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    (palifermin)
  • -- SAFETY NET®

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Patient Assistance Programs - SAFETY NET®
Support Programs - Overview
SAFETY NET®
SAFETY NET® 

The SAFETY NET® Foundation is a well-established patient assistance program that provides access to Amgen products for qualifying patients. Through a simple registration and enrollment process, patients who qualify for the SAFETY NET® Foundation can receive needed Amgen products through their enrolled provider.

Who is eligible? How can patients apply?

Certain uninsured or underinsured patients with limited financial resources are eligible for the SAFETY NET® Foundation. These patients must meet insurance and income eligibility criteria. Patients can apply for assistance through a sponsoring health care professional. To discuss enrollment, patients and providers may call the toll-free number.

When calling the SAFETY NET® Foundation, please be prepared with the following information:

Provider Information
  • Provider name
  • Name of contact person
  • Address of contact person
  • Telephone/fax numbers of contact person

Patient Information*
  • Written patient's writtenauthorization
  • Patient name
  • Social Security number
  • Duration of therapy
  • Patient's annual family income
  • Insurance information for all insurance plans in which the patient participates, including name of insurer, pending insurance coverage (and anticipated effective date), and any denied claim (with reason[s] for denial).
Download Patient Authorization Form (PDF, 45 Kb)
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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

  1. Kepivance® (palifermin) prescribing information, Amgen.
  2. Spielberger R, Stiff P, Bensinger W, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med.2004;351:2590-2598.
  3. Rubenstein EB, Peterson DE, Schubert M, et al. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004;100(suppl 9):2026-2046.
  4. Spielberger R, Emmanouilides C, Stiff P, et al. Use of recombinant human keratinocyte growth factor (palifermin) can reduce severe oral mucositis in patients with hematologic malignancies undergoing autologous peripheral blood progenitor cell transplantation after radiationbased conditioning. J Support Oncol.2004;2(suppl 2):73-74.

© 2006 Amgen All Rights Reserved. Prescribing Information for Kepivance®

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  • Amgen Medical Information Connection™
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