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® Is the Only Once-Weekly, In-Office, Subcutaneous Injection Proven to Deliver the Lasting Stability Chronic ITP Demands1,2

PLATELET CONTROL

Nplate® Offers Non-Splenectomized Patients the Potential for Overall and Durable Platelet Response1,2

Overall and durable platelet response in non-splenectomized patients1,2

Overall and durable platelet response in non-splenectomized patients

Patients in the control arm received placebo. Some patients in both arms were receiving concurrent
ITP medications at baseline and were allowed to continue receiving them.1,2

  • Onset of response: 37% of non-splenectomized patients (15/41) treated with Nplate® responded after 1 dose3,*

Patients maintained platelet counts ≥ 50 x 109/L throughout the 6-month pivotal trial4

Median weekly platelet counts in non-splenectomized patients2

Median weekly platelet counts in non-splenectomized patients

Median weekly platelet count includes all patients, even those receiving rescue therapy. Error bars indicate the range from the first to the third quartiles.
Red line indicates platelet count of 50 x 109/L.2

*Defined as platelet count ≥ 50 x 109/L measured 1 week after the first dose. In patients who received placebo, 0% achieved this response.3

CONCURRENT/RESCUE THERAPIES

Nplate® Helped Patients Reduce or Discontinue Concurrent ITP Therapy and Reduced the Need for Rescue Therapy1,2

Concurrent or rescue ITP therapies

Non-splenectomized patients who reduced or discontinued* concurrent ITP therapies1,2

Non-splenectomized patients who reduced or discontinued concurrent ITP therapies

n = number of patients receiving concurrent ITP medication baseline.2

Changes could be made to concurrent ITP therapies (corticosteroids, azathioprine, or danazol) during the first 12 weeks of study when platelet counts were > 100 x 109/L.2

Non-splenectomized patients receiving rescue therapy1,2

Non-splenectomized patients receiving rescue therapy

Rescue therapies included corticosteroids, intravenous immunoglobulin (IVIG), platelet transfusions, and anti-D immunoglobulin and were permitted for bleeding, for wet purpura, or if the patient was at immediate risk for hemorrhage.1

*Discontinuation was defined as discontinuation of all therapies for patients receiving multiple concomitant baseline therapies.1

Watch why Dr Steven Fein chooses Nplate® for second-line treatment in adults with chronic ITP

Patient Case: A Chronic ITP Patient Needs Second-Line Treatment

PLATELET CONTROL

Nplate® Offers the Majority of Splenectomized Patients the Potential to Achieve a Target Platelet Response1,2

Overall and durable platelet response in splenectomized patients

Overall and durable platelet response in splenectomized patients

Patients in the control arm received placebo. Some patients in both arms were receiving concurrent
ITP medications at baseline and were allowed to continue receiving them.1

  • Onset of response: 24% of splenectomized patients (10/42) treated with Nplate® responded after 1 dose3,*

Patients maintained platelet counts ≥ 50 x 109/L throughout the 6-month pivotal trial2

Median weekly platelet counts in splenectomized patients2

Median weekly platelet counts in splenectomized patients

Median weekly platelet count includes all patients, even those receiving rescue therapy. Error bars indicate the range from the first to the third quartiles.
Red line indicates platelet count of 50 x 109/L.2

*Defined as platelet count ≥ 50 x 109/L measured 1 week after the first dose. In patients who received placebo, 0% achieved this response.3

CONCURRENT/RESCUE THERAPIES

Nplate® Helped Patients Reduce or Discontinue Concurrent ITP Therapy and Reduced the Need for Rescue Therapy1,2

Concurrent or rescue ITP therapies

Splenectomized patients who reduced or discontinued* concurrent ITP therapies1,2

Splenectomized patients who reduced or discontinued concurrent ITP therapies

n = number of patients receiving concurrent ITP medication baseline.2

Changes could be made to concurrent ITP therapies (corticosteroids, azathioprine, or danazol) during the first 12 weeks of study when platelet counts were > 100 x 109/L.2

Splenectomized patients receiving rescue therapy1,2

Splenectomized patients receiving rescue therapy

Rescue therapies included corticosteroids, intravenous immunoglobulin (IVIG), platelet transfusions, and anti-D immunoglobulin and were permitted for bleeding, for wet purpura, or if the patient was at immediate risk for hemorrhage.1

*Discontinuation was defined as discontinuation of all therapies for patients receiving multiple concomitant baseline therapies.1

Watch why Dr Terry Gernsheimer and Dr Michael Tarantino choose Nplate® for second-line treatment following relapse after splenectomy in adults with chronic ITP

