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

For One Less Thing That May Keep Your Pediatric Patients From Doing What They Love, Boost Their Platelet Counts With Nplate® to Reduce the Risk of Bleeding1

PLATELET CONTROL

Nplate® Offers Pediatric Patients the Potential for Overall and Durable Platelet Response

Platelet response in the 24-week phase 3 pediatric trial1

Platelet response in the 24-week phase 3 pediatric trial

7 out of 10 pediatric patients reached target platelet counts with Nplate® 1,*

*Based on overall platelet response.

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Watch why Dr Michael Tarantino chooses Nplate® for second-line treatment in pediatric patients with ITP

Nplate® Treatment in Pediatric ITP

ITP, immune thrombocytopenia.

STUDY DESIGN

Nplate® Was Studied in a Pediatric Population 1–17 Years of Age

Phase 3 pediatric pivotal trial (N = 62)1,2

  • Patients were refractory or relapsed after at least one prior ITP therapy with a platelet count ≤ 30 x 109/L
  • Patients were stratified by age and randomized (2:1) to receive a starting dose of 1 mcg/kg subcutaneously weekly either Nplate® or placebo
    • Age categories were ≥ 1 to < 6 years, 6 to < 12 years, and 12 to < 18 years
  • Over a 24-week treatment period, dose was titrated up to a maximum of 10 mcg/kg weekly of either Nplate® or placebo in an effort to maintain a target platelet count of ≥ 50–200 x 109/L
  • Primary endpoint: Incidence of durable platelet response as defined by weekly platelet responses (platelet count > 50 x 109/L)
  • Secondary endpoint: Overall platelet response defined as a durable or a transient platelet response
    • A transient platelet response was the achievement of any weekly platelet counts ≥ 50 x 109/L for any 4 weeks during the treatment without a durable platelet response
  • Platelet responses were excluded for 4 weeks after receiving rescue medications

TREATMENT RESPONSE

Nplate® Offers Pediatric Patients the Potential for Durable Treatment Response3

  • ~ 94% of pediatric patients responded to treatment with Nplate®*
  • 30-month median duration of response†
  • ~ 7.5 years maximum platelet response†

*Defined as one or more platelet count ≥ 50 x 109/L in the absence of rescue medication.

†Response defined as a median monthly platelet count ≥ 50 x 109/L.

STUDY DESIGN

Nplate® Was Studied in a Long-Term Extension Study of Up To ~ 7.5 Years in Pediatric ITP3,*

Long-term extension trial study design (N = 66)

  • Pediatric subjects who had previously completed an Nplate® ITP study were eligible to participate in the study
  • Primary endpoints were incidence and exposure-adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation
  • Secondary endpoint was platelet response to Nplate®
  • Nplate® was administered weekly by subcutaneous injection
  • Consider long-term study design limitations when interpreting results. This study includes patients from multiple prior studies, is not blinded, not controlled, and includes inherent self-selection bias
See the corresponding safety data

*Median study duration was 2.8 years (N = 65).3

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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. Nplate® (romiplostim) prescribing information, Amgen. 2. Tarantino M, Bussel J, Blanchette V, et al. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016;388:45-54. 3. Data on file, Amgen; Pediatric long-term trial clinical study report; 2017.