ASH Clinical News December 2016 | Page 116

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.

Help restore stability
In immune thrombocytopenia (ITP), as platelet counts fall the risk for bleeding events rises.1,2
At the first sign of relapse in adult chronic ITP, consider Nplate®.3-5

Important Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute
Myelogenous Leukemia
n In Nplate® clinical trials of patients with myelodysplastic syndromes
(MDS) and severe thrombocytopenia, progression from MDS to acute
myelogenous leukemia (AML) has been observed.
n Nplate® is not indicated for the treatment of thrombocytopenia due to
MDS or any cause of thrombocytopenia other than chronic ITP.
Thrombotic/Thromboembolic Complications
n 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®.
n 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®
n Hyporesponsiveness or failure to maintain a platelet response
with Nplate® should prompt a search for causative factors, including
neutralizing antibodies to Nplate®.
n 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).
n 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
n Obtain CBCs, including platelet counts, weekly during the dose
adjustment phase of Nplate® therapy and then monthly following
establishment of a stable Nplate® dose.

n

Obtain CBCs, including platelet counts, weekly for at least two weeks
following discontinuation of Nplate®.

Adverse Reactions
n In the placebo-controlled trials, 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.
n 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%).
n 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 Brief Summary of Prescribing Information in preceding pages.

Learn more at NplateHCP.com

References: 1. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346:995-1008. 2. Cines DB, McMillan R. Management of adult idiopathic thrombocytopenic purpura. Annu Rev Med. 2005;56:425-442. 3. Provan D, Stasi R, Newland AC, et al. International
consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115:168-186. 4. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune
thrombocytopenia. Blood. 2011;117:4190-4207. 5. Nplate® (romiplostim) prescribing information, Amgen.
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