Indication

EPICEL (cultured epidermal autografts) is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater then or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

Important Safety Information

EPICEL (cultured epidermal autografts) is contraindicated in patients with known hypersensitivity to agents used in the manufacture of EPICEL or with a known history of anaphylaxis to vancomycin amikacin, or amphotericin. EPICEL should not be used in patients with known sensitivites to materials of bovine or murine origin. It is containdicated for use on clinically infected wounds.

Because EPICEL is manufactured with and contains residual amounts of murine cells, FDA considers it a xenotransplantation product. Therefore, recipients should not donate whole blood, blood components, source plasma, source leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans because there is a potential risk of carrying an infection that is transmitted from mouse cells to humans.

The EPICEL product is intended solely for autologous use. Patients undergoing the surgical procedure associated with EPICEL are not routinely tested for transmissible infectious diseases. Discontinue use of the patient shows evidence of allergic reaction.

If clinical signs of infection are present of develop, do not apply EPICEL until the infection is adequately treated.

The effectiveness of EPICEL has not been proven in clinical studies.

The long term safety of EPICEL is unknown.

Men and women who intend to have children should be advised that the effects, if any, of EPICEL on fetal development have not been assessed. In addition, the safety of EPICEL has not been studied in pregnant and nursing women.

Patient information supplied by attending burn teams from 1989 to 1996 reported the adverse events of highest incidence as: death (13%), infection (14%), and graft tear (8%) or graft blister (4%). Some of these events may have been due to the underlying burn injury and not the device itself.

From June 1998 through August 2006 adverse events received by Genzyme were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included death (9%), sepsis (3.7%) multi-organ failure (3.3%) and skin graft failure/graft complication (1.3%). The relationship of these events to EPICEL has not been established.

References

1. Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell. 1975;6:331-43.