{
 "query": "paclitaxel",
 "ingredient": "paclitaxel",
 "slug": "paclitaxel",
 "rxcui": "56946",
 "brands": [
  "Abraxane"
 ],
 "names": [
  "paclitaxel",
  "paclitaxel poliglumex",
  "paclitaxel protein-bound"
 ],
 "classes": [
  {
   "id": "L01CD",
   "name": "Taxanes"
  }
 ],
 "alternatives": [
  "cabazitaxel",
  "docetaxel",
  "paclitaxel poliglumex"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 26
  },
  "boxed_warning": "WARNING: SEVERE MYELOSUPPRESSION \u2022 Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. \u2022 Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. \u2022 Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . \u2022 Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) \u2022 Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) \u2022 Perform frequent complete blood cell counts on all patients receiving ABRAXANE. ( 5.1 , 5.3 )",
  "indications_and_usage": "is a microtubule inhibitor indicated for the treatment of: \u2022 Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) \u2022 Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ( 1.2 ) \u2022 Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 ) 1.1 Metastatic Breast Cancer ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1.2 Non-Small Cell Lung Cancer ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 1.3 Adenocarcinoma of the Pancre...",
  "contraindications": "is contraindicated in patients with: \u2022 Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions (5.1) ] \u2022 A history of severe hypersensitivity reactions to ABRAXANE [see Warnings and Precautions (5.5) ] \u2022 Neutrophil counts of < 1,500 cells/mm 3 . ( 4 ) \u2022 Severe hypersensitivity reactions to ABRAXANE. ( 4 )",
  "warnings_and_cautions": "\u2022 Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ( 5.2 ) \u2022 Sepsis occurred in patients with or without neutropenia who received ABRAXANE in combination with gemcitabine; interrupt ABRAXANE and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3 , then resume treatment at reduced dose levels. ( 5.3 ) \u2022 Pneumonitis occurred with the use of ABRAXANE in combination with gemcitabine; permanently discontinue treatment with ABRAXANE and gemcitabine. ( 5.4 ) \u2022 Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug. ( 4 , 5.5 ) \u2022 Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment. ( 2.5 , 5.6 ) \u2022 ABRAXANE contains albumin derived from human blood, which has a theoretical risk of viral transmission. ( 5.7 ) \u2022 ABRAXANE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Severe Myelosuppression Severe myelosuppression (primarily neutropenia) is dose-dependent...",
  "warnings": "",
  "adverse_reactions": "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. The most common adverse reactions (\u2265 20%) with single-agent use of ABRAXANE in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea [see Adverse Reactions (6.1) ] . The most common adverse reactions (\u2265 20%) of ABRAXANE in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue [see Adverse Reactions (6.1) ]. The most common serious adverse reactions of ABRAXANE in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%). The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 , 2.7 ) 8/2020 Contraindications ( 4 ) 8/2020 Warnings and Precautions ( 5.1 , 5.2 ) 8/2020",
  "information_for_patients": "Advise the patient to read the approved patient labeling (Patient Information). Severe Myelosuppression \u2022 Patients must be informed of the risk of low blood cell counts and severe and life-threatening infections and instructed to contact their healthcare provider immediately for fever or evidence of infection [see Warnings and Precautions (5.1) , (5.3) ]. Severe Neuropathy \u2022 Patients must be informed that sensory neuropathy occurs frequently with ABRAXANE and patients should advise their healthcare providers of numbness, tingling, pain, or weakness involving the extremities [see Warnings and Precautions (5.2) ]. Pneumonitis \u2022 Instruct patients to contact their healthcare provider immediately for sudden onset of dry persistent cough, or shortness of breath [see Warnings and Precautions (5.4) ] . Severe Hypersensitivity \u2022 Instruct patients to contact their healthcare provider for signs of an allergic reaction, which could be severe and sometimes fatal [see Warnings and Precautions (5.5) ]. Common Adverse Reactions \u2022 Explain to patients that alopecia, fatigue/asthenia, and myalgia/arthralgia occur frequently with ABRAXANE. \u2022 Instruct patients to contact their healthcare providers for ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Metastatic Breast Cancer Data from 106 patients accrued in two single arm open label studies and from 460 patients enrolled in a randomized comparative study were available to support the use of ABRAXANE in metastatic breast cancer. Single Arm Open Label Studies In one study, ABRAXANE was administered as a 30-minute infusion at a dose of 175 mg/m 2 to 43 patients with metastatic breast cancer. The second trial utilized a dose of 300 mg/m 2 as a 30-minute infusion in 63 patients with metastatic breast cancer. Cycles were administered at 3-week intervals. Objective responses were observed in both studies. Randomized Comparative Study This multicenter trial was conducted in 460 patients with metastatic breast cancer. Patients were randomized to receive ABRAXANE at a dose of 260 mg/m 2 given as a 30-minute infusion, or paclitaxel injection at 175 mg/m 2 given as a 3-hour infusion. Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases. Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting, 40% in the metastatic...",
