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
Listen to the Nplate® Experts

Watch videos about Nplate® and listen to specialists discuss how to identify appropriate immune thrombocytopenia (ITP) patients for Nplate® treatment, Nplate® dosing, and treatment of patients at various disease stages.

The videos here are also available throughout other pages of this website.

Select tabs below to access the different videos.
  • Newly Diagnosed/
    Persistent ITP
  • Chronic ITP
  • Nplate® MOA
  • Pediatric ITP
  • Nplate® Dosing
  • Newly Diagnosed/
    Persistent ITP
  • Chronic ITP
  • Nplate® MOA
  • Pediatric ITP
  • Nplate® Dosing
Navigating ITP Therapies

Navigating ITP Therapies: Dr. Michael Tarantino Explores ASH and ICR Recommendations, Nplate® Efficacy, Patient experiences, and Access Resources

Join Dr Michael Tarantino as he touches upon ASH and ICR ITP treatment recommendations for first-line steroid use in adult patients, reviews the clinical trial data of second-line Nplate® in adult patients with newly diagnosed or persistent ITP, overviews Nplate® access and coverage resources for your patients, and speaks with a patient who took the next step with Nplate®.

ITP Expert Discusses Nplate® for Newly Diagnosed/Persistent
ITP Patients

ITP expert on Nplate® for newly diagnosed/persistent ITP patients

Dr Dana Thompson reviews updates to ITP treatment guidelines around limiting steroid use to 6–8 weeks, the label expansion of Nplate® to include newly diagnosed/persistent ITP patients, and how these changes have informed his treatment approach.1,2

Listen in as he talks specifically about moving on to second-line therapy with Nplate® earlier in patient example, Ruby, and as a result how she is able to achieve treatment-free remission.3

Patient Case Discussion

Patient Case: Nplate® within 8 weeks of ITP diagnosis

Dr Steven Fein walks through an example patient case with Ruby, who was diagnosed with ITP 8 weeks ago. After an initial course of steroids, Ruby achieved treatment-free remission with Nplate®.3

Nplate® Clinical Trial Data Discussion

Nplate® clinical trial data discussion

Nplate® study investigator Dr Adrian Newland and Dr Ivy Altomare discuss the phase 2 trial of Nplate® in steroid-dependent/refractory ITP patients and how they can achieve treatment-free remission with Nplate® use right after steroid failure.3

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Patient Case: A Chronic ITP Patient Needs Second-Line Treatment

Patient case: A chronic ITP patient needs second-line treatment

Dr Steven Fein discusses a chronic ITP patient case example that’s similar to what he sees in practice: steroid-dependent patients who need greater platelet control after first-line treatment.4

ITP Experts Discuss Chronic ITP and Nplate®

ITP experts discuss chronic ITP and Nplate®

Nplate® study investigators Drs Michael Tarantino and Terry Gernsheimer discuss how chronic ITP impacts patients, their clinical experience with ITP, prescribing Nplate® after first-line treatment failure, and the pivotal Nplate® trials.4

Nplate® After Splenectomy Relapse in Adult ITP

Nplate® after splenectomy relapse in adult ITP

Drs Terry Gernsheimer and Michael Tarantino, Nplate® study investigators, talk about next steps for patient care after splenectomy relapse in adults with chronic ITP and the Nplate® clinical trial for this specific patient type.4

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Nplate® Mechanism of Action

Nplate® mechanism of action (MOA)

An animated video that reviews the pathophysiology of immune thrombocytopenia (ITP; also called idiopathic thrombocytopenic purpura), the role of thrombopoietin, and how Nplate®, a thrombopoietin receptor agonist, increases platelet production in patients with ITP.4

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Nplate® Treatment in Pediatric ITP

Nplate® treatment in pediatric ITP

Dr Michael Tarantino, Nplate® study investigator, discusses the challenges faced by children with ITP, considerations for treatment, and how Nplate® as a second-line treatment can help. He also provides details from the Nplate® phase 3 clinical trial.4

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Personalized Nplate® Dosing

Nplate®: Personalized dosing for adult ITP

In less than 3 minutes, Dr Steven Fein reviews Nplate® dosing based on a patient’s weekly platelet counts and goals for adult ITP treatment.4

Nplate® Adult Dosing Perspectives

Expert perspective: Nplate® dosing in adults

Nplate® study investigators Drs Michael Tarantino and Terry Gernsheimer give an in-depth look at Nplate® dosing in adult ITP. They discuss their clinical approach and how they individualize Nplate® to each ITP patient.4

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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 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®

  • 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 (1‑800‑772‑64361‑800‑772‑6436). 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.
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. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. 2. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. 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(2):262-273. 4. Nplate® (romiplostim) prescribing information, Amgen. 5. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.