Nplate® (romiplostim)

The Nplate® Share Program

As part of its ongoing commitment to improve access to healthcare, Amgen actively supports a comprehensive reimbursement program for your eligible Nplate® patients. The Nplate® Share Program assists commercially insured patients with their out-of-pocket requirements for Nplate®

Enrollment:

Patients must be enrolled in the Nplate® NEXUS Program and provide the following information: name and Social Security number, annual income, household, insurance information, Nplate® NEXUS Program identification number, and physician information.

To enroll, contact your Amgen sales representative for more information, or you can call the Nplate® NEXUS hotline at 1-877-NPLATE1 (1-877-675-2831) or visit http://www.nplatenexus.com/.

Eligibility Criteria:

  • To be eligible, patients must be receiving Nplate® for the FDA-approved indication in an outpatient setting, have commercial insurance and an adjusted household gross income of four times the federal poverty level or less annually.
  • Patients are enrolled in the program for a 12-month period based on their individual insurance plan year.
  • Patients must be United States residents not residing in Massachusetts or any other state where the program is prohibited by law.
  • Medicare and Medicaid patients, or any other patient whose prescription is paid in full or in part by any federal healthcare program, are not eligible for the Nplate® Share Program.

Assistance From Independent Nonprofit Co-pay Foundations

Patients who are commercially and government insured (including Medicare), but need financial assistance, can be referred to independent nonprofit co-pay foundations. Amgen makes donations to these foundations that, in turn, help qualifying insured patients with out-of-pocket costs, including co-payments and premiums, to cover the medicines they need.

Amgen Assist™ can help patients identify which co-pay foundations they may be qualified for, and provide referrals for these foundations. However, Amgen Assist™ cannot guarantee that a patient will receive assistance since these co-pay foundations are independent and not affiliated with Amgen. Each foundation has its own eligibility criteria which includes an evaluation of individual’s financial, medical, and insurance status.

For more information about co-pay support or referral to an independent co-pay foundation, call one of our coverage and reimbursement services specialists at 1-800-272-9376.


Product Information

Indications

Nplate® is 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 increases the risk for bleeding.  Nplate® should not be used in an attempt to normalize platelet counts.

Important Safety Information

Serious adverse reactions associated with Nplate® in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate® discontinuation.

Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis

  • Nplate® administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow.
  • In clinical studies, Nplate® was discontinued in four of the 271 patients because of bone marrow reticulin deposition. Six additional patients had reticulin observed upon bone marrow biopsy. All 10 patients with bone marrow reticulin deposition had received Nplate® doses > 5 mcg/kg, and 6 received doses > 10 mcg/kg.
  • Progression to marrow fibrosis with cytopenias was not reported in the controlled clinical studies. In the extension study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.
  • Clinical studies have not excluded a risk of bone marrow fibrosis with cytopenias.
  • Prior to initiation of Nplate® examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities. Following identification of a stable Nplate® dose, examine peripheral blood smears and CBCs monthly for new or worsening morphological abnormalities (eg, teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
  • If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with Nplate® and consider a bone marrow biopsy, including staining for fibrosis.

Worsened Thrombocytopenia After Cessation of Nplate®

  • Discontinuation of Nplate® may result in thrombocytopenia of greater severity than was present prior to Nplate® therapy. This worsened thrombocytopenia may increase the patient’s risk of bleeding, particularly if Nplate® is discontinued while the patient is on anticoagulants or antiplatelet agents.
  • In clinical studies 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 two weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.

Thrombotic/Thromboembolic Complications

  • Thrombotic/thromboembolic complications may result from excessive increases in platelet counts. Excessive doses of Nplate® or medication errors that result in excessive Nplate® doses may increase platelet counts to a level that produces thrombotic/thromboembolic complications. In controlled clinical studies, the incidence of thrombotic/thromboembolic complications was similar between Nplate® and placebo.
  • 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.

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® or bone marrow fibrosis. 
  • 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.

Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS)

  • Nplate® stimulation of the TPO receptor on the surface of hematopoietic cells may increase the risk for hematologic malignancies. In controlled clinical studies among patients with chronic ITP, the incidence of hematologic malignancy was low and similar between Nplate® and placebo.
  • In a separate single-arm clinical study of 44 patients with myelodysplastic syndromes (MDS), 11 patients were reported as having possible disease progression, among whom 4 patients had confirmation of acute myelogenous leukemia (AML) during follow-up.
  • Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.

Laboratory Monitoring

  • Monitor CBCs, including platelet counts and peripheral blood smears, prior to initiation, throughout, and following discontinuation of Nplate® therapy.
  • Prior to the initiation of Nplate®, examine the peripheral blood differential to establish the baseline extent of red and white blood cell abnormalities. 
  • Obtain CBCs, including platelet counts and peripheral blood smears, 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 2 weeks following discontinuation of Nplate®.

Nplate® Distribution Program

  • Nplate® is available only through a restricted distribution program called Nplate® NEXUS (Network of Experts Understanding and Supporting Nplate® and Patients) Program.  Under the Nplate® NEXUS Program, only prescribers and patients registered with the program are able to prescribe, administer, and receive Nplate®.  This program provides educational materials and a mechanism for the proper use of Nplate®.  To enroll in the Nplate® NEXUS Program, call 1-877-NPLATE1 (1-877-675-2831). 

General Safety

  • In the placebo-controlled studies, 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%).
  • As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein.