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What is Apligraf?What is Apligraf®Safety Information

Apligraf® is a unique advanced product, containing living cells, proteins produced by the cells, and collagen. Because it is cell based, the body can use the elements in Apligraf® to help promote healing. As a result, Apligraf® is safe and well tolerated, with no major reported side effects.

Apligraf® application is painless.

 

Safety information for diabetic foot ulcer:
Apligraf® has been used over 250,000 to treat patients.

Your doctor should not apply Apligraf® if the wound is infected or if you have an allergy to bovine collagen or any of the components in the Apligraf®* shipping media. Although in clinical studies of more than 1,000 patients, no allergic reactions have been reported, you should notify your physician if you have any allergy symptoms.

In a study of patients treated with Apligraf®, the most common health problems were related to an open ulcer, the skin, or diabetes. These potential problems were generally temporary or treatable by a doctor and similar to those found in patients treated with moist gauze or removal of weight from the foot.

The most common health problems experienced were a new foot ulcer, suspected wound infection, a skin tear or cut, skin inflammation, bone infection, rash pain, low blood sugar or high blood sugar, non-wound infection, bruising, swelling, worsening ulcer, and dry skin.

Some patients experienced other health problems not associated with the skin or their diabetes, the incidences of which were similar between patients receiving Apligraf® or those treated with moist gauze and removal of weight from the foot.

While the safety of Apligraf® has not been studied beyond 6 months, Apligraf® has an established safety profile in over 250,000 applications during the last 10 years. Patients treated with Apligraf® have shown no increased risk of developing cancer; however, the long-term possibility has not been evaluated.

* Contains agarose, L-glutamine, hydrocortisone/bovine serum albumin, bovine insulin, human transferrin, triiodothyronine, ethanolamine, O-phosphoryl-ethanolamine, adenine, selenious acid, DMEM powder, and HAM’s F-12 powder.

Link to prescribing information

 

Safety information for venous leg ulcer:
Apligraf® has been used over 250,000 times to treat pateints.

Your doctor should not apply Apligraf® if the wound is infected or if you have an allergy to bovine collagen or any of the components in the Apligraf®* shipping media. Although in clinical studies of more than 1,000 patients no allergic reactions have been reported, you should notify your physician if you have any allergy symptoms.

In a study of patients treated with Apligraf®, the most common health problems were related to an open ulcer or the skin. These potential problems were generally temporary or treatable by a doctor and similar to those found in patients treated with compression therapy.

The most common health problems experienced were suspected wound infection, skin inflammation, wound drainage, swelling, a skin tear or cut, pain, new ulcer, and red flaky skin. Suspected wound infection was more common in patients receiving Apligraf®. Some patients experienced other health problems not associated with the skin, the incidences of which were similar between patients receiving Apligraf® or compression therapy.

While the safety of Apligraf® has not been studied beyond one year, Apligraf® has an established safety profile in over 250,000 patients during the last 10 years. Patients treated with Apligraf® have shown no increased risk of developing cancer; however, the long-term possibility has not been evaluated.

* Contains agarose, L-glutamine, hydrocortisone/bovine serum albumin, bovine insulin, human transferrin, triiodothyronine, ethanolamine, O-phosphoryl-ethanolamine, adenine, selenious acid, DMEM powder, and HAM’s F-12 powder.

Link to prescribing information

References:

3. Falanga V, Sabolinski ML. A bilayered living skin construct (Apligraf®) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999;7:201-207.

4. Veves A, Falanga V, et al. Graftskin, a human skin equivalent, is effective in management of non-infected neuropathic diabetic foot ulcers. Diabetes Care. 2001;24:290-295