain (n=3; 27%) and pruritus (n=1; 9%).
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in studies with other products.
In a single-arm clinical study, anti-C7 antibodies against Type VII collagen were assessed in 7 patients at baseline, 1, 3, and 6 months and then annually for 5 years at physician's discretion after treatment with ZEVASKYN. Out of 7 patients, circulating anti-C7 antibodies were detected in 2 patients which resolved at 1 year follow-up. Tissue-bound anti-C7 antibodies were detected in 4 patients which resolved in 3 patients at 1 year follow-up. In 1 patient with positive baseline anti-C7 antibodies, localized immunoreactants were observed at treated sites for up to 2 years after treatment.
In the VIITAL study, anti-C7 antibodies were assessed at baseline and at physician's discretion at Months 3 and 6. Eight patients were biopsied at either Month 3 or 6, and none of those patients tested positive for C7 immune complexes [see Clinical Studies (14)].
Because of the small sample size, there is limited data to determine the effect of anti-C7 antibodies on the pharmacodynamics, safety, and/or effectiveness of ZEVASKYN.
There are no available data with ZEVASKYN use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ZEVASKYN.
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.
Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy at the time of treatment with ZEVASKYN.
There is no information regarding the presence of ZEVASKYN in human milk, its effect on the breastfed infant, or its effects on milk production. Animal lactation studies have not been conducted with ZEVASKYN.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZEVASKYN and any potential adverse effects on the breast-fed infant from ZEVASKYN or from the underlying maternal condition.
No studies were performed to evaluate the effect of ZEVASKYN on fertility.
The safety and effectiveness of ZEVASKYN have been established in pediatric patients. The use of ZEVASKYN in pediatric patients was supported by evidence from one clinical study which included two pediatric patients aged 6 years and 16 years [see Adverse Reactions (6) and Clinical Studies (14)].
The safety and effectiveness of ZEVASKYN have not been studied in geriatric patients ≥65 years of age.
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