Nplate® After Splenectomy Relapse in Adult ITP

STUDY DESIGN FOR THE TWO PHASE 3 PIVOTAL TRIALS

Two Parallel, Double-Blind, Phase 3 Trials in Patients With Adult Chronic ITP1,2

Nplate® was studied vs placebo in 2 parallel, double-blind, 24-week, phase 3 trials in patients with adult chronic immune thrombocytopenia (ITP). One trial enrolled splenectomized patients (n = 63), the other enrolled non-splenectomized patients (n = 62).1,2

  • Patients must have completed ≥ 1 prior treatment* and had a platelet count of ≤ 30 x 109/L prior to study entry
  • Patients were randomized (2:1) to 24 weeks of Nplate® (1 mcg/kg subcutaneous) or placebo
  • Nplate® dose adjustments were based on platelet counts, and dose adjustments of concomitant ITP therapies were allowed

Pivotal trials endpoint definitions1,2

Primary Endpoint:
Durable platelet response

  • Weekly platelet responses (platelet count ≥ 50 x 109/L) during at least 6 of the last 8 weeks of treatment in 24-week treatment period
  • No rescue therapy at any time during treatment

Secondary Endpoint:
Overall platelet response

  • Overall platelet response = durable plus transient platelet responses
  • Transient platelet response: ≥ 4 weekly responses without durable response from weeks 2 to 25, excluding platelet counts within 8 weeks of rescue therapy
Review the article for the Nplate® pivotal trials

When a timely and efficacious response matters, Nplate® restores stability for 8 out of 10 patients†
See the adult chronic ITP pooled safety data

*Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. (Rituximab is not FDA-approved for use in ITP.)5

†Based on overall platelet response (88%) in non-splenectomized patients.1

PLATELET CONTROL

Nplate® Offers Patients With Chronic ITP the Potential for Lasting Platelet Control and Stability1,2

  • The majority of patients achieved a platelet response for 27 weeks or greater3
  • The maximum number of weeks with a platelet response was 1843

STUDY DESIGN

Open-Label, Single-Arm, Extension Study in Adult Patients With Chronic ITP*

  • 292 adult patients enrolled from previous Nplate® clinical trials, regardless of whether they had received Nplate® in those trials6
  • Primary safety assessment: incidence of adverse events (AEs), including death, thrombosis, bleeding, abnormal laboratory values, and the incidence of neutralizing antibody formation6

TREATMENT DURATION

1 to 277 weeks (mean: 110 weeks). Patients entered study at different times during the defined 277-week study period6

Nplate® or placebo/standard-of-care (SOC) patients from prior Nplate® trials

Prior Nplate® patients:
continued on their same dose*

Prior placebo/SOC patients:
started on Nplate® 1 mcg/kg/wk*

On Nplate® until end of
study or discontinuation

Study enrollment and completion6

TREATMENT PERIOD # of patients
> 24 weeks 271 patients (93%)
> 48 weeks 242 patients (83%)
> 96 weeks 117 patients (40%)
> 144 weeks 93 patients (32%)
> 192 weeks 53 patients (18%)
> 240 weeks 23 patients (8%)

291 patients received at least one dose of Nplate® during the rolling enrollment period6

  • During the 277-week study period, treatment duration varied due to study entry at different times and discontinuation (mean treatment was 110 weeks)
  • 8% (23/291) of patients were treated longer than 240 weeks

200 patients completed the study6

  • Completers were defined as those who were followed through the last study visit, regardless of whether they were still on treatment1
  • The most common reason for discontinuing the trial was withdrawn consent (25 patients)
    • Other reasons included death while on study (15 patients); adverse events, alternative therapy, and other reasons (11 patients each); administrative decision (7 patients); noncompliance, protocol-specified criteria, and lost to follow-up (3 patients each); and pregnancy and protocol deviation (1 patient each)
Review the article for the Nplate® long-term safety study
See the adult long-term extension safety data

*Given as a once-weekly subcutaneous injection. Patients who had been off Nplate® for 24 weeks or who had not previously received Nplate® initiated therapy at 1 mcg/kg. Dose adjustments were allowed to maintain platelet counts ≥ 50 x 109/L.1 The recommended starting dose for Nplate® is 1 mcg/kg and the maximum weekly dose is 10 mcg/kg. Please see Nplate® full Prescribing Information for complete dosing instructions, including guidelines for dose adjustments.6

ITP, immune thrombocytopenia.

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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. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenia purpura: a double-blind randomised controlled trial. Lancet. 2008;371(9610):395-403.3. Data on file, Amgen; Onset of Response; 2018. 4. Data on file, Amgen; Duration of Response; 2017. 5. RITUXAN® (rituximab) full Prescribing Information, Genentech, Inc. 6. 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.