REMS File

Nplate for Subcutaneous Injection

Brand NameNplate for Subcutaneous Injection
Generic Nameromiplostim
Marketed byAmgen Inc.
NDA/BLA HolderAmgen
NDA/BLA Number BLA 125268
NDA/BLA Approval Date8/22/2008
StatusApproved
Review ClassificationNot Applicable
REMS Approval Date8/22/2008
Class REMSNo
REMS Source Documenthttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129516.pdf
Boxed Warning?No
Boxed WarningNot Applicable
IndicationNplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. (1)
Route of AdministrationSubcutaneous Injection
Mechanism of ActionNplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.
RisksBone marrow malignancy Thrombocytopenia
Risks (MedGuide Language)Nplate increases the risk for reticulin deposition within the bone marrow; clinical studies have not ruled out the possibility that reticulin and other fiber deposition may result in bone marrow fibrosis with cytopenias. Monitor peripheral blood for signs of marrow fibrosis. (5.1)
Approved Labelinghttp://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf
Medication Guide?Yes
Medication Guidehttp://www.fda.gov/downloads/Drugs/DrugSafety/ucm088667.pdf
Medication Guide Version2008
Communication Plan?Yes
Communication Plan
  1. Nplate™ NEXUS Program Website
  2. Nplate™ NEXUS Program Healthcare Provider Introductory Letter
Elements to Assure Safe Use?Yes
Elements to Assure Safe Use
  1. Nplate™ will only be prescribed by healthcare providers who are specially certified
  2. Nplate™ will only be dispensed by practitioners (physicians' offices) and healthcare settings (i.e., hospitals/institutions) that are specially certified
  3. Each patient treated with Nplate™ must be enrolled in the Nplate™ NEXUS Program for documentation of safe use conditions
  4. Each patient treated with Nplate™ is subject to certain monitoring
Implementation System?Yes
Implementation SystemNplate™ NEXUS Program Call Center will:
  1. Maintain a database of all enrolled certified healthcare settings and practioners that dispense and/or administer the drug, and patients who have documentation of safe-use conditions to moniro and evaluate implemntation of elements
  2. Monitor distribution of Nplate™ to determine wheter the drug is only drop-shipped to certified hospitals and prescribers who dispense the drug
  3. Monitor certified healthcare settings and practitioners ordering to ensure only enrolled patients are receiving Nplate™
  4. Monitor healthcare setting and practioner compliance with the baseline data collection, the periodic safety monitoring and reauthorization, discontinuation procedure, and post-discontinuation follow-up of all patients treated with Nplate™. If a healthcare setting or practitioner is found to be non-compliant with the Nplate™ NEXUS Program, Amgen may prevent the healthcare setting or practitioner from enrollling new patients and require the prescriber to order Nplate™ directly through the Nplate™ NEXUS Program
  5. Based on monitoring and evaluation of these elements to assure safe-use, Amgen will take reasonable steps to work to imporve implementation of these elements
Assessment ProgramSee Nplate REMS for complete Assessment Program
Assessment Program TimelineREMS Assessments will be submitted to FDA every 6 months for the first 24 months following approval, then annually (from REMS approval date) thereafter
Branded ProgramNplate™ NEXUS Program
Program DescriptionNplate™ is only available through the Nplate™ NEXUS (Network of Experts Understanding and Supporting Nplate™ and patients) Program. This program is designed to promote informed risk-benefit decisions before initiating treatment and while patients are on treatment to assure appropriate use of Nplate™ in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate™ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts. Nplate™ is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. The Nplate™ NEXUS Program consists of a patient registry and a requirement for prescribers to complete baseline and periodic safety information for every patient. As a prescriber, you must enroll in the Nplate™ NEXUS Program in order to prescribe Nplate™ by completing the Nplate™ NEXUS Program Healthcare Provider Enrollment Form. Prescribers are required to comply with the program requirements.
Link to Branded Programhttp://www.nplatenexus.com/
Deemed/ApprovedApproved
Approval Lettershttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125268s000ltr.pdf

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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