  "brand_name": "ABRAXANE",
  "manufacturer": "Abraxis BioScience, LLC",
  "application_number": "NDA021660",
  "pharm_class_epc": [
   "Microtubule Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20221031",
  "set_id": "24d10449-2936-4cd3-b7db-a7683db721e4",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 102661,
  "serious": 97571,
  "death": 15977,
  "hospitalization": 40146,
  "primary_suspect": 102470,
  "top_reactions": [
   [
    "Off Label Use",
    6199
   ],
   [
    "Nausea",
    5808
   ],
   [
    "Dyspnoea",
    5545
   ],
   [
    "Neutropenia",
    5464
   ],
   [
    "Diarrhoea",
    5417
   ],
   [
    "Malignant Neoplasm Progression",
    4930
   ],
   [
    "Anaemia",
    4807
   ],
   [
    "Fatigue",
    4655
   ],
   [
    "Death",
    4612
   ],
   [
    "Neuropathy Peripheral",
    4352
   ],
   [
    "Disease Progression",
    4075
   ],
   [
    "Pyrexia",
    3924
   ],
   [
    "Vomiting",
    3800
   ],
   [
    "Myelosuppression",
    3683
   ],
   [
    "Febrile Neutropenia",
    3574
   ]
  ],
  "by_year": {
   "2019": 8801,
   "2020": 8572,
   "2021": 8691,
   "2022": 9213,
   "2023": 9410,
   "2024": 10898,
   "2025": 11193,
   "2026": 5206
  },
  "by_year_primary": {
   "2019": 8801,
   "2020": 8572,
   "2021": 8686,
   "2022": 9154,
   "2023": 9359,
   "2024": 10883,
   "2025": 11156,
   "2026": 5190
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20131108",
   "reason": "Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the \"Clinical Studies\" and \"Specific Adverse Events\" sections.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120627",
   "reason": "The affected lots of Carboplatin Injection, Cytarabine  Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the pot",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 24,
  "nda": 4,
  "anda": 20,
  "first_approval": "19921229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS TOTOWA",
   "ALEMBIC",
   "AM REGENT",
   "BRISTOL-MYERS",
   "CIPLA",
   "FRESENIUS KABI USA",
   "GLAND"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1992"
 },
 "trials": {
  "total": 6195,
  "completed": 2420,
  "terminated": 780,
  "with_results": 1208,
  "industry": 2630,
  "phase3": 1148,
  "results_share": 0.4991735537190083,
  "terminated_share": 0.12590799031476999
 },
 "pubmed": {
  "rct": 1565,
  "meta": 209,
  "recent_rct": 317,
  "cochrane": [
   {
    "pmid": "35188221",
    "title": "Weekly versus tri-weekly paclitaxel with carboplatin for first-line treatment in women with epithelial ovarian cancer",
    "year": "2022"
   },
   {
    "pmid": "21563139",
    "title": "Short versus long duration infusions of paclitaxel for any advanced adenocarcinoma",
    "year": "2011"
   },
   {
    "pmid": "12535492",
    "title": "Short versus long duration infusions of paclitaxel for any adenocarcinoma",
    "year": "2003"
   },
   {
    "pmid": "12519619",
    "title": "Short versus long duration infusions of paclitaxel for any adenocarcinoma",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "paclitaxel",
   "Abraxane"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3331,
  "beneficiaries": 961,
  "spend": 8354249.59,
  "by_brand": [
   {
    "brand": "Paclitaxel",
    "claims": 2204,
    "per_claim": 92.759514519,
    "is_generic": true
   },
   {
    "brand": "Abraxane",
    "claims": 984,
    "per_claim": 7279.9025813,
    "is_generic": false
   },
   {
    "brand": "Paclitaxel Protein-Bound",
    "claims": 143,
    "per_claim": 6897.7865734,
    "is_generic": true
   }
  ],
  "per_claim": 2508.030498348844
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "paclitaxel",
  "matched": "paclitaxel",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 62,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death appears in 1.7x the share of reports seen across all of FAERS (-3)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 89,
   "letter": "A",
   "why": [
    "1565 randomized trials and 209 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 50% of completed registered trials posted results (-8)"
   ],
   "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 $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (20 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, dyspnoea, neutropenia. 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 cabazitaxel, docetaxel, paclitaxel poliglumex? 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.)"
 ]
}