{
 "query": "carfilzomib",
 "ingredient": "carfilzomib",
 "slug": "carfilzomib",
 "rxcui": "1302966",
 "brands": [
  "Kyprolis"
 ],
 "names": [
  "carfilzomib"
 ],
 "classes": [
  {
   "id": "L01XG",
   "name": "Proteasome inhibitors"
  }
 ],
 "alternatives": [
  "bortezomib",
  "ixazomib"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.",
  "contraindications": "None. None. ( 4 )",
  "warnings_and_cautions": "Cardiac Toxicities : Monitor for signs and symptoms of cardiac failure or ischemia. Withhold Kyprolis and evaluate promptly. ( 5.1 ) Acute Renal Failure : Monitor serum creatinine regularly. ( 5.2 ) Tumor Lysis Syndrome (TLS) : Administer pre-treatment hydration. (2.1 ) Monitor for TLS, including uric acid levels and treat promptly. ( 5.3 ) Pulmonary Toxicity, including Acute Respiratory Distress Syndrome, Acute Respiratory Failure, and Acute Diffuse Infiltrative Pulmonary Disease : Withhold Kyprolis and evaluate promptly. ( 5.4 ) Pulmonary Hypertension : Withhold Kyprolis and evaluate. ( 5.5 ) Dyspnea : For severe or life-threatening dyspnea, withhold Kyprolis and evaluate. ( 5.6 ) Hypertension, including Hypertensive Crisis : Monitor blood pressure regularly. If hypertension cannot be controlled, interrupt treatment with Kyprolis. ( 5.7 ) Venous Thrombosis : Thromboprophylaxis is recommended. ( 5.8 ) Infusion-related Reactions : Premedicate with dexamethasone. ( 2.1 , 5.9 ) Hemorrhage : Fatal or serious cases of hemorrhage may occur, including gastrointestinal, pulmonary, and intracranial hemorrhage. Promptly evaluate signs and symptoms of blood loss. ( 5.10 ) Thrombocytopenia : ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Toxicities [see Warnings and Precautions (5.1) ] Acute Renal Failure [see Warnings and Precautions (5.2) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Pulmonary Hypertension [see Warnings and Precautions (5.5) ] Dyspnea [see Warnings and Precautions (5.6) ] Hypertension [see Warnings and Precautions (5.7) ] Venous Thrombosis [see Warnings and Precautions (5.8) ] Infusion-Related Reactions [see Warnings and Precautions (5.9) ] Hemorrhage [see Warnings and Precautions (5.10) ] Thrombocytopenia [see Warnings and Precautions (5.11) ] Hepatic Toxicity and Hepatic Failure [see Warnings and Precautions (5.12) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.13) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.14) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.15) ] The most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, di...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Discuss the following with patients prior to treatment with Kyprolis: Cardiac Toxicities: Advise patients of the risks and symptoms of cardiac failure and ischemia [see Warnings and Precautions (5.1) ] . Dehydration: Counsel patients to avoid dehydration, since patients receiving Kyprolis therapy may experience vomiting and/or diarrhea. Instruct patients to seek medical advice if they experience symptoms of dehydration [see Warnings and Precautions (5.3) ] . Respiratory: Advise patients that they may experience cough or shortness of breath (dyspnea) during treatment with Kyprolis. This most commonly occurs within a day of dosing. Advise patients to contact their healthcare provider if they experience shortness of breath [see Warnings and Precautions (5.6) ] . Venous Thrombosis: Inform patients of the risk of venous thromboembolism and discuss the options for prophylaxis. Advise patients to seek immediate medical attention for symptoms of venous thrombosis or embolism [see Warnings and Precautions (5.8) ] . Infusion-Related Reactions: Advise patients of the risk of infusion-related reactions and discuss the common signs and symptoms of infusion-related reactions with the patients [s...",
  "spl_medguide": "",
