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
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After First-Line Treatment
Failure, Choose Nplate®
See Why Nplate® May Be the Right Choice for Second-Line

Which of these patient types* do you most commonly see in your practice? Select a patient and see where Nplate® fits within their immune thrombocytopenia (ITP) treatment journey

Ruby
36 y/o school teacher; newly diagnosed ITP
Hypothetical patient profile of newly diagnosed ITP patient

Ruby received her ITP diagnosis 8 weeks ago with a platelet count of 40 x 109/L. Her first-line treatment was IVIG + 2 weeks of prednisone and 3-week taper1,2


Carlos
54 y/o mechanic; persistent ITP
Hypothetical patient profile, persistent ITP patient

Carlos received his ITP diagnosis 4 months ago with a platelet count of 25 x 109/L. His first-line treatment was 4 days of dexamethasone1,2


Ingrid
41 y/o bank executive; persistent ITP
Hypothetical patient profile, persistent ITP patient

Ingrid received her ITP diagnosis 8 months ago with a platelet count of 12 x 109/L. Her first-line treatment was IVIG + 4 weeks of prednisone and 6-week taper1,2


Cindy
65 y/o small business owner; chronic ITP
Hypothetical patient profile, chronic ITP patient

Cindy received her ITP diagnosis 1 year ago with a platelet count of 10 x 109/L. Her first-line treatment started with IVIG + 4 months of prednisone and taper, followed by steroid pulses at 7 and 10 months2,3


*For illustrative purposes. Patient types are hypothetical and not actual patients.

Ruby, 36-year-old
school teacher

Ruby received her ITP diagnosis 8 weeks ago with a platelet count of 40 x 109/L. Her first-line treatment was IVIG + 2 weeks of prednisone and 3-week taper1,2

Hypothetical female patient profile of newly diagnosed ITP patient

Ruby’s medical history and ITP journey

  • Asymptomatic at ITP diagnosis1,2
  • After a 2-week watch and wait period, platelet counts dropped to 15 x 109/L with bruising on lower extremities and fatigue1,2
  • Received IVIG and 2 weeks of prednisone + 3-week taper1,2
  • At the end of the 3-week taper period, platelet counts dropped to 30 x 109/L1,2
  • While off prednisone, platelet counts dropped further to 25 x 109/L1,2

Ruby's perspective on first-line treatment

  • Frustrated with the side effects she is experiencing1,2,4
  • Concerned about taking second course of steroids1,2,4
  • Goal is for platelet stability that lasts, even if off treatment1,2,4
Hypothetical female patient profile of newly diagnosed ITP patient
When I started Nplate®,
the goal was to stabilize
my platelet counts. And
now here I am off all
ITP treatment.
  • See how Ruby and her doctor took the next step with Nplate®

    Ruby achieved treatment-free remission with Nplate® after a first course of steroids4,5,*

    • Initiated Nplate® at 1 mcg/kg; adjusted dose to achieve a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L4
    • At week 31 on Nplate®, after platelet counts remained > 200 x 109/L for 2 consecutive weeks, Nplate® dose was tapered down by 1 mcg/kg, down to 0 mcg/kg and taken off Nplate®5
    • At week 55 on Nplate®, achieved treatment-free remission after being off all ITP treatment for ≥ 6 months with platelet counts ≥ 50 x 109/L4,5

    Response on Nplate®4,5

    Nplate® response for newly diagnosed ITP patient Nplate® response for newly diagnosed ITP patient

    *In the phase 2 remission study of adults with ITP for ≤ 6 months who had an insufficient response to first-line treatment, 32% (n = 24/75) of patients achieved treatment-free remission, defined as maintaining platelet counts ≥ 50 x 109/L with no ITP treatment for at least 6 months.4,5

    See clinical data on patients like Ruby

    Hear Dr Steven Fein walk through Ruby’s hypothetical patient case

    Patient Case Discussion

Carlos,
56-year-old mechanic

Carlos received his ITP diagnosis 4 months ago with a platelet count of 25 x 109/L. His first-line treatment was 4 days of dexamethasone1,2

Hypothetical male patient profile, persistent ITP patient

Carlos’ medical history and ITP journey

  • Comorbidities: Type 2 diabetes controlled with medication1,2
  • Asymptomatic at ITP diagnosis; did not follow up for 8 weeks1,2
  • At follow-up 8 weeks after diagnosis, platelet counts dropped to 20 x 109/L with heavy bruising and persistent nosebleed1,2
  • Received dexamethasone and discontinued use after 4 days1,2
  • While off dexamethasone, his platelet counts dropped to 30 x 109/L and further to 22 x 109/L1,2

Carlos’ perspective on first-line treatment

  • Experienced high blood sugar and irritability1,2
  • Doesn’t want a daily medication that also affects his diet1,2
  • Has a goal of treatment-free remission1,2
Hypothetical male patient profile, persistent ITP patient
I want an ITP
treatment that doesn't
require me to take it
every day and to not
have to schedule it
around meals.
  • See how Carlos and his doctor took the next step with Nplate®

