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Apligraf Generic Name & Formulations
Legal Class
PP
General Description
Living, bi-layered skin substitute (made from cells processed using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen); per circular disk (in a heavy gauge polyethylene bag with 10% CO2/air atmosphere and agarose nutrient medium); shipping medium (contains agarose, L-glutamine, hydrocortisone, human recombinant insulin, ethanolamine, O-phosphorylethanolamine, adenine, selenious acid, DMEM powder, HAM’s F-12 powder, sodium bicarbonate, calcium chloride, water for inj).
Pharmacological Class
Medical device.
How Supplied
Single-patient use bag—1
Manufacturer
Generic Availability
NO
Apligraf Indications
Indications
For use with standard therapeutic compression to treat non-infected partial and/or full-thickness skin loss ulcers due to venous insufficiency of >1month duration and which have not adequately responded to conventional ulcer therapy. For use with standard diabetic foot ulcer care to treat full-thickness neuropathic diabetic foot ulcers of ≥3weeks duration and which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure.
Limitations of Use
Efficacy and safety have not been established for patients receiving >5 device applications, pregnant women, acute wounds, burns and ulcers caused by pressure. Persistence of Apligraf cells on the wound and safety in venous ulcer patients beyond 1yr and in diabetic foot ulcer patients beyond 6months have not been evaluated.
Apligraf Dosage and Administration
Adults and Children
See full labeling. Handle using sterile technique. Place on a prepared wound bed within 15mins of opening the package. Venous leg ulcer: apply to a clean, debrided wound after thorough irrigation with non-cytotoxic solution; discontinue previous ulcer treatments other than standard therapeutic compression. Diabetic foot ulcer: apply to a clean, dry, debrided wound base after thorough cleansing with sterile saline solution; hemostasis must be achieved prior to application.
Apligraf Contraindications
Contraindications
On clinically infected wounds.
Apligraf Boxed Warnings
Not Applicable
Apligraf Warnings/Precautions
Warnings/Precautions
Do not open or use after expiration date, or if the pH is not within the acceptable range (6.8–7.7) as determined by the provided color chart. Allergies to bovine collagen or the components in the agarose shipping medium. Discontinue if an immunologic reaction occurs. Do not use if evidence of container damage or product contamination. Product should not be reused, frozen, or sterilized after opening. Evaluate and treat accordingly if signs of infection develops. Minimize exudation appropriately.
Apligraf Pharmacokinetics
See Literature
Apligraf Interactions
Interactions
Avoid use with cytotoxic agents (including Dakin’s solution, mafenide acetate, Scarlet Red dressing, tincoban, zinc sulfate, povidone-iodine solution, chlorhexidine, polymyxin/nystatin); concomitant use degrades Apligraf or reduces cell viability.
Apligraf Adverse Reactions
Adverse Reactions
For venous leg ulcers: suspected wound infection, cellulitis, exudate, peripheral edema, pain, death, pruritus, skin ulcer, infection, positive wound culture, rhinitis, dermatitis, CHF, accidental injury, dyspnea, pharyngitis, rash, asthenia, arrhythmia, abscess, increased cough, erythema, kidney failure. For diabetic foot ulcers: neuropathic ulcer, suspected wound infection, cellulitis, osteomyelitis, vesicular bullous rash, pain, hypoglycemia, infection, hematoma, non-neuropathic skin alteration, bone dislocation, others.
Apligraf Clinical Trials
See Literature
Apligraf Note
Not Applicable
Apligraf Patient Counseling
See Literature
