How it works:

Severe oral mucositis is a condition in which the sensitive cells lining the mouth and throat are damaged by cancer treatments such as chemotherapy (with or without radiation) and become painful mouth sores. Kepivance® is a recombinant (genetically engineered) form of human keratinocyte growth factor (KGF), a protein that is naturally produced by the body. Kepivance® reduces the incidence and duration of or severe oral mucositis by helping protect existing cells that line the mouth and throat from the damage caused by chemotherapy and radiation, and by stimulating the growth and development of new cells.

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Launched in 2005, Kepivance® is approved by the FDA to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without irradiation, followed by bone marrow transplant. The safety and efficacy of Kepivance® have not been established in patients with non-hematologic malignancies. Kepivance® reduces the incidence and duration of severe oral mucositis in these patients by protecting the epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation and by stimulating the growth and development of new epithelial cells to build up the mucosal barrier.

In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials was skin rash in less than 1% of patients. Other serious adverse reactions included fever, gastrointestinal events and respiratory events. The most commonly reported adverse reaction were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.