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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How Nplate® works
Nplate® increases platelet production at a rate that outpaces platelet destruction1,2
Nplate® increases platelet production through binding and activation of the thrombopoietin (TPO) receptor, a mechanism analogous to endogenous TPO.1,2

A TPO receptor agonist, Nplate® is an Fc-peptide fusion protein (peptibody) that contains 2 single-chain subunits, each having a region with 2 TPO receptor-binding domains.1

Nplate® has no amino acid sequence homology to eTPO.1 As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein. In clinical studies of patients with ITP, the incidence of binding antibody development during treatment with Nplate® or a non-US-approved romiplostim product was 4% (50/1112). Of the patients with positive antibodies who developed to romiplostim or to TPO, 5 patients had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No apparent correlation was observed between antibody activity and clinical effectiveness or safety.1,4

Review Nplate® safety profile in adults with newly diagnosed/persistent ITP. Learn more

Learn about the mechanism of action of Nplate (romiplostim) to help restore stability

Nplate® mimics the body’s natural production of platelets1,3

Nplate® targets megakaryocyte and platelet development via the same pathway as eTPO.1,3

In normal thrombopoiesis
In adult ITP, treated with Nplate®
Normal thrombopoiesis
Nplate (romiplostim) binds to the TPO receptor
Nplate (romiplostim) works to increase platelet production


eTPO induces platelet production
by binding at the TPO receptor,
also known as c-MPL,
on megakaryocytes.3


Nplate® binds to the TPO receptor,
activating the same signaling
pathways as eTPO,
resulting in megakaryocyte
and platelet development.1


Nplate®, a TPO mimetic, increases platelet production and can outpace platelet destruction in ITP.1,2
In normal thrombopoiesis


eTPO induces platelet production
by binding at the TPO receptor,
also known as c-MPL,
on megakaryocytes.3
In adult ITP, treated with Nplate®


Nplate® binds to the TPO receptor,
activating the same signaling
pathways as eTPO,
resulting in megakaryocyte
and platelet development.1
In adult ITP, treated with Nplate®


Nplate®, a TPO mimetic, increases
platelet production and can
outpace platelet destruction in ITP.1,2
Nplate® mechanism of action
Watch this instructional video to learn how Nplate® works.
Watch this video to learn how Nplate (romiplostim) works
Nplate® mechanism of action

Nplate® is a TPO mimetic that works to target megakaryocyte and platelet development via the same pathway as eTPO.1,3

Mechanism of action representations are for illustrative purposes only and are not meant to imply clinical efficacy.

Review dosing and titration for once-weekly Nplate®.1 Learn more

Nplate® mechanism of action

Nplate® is a TPO mimetic that works to target megakaryocyte and platelet development via the same pathway as eTPO.1,3

Mechanism of action representations are for illustrative purposes only and are not meant to imply clinical efficacy.

Review dosing and titration for once-weekly Nplate®.1 Learn more

NEXT Learn about the symptoms and risks of ITP

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. Nplate® (romiplostim) prescribing information, Amgen. 2. Gernsheimer TB, George JN, Aledort LM, et al. Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenia (ITP). J Thromb Haemost. 2010;8(6):1372-1382. 3. Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005;115(12):3339-3347. 4. Kuter DJ, Bussel JB, Newland A. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423.