Prescription medicine
Romiplostim Brand names: Nplate
Romiplostim (Nplate) is a prescription medicine with an FDA approval on record since 2008. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the romiplostim FDA label on DailyMed (effective June 23, 2026, Amgen, Inc); the BLA 125268 record on Drugs@FDA; every romiplostim label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNplate 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.
Forms and strengths
- 0.25ml
- 0.5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 22, 2008 Nplate, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 14,968 through July 30, 2026
What is romiplostim used for?
From the label: indications and usageNplate 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. ( 1.1 ) Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). […]
FDA pharmacologic class: Thrombopoietin Receptor Agonist.
Source: FDA drug label (Nplate), Amgen, Inc, effective June 23, 2026 (SPL set c45f9a58-37c1-4f76-8e36-97d38c577037), via openFDA; the full label on DailyMed
What does the patient leaflet for romiplostim say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Nplate?Nplate can cause serious side effects, including: Worsening of a precancerous blood condition to a blood cancer (leukemia). Nplate is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS), or for any condition other than immune thrombocytopenia (ITP). If you have MDS and receive Nplate, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia. Higher risk for blood clots. You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), heart attack and strokes have happened in people with ITP during treatment with Nplate. You may get blood clots in the veins of your liver (portal vein thrombosis) with or without chronic liver disease. This may affect your liver function. Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects. Your healthcare provider may change your dose or stop Nplate depending upon the change in your blood platelet count. You must have blood platelet counts done before you start, during, and after Nplate therapy is stopped ( see “How will I receive Nplate?” ). See “What are the possible side effects of Nplate?” for other side effects of Nplate.
From the patient leaflet: What should I avoid while receiving Nplate?Avoid situations or medicines that may increase your risk of bleeding.
Source: FDA drug label (Nplate), Amgen, Inc, effective June 23, 2026 (SPL set c45f9a58-37c1-4f76-8e36-97d38c577037), via openFDA; the full label on DailyMed
Is there a generic for romiplostim (Nplate)?
No generic romiplostim is approved (Drugs@FDA, October 8, 2026).
- 2008 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has romiplostim been recalled?
The FDA's Enforcement Report lists 1 recall naming romiplostim since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the romiplostim label say about other medicines?
The romiplostim label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | DRUG INTERACTIONS Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin [see Clinical Studies ( 14.1 )]. |
| Danazol | drug interactions | DRUG INTERACTIONS Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin [see Clinical Studies ( 14.1 )]. |
Source: FDA drug label (Nplate), Amgen, Inc, effective June 23, 2026 (SPL set c45f9a58-37c1-4f76-8e36-97d38c577037), via openFDA; the full label on DailyMed
What do FAERS reports show for romiplostim?
The FDA Adverse Event Reporting System holds 14,968 reports that list romiplostim among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,626 are coded as a death and 3,845 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other thrombopoietin receptor agonists
- the pharmacologic class, with prices and generics
- Romiplostim side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other