INDICATIONS

Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months 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 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.

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PRESCRIBING INFORMATION INDICATIONS IMPORTANT SAFETY INFORMATION VISIT PATIENT SITE

Early Nplate® Use Could Give Your Patients Platelet Control and the Opportunity for Treatment-Free Remission1

Adult Remission Data

PLATELET CONTROL

Nplate® Offers Patients the Potential for a Rapid Platelet Response and Lasting Stability1,2

93% of patients achieved a platelet response

Platelet Response

93% of patients achieved any platelet response2,*
(n = 70/75)

7 day rapid onset potential

Rapid Onset

Rapid onset as early as 7 days with median time to onset of 2.1 weeks1,3,†
(95% Cl: 1.1, 3.0)

Equal to or greater than 11 months lasting stability

Lasting stability

Most patients (61%) achieved and maintained a platelet response for
≥ 11 months (n = 46/75)1


*Platelet response was defined as a platelet count ≥ 50 x 109/L.2

†5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.3

CI, confidence interval.

TREATMENT-FREE REMISSION

Secondary Endpoint:

~ 1/3 of Patients Achieved Treatment-Free Remission, Maintaining Platelet Counts ≥ 50 x 109/L With No ITP Treatment for at Least 6 Months1,2

Platelet count and dose in patients achieving treatment-free remission (n = 24)1-3

Platelet count and dose in patients achieving treatment-free remission
  • 32% of patients achieved treatment-free remission (n = 24/75)1,2
    • Nplate® maintained every platelet count at ≥ 50 x 109/L for at least 6 months without any ITP treatment2
    • Nplate® was used right after insufficient response to steroids2
  • Median time to onset of treatment-free remission was 27 weeks (range, 6–57)1,2
    • 20/24 patients were tapered off of Nplate® as determined by their platelet count and entered remission during the 52-week treatment period based on the recommended dosage regimen in the Nplate® PI1-3,*
    • Adjust the weekly Nplate® dose by increments of 1 mcg/kg (not to exceed 10 mcg/kg) to maintain a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L1,2
      • In patients achieving treatment-free remission, median weekly Nplate® dose was 1.7 mcg/kg prior to stopping treatment (range, 0.7–7.6)4
  • Dose was adjusted† up or down to achieve a stable platelet count ≥ 50 x 109/L to ≤ 200 x 109/L1-3

In a post hoc subgroup analysis of the newly diagnosed ITP patients (<3 months) and persistent ITP patients (≥3–≤12 months): 38% of the newly diagnosed patients and 23% of the persistent patients achieved treatment-free remission respectively5,*

*Post hoc subgroup analysis was performed on newly diagnosed (n=45) and persistent ITP patients (n=30) from the same phase 2 clinical trial. The remission rate in each subgroup was not a study objective and was not powered to assess efficacy.5

Learn more about dosing Nplate®  for potential treatment-free remission

BASED ON A RETROSPECTIVE OBSERVATIONAL STUDY

Clinical and Real Word Evidence data Support Starting Nplate® in 2L for an Opportunity to Reach Remission6,†

Observed rates of remission when used in 2L and 3L

Started and remained
on Nplate® in 2L6

51% TFR

Achieved treatment-free remission†
(n = 21/41)

Started Nplate® in 3L6

8% TFR

Achieved treatment-free remission†
(n = 2/26)

RWE study is consistent with phase 2 treatment-free remission data in 2L1,6

† Treatment-free remission definition: Maintained all platelet counts at ≥ 50 x 109/L for ≥ 6 months without any ITP treatment.6

2L, second line; 3L, third line; ITP,  immune thrombocytopenia; RWE, real-world evidence; TFR, treatment-free remission.

  • Study Design6
    Observational, retrospective, multicenter study of 121 adult patients with ITP up to 5.6 years after they were diagnosed. 20 patients had newly diagnosed ITP, 19 patients had persistent ITP, and 82 patients had chronic ITP. Study took place between November 2016 and January 2018 and was not powered/ designed to assess efficacy of the treatment groups.

