The Nplate FIRST STEP™ Program

Nplate FIRST STEP

As part of Amgen's ongoing commitment to improving access to healthcare, Amgen actively supports a comprehensive co-pay coupon program for Nplate^® patients who meet certain eligibility requirements. The Nplate FIRST STEP™ Program is intended to assist eligible patients with their deductible co-insurance or co-payment requirement for Nplate^®. There is no income eligibility requirement for this program. At the time of the first injection, Amgen will pay 100% of an eligible patient’s deductible co-insurance or co-payment requirement. For all subsequent injections, Amgen will pay the patient’s deductible co-insurance or co-payment amount in excess of $25 per cycle up to a combined total of $5,000 per 6-month program period.

Patients who participate in Medicare, Medicaid or any other federally funded healthcare program are ineligible for program benefits. This program is not valid in Massachusetts or where otherwise prohibited by law. Certain other program restrictions and limitations apply. To determine if you meet the eligibility requirements or for more information regarding program restrictions and limitations, please call 1-888-65-STEP1 (1-888-657-8371) or go online to www.AmgenFIRSTSTEP.com. Amgen reserves the right to cancel or modify this program at any time.

For ITP reimbursement support or more information about any of the programs listed above, please contact the Amgen Assist™ hotline at 1-888-4ASSIST (1-888-427-7478) or visit http://www.amgenassistonline.com.

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INDICATION

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

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 study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate^® therapy. Clinical studies 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 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 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.

Laboratory Monitoring

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^®.

Adverse Reactions

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%).

Please see Prescribing Information and Medication Guide

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