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U.S. Department of Health and Human Services

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Questions and Answers on Palifermin (Keratinocyte Growth Factor)

What is palifermin?

Palifermin is a modified version of a naturally occurring human protein called keratinocyte growth factor (KGF) that is manufactured in a laboratory. KGF stimulates the growth of cells in tissues such as the skin and the surface layer of the mouth, stomach, and colon. KGF helps maintain the normal structure of the skin and gastrointestinal surface (lining) and assists in repair of the skin and gastrointestinal lining by stimulating cells to divide, grow and develop. Palifermin, like the natural KGF, stimulates these cells to grow and reproduce in animals and in humans.

What is palifermin used to treat?

Palifermin is used to reduce the chances of developing severe mucositis (injury to the cells lining the mouth) and to shorten the time with severe mucositis in patients with cancer who receive high doses of chemotherapy and radiation therapy followed by stem cell rescue. On average, patients treated with palifermin reported less mouth soreness and used less narcotic pain medication than those in the placebo-treated group. Similar findings were observed in a smaller study in patients with leukemia and lymphoma undergoing bone marrow transplantation. Palifermin has not been fully tested in all types of cancer. It should be used only in patients with leukemia and lymphoma. Studies to determine whether palifermin can be safely used in other types of cancer are in progress.

What is mucositis?

Mucositis is an inflammation of the mucous membranes (lining of the mouth and gastrointestinal tract) that can be caused by chemotherapy and radiation therapy. Severe oral mucositis is a very common complication of bone marrow transplantation for which there is no effective treatment. Patients with severe oral mucositis develop sores and ulcers in the lining of the mouth, causing pain and difficulty eating and swallowing. In the most severe form, patients need to receive nutrition and fluid into the veins because they cannot eat or drink and may require narcotics (e.g., pain killers such as morphine or oxycodone) for treatment of the associated pain. While not generally life-threatening, it is a very important cause of pain and the primary cause for poor nutrition in bone marrow transplant patients.

How does palifermin work?

Chemotherapy and radiation therapy kill rapidly growing cells, both tumor cells and normal cells, including hair, cells lining the mouth, and blood cells. Palifermin works by attaching to a protein called keratinocyte growth factor receptor (KGFr); after attachment of cells to the receptor, the cells are stimulated to reproduce, grow, and develop. Palifermin is believed to work by stimulating the cells of the lining of the mouth. This leads to faster replacement of the cells killed by chemotherapy and radiation therapy and speeds up the healing process.

How is palifermin given?

Palifermin is given into the vein for 3 days just before the start of chemotherapy/radiation therapy and for 3 days following chemotherapy. Palifermin should not be given on the same day as chemotherapy or radiation therapy.

What are the potential side effects associated with palifermin?

The most common side effects of palifermin are skin rash, unusual sensations in the mouth (tingling, tongue thickness), and asymptomatic increases in proteins in the blood suggesting irritation of the pancreas. No serious side effects were reported that were thought to be due to palifermin.

Where can I find more information on palifermin and mucositis?

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