Kepivance® is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance® have not been established in patients with non-hematologic malignancies.

Important Safety Information

In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance® was skin rash reported in less than 1% of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance® or placebo with the most frequent being fever, gastrointestinal events, and respiratory events. The most commonly reported adverse reactions attributed to Kepivance® were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.

* Results from a randomized, double-blind, placebo-controlled, phase 3 study (N = 212) in which patients with hematologic malignancies who were undergoing hematopoietic stem cell transplantation (HSCT) after myelotoxic therapy received either Kepivance® or placebo.^1,2
† Analyses were performed in the overall patient population (patients who did not experience the event were assigned a duration of 0 days), and in a subset of patients who developed Grade 3/4 oral mucositis. Oral assessments were based on the World Health Organization (WHO) oral toxicity scale.²
‡ Mouth and throat soreness (MTS) and functional activity scores were collected with the use of a daily questionnaire and measured using a 5-point scale. MTS was a prespecified endpoint. Other functional activities were planned analyses.²

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