Watch why Dr. Michael Tarantino chooses Nplate® for second-line treatment in newly diagnosed/persistent ITP

Navigating ITP Therapies

Where could your patients be in 6 months?Don’t wait—Choose Nplate® first when your ITP patient needs second-line treatment1

*This regimen includes reducing, withholding, and discontinuing Nplate® if/when platelet counts exceed certain levels. Of the 24 patients who achieved treatment‑free remission, 20 (83%) discontinued Nplate® based on this regimen during the 52-week treatment period; 4 patients (17%) tapered Nplate® at the end of the 52-week treatment period using a different dosage adjustment approach per the study protocol.1-3

†Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate® Prescribing Information).2

STUDY DESIGN & PATIENTS

The First Prospective Trial to Evaluate Treatment-Free Remission With Nplate®

Nplate® was studied in adult patients with newly diagnosed/persistent ITP

Nplate® was studied in a 52-week, open-label, single-arm, phase 2 trial of 75 adults with newly diagnosed/persistent ITP for ≤ 6 months who had an insufficient response (platelet count ≤ 30 x 109/L) to first-line ITP treatment, including corticosteroids.1-4,* The primary endpoint was the cumulative number of months in which a patient achieved a median platelet count ≥ 50 x 109/L. 1 The secondary endpoint was the rate of remission, defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months without any ITP treatment.1-4

Patients received Nplate® within 6 months of diagnosis, right after insufficient response to first-line treatment1-4

  • 96% (n = 72/75) of patients received prior corticosteroid treatment, with no prior rituximab use or splenectomy
  • Nplate® was initiated early in the course of the disease (2.2 months median time from diagnosis to Nplate®; range 0.1–6.6) at 1 mcg/kg and adjusted to achieve a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L†
  • At the end of the 52-week treatment period, patients who had not entered remission, were still receiving Nplate®, and maintained a platelet count ≥ 50 x 109/L had their dose tapered by 1 mcg every 2 weeks, as long as weekly platelet counts remained ≥ 50 x 109/L
See the adult newly diagnosed/persistent ITP safety data

*First-line treatments could have also included immunoglobulins, anti-D immunoglobulin, or vinca alkaloids.1

†Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate® Prescribing Information).
ITP, Immune thrombocytopenia.

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Important Safety Information

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) 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 ITP.

Thrombotic/Thromboembolic Complications

  • Thrombotic/thromboembolic complications have resulted from increases in platelet counts with Nplate® use in the ITP population, including deep vein thrombosis (1.4%), pulmonary embolism (1.2%) and myocardial infarction (0.8%). Other thrombotic events including transient ischemic attack have been reported. These events have occurred regardless of platelet counts. Portal vein thrombosis has been reported in patients both with and without chronic liver disease receiving Nplate®.
  • 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.

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®.
  • 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.
Adverse Reactions
Adult ITP
  • In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Adverse drug reactions in adults with a ≥ 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%).
  • The safety profile of Nplate® was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate® compared with placebo or standard of care) occurred in Nplate® patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months.
Pediatric ITP
  • The most common adverse reactions experienced by ≥ 5% of patients receiving Nplate® with ≥ 5% higher incidence in the Nplate® arm across the two placebo-controlled trials were contusion (41%), upper respiratory tract infection (31%), oropharyngeal pain (25%), pyrexia (24%), diarrhea (20%), rash (15%), and upper abdominal pain (14%).
  • In pediatric patients of age ≥ 1 year receiving Nplate® for ITP, adverse reactions with an incidence of ≥ 25% in the two randomized trials were: contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%).
  • In a long term, single arm, open label pediatric safety study, headache occurred in 78/203 patients (38%); the incidence rates of other adverse reactions were similar to those reported in the placebo-controlled studies.

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.

INDICATIONS

Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months 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 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.

Please see full Prescribing Information and Medication Guide.

Important Safety Information

Risk of
Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

  • In Nplate® (romiplostim) 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 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®.
  • 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.

Loss of Response to Nplate®

References: 1. Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172(2):262-273.
2. Nplate® (romiplostim) prescribing information, Amgen. 3. Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172(Suppl):1-4. 4. Data on file, Amgen; Clinical Study Report 20080435; 2014. 5. Newland AC. Viallard J, Lopez Fernandez MF, et al. Romiplostim for the Treatment of Adult Patients with Newly Diagnosed or Persistent Immune Thrombocytopenia: Subgroup Analysis from a Phase 2 Study. American Society for Hematology. 2021;311. Abstract 3157. 6. Lozano ML, Mingot-Castellano ME, Perera MM, et al. Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia. Sci Rep. 2019;9(1):16680. 7. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.