Glossary
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Anti-D
Anti-D antibody is a blood product used to achieve a temporary and occasionally long-term elevation of the platelet counts.[10]
Autoantibodies
Proteins that attach to the body's healthy tissues by mistake.[29]
Autoimmune disorder
Where the body's immune system attacks healthy cells in the body by mistake.[30]
Epistaxis
Bleeding from the nose.[30]
Hematuria
The presence of red blood cells in the urine.[31]
Idiopathic
Denoting a disease of unknown cause.[32]
Incidence
Incidence is the number of new cases of a condition, symptom, death, or injury that arise during a specific period of time, such as in a year.[30]
Intracranial hemorrhage
An intracranial hemorrhage is bleeding in the brain caused by the rupture of a blood vessel within the head.[30]
Macrophages
A type of immune cell that eats foreign substances in an effort to protect the body from infection.[30]
Megakaryocytes
Platelet precursors.[30]
Menorrhagia
Abnormally profuse menstrual flow.[33]
Monoclonal antibody
An antibody produced by a clone or genetically homogeneous population of fused hybrid cells, i.e., hybridoma; hybrid cells are cloned to establish cell lines producing a specific antibody that is chemically and immunologically homogeneous.[32]
Mucocutaneous
Relating to mucous membrane and skin; denoting the line of junction of the two at the nasal, oral, vaginal, and anal orifices.[32]
Petechiae
Minute hemorrhagic spots, of pinpoint to pinhead size, in the skin, which are not blanched by pressure.[32]
Platelets
Minute colorless disklike cells that assist in blood clotting by adhering to other platelets and to damaged epithelium.[33]
Purpura
Purpura is purple-colored spots and patches that occur on the skin, on organs, and in mucous membranes, including the lining of the mouth.[30]
Remission
Abatement or lessening in severity of the symptoms of a disease. The period during which such abatement occurs.[32]
Splenomegaly
Splenomegaly is an enlargement of the spleen beyond its normal size.[30]
Thrombocytopenia
Thrombocytopenia is any disorder in which there are not enough platelets. Platelets are cells in the blood that help blood to clot. This condition is sometimes associated with abnormal bleeding.[30]
Thrombopoietin
A hormone that regulates blood platelet production by promoting the proliferation and maturation of megakaryocyte progenitor cells and the development of megakaryocytes into blood platelets.[33]
Thrombopoietin receptor
Thrombopoietin acts through its receptor, Mpl, to stimulate the proliferation and maturation of megakaryocytes and their progenitors.[34]
Please see Prescribing Information and Medication Guide
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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