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

Once-Weekly, In-Office Nplate® Subcutaneous Injection Proven to Provide ITP Control—Have Confidence in Your Choice1,2

Dosing

DOSING CALCULATOR

Nplate® Dosing Can Be Individualized and Allows for a Maximum Weekly Dose of Up to 10 mcg/kg1

  • The initial dose for Nplate® is 1 mcg/kg based on actual body weight
  • Administer Nplate® as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response

4 Easy Steps To Calculate Your Patient's Total Nplate® Injection Volume1

This dosing calculator provides assistance only. It is not designed or intended to replace the physician’s clinical judgment in determining the appropriate dose for his or her patient.

  • Adult patients: Actual body weight at initiation of therapy should always be used when calculating the dose
  • Pediatric patients: Base future dose adjustments on changes in platelet counts and body weight (reassessment of body weight every 12 weeks is recommended)
mcg/kg

STEP 3: Note total dose (mcg) and injection volume (mL)

Patient's Total Dose--
Patient's Total Dose (mcg) =
patient's weight (kg) x dose (mcg/kg)
Injection Volume--
Injection Volume (mL) =
patient's total dose
500 mcg/mL

STEP 4: Determine Nplate® vial(s) required for single use

Using your patient's total dose and/or injection volume calculated in STEP 3, refer to the full Prescribing Information to determine the appropriate vial required for single-use dose.

Individualize ITP treatment
with Nplate®

Tips for dosing success

  • See the Nplate® dosing and titration guide to Start, Adjust, Maintain, and Monitor
  • Use the lowest dose of Nplate® to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding
  • As the injection volume may be very small, use a syringe that contains 0.01 mL graduations
Watch the directions for Nplate® reconstitution and administration

*The recommended starting dose for Nplate® is 1 mcg/kg.

DOSING & TITRATION GUIDE

Dose for ITP Control and the Potential for Treatment-Free Remission1

Use the lowest dose of Nplate® to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding. Administer Nplate® as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response. Do not exceed maximum weekly dose of 10 mcg/kg.

  • Adult patients: Actual body weight at initiation of therapy should always be used when calculating the dose
  • Pediatric patients: Base future dose adjustments on changes in platelet counts and body weight (reassessment of body weight every 12 weeks is recommended)

Step 1START

Nplate® dose based on body weight (week 1)1

Initial dose: 1 mcg/kg based on actual body weight

Step 2ADJUST

Dose to stabilize platelet count (week 2 to n)1

Adjust Nplate® weekly based upon platelet count response. The goal is to find the dose at which platelet count is between 50–200 x 109/L for ≥ 4 weeks without further changes in dose. Nplate® dosing can be individualized and allows for a maximum weekly dose of up to 10 mcg/kg.

  • If platelet count is < 50 x 109 /L, increase by 1 mcg/kg
  • If platelet count is ≥ 50 x 109/L and ≤ 200 x 109/L, maintain dose
  • If platelet count is > 200 x 109/L and ≤ 400 x 109/L for 2 consecutive weeks, reduce by 1 mcg/kg
  • If platelet count is > 400 x 109/L, DO NOT DOSE. Continue assessing platelet count weekly. After platelet count is < 200 x 109/L, resume at dose decreased by 1 mcg/kg

Weekly CBCs including platelet counts are required until dose is adjusted. In clinical studies, most adult patients who responded to Nplate® achieved and maintained platelet counts ≥ 50 x 109/L with a median dose of 2–3 mcg/kg.

Step 3MONITOR

Monthly stable platelet count over time (week n+1)1

Once an Nplate® stable dose is achieved—platelet count is 50–200 x 109/L
for ≥ 4 weeks without having changed the dose—maintain dose and monitor monthly (CBCs including platelet counts).

Titrate Nplate® according to individual patient response; adjust the weekly dose of Nplate® by increments of 1 mcg/kg until the patient achieves a platelet count of ≥ 50 x 109/L, as necessary, to reduce the risk of bleeding.1

Do not exceed maximum weekly dose of 10 mcg/kg.1

To mitigate against medication errors (both overdose and underdose), ensure that the preparation and administration instructions in the full Prescribing Information are followed.

Discontinuation

Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate® therapy at the maximum weekly dose of 10 mcg/kg. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate®.1

CBC, complete blood count; ITP, Immune thrombocytopenia.

DOSING STUDIES

For Your Best Chance to Achieve Platelet Control, Titrate Nplate® Weekly
Per Label1

Post-hoc pooled analysis of Nplate® responders across different phases of ITP3,*

Distribution of Nplate® responders at first platelet response (n = 570)3,*,†,‡

Post-hoc pooled analysis of Nplate® responders across different phases of ITP
  • In the phase 2 study, rapid onset of platelet response was observed as early as 7 days, with a median of 2.1 weeks. The post-hoc pooled analysis shown here supports these results1,3,4,§
  • However, many patients may require titration to higher doses of Nplate® to achieve platelet response3
  • Data from the post-hoc analysis showed 30% of Nplate® responders required
    3–6 mcg/kg of Nplate®, while 8% required 7–10 mcg/kg3

Titrate Nplate® up weekly by 1 mcg/kg to achieve a platelet response—to a maximum weekly dose of 10 mcg/kg1

Continue Weekly Titration Until a Maintenance Dose Is Achieved1

Post-hoc pooled analysis of Nplate® patients achieving maintenance across different phases of ITP5,**