  "clinical_studies": "14.1 In Combination with Lenalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma ASPIRE (NCT01080391) ASPIRE was a randomized, open-label, multicenter trial which evaluated the combination of Kyprolis with lenalidomide and dexamethasone (KRd) versus lenalidomide and dexamethasone alone (Rd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy (A line of therapy is a planned course of treatment [including sequential induction, transplantation, consolidation, and/or maintenance] without an interruption for lack of efficacy, such as for relapse or progressive disease). Patients who had the following were excluded from the trial: refractory to bortezomib in the most recent regimen, refractory to lenalidomide and dexamethasone in the most recent regimen, not responding to any prior regimen, creatinine clearance < 50 mL/min, ALT/AST > 3.5 \u00d7 ULN and bilirubin > 2 \u00d7 ULN, New York Heart Association Class III to IV congestive heart failure, or myocardial infarction within the last 4 months. In the KRd arm, Kyprolis was evaluated at a starting dose of 20 mg/m 2 , which was increased to 27 mg/m 2 on Cycle 1, Day 8 onward. Kyprolis...",
  "brand_name": "KYPROLIS",
  "manufacturer": "Onyx Pharmaceuticals, Inc.",
  "application_number": "NDA202714",
  "pharm_class_epc": [
   "Proteasome Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20250618",
  "set_id": "ea66eb30-e665-4693-99a1-a9d3b4bbe2d6",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 27471,
  "serious": 21010,
  "death": 4191,
  "hospitalization": 8984,
  "primary_suspect": 27462,
  "top_reactions": [
   [
    "Plasma Cell Myeloma",
    2942
   ],
   [
    "Off Label Use",
    2394
   ],
   [
    "Death",
    1722
   ],
   [
    "Thrombocytopenia",
    1521
   ],
   [
    "Fatigue",
    1497
   ],
   [
    "Pneumonia",
    1345
   ],
   [
    "Pyrexia",
    1129
   ],
   [
    "Neutropenia",
    1100
   ],
   [
    "Diarrhoea",
    1097
   ],
   [
    "Anaemia",
    1085
   ],
   [
    "Dyspnoea",
    1063
   ],
   [
    "Nausea",
    1053
   ],
   [
    "Acute Kidney Injury",
    863
   ],
   [
    "Drug Ineffective",
    840
   ],
   [
    "Hypertension",
    709
   ]
  ],
  "by_year": {
   "2019": 2028,
   "2020": 2014,
   "2021": 2290,
   "2022": 2518,
   "2023": 2854,
   "2024": 2285,
   "2025": 1940,
   "2026": 686
  },
  "by_year_primary": {
   "2019": 2028,
   "2020": 2014,
   "2021": 2290,
   "2022": 2512,
   "2023": 2854,
   "2024": 2282,
   "2025": 1940,
   "2026": 686
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20161215",
   "reason": "Lack of Assurance of Sterility: Potential cracks in glass vials",
   "firm": "Amgen, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 10,
  "nda": 2,
  "anda": 5,
  "first_approval": "20120720",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 1,
  "sponsors": [
   "AMNEAL PHARMS NY",
   "APOTEX",
   "BRECKENRIDGE",
   "DR REDDYS",
   "EUGIA PHARMA",
   "HAINAN POLY PHARM. CO., LTD.",
   "MSN",
   "ONYX PHARMS AMGEN"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/20/2012"
 },
 "trials": {
  "total": 278,
  "completed": 119,
  "terminated": 43,
  "with_results": 91,
  "industry": 172,
  "phase3": 37,
  "results_share": 0.7647058823529411,
  "terminated_share": 0.15467625899280577
 },
 "pubmed": {
  "rct": 60,
  "meta": 13,
  "recent_rct": 32,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 244019.56,
  "records": 532,
  "by_name": [
   [
    "Kyprolis",
    244019.56
   ]
  ],
  "names_checked": [
   "carfilzomib",
   "Kyprolis"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1643,
  "beneficiaries": 211,
  "spend": 17709545.35,
  "by_brand": [
   {
    "brand": "Kyprolis",
    "claims": 1643,
    "per_claim": 10778.785971,
    "is_generic": false
   }
  ],
  "per_claim": 10778.78597078515
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 93,
   "letter": "A",
   "why": [
    "Death appears in 1.7x the share of reports seen across all of FAERS (-2)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 53,
   "letter": "D",
   "why": [
    "60 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $244,020 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (5 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are plasma cell myeloma, death, thrombocytopenia. 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?",
  "Why this one over bortezomib, ixazomib? What would make you pick one of those instead?",
  "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.)"
 ]
}