{
 "query": "romiplostim",
 "ingredient": "romiplostim",
 "slug": "romiplostim",
 "rxcui": "805452",
 "brands": [
  "Nplate"
 ],
 "names": [
  "romiplostim"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "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. ( 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]). ( 1.2 ) Limitations of Use: 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 increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. ( 1 ) 1.1 Patients with Immune Thrombocytopenia (ITP) Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have ha...",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "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....",
  "warnings": "",
  "adverse_reactions": "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 (\u2265 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 \u2265 5% higher patient incidence in Nplate versus placebo. ( 6.1 ) In pediatric patients, the most common adverse reactions (\u2265 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 rat...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Thrombotic/Thromboembolic Complications ( 5.2 ) 02/2025 Warnings and Precautions, Loss of Response to Nplate ( 5.3 ) 02/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of Nplate for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.3) ] . Inform patients of the following risks and considerations for Nplate: Nplate therapy is administered to achieve and maintain a platelet count \u2265 50 \u00d7 10 9 /L as necessary to reduce the risk for bleeding; Nplate is not used to normalize platelet counts. Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy. Nplate therapy may increase the risk of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination. Too much Nplate may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications....",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 03/2025 MEDICATION GUIDE Nplate \u00ae (N-pl\u0101t) (romiplostim) for injection 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 ...",
  "clinical_studies": "14.1 Adults with ITP The safety and efficacy of Nplate in adults with ITP were assessed in two double-blind, placebo-controlled clinical studies, an open-label single-arm study, and in an open-label extension study. Studies 1 (NCT00102336) and 2 (NCT00102323) In Studies 1 and 2, patients with ITP who had completed at least one prior treatment and had a platelet count of \u2264 30 \u00d7 10 9 /L prior to study entry were randomized (2:1) to 24 weeks of Nplate (1 mcg/kg subcutaneous [SC]) or placebo. The median time since ITP diagnosis for Studies 1 and 2 was 2.1 years (range 0.1 to 31.6) and 8 years (range 0.6 to 44.8), respectively. Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Rescue therapies (i.e., corticosteroids, IVIG, platelet transfusions, and anti-D immunoglobulin) were permitted for bleeding, wet purpura, or if the patient was at immediate risk for hemorrhage. Patients received single weekly SC injections of Nplate, with indiv...",
  "brand_name": "Nplate",
  "manufacturer": "Amgen, Inc",
  "application_number": "BLA125268",
  "pharm_class_epc": [
   "Thrombopoietin Receptor Agonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260623",
  "set_id": "c45f9a58-37c1-4f76-8e36-97d38c577037",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9202,
  "serious": 6097,
  "death": 1125,
  "hospitalization": 2433,
  "primary_suspect": 9200,
  "top_reactions": [
   [
    "Off Label Use",
    1251
   ],
   [
    "Platelet Count Decreased",
    1101
   ],
   [
    "Platelet Count Abnormal",
    744
   ],
   [
    "Drug Ineffective",
    689
   ],
   [
    "Thrombocytopenia",
    536
   ],
   [
    "Death",
    435
   ],
   [
    "Headache",
    428
   ],
   [
    "Product Storage Error",
    345
   ],
   [
    "Fatigue",
    320
   ],
   [
    "Therapy Non-Responder",
    276
   ],
   [
    "Thrombocytosis",
    259
   ],
   [
    "Nausea",
    258
   ],
   [
    "Platelet Count Increased",
    246
   ],
   [
    "Circumstance Or Information Capable Of Leading To Medication Error",
    238
   ],
   [
    "Haemorrhage",
    238
   ]
  ],
  "by_year": {
   "2019": 643,
   "2020": 558,
   "2021": 553,
   "2022": 605,
   "2023": 826,
   "2024": 790,
   "2025": 684,
   "2026": 464
  },
  "by_year_primary": {
   "2019": 642,
   "2020": 558,
   "2021": 553,
   "2022": 605,
   "2023": 826,
   "2024": 790,
   "2025": 683,
   "2026": 464
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20080822",
  "rems": false,
  "rems_last": "20210129",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "AMGEN"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/22/2008"
 },
 "trials": {
  "total": 123,
  "completed": 59,
  "terminated": 14,
  "with_results": 32,
  "industry": 63,
  "phase3": 26,
  "results_share": 0.5423728813559322,
  "terminated_share": 0.11382113821138211
 },
 "pubmed": {
  "rct": 34,
  "meta": 11,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 77089.5,
  "records": 110,
  "by_name": [
   [
    "Nplate",
    77089.5
   ]
  ],
  "names_checked": [
   "romiplostim",
   "Nplate"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1734,
  "beneficiaries": 285,
  "spend": 17623974.03,
  "by_brand": [
   {
    "brand": "NPlate",
    "claims": 1734,
    "per_claim": 10163.768183,
    "is_generic": false
   }
  ],
  "per_claim": 10163.768183391005
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20111206",
   "title": "Nplate and Promacta - Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm280165.htm",
   "kind": "drug",
   "matched": "nplate"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 87,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 48,
   "letter": "F",
   "why": [
    "34 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $77,090 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Nplate and Promacta - Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and P). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are platelet count decreased, platelet count abnormal. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}