Romiplostim

Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.

• 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. ( 1.1 ) 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.

• None.contraindicated

Patients with Immune Thrombocytopenia (ITP) Recommended Initial Dose: 1 mcg/kg once weekly as a subcutaneous injection. Adjust dose based on platelet response. ( 2.1 ) Patients acutely exposed to myelosuppressive doses of radiation Recommended Dose: 10 mcg/kg administered once as a subcutaneous injection. Administer the dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation. ( 2.2 ) See Full Prescribing Information for instructions on reconstitution, preparation, and administration. ( 2.3 ) Reconstitution and Dilution of Nplate Single Dose Vials 2.1 Patients with Immune Thrombocytopenia (ITP) Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 × 10 9 /L as necessary to reduce the risk for bleeding. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. The prescribed Nplate dose may consist of a very small volume (e.g., 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations. Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg [see Warnings and Precautions ( 5.3 )] . Obtain complete blood counts (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 2 weeks following discontinuation of Nplate.

In some patients with MDS, Nplate increases blast cell counts and increases the risk of progression to acute myelogenous leukemia. ( 5.1 ) Thrombotic/thromboembolic complications have resulted from increases in platelet counts with Nplate use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. ( 5.2 ) Severe thrombocytopenia may persist during Nplate treatment due to neutralizing antibodies or other causes. ( 5.3 ) 5.1 Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate. A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. This trial consisted of a 58-week study period with a 5-year long-term follow-up phase. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo). During the 58-week study period, progression to AML occurred in 10 (6.0%) patients in the Nplate arm and 4 (4.8%) patients in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). Of the 250 patients, 210 (84.0%) entered the long-term follow-up phase of this study.

The following clinically significant adverse reactions are discussed in greater detail in other sections: Progression of Myelodysplastic Syndromes [see Warnings and Precautions ( 5.1 )] Thrombotic/Thromboembolic Complications [see Warnings and Precautions ( 5.2 )] Loss of Response to Nplate [see Warnings and Precautions ( 5.3 )] In adult patients, the most common adverse reactions (≥ 5% higher patient incidence in Nplate versus placebo) are arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia. Headache was the most commonly reported adverse reaction that did not occur at ≥ 5% higher patient incidence in Nplate versus placebo. ( 6.1 ) In pediatric patients, the most common adverse reactions (≥ 25%) are: contusion, upper respiratory tract infection, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The data described below reflect Nplate exposure to 271 adult patients with ITP, aged 18 to 88, of whom 62% were female.

Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman. Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In rat and rabbit embryo-fetal development toxicity studies, no evidence of fetal harm was observed at romiplostim doses up to 11 times (rats) and 82 times (rabbits) the maximum human dose (MHD) based on systemic exposure (AUC). In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred.

Metabolism

Patients with Immune Thrombocytopenia (ITP) In the long-term extension study in adult patients with ITP receiving weekly treatment of Nplate subcutaneously, the pharmacokinetics of romiplostim over the dose range of 3 to 15 mcg/kg indicated that peak serum concentrations of romiplostim were observed about 7 to 50 hours post dose (median: 14 hours) with half-life values ranging from 1 to 34 days (median: 3.5 days). The serum concentrations varied among patients and did not correlate with the dose administered.

Overdoses due to medication errors have been reported in patients receiving Nplate. In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In this case, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations [see Dosage and Administration ( 2.1 , 2.3 )] .

• Aug 22, 2008BLABLA125268Amgen

1. 1Drug Ineffective1,72512%
2. 2Platelet Count Decreased1,70612%
3. 3Off Label Use1,1998.2%
4. 4Death9936.8%
5. 5Platelet Count Abnormal9456.4%
6. 6Therapeutic Response Decreased9416.4%
7. 7Thrombocytopenia9346.4%
8. 8Headache5914.0%
9. 9Fatigue4623.2%
10. 10Hospitalisation3812.6%
11. 11Haemorrhage3792.6%
12. 12Platelet Count Increased3782.6%
13. 13Arthralgia3552.4%
14. 14Product Storage Error3452.4%
15. 15Nausea3402.3%

The 10 most recently updated of 117 ClinicalTrials.gov registrations naming Romiplostim as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
  Recruiting · Phase 2 · Interventional · 164 enrolled · Novartis Pharmaceuticals
  NCT07421167updated 2026-06-11
• Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Peking Union Medical College Hospital
  NCT07532408updated 2026-06-04
• CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Peking Union Medical College Hospital
  NCT07523009updated 2026-06-04
• Romiplostim for Oral TPO-RA Resistant ITP
  Recruiting · Interventional · 60 enrolled · The First Affiliated Hospital of Soochow University
  NCT07612319updated 2026-05-28
• A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia
  Not yet recruiting · Phase 1 · Interventional · 280 enrolled · Shanghai 10th People's Hospital
  NCT07595133updated 2026-05-19
• Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
  Recruiting · Phase 2 · Interventional · 220 enrolled · Peking University People's Hospital
  NCT07586813updated 2026-05-14
• Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
  Recruiting · Phase 2 · Interventional · 220 enrolled · Peking University People's Hospital
  NCT07586826updated 2026-05-14
• Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients
  Recruiting · Phase 2 · Interventional · 50 enrolled · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  NCT07043894updated 2026-05-07
• Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia
  Not yet recruiting · Phase 2 · Interventional · 43 enrolled · Peking Union Medical College Hospital
  NCT07572084updated 2026-05-07
• CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA
  Not yet recruiting · Phase 2 · Interventional · 43 enrolled · Peking Union Medical College Hospital
  NCT07558434updated 2026-04-30

Frequently asked questions

How does Romiplostim work?

Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.

What is Romiplostim used for?

According to FDA labeling, Romiplostim carries indications including: 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. ( 1.1 ) 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Romiplostim?

Romiplostim is classified as Other systemic hemostatics, Thrombopoietin Receptor Agonist, Thrombopoietin Receptor Agonists, Increased Megakaryocyte Maturation, Increased Platelet Production.

What are the brand names for Romiplostim?

Romiplostim is marketed under brand names including Nplate.

What are the contraindications for Romiplostim?

Romiplostim labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.