Apligraf®
Essential Prescribing Information

Numbers in parentheses ( ) refer to sections in the main part of the product labeling.

Device Description
Apligraf® is supplied as a living, bi-layered skin substitute manufactured using neonatal foreskin keratinocytes and fibroblasts with bovine Type I collagen. (1)

Intended Use/Indications
Apligraf® is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2)

Apligraf® is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2)

Contraindications
Apligraf® is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8)

Warnings and Precautions
If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5)

Adverse Events
All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6)

Maintaining Device Effectiveness
Apligraf® has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F - 73°F (20°C-23°C) until ready for use. Apligraf® should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf® may be contaminated or compromised, it should not be used. Apligraf® should not be used beyond the listed expiration date. (9)

Use in Specific Populations
The safety and effectiveness of Apligraf® have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure.

Patient Counseling Information
VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf®.

DFU patients should be counseled that Apligraf® is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers.

Treatment of Diabetes
Apligraf® does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient's diabetes should be according to standard medical practice.

How Supplied
Apligraf® is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium, ready for single use. To maintain cell viability, Apligraf® should be kept in the sealed bag at 68°F - 73°F (20°C-23°C) until use. Apligraf® is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8)

Patent Numbers:
4,485,096
5,106,949
5,536,656

Manufactured and distributed by:
Organogenesis Inc.
Canton, MA 02021

REV: APRIL 2006    PRINTED IN USA    Apg-A-0104