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Expert Insights on ITP: Moving from First to Second-Line Treatment Options

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For adults with newly diagnosed or persistent immune thrombocytopenia, what comes next after first-line treatment failure?

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Important Safety Information

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  • Overview

    Immune thrombocytopenia (ITP) is a rare hematological disorder that’s characterized by unpredictable rates and severe bleeding events. And while corticosteroids remain a cornerstone first-line treatment as an acute therapy, ITP rarely resolves with first-line treatment. That’s why Dr. Steve Fein joins Dr. Charles Turck to discuss his clinical decision-making rationale when moving from first to second-line treatment options as well as the use of Nplate® as a second-line treatment option.

  • Indications

    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 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®

    • 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 (1‑800‑772‑6436). 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.

    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.

    Please see full Prescribing Information and Medication Guide.

Schedule29 Nov 2021
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