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
Nplate® campaign-Reasons to choose Nplate® first at second-line for patients at any stage of their ITP journey
Nplate® campaign-Reasons to choose Nplate® first at second-line for patients at any stage of their ITP journey

Don't Wait. Treat Now With Nplate®

Rapid Efficacy That Lasts, No Known Drug Interactions OR Food Restrictions, Opportunity for Treatment-Free Remission1-3

Choose Nplate® first at second-line—Learn Why
Nplate® dosing calendar
Learn about once-weekly dosing
Treatment-free remission
See the opportunity for treatment-free remission
Nplate® physician videos
Hear why experts choose Nplate® after first-line failure
Don’t Wait. Nplate®—The Brand You Know with Over 483,000 Patients Served Globally.4,*

CLINICAL STUDIES DEMONSTRATED:

Rapid Efficacy That Lasts1,2

Nplate® is the only approved immune thrombocytopenia (ITP) therapy with treatment-free remission in the label

93% of patients achieved any platelet response
93% of patients achieved any platelet response†
(n = 70/75)1
Responses seen as early as seven days with median of 2.1 weeks
Responses seen as early
as 7 days with a median of 2.1 weeks1,5,‡​
Approximately one-third of ITP patients achieved treatment-free remission
~ 1/3 of patients achieved
treatment-free remission and median time to onset was ~ 6 months
(range, 6–57 weeks)1 (n = 24/75)1
  • ASH ITP guidelines suggest Nplate® as a second-line therapy over non–TPO-RAs like rituximab and limiting duration of steroids to ≤ 6 weeks6,§

Lasting stability: Most patients (61%) achieved and maintained a platelet response for ≥ 11 months (n = 46/75)2

*Number of patients on Nplate® estimated from launch through June 30, 2023. Data collected are worldwide.

†Platelet response was defined as a platelet count ≥ 50 x 109/L during 12-month treatment period.1

‡95% CI: 1.1, 3.0; 5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively. 1,5

§Rituximab is not FDA-approved for use in ITP.7

  • Study Design
    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. 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.1,8 The primary endpoint of the study (N = 75) was the cumulative number of months in which patients achieved a platelet response.1,2,5,9

BASED ON A RETROSPECTIVE OBSERVATIONAL STUDY

Clinical and Real Word Evidence data Support Starting Nplate® in 2L for an Opportunity to Reach Remission6,**

Observed rates of remission when used in 2L and 3L

Started and remained
on Nplate® in 2L8

51% TFR

Achieved treatment-free remission**
(n = 21/41)

Started Nplate® in 3L8

8% TFR

Achieved treatment-free remission**
(n = 2/26)

RWE study is consistent with phase 2 treatment-free remission data in 2L2,8

**Treatment-free remission definition: Maintained all platelet counts at ≥ 50 x 109/L for ≥ 6 months without any ITP treatment.8

2L, second line; 3L, third line; ITP,  immune thrombocytopenia; RWE, real-world evidence; TFR, treatment-free remission.

  • Study Design8
    Observational, retrospective, multicenter study of 121 adult patients with ITP up to 5.6 years after they were diagnosed. 20 patients had newly diagnosed ITP, 19 patients had persistent ITP, and 82 patients had chronic ITP. Study took place between November 2016 and January 2018 and was not powered/ designed to assess efficacy of the treatment groups.

Choose Nplate® first when your ITP patient needs second-line treatment.2
See the study data on rapid and lasting efficacy

Established Safety Profile Without Food Restrictions

Once-weekly, in-office, subcutaneous injection1

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

Only TPO-RA that can be taken with or without food and without any dietary restrictions

  • Including bread, milk and cereal, ice cream, cheese, tofu, calcium-fortified orange juice, yogurt, pizza, and leafy green vegetables1
No daily pill reminders

No need to wonder if your patient is taking a pill every day1,10-12

Established Safety Profile

5 years

No new safety signals observed up to 5 years of continuous treatment13

No liver monitoring required

No liver monitoring and no known drug interactions1,3

  • No interactions with other drugs (eg, statins, multivitamins, and CYP enzyme inhibitors or inducers††)1
See established safety profile of Nplate®

†† The following is not intended to be a comprehensive list and includes examples of CYP3A4 and CYP2C9 inhibitors and inducers. CYP3A4 inhibitors include amiodarone, aprepitant, ciprofloxacin, clarithromycin, haloperidol, ketoconazole, metoprolol, paroxetine, risperidone, ritonavir, tramadol, and verapamil. CYP3A4 inducers include griseofulvin and St John’s wort. CYP2C9 inhibitors include fluconazole, fluoxetine, metronidazole, and trimethoprim/sulfamethoxazole. CYP2C9 inducers include carbamazepine, phenobarbital, phenytoin, and rifampin.14

AFTER THE CLINICAL DECISION HAS BEEN MADE, CONSIDER THAT:

Nplate® Has the Highest Percentage of Patient Claims With $0 OOP Costs vs Oral Agents‡‡ and Broad Coverage15,16

$0 OOP costs for Nplate®15

of patient claims<sup>‡‡</sup>

$0 OOP costs for
oral ITP medications15

of patient claims<sup>‡‡</sup>

Nplate® also offers broad coverage (87%).16
See cost and coverage information

‡‡ Analysis from 2021 to 2022 for Commercial and Medicare patient claims combined. Data based on IQVIA LAAD claims data. Oral OOP percent is a weighted average of claims for eltrombopag, avatrombopag, and fostamatinib disodium hexahydrate.15

2L, second line; AE, adverse event; ASH, American Society of Hematology; CI, confidence interval; OOP, out-of-pocket; TPO-RA, thrombopoietin receptor agonist.

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483,000+ Served Worldwide4

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; Clinical Study Report 20080435; 2014. 4. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023. 5. Data on file, Amgen; Time to Onset, biostatistical analysis; 2019. 6. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. 7. Rituxan® (rituximab) full Prescribing Information, Genentech. 8. Lozano ML, Mingot-Castellano ME, Perera MM, et al. Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia. Sci Rep. 2019;9(1):16680. 9. 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. 10. Promacta® (eltrombopag) full Prescribing Information, Novartis. 11. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 12. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 13. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. 14. Gilani B, Cassagnol M. Biochemistry, Cytochrome P450. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; January 2024. https://www.ncbi.nlm.nih.gov/books/NBK557698/. 15. Data on file, Amgen; Nplate® IQVIA LAAD 2021 and 2022 OOP Cost Analysis Medicare Commercial Combined ALL; 2023. 16. Data on file, Amgen; Nplate® - coverage from MMIT; 2023.