Nplate® as Second-line ITP Treatment in Adults
Expert recommendations for first-line ITP treatment options include corticosteroids as well as anti-D and IVIG. Consensus is that corticosteroids given as initial therapy should be used for 3 to 4 weeks and then tapered off.[10][17]
Recent expert recommendations recognize Nplate® as a second-line treatment option for chronic ITP
Recent expert publications concur that Nplate® has proven efficacy in patients with chronic ITP, and provide recommendations for TPO-receptor agonists, including Nplate®, as second-line treatment options for ITP.[10][17]
- According to the 2011 American Society of Hematology ITP guideline update[17]:
-
- — “We recommend: Thrombopoietin receptor agonists for patients at risk of bleeding who relapse after splenectomy
or who have a contraindication to splenectomy and who have failed at least one other therapy.” - — “We suggest: Thrombopoietin-receptor agonists may be considered for patients at risk of bleeding who have
failed one line of therapy such as corticosteroids or IVIg and who have not had splenectomy.” - — “Strong recommendations are usually indicated by the phrase ‘we recommend…’ and weak recommendations by
the phrase ‘we suggest…’.”
- — “We recommend: Thrombopoietin receptor agonists for patients at risk of bleeding who relapse after splenectomy
- According to the International ITP Consensus Report (ICR)[10]*:
-
- — Nplate® is part of the ICR Grade A recommendation for the TPO-receptor agonist class as second-line treatment.
- — The grade A recommendation is defined as a standard of evidence that requires at least one randomized,
controlled trial as part of a body of literature of overall good quality and consistency. - — The graded rating system is not meant to imply comparison of safety or efficacy of the treatments, but rather
to describe various levels of evidence.
*Amgen Ltd. was among the sponsors of the International ITP Consensus Report.
Click here for more information on expert recommendations in ITP management.
Consider at least 6–12 months of Nplate® therapy as studied in the phase 3 and Nplate® or SOC trials[3][5][6]
- Assess continuing Nplate® on a case-by-case basis.
*Initiation of Nplate® therapy after insufficient response to corticosteroids.
†Spontaneous remission defined as late response not attributed to definitive treatment.[9]
Have questions about the timing of Nplate® initiation? Talk to a live representative
Treatment duration can be tailored to each patient’s needs
When concluding treatment with Nplate®, no dose tapering is required[6]
- After the final dose of Nplate®, monitor CBCs for at least 2 weeks to assess for worsening thrombocytopenia. Worsening thrombocytopenia occurred after Nplate® discontinuation in 7% (4/57) of chronic ITP patients who had discontinued Nplate® in clinical studies; this worsened thrombocytopenia resolved within 14 days.[6]
Nplate®: Used in more than 5,000 adult patients with chronic ITP as of March 2011.[1]
The first approved TPO-receptor agonist[6][22][23]
Have questions about initiating or discontinuing Nplate®?
INDICATION
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic 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 chronic 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.
Important Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
- In Nplate® 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 chronic 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®. Nplate® should be used with caution in patients with ITP and chronic liver disease.
- 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.
Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
- 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 study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy. Clinical studies are in progress to assess the risk of bone marrow fibrosis and clinical consequences with cytopenias.
- If new or worsening morphological abnormalities or cytopenia(s) occur, consider a bone marrow biopsy to include staining for fibrosis.
Worsened Thrombocytopenia after Cessation of Nplate®
- In clinical studies of patients with chronic ITP who had Nplate® discontinued, four of 57 patients developed thrombocytopenia of greater severity than was present prior to Nplate® therapy. This worsened thrombocytopenia resolved within 14 days.
- Following discontinuation of Nplate®, obtain weekly CBCs, including platelet counts, for at least 2 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines.
Lack or 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.
Laboratory Monitoring
- Obtain CBCs, including platelet counts, weekly during the dose adjustment phase of Nplate® therapy and then monthly following establishment of a stable Nplate® dose.
- Obtain CBCs, including platelet counts, weekly for at least two weeks following discontinuation of Nplate®.
Adverse Reactions
- In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.
- Most common adverse reactions (≥ 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%).
Please see Prescribing Information and Medication Guide
Have questions about the Indication, Important Safety Information, Prescribing Information or Medication Guide?
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Clinical studies have evaluated the safety and efficacy of Nplate® treatment in adult patients with chronic ITP. Nplate® clinical trials have been conducted in both splenectomized and non-splenectomized patients, with some patients receiving Nplate® treatment for > 5 years.
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