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*Before providing any patient-identifiable information (including name, social security number, address, ZIP Code, insurance policy number, or employer) to the SAFETY NET® Foundation staff, the provider must have the patient's written authorization to disclose such information for purposes of seeking reimbursement assistance or enrollment in the SAFETY NET® Foundation and provide such written authorization to the Reimbursement Connection®.
Amgen reserves the right to approve or deny any SAFETY NET® Foundation application or to modify or discontinue the program with respect to any patient or provider, or in its entirety, at any time. Amgen reserves the right to make an independent determination of eligibility in all cases.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
References
© 2006 Amgen All Rights Reserved. Prescribing Information for Kepivance®