Version July 2025
Dystrophic epidermolysis bullosa: Topical: One sheet covers an area 41.25 cm2. Up to 12 sheets may be manufactured from patient-specific biopsies for potential use. Note: Dose is based on surface area of the wound(s).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Nervous system: Procedural pain
1% to 10%: Dermatologic: Pruritus
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Reactions to vancomycin, amikacin, or product excipients may precipitate severe hypersensitivity reactions, including anaphylaxis, with prademagene zamikeracel application. Dyspnea, itching, hives, nausea, runny nose, swelling, and watery eyes have occurred.
• Infection: Prademagene zamikeracel is derived from human and bovine reagents and has a risk of transmitting infectious diseases caused by known or unknown agents. Although human and animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma prior to use, these measures may not eliminate the risk of transmission of these or other infectious diseases/agents.
• Insertional oncogenesis: There is a potential risk of retroviral vector-mediated insertional oncogenesis following treatment with prademagene zamikeracel. Patients may develop malignancies and should be monitored lifelong. If a malignancy occurs, contact the manufacturer (1-844-888-2236) for reporting and to obtain instructions on collection of samples for testing.
Zevaskyn: FDA approved April 2025; availability anticipated in 3rd quarter of 2025.
Prademagene zamikeracel is shipped directly to qualified treatment centers and is patient specific.
Topical: Prademagene zamikeracel topical application is a surgical procedure performed in an appropriate setting (eg, operating room under aseptic conditions) by a qualified health care provider. Refer to manufacturer's labeling for administration technique.
Recessive dystrophic epidermolysis bullosa: Treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa.
None known.
There are no known significant interactions.
Patients who could become pregnant should use effective contraception at the time of treatment.
Animal reproduction studies have not been conducted.
It is not known if prademagene zamikeracel is present in breast milk.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor lifelong for post application malignancies secondary to retroviral vector mediated insertional oncogenesis; application-related infection or irritation (eg, fever, increased drainage, worsening pain, swelling); signs and symptoms of hypersensitivity; antidrug antibodies.
In patients with recessive dystrophic epidermolysis bullosa (RDEB), both copies of the COL7A1 gene are mutated, resulting in the absence or low levels of biologically active C7 protein that form anchoring fibrils (AFs). The lack of AFs disrupts the connection between the epidermis and the dermis and causes skin fragility and other signs and symptoms of RDEB. Prademagene zamikeracel consists of a patient's own cells that have been gene-modified through retroviral vector transduction to express the COL7A1 gene to produce the C7 protein. These cells are formed into cellular sheets for topical application onto wounds.
