Enroll in the Nplate® NEXUS Program to get your patients started on Nplate®.
The Nplate® NEXUS Program connects you with Nplate® access, support, education, and safety monitoring
Nplate® is available only through the Nplate® NEXUS Program
- Nplate® therapy, support, education, and safety monitoring are available to healthcare providers and their patients who are enrolled in the Nplate® NEXUS Program. The Nplate® NEXUS Program is what the FDA refers to as a Risk Evaluation and Mitigation Strategy (REMS), implemented as part of the FDA Amendments Act of 2007.
- Only prescribers enrolled in Nplate® NEXUS Program may prescribe Nplate®.
Through this required REMS, Amgen will gather long-term safety data on Nplate® therapy. Visit the Nplate® NEXUS website.
The Nplate® NEXUS Program is a single point of access to:
- Simple enrollment and ordering
- Monitoring program to collect patient safety data
- Nplate® NEXUS Healthcare Professional Brochure
- Nplate® NEXUS Patient Brochure
Have questions about the Nplate® NEXUS Program? Talk with a live representative
How to enroll your patient in the Nplate® NEXUS Program:
1. DISCUSS the risks and benefits of Nplate® and review the Medication Guide and Nplate® NEXUS
Program Patient Enrollment Form with your patient.*
2. INSTRUCT your patient to complete and sign pages 2 and 3 of the Patient Enrollment Form.
3. FAX the signed forms to 1-877-NPLATE0 (1-877-675-2830). Enrollment is confirmed by fax, and
a NEXUS ID number will be issued for your patient.
4. COMPLETE the NEXUS Patient Baseline Data Form and fax to 1-877-NPLATE0 within 30 days of
*Spanish-language versions of patient materials are available online.
By enrolling in the Nplate® NEXUS Program, a healthcare provider agrees to educate patients on the benefits and risks of Nplate® therapy and to report adverse events to the Nplate® NEXUS Program. For simple instructions on how to get started with Nplate® for you and your patients, download the Quick Reference Guide to the Nplate® NEXUS Program.Connect to the Nplate® NEXUS Program website.
Have questions about the Nplate® NEXUS Program?
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. 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.
IMPORTANT SAFETY INFORMATION
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
- In Nplate® clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed.
- Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.
- Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate®. Nplate® should be used with caution in patients with ITP and chronic liver disease.
- To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L.
Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
- Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®.
- In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy. Clinical trials are in progress to assess the risk of bone marrow fibrosis and clinical consequences with cytopenias.
- If new or worsening morphological abnormalities or cytopenia(s) occur, consider a bone marrow biopsy to include staining for fibrosis.
Worsened Thrombocytopenia after Cessation of Nplate®
- In clinical trials of patients with chronic ITP who had Nplate® discontinued, four of 57 patients developed thrombocytopenia of greater severity than was present prior to Nplate® therapy. This worsened thrombocytopenia resolved within 14 days.
- Following discontinuation of Nplate®, obtain weekly CBCs, including platelet counts, for at least 2 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.
Lack or Loss of Response to Nplate®
- Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®.
- To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). Amgen will assay these samples for antibodies to Nplate® and thrombopoietin (TPO).
- Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.
- Obtain CBCs, including platelet counts, weekly during the dose adjustment phase of Nplate® therapy and then monthly following establishment of a stable Nplate® dose.
- Obtain CBCs, including platelet counts, weekly for at least two weeks following discontinuation of Nplate®.
- In the placebo-controlled trials, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.
- Most common adverse reactions (≥ 5% higher patient incidence in Nplate® versus placebo) were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%) , Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
Please see Prescribing Information and Medication Guide
THE NPLATE® FIRST STEP™ PROGRAM
Helps your eligible commercially insured patients who are appropriate for Nplate® treatment meet their out-of-pocket costs.Learn How To Enroll Your Practice
ACCESS THE NPLATE® CLINICAL DATA YOU NEED
Clinical studies have evaluated the safety and efficacy of Nplate® treatment in adult patients with chronic ITP. Nplate® clinical trials have been conducted in both splenectomized and non-splenectomized patients, with some patients receiving Nplate® treatment for > 5 years.Review Nplate® Clinical Data
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