Prademagene zamikeracel
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Receipt and Preparation Receipt of ZEVASKYN ZEVASKYN is shipped directly to the qualified treatment center sealed in transport packaging. If the patient is expected to be ready for same-day application, transport the packaging to the operating room. Hold at room temperature (15-25°C) until preparation to maintain cell viability.
If the patient is not expected to be ready for same-day application, store the packaging containing ZEVASKYN in a secure onsite location at room temperature (15-25°C) until preparation to maintain cell viability. Preparation ZEVASKYN is to be prepared by the manufacturer in an appropriate healthcare setting for surgical application by a qualified healthcare provider.
Manufacturer will conduct Quality Control (QC) testing to release the product immediately prior to surgery in the operating room. Verify patient’s identity during preparation. Hold ZEVASKYN at room temperature (15-25°C) until application. Apply all selected sheets in a single surgical session.
Administration Below is the list of standard surgical supplies needed for ZEVASKYN administration and not provided by the manufacturer: scalpel scissors forceps resorbable sutures non-adhesive dressings topical antibiotic ointment 1. Verify patient’s identity prior to ZEVASKYN application. Do not apply ZEVASKYN if the information on the patient-specific label(s) does not match the intended patient. 2.
Prepare wound by debridement under general or other appropriate anesthesia to accommodate ZEVASKYN sheet(s). 3. Before surgical application, pick up ZEVASKYN sheet with forceps by grasping the titanium ligating clips (Figure 1). Handle ZEVASKYN sheets only with forceps and only by the titanium ligating clips. Figure 1. ZEVASKYN sheets removed with forceps for application 4.
Do not trim ZEVASKYN sheets. 5. Apply unaltered ZEVASKYN sheets onto the wound bed only (nylon suture on the ZEVASKYN sheet facing away from wound) by affixing via resorbable sutures. Do not suture ZEVASKYN onto healthy intact skin. Do not overlap ZEVASKYN sheets on wounds. 6. Apply all selected sheets in a single surgical session. 7.
Cover area of application of ZEVASKYN sheets with non-adhesive dressings and topical antibiotic ointment. After ZEVASKYN application 8. Instruct patient to leave the treated area undisturbed for 5-10 days at the discretion of the physician based on individual needs for immobilization of treated areas and post-surgical recovery. 9.
Instruct patient to keep dressings dry and not submerge the treated area in water until the gauze of the ZEVASKYN product falls off the treatment site. Gauze backing should fall off within 2-3 weeks of ZEVASKYN surgical application.
Contraindications
None. None.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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. Clinical Considerations Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy at the time of treatment with ZEVASKYN.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.