allogeneic cultured keratinocytes and fibroblasts (Rx)

Brand and Other Names:StrataGraft, allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical bioengineered skin graft

  • Each rectangular sheet ~100 cm2 (~8cm x 12.5cm)

Burns

Allogeneic cellularized scaffold product for treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)

Surgically apply to prepared wound bed following excision/debridement

Construct is ~100 cm2 (~8 cm x 12.5 cm) off-white rectangle; may trim construct to fit shape and size of wound area

Surface area of construct should be equal to surface area of wound to be treated

Multiple constructs may be applied to cover large wound areas

If multiple constructs required, abut the constructs; not necessary to overlap edges

Each construct is for single patient only

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and allogeneic cultured keratinocytes and fibroblasts

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Pruritus (11%)

            1-10%

            Blisters (4%)

            Hypertrophic scar (3%)

            Impaired healing (3%)

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            Warnings

            Contraindications

            Known allergies to murine collagen or products containing ingredients of bovine or porcine origin

            Cautions

            Contains glycerin; avoid in patients with known sensitivity

            Severe hypersensitivity reactions may occur; monitor for both early and late symptoms and signs following application; treat according to standard medical practice

            Because this is a xenotransplantation product, recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans

            Transmission of infectious diseases

            • Contains cells from human donors and may transmit infectious diseases or infectious agents, such as viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD] or variant CJD)
            • Classified as a xenotransplantation product because of historic exposure of the keratinocyte cells to well-characterized mouse cells
            • Cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are no longer used in the manufacture of StrataGraft; however, these measures do not entirely eliminate risk of transmitting infectious diseases and disease agents
            • Transmission of infectious diseases or agents has not been reported

            Drug interaction overview

            • Mafenide
              • Not recommended
              • Mafenide acetate, a topical antimicrobial, reduces keratinocyte viability and disrupts integrity of tissue-engineered human skin substitutes composed of keratinocytes
            • Silver-containing antimicrobials and dressings
              • Not recommended
              • Data suggest silver may decrease viability of keratinocytes and human dermal fibroblasts
            • Chlorhexidine
              • Not recommended
              • Chlorhexidine topical antiseptic shown to be toxic to keratinocytes and human dermal fibroblasts
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            Pregnancy & Lactation

            Pregnancy

            There are no available data regarding use in pregnant females

            No animal reproductive and developmental toxicity studies have been conducted to assess whether it can cause fetal harm

            Lactation

            Data are unavailable on presence in human milk, effect on breastfed infants, or effect on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Allogeneic cellularized scaffold product containing metabolically active cells that produce and secrete a variety of growth factors and cytokines

            Growth factors, cytokines, and extracellular matrix proteins are known to be involved in wound repair and regeneration

            Does not remain permanently engrafted, but is replaced by the patient’s own cells over time, eliminating or reducing the need for autografting to attain definitive closure of the majority of treated wounds

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            Administration

            Preparation

            Following wound bed preparation (excision/debridement), determine number of constructs that need to be thawed

            Two operators (a sterile operator and a nonsterile operator) are required for the procedures

            Follow instructions and diagrams provided in Prescribing Information

            Topical Application

            Apply in appropriate aseptic conditions by a trained healthcare provider

            Follow the steps below for topical application

            • If using fibrin glue to anchor constructs, apply before placing the meshed construct on the prepared wound bed; if using anchoring methods other than fibrin glue, start with next step
            • Place the meshed StrataGraft with the dermal (shiny) side down in contact with prepared wound bed; ensure epidermal (matte) side is facing up; abut constructs when placing multiple constructs; overlapping edges is not required
            • Note
              • If treated area is smaller than 1 construct, trim excess before or after anchoring to the wound bed
              • Ensure construct has contact across entire surface of the wound bed
              • Do not stretch or expand construct; doing so may degrade structural integrity
            • Anchor construct with staples, tissue adhesive (eg, cyanoacrylate), or sutures to keep from dislodging; place porous, nonadherent contact dressing over construct and leave dressing in place for 1 week before changing
            • Place second layer of dressing that does not contain silver
            • Placement of an outer bolster or wrap that keeps from moving as clinically appropriate is at the discretion of the physician

            Storage

            Constructs: Freeze between -70ºC and -90ºC (-94ºF to -130ºF)

            Hold solution: Refrigerate at 2-8ºC (36-46ºF)

            Hold dishes: Store at ambient temperatures

            Do not use any of the above components if they have been compromised

            Dispose of unused constructs as surgical biohazardous waste in accordance with local requirements

            Dispose of materials that have come into contact with constructs as surgical biohazardous waste in accordance with local requirements

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            Images

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.