Apligraf® Is Well Tolerated
Apligraf is well-tolerated in over 80,000 patient applications.1
However, among patients with suspected wound infection, Apligraf-treated patients achieved an overall higher rate of complete wound closure (download complete prescribing information) – During wound healing, Apligraf may take on the appearance of a yellowish-white gelatinous material, which may have led to an inappropriate diagnosis of wound infection.
Apligraf should not be used on infected wounds, or on patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. Please consult the complete prescribing information for a complete description of Apligraf and its components.
Adverse Events:
In the controlled clinical study conducted in patients with ulcers due to venous insufficiency of greater than one month in duration, the incidence of adverse events was comparable between the two study groups, with the exception of suspected infection, which was reported more frequently in Apligraf-treated (29.2%) than control patients (14.0%). There were 1 life-threatening and 3 severe infections in the Apligraf group and none in the control arm. Of these, two severe infections were considered related to treatment, however, one occurred one month after last application of Apligraf and the other occurred following application on a pre-existing Pseudomonas infection. While the overall incidence of wound infection was higher in the Apligraf arm, the incident of wound closure was 72/130 (55.4%) and 54/110 (49.1%) for Apligraf and control treated patients, respectively.
Reference:
¹Data on file at Organogenesis Inc.