    Carlos achieved a rapid response and treatment-free remission with Nplate®4,5,*

    • Initiated Nplate® at 1 mcg/kg; adjusted dose to achieve a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L4
    • At week 14 on Nplate®, after platelet counts remained > 200 x 109/L for 2 consecutive weeks, Nplate® dose was tapered down by 1 mcg/kg, down to 0 mcg/kg and taken off Nplate®4,5
    • At week 38 on Nplate®, achieved treatment-free remission after being off all ITP treatment for ≥ 6 months with platelet counts ≥ 50 x 109/L4,5

    Response on Nplate®4,5

    Nplate® response for persistent ITP patient Nplate® response for persistent ITP patient

    *In the phase 2 remission study of adults with ITP for ≤ 6 months who had an insufficient response to first-line treatment, the median time to onset of platelet response (platelet count ≥ 50 x 109/L) was 2.1 weeks. 32% (n = 24/75) of patients achieved treatment-free remission, defined as maintaining platelet counts ≥ 50 x 109/L with no ITP treatment for at least 6 months.4,5

    See clinical data on patients like Carlos

Ingrid, 41-year-old
bank executive

Ingrid received her ITP diagnosis 8 months ago with a platelet count of 12 x 109/L. Her first-line treatment was IVIG + 4 weeks of prednisone and 6-week taper1,2

Hypothetical female patient profile, persistent ITP patient

Ingrid’s medical history and ITP journey

  • Presented with petechiae on extremities and pronounced ecchymosis on right knee1,2
  • Received IVIG + 4 weeks of prednisone and 6-week taper, but fatigue, insomnia, and irritability worsened while on steroids1,2
  • At the end of the 6-week taper period, platelet count was 80 x 109/L1,2
  • While off prednisone, platelet counts dropped further to 19 x 109/L1,2

Ingrid’s perspective on first-line treatment

  • Fatigue that worsened while on steroids2
  • Worried about bruising and spontaneous bleeding due to her active lifestyle2
Hypothetical female patient profile, persistent ITP patient
I made the right choice
going with Nplate®. It
got my platelet counts
up quickly and they’ve
stayed pretty stable.
  • See how Ingrid and her doctor took the next step with Nplate®

    Ingrid achieved long-term platelet stability with Nplate®4*

    • Initiated Nplate® at 1 mcg/kg; adjusted dose to achieve and maintain a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L4
    • At week 42 on Nplate®, dose was titrated to 3 mcg/kg and platelet counts stabilized4,5
    • At week 76 on Nplate®, Ingrid maintained her Nplate® dose at 3 mcg/kg with platelet counts between 100 x 109/L and 200 x 109/L4,5

    Response on Nplate®4

    Nplate® response for persistent ITP patient Nplate® response for persistent ITP patient

    *In the phase 2 remission study of adults with ITP for ≤ 6 months who had an insufficient response to first-line treatment, 61% (n = 46/75) of patients sustained platelet counts ≥ 50 x 109/L for ≥ 11 months.4,5

    See clinical data on patients like Ingrid

Cindy, 65-year-old
small business owner

Cindy received her ITP diagnosis 1 year ago with a platelet count of 10 x 109/L. Her first-line treatment started with IVIG + 4 months of prednisone and taper, followed by steroid pulses at 7 and 10 months2,3

Hypothetical female patient profile, chronic ITP patient

Cindy’s medical history and ITP journey

  • Comorbidities: Hypertension, type 2 diabetes controlled with medication1-3
  • At diagnosis, hospitalized for acute ITP with persistent nosebleed, gingival bleeding, petechial rash on legs, and bruising on arms1-3
  • After 4 months of prednisone + taper, platelet counts were 73 x 109/L1-3
  • Became steroid-dependent, requiring steroid pulses at months 7 and 101-3
  • At 12 months, platelet counts dropped to 19 x 109/L1-3
Hypothetical female patient profile, chronic ITP patient 
Knowing my platelet
count each week gives
me confidence that I
am staying ‘in the
target zone.’
  • See how Cindy and her doctor took the next step with Nplate®

    Cindy achieved long-term platelet stability with Nplate®4,*

    • Initiated Nplate® at 1 mcg/kg; adjusted dose to achieve and maintain a platelet count ≥ 50 x 109/L to ≤ 200 x 109/L4,5
    • At week 3 on Nplate®, dose was 3 mcg/kg and platelet counts were over 200 x 109/L4,5
    • After a few dose adjustments, Cindy’s Nplate® dose was 2 mcg/kg at week 11 and platelet counts stabilized in the 80 x 109/L to 90 x 109/L range thereafter4,5

    Response on Nplate®4,5

    Nplate® response for chronic ITP patient Nplate® response for chronic ITP patient

    *In the phase 3 study of adults with chronic ITP who had completed ≥ 1 prior treatment and were not splenectomized, 61% (n = 25/41) of patients who received Nplate® achieved durable platelet response and 88% (n = 36/41) achieved overall platelet response.4

    See clinical data on patients like Cindy

    Hear Dr Steven Fein walk through Cindy’s hypothetical patient case

    Patient Case: A Chronic ITP Patient Needs Second-Line Treatment
IVIG, intravenous immunoglobulin.
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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 DC, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. 3. Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425-442. 4. Nplate® (romiplostim) prescribing information, Amgen. 5. 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. 6. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.