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

Patients Treated With Nplate® Experienced Changes in Health-Related Quality of Life (HRQoL) Domains Compared to Placebo

HRQoL

CHANGE IN HRQoL DOMAINS

In a Post Hoc Analysis, Patients Treated With Nplate® Experienced Changes in HRQoL Domains1

Non-splenectomized patients

ITP Patient Assessment Questionnaire (ITP-PAQ) mean change scores from baseline for non-splenectomized patients (n = 61)1,*,†

ITP patient assessment questionnaire mean change scores from baseline for non-splenectomized patients
ITP patient assessment questionnaire mean change scores from baseline for non-splenectomized patients

Splenectomized patients

ITP Patient Assessment Questionnaire (ITP-PAQ) mean change scores from baseline for splenectomized patients (n = 58)1,*,†

ITP patient assessment questionnaire mean change scores from baseline for splenectomized patients
ITP patient assessment questionnaire mean change scores from baseline for splenectomized patients

Pooled data

Mean ITP-PAQ score change from baseline to week 24 comparing Nplate® (n = 84) vs placebo (n = 41) in all patients1,*,†

Mean ITP-PAQ score change from baseline to week 24 comparing Nplate® vs placebo in all patients
Mean ITP-PAQ score change from baseline to week 24 comparing Nplate® vs placebo in all patients

*Placebo comparison may limit real-world comparison.1

†Length of disease may influence the change in quality of life.1

‡Overall quality of life was one of the domains and not a composite endpoint of the other domains.1,2

ITP, immune thrombocytopenia.

ITP-PAQ

Questionnaire Assessing HRQoL Domains and the Impact of ITP on a Patient’s Functioning and Well-being2

These data come from an analysis of a secondary descriptive endpoint from the pivotal trials that examined the change from baseline of scores from a validated Patient Reported Outcome (PRO) instrument over a 24-week period.2

  • The PRO instrument—ITP patient assessment questionnaire (ITP-PAQ)—is a validated, specialized HRQoL questionnaire to investigate the impact of ITP on a patient’s functioning and well-being in the 10 domains noted in the graphs above2
    • The ITP-PAQ is the first disease-specific HRQoL questionnaire developed for use in adults with chronic ITP
  • Patients self-administered the ITP-PAQ at baseline (before Nplate® or placebo) and at weeks 4, 12, and 24. Patients were blinded to their current platelet count results before completing the ITP-PAQ2
  • Important consideration: This analysis was not powered to show a treatment effect and contains data from a secondary descriptive endpoint2

Click on the buttons below to see the questions that were asked within the ITP-PAQ

  • Activity2

    In the past 4 weeks, ...

    • How much have your ITP symptoms or the effects of its treatments interfered with your ability to exercise?
    • To what extent has having ITP limited the types of physical or sporting activities you participate in?

    5-point scale from extremely to not at all.

  • Bother2

    In the past 4 weeks, ...

    • How often did you feel physically unattractive due to bruising, scarring, wounds, or the effects of ITP medications?*
    • Overall, to what extent have ITP and its treatments affected your physical health?†
    • Overall, how bothered have you been by the effect of ITP and its treatments on your physical health?†

    *5-point scale from all the time to never.

    †7-point scale from extremely to not at all.

  • Fatigue/sleep2,*

    In the past 4 weeks, how often did ITP or its treatments...

    • Cause you to have difficulty falling asleep at bedtime?
    • Cause you to awaken during the night?
    • Cause you to feel sleepy during the daytime?
    • Cause you to feel physically fatigued?

    *5-point scale from all the time to never.

  • Fear2,*

    In the past 4 weeks,...

    • How fearful have you been of having a bleeding episode (nose bleeds, gum bleeds, etc)?
    • How fearful have you been of death or dying?
    • How fearful have you been of being too far away from your doctor in case you needed medical help?
    • How fearful have you been about getting an infection?
    • How fearful have you been of needing to have emergency surgery (due to concerns about bleeding during surgery)?

    *5-point scale from extremely fearful to not at all fearful.

  • Fertility (subscale under women’s reproductive health)2,*,†

    • How much has having ITP made it less likely that you would get pregnant?
    • How much has having ITP made it less likely that you would give birth?
    • How much has having ITP made it less likely that you would adopt?

    *5-point scale from extremely to not at all.

    †Questions completed by women only.

  • Menstrual symptoms (subscale under women’s reproductive health)2,*,†

    Thinking about your last period, ...

    • How bothered were you by heavier bleeding than before having ITP?
    • How bothered were you by bleeding for more days than before having ITP?
    • How bothered were you by more pain than before having ITP?

    *5-point scale from extremely to not at all.

    †Questions completed by women only.

  • Overall quality of life (QoL)2,*

    In the past 4 weeks, ...

    • Overall, to what extent have ITP and its treatments affected your quality of life?*
    • Overall, how bothered have you been by the effect of ITP and its treatments on your quality of life?*
    • I have made significant changes to my lifestyle because I have ITP.†
    • My ITP prevents me from doing things in life that I want to do.†
    • My ITP prevents my spouse, partner, or family members from doing things in life that they want to do.†

    *7-point scale from extremely to not at all.

    †4-point scale from strongly agree to strongly disagree.

  • Psychological2

    In the past 4 weeks, ...

    • How often did you feel like you had no control over your health because of your ITP or its treatments?*
    • How often did you feel like you were unable to manage stress because of your ITP or its treatments?*
    • How often did you have feelings of sadness or depression because of your ITP or its treatments?*
    • Overall, how much has ITP or its treatments affected you psychologically (mental state, emotions)?†
    • Overall, how bothered have you been by the effect that ITP or its treatments has had on you psychologically (mental state, emotions)?†

    *5-point scale from all the time to never.

    †5-point scale from extremely to not at all.

  • Social activity2

    In the past 4 weeks, ...

    • How often has having ITP limited your ability to participate in social activities?*
    • How often have you avoided social activities to limit your exposure to infection?*
    • How bothered were you by what people might think about your bruising or scarring?†
    • To what extent have you been unable to lead a normal social life because of your ITP?†

    *5-point scale from all the time to never.

    †5-point scale from extremely to not at all.

  • Symptoms2,*

    In the past 4 weeks, how often did you…

    • Have either bruising or petechiae (broken blood vessels)?
    • Have wounds or scars from blood tests, injections, or IV needles?
    • Have blood blisters in your mouth?
    • Have bleeding episodes (nose bleeds, gum bleeds, etc)?
    • Have muscle aches?
    • Have cramps in your legs?

    *5-point scale from all the time to never.

  • Women's reproductive health2

    See Fertility and Menstrual symptoms.

  • Work2,*

    Since you were diagnosed, ...

    • To what degree has ITP negatively interfered with your choice of careers?
    • How much has ITP negatively interfered with your ability to get a promotion at your job?
    • How much has ITP negatively interfered with your relationships with coworkers?
    • How fearful have you been of losing your job because of your ITP?

    *5-point scale from extremely to not at all, with a not applicable option.

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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. George JN, Mathias SD, Go RS, et al. Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo-controlled trials. Br J Haematol. 2009;144:409-415. 2. Mathias SD, Bussel JB, George JN, McMillan R, Okano GJ, Nichol JL. A disease-specific measure of health-related quality of life for use in adults with immune thrombocytopenia purpura: its development and validation. Health Qual Life Outcomes. 2007;5:11. 3. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.