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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For adults with newly diagnosed/persistent ITP right after
an insufficient response to steroids*

Your next move
could determine hers

For adults with newly diagnosed/persistent ITP right after
an insufficient response to steroids*

Start Nplate® earlier to give your patients platelet control and the opportunity for treatment‑free remission1,2

Could your next patient benefit?

Treatment-free remission was a secondary endpoint defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months in the absence of any ITP treatment, and occurred in 32% (n = 24/75) of patients.1,2

The primary endpoint of the study (N = 75) was the cumulative number of months in which patients achieved a platelet response.2

*Nplate® was initiated following a platelet count ≤ 30 x 109/L at any time during the 4-week screening period. Nplate® was initiated within 6 months of ITP diagnosis.1,2

STUDY DESIGN

In newly diagnosed/persistent ITP

The first prospective trial to evaluate treatment‑free remission with Nplate® (romiplostim)2

Nplate® was studied in a 52-week, open-label, single-arm, phase 2 trial of 75 adults with ITP for ≤ 6 months who had an insufficient response (platelet count ≤ 30 x 109/L) to first-line ITP treatment, including corticosteroids.1-4,*

  • Nplate® was initiated 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
Primary endpoint:

Cumulative number of months in which a patient achieved a median platelet count ≥ 50 x 109/L2

Select secondary endpoint:

Rate of remission, defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months without any ITP treatment2

The lack of a placebo control group prevents determination of remission rates without Nplate®.2

*First-line treatments could have also included immunoglobulins, anti-D immunoglobulin, or vinca alkaloids.2

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

TPO-RA, thrombopoietin receptor agonist.

PATIENT CHARACTERISTICS

Nplate® (romiplostim) clinical trial in adults with newly diagnosed/persistent ITP1,2

Patients received Nplate® within 6 months of diagnosis,
right after insufficient response to steroids1,2

NO PRIOR
rituximab* or splenectomy2,4
96% of patients

received prior corticosteroid treatment

(n = 72/75)

INITIATED EARLY
in the course of disease1
2.2 months

median time from diagnosis to Nplate®

(range, 0.1-6.6)

*Rituximab is not FDA-approved for use in ITP.5

PLATELET CONTROL

Nplate® (romiplostim) offers patients the potential for a rapid platelet response and lasting stability1,2

Primary endpoint: 61% of patients sustained platelet counts ≥ 50 x 109/L
for ≥ 11 months (n = 46/75)2

Platelet response

of patients achieved
a platelet response1,*

(n = 70/75)

Rapid onset

median time to onset, with
responses occurring as early
as week 1 of treatment1,6,

(95% Cl: 1.1, 3.0)

*Platelet response was defined as a platelet count ≥ 50 x 109/L.1

5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.6

CI, confidence interval.

TREATMENT‑FREE REMISSION

Clinical trial results demonstrated that treatment-free remission is possible with Nplate® (romiplostim)1,2

~1 out of 3* 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 treatment1
  • Nplate® was used right after insufficient response to steroids1

Median time to onset of treatment‑free remission was 27 weeks (range, 6–57)1,2

  • Most patients were tapered off of Nplate® as determined by their platelet counts following the PI-recommended dosing regimen (n = 20/24)1-3
  • 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 reductions are described for platelet counts > 200 x 109/L. Please see Section 2.1 of the Nplate® Prescribing Information1‑3
Platelet count and dose in patients achieving
treatment-free remission (n = 24)1-3
20/24 patients entered remission during the 52-week treatment period
based on the recommended dosage regimen in the Nplate® PI1-3,†
Visit the dosing page to learn more about Nplate® dosing.

*32% of patients achieved treatment‑free remission.1,2

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

SAFETY PROFILE/SIDE EFFECTS

The side effect profile was consistent with the known profile of Nplate® (romiplostim)2

No new safety signals were observed. Most adverse events were mild to moderate in severity1,2

Most common adverse events during the treatment period (N = 75)2
ADVERSE EVENT n (%)
Headache 12 (16)
Arthralgia 11 (15)
Nasopharyngitis 9 (12)
Hematoma 8 (11)
Cough 7 (9)
  • 84% of patients (n = 63/75) reported treatment-emergent adverse events
  • Serious treatment-related adverse events were reported in 3 patients: gastritis, increased transaminases,* and reversible ischemic neurologic deficit (1 patient each)
Most common (≥ 5%) bleeding events during the treatment period (N = 75)2
BLEEDING EVENT n (%)
Hematoma 8 (11)
Petechiae 7 (9)
Epistaxis 6 (8)
  • Any bleeding event occurred in 31% of patients (n = 23/75)
  • No serious bleeding event occurred

*Led to discontinuation of Nplate®.2

GUIDELINES

2019 Immune thrombocytopenia
treatment guidelines

Limit duration of first-line steroid use prior to starting a second-line ITP treatment, such as Nplate® (romiplostim)7,8

In 2019 the American Society of Hematology (ASH) and the International Consensus Report (ICR) released updates to their guidelines for ITP treatment. These updates are based on a critical review of relevant articles published over the last 10 years.7,8

Recent evidence suggests that ITP is often managed with prolonged steroid use, exposing patients to side effects that may have long-term implications.7

ASH and ICR ITP treatment guidelines recommend limiting duration of steroid use to a maximum of 6 to 8 weeks7,8
ASH recommendation8
≤ 6 weeks of steroid treatment

is preferred vs prolonged, continuous use

Delay splenectomy until after 1 year

Access the full ASH Guidelines.
Read more

ICR recommendation7
≤ 6 weeks of steroid treatment (8 weeks max)

in patients who achieve a response

even if platelet counts drop during taper

Delay splenectomy until ≥ 1 year to 2 years

Access the full ICR Guidelines.
Read more

EXPERT VIDEO

Experts discuss using Nplate® (romiplostim) earlier for potential treatment-free remission1,2

Dr Adrian Newland (primary investigator) and Dr Ivy Altomare discuss results from the phase 2 study and how they could impact patients’ immune thrombocytopenia treatment goals2

Experts discuss using Nplate earlier for potential treatment-free remission
Expert Video

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.

References: 1. Nplate® (romiplostim) prescribing information, Amgen. 2. 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. 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. RITUXAN® (rituximab) full Prescribing Information, Genentech, Inc. 6. Data on file, Amgen; Time to Onset, biostatistical analysis; 2019. 7. 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. 8. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866.

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