Pivotal Trials (Pooled)
Pediatric Safety Profile Was Established in a 12- and 24-Week Trial2,*
Common adverse reactions from 2 placebo-controlled pediatric studies2,†
|ADVERSE REACTIONS BY BODY SYSTEM||
(n = 59)
(n = 24)
|Infections and Infestations|
|Upper Respiratory Tract Infection||18 (31%)||6 (25%)|
|Ear Infection||3 (5%)||0 (0.0%)|
|Gastroenteritis||3 (5%)||0 (0.0%)|
|Sinusitis||3 (5%)||0 (0.0%)|
|Respiratory, Thoracic, and Mediastinal Disorders|
|Oropharyngeal Pain||15 (25%)||1 (4%)|
|Diarrhea||12 (20%)||3 (13%)|
|Abdominal Pain Upper||8 (14%)||1 (4%)|
|Skin and Subcutaneous Tissue Disorders|
|Rash||9 (15%)||2 (8%)|
|Purpura||4 (7%)||0 (0.0%)|
|Urticaria||3 (5%)||0 (0.0%)|
|General Disorders and Administration Site Conditions|
|Pyrexia||14 (24%)||2 (8%)|
|Peripheral Swelling||4 (7%)||0 (0.0%)|
|Injury, Poisoning, and Procedural Complications|
|Contusion||24 (41%)||8 (33%)|
Nplate® was studied in pediatric patients with ITP in a Phase 3 study and Phase 1/2 study.
Phase 1/2 study (N = 22):
Nplate® was studied in patients diagnosed with ITP at least 6 months prior to enrollment with a platelet count ≤ 30 x 109/L2
*The 12-week trial was the phase 1/2 trial. The 24-week trial was the phase 3 trial.
†≥ 5% incidence and ≥ 5% more frequent in the Nplate® arm.
Long-Term Extension Data
Nplate® Was Studied in a Long-Term Extension Study in Pediatric Patients7
The most frequently occurring (> 45%) adverse events were headache (58.5%), contusion (50.8%), epistaxis, upper respiratory tract infection and vomiting (49.2% each), cough and oropharyngeal pain (46.2% each). The most frequently reported (> 5%) Grade 3 or 4 adverse events were thrombocytopenia (9.2%) and headache (6.2%).
ITP, immune thrombocytopenia.
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.
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.
References: 1. Kuter DJ, Bussel JB, Newland A. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. 2. Nplate® (romiplostim) prescribing information, Amgen. 3. Promacta® (eltrombopag) full Prescribing Information, Novartis. 4. Doptelet® (avatrombopag) full Prescribing Information, Sobi. 5. Tavalisse® (fostamatinib disodium hexahydrate) full Prescribing Information, Rigel. 6. Data on file, Amgen; Clinical Study Report 20080435; 2014. 7. Data on file, Amgen; Pediatric long-term data 20090340; 2017.