Distribution of patients by maintenance doses of Nplate® (n = 478)5,**,††

Post-hoc pooled analysis of Nplate® patients achieving maintenance across different phases of ITP
  • In the post-hoc pooled analysis, 45% of patients required a maintenance dose of 1–2 mcg/kg of Nplate®5
  • However, most patients required dosing higher than 1–2 mcg/kg of Nplate® to achieve maintenance5
  • 40% of patients required 3–6 mcg/kg and 14% required 7–10 mcg/kg5
  • Maintenance dose was defined as the dose required to achieve platelet counts 50–200 x 109/L for ≥ 4 weeks without dose adjustments1,5

Titrate Nplate® up to a maximum of 10 mcg/kg/week to stabilize platelet count—once a stable dose is achieved, monitoring can be reduced to monthly1

  • Maintenance dose was defined as the dose required to achieve platelet counts 50–200 x 109/L for ≥ 4 weeks without dose adjustments1,5

PHASE 2 STUDY DESIGN: Nplate® was studied in a 52-week, open-label, single-arm, phase 2 trial of 75 adults with immune thrombocytopenia (ITP) for ≤ 6 months who had an insufficient response to first-line ITP treatment. Patients received Nplate® as a weekly subcutaneous injection for 12 months, with a starting dose of 1 mcg/kg, titrated per label to maintain platelet counts of 50 x 109/L to 200 x 109/L. 61% (n = 46/75) of patients sustained platelet counts ≥ 50 x 109/L for ≥ 11 months (primary endpoint).1,2

* Based on the Adult ITP Efficacy Set which consisted of adult subjects (age ≥ 18 years at screening) who received ≥ 1 romiplostim dose in one of several studies. Only patients whose starting dose was 1 mcg/kg and dose was titrated per label (1 mcg/kg/week) with the aim of achieving a response were included (n = 651). 570 out of 651 patients (88%) achieved a platelet response.3

† Platelet response was defined as platelet count ≥ 50 x 109/L at any scheduled visit, excluding counts obtained after discontinuation of Nplate® or within 8 weeks after receipt of rescue medications.3

‡ The graph only illustrates the proportion of patients who responded to Nplate® at doses per label. Out of the patients who responded to Nplate®, 44.4% achieved first platelet response at 1 mcg/kg, 17.0% at 2 mcg/kg, 14.9% at 3 mcg/kg, 5.6% at 4 mcg/kg, 5.8% at 5 mcg/kg, 3.2% at 6 mcg/kg, 2.5% at 7 mcg/kg, 1.6% at 8 mcg/kg, 1.6% at 9 mcg/kg, and 2.1% at 10 mcg/kg.1

§ 95% Cl: 1.1, 3.0; 5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.

**Based on the Adult ITP Efficacy Set which consisted of adult subjects (age ≥ 18 years at screening) who received ≥ 1 romiplostim dose in one of several studies. Only patients whose starting dose was 1 mcg/kg and dose was titrated per label (1 mcg/kg/week) with the aim of achieving a response were included (n = 651). 570 out of 651 patients (88%) achieved a platelet response.3 478 out of 570 patients (84%) attained a maintenance dose of Nplate®. A maintenance dose is defined as one at which platelet count is 50–200 x 109/L for ≥ 4 weeks without changing the dose.5,6

††The graph only illustrates the proportion of patients who responded to Nplate® at doses per label. In accordance with label, 23.8% achieved maintenance at 1 mcg/kg, 21.5% at 2 mcg/kg, 17.8% at 3 mcg/kg, 11.1% at 4 mcg/kg, 6.9% at 5 mcg/kg, 3.8% at 6 mcg/kg, 3.6% at 7 mcg/kg, 2.5% at 8 mcg/kg, 2.5% at 9 mcg/kg, and 5% at 10 mcg/kg.1,5

CI, confidence interval.

IMPORTANT FACTORS OF TREATMENT

Nplate® Offers a Once-Weekly, In-Office, Subcutaneous Injection1

No daily pill reminders

No need to
remember to take
a pill every day1,7-10

No liver monitoring required

No liver monitoring, and
no known drug interactions
(eg, antacids, statins, and
anti-hypertensive medications)1,6

Only TPO-RA that can be taken with or without food

No known dietary restrictions, (given with or without food), including bread, milk and cereal, ice cream, cheese, tofu, calcium-fortified orange juice, yogurt, pizza, and leafy green vegetables1

DOSING & ADMINISTRATION VIDEOS

Dose for Confidence

See what Nplate® dosing* and administration might look like for you and your practice

Always reference the complete dosing and administration information in the full Prescribing Information for Nplate®. Download now >

Personalized Nplate® Dosing

ITP specialist Steven Fein gives a quick and comprehensive overview of personalized adult dosing with Nplate® and what it means for patients.

Nplate® Adult Dosing and Reconstitution

An overview of the preparation and administration process of Nplate®.

Nplate® Adult Dosing Perspectives

Two leading hematologists, Dr Michael Tarantino and Dr Terry Gernsheimer, discuss Nplate® dosing and titration to address their patients’ needs.

*The recommended starting dose for Nplate® is 1 mcg/kg.1 Please see the Nplate® full Prescribing Information for complete dosing instructions, including guidelines for dose adjustments.

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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. 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. Data on file, Amgen; Distribution of Nplate® doses at first platelet response (Adult ITP Efficacy Set); 2024. 4. Data on file, Amgen; Time to onset, biostatistical analysis; 2019. 5. Data on file, Amgen; Distribution of Nplate® maintenance doses (Adult ITP Efficacy Set); 2023. 6. Data on file, Amgen; Investigator’s brochure; 2022. 7. Promacta® (eltrombopag) full Prescribing Information, Novartis. 8. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 9. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 10. Data on file, Amgen; Clinical Study Report 20080435; 2014. 11. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.