FDA.reportPublic FDA data

Docetaxel

openFDA label record#

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Brand name
Docetaxel
Generic name
DOCETAXEL
Manufacturer
Hospira, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
6b9999bb-869e-4d25-838c-23c3ab280044
SPL ID
0eff97af-e2cd-46d7-84d3-0445a0910b1a
Version
7
Effective date
2025-01-31
Source export date
2026-08-01
Applications, Product NDCs, Package NDCs table
ApplicationsProduct NDCsPackage NDCsRxCUIsUNIIsRoutes
NDA0222340409-0365, 0409-4235, 0409-50680409-4235-01, 0409-5068-01, 0409-0365-011001405, 186048015H5577CQDINTRAVENOUS

Boxed warning cross-check#

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boxed warning

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2 [ see Warnings and Precautions (5.1) ] . Avoid the use of Docetaxel Injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of Docetaxel Injection [ see Warnings and Precautions (5.2) ]. Do not administer Docetaxel Injection to patients with neutrophil counts of ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) • Do not administer Docetaxel Injection to patients with neutrophil counts

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Second primary malignancies: In patients treated with Docetaxel Injection-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ( 5.7 ) • Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. ( 5.8 ) • Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. ( 5.9 ) • Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. ( 5.10 ) • Asthenia: Severe asthenia may occur and may require treatment discontinuation. ( 5.11 ) • Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 , 8.3 ) • Alcohol content: The alcohol content in a dose of Docetaxel Injection may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion. ( 5.13 ) • Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment. ( 5.14 ) 5.1 Toxic Deaths Breast Cancer Docetaxel administered at 100 mg/m 2 was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN). Among patients dosed at 60 mg/m 2 , mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function. Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths. Non-small Cell Lung Cancer Docetaxel administered at a dose of 100 mg/m 2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum-based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two ...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The most serious adverse reactions from docetaxel are: • Toxic Deaths [ see Boxed Warning , Warnings and Precautions (5.1) ] • Hepatic Impairment [ see Boxed Warning , Warnings and Precautions (5.2) ] • Hematologic Effects [ see Boxed Warning , Warnings and Precautions (5.3) ] • Enterocolitis and Neutropenic Colitis [ see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [ see Boxed Warning , Warnings and Precautions (5.5) ] • Fluid Retention [ see Boxed Warning , Warnings and Precautions (5.6) ] • Second Primary Malignancies [ see Warnings and Precautions (5.7) ] • Cutaneous Reactions [ see Warnings and Precautions (5.8) ] • Neurologic Reactions [ see Warnings and Precautions (5.9) ] • Eye Disorders [ see Warnings and Precautions (5.10) ] • Asthenia [ see Warnings and Precautions (5.11) ] • Alcohol Content [ see Warnings and Precautions (5.13) ] The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. 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. Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established. Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Breast Cancer Monotherapy with Do...

adverse reactions table

Table 3: Summary of Adverse Reactions in Patients Receiving Docetaxel at 100 mg/m2Adverse ReactionAll Tumor Types Normal LFTsNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN n=2045 %All Tumor Types Elevated LFTsElevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN n=61 %Breast Cancer Normal LFTs n=965 %HematologicNeutropenia <2000 cells/mm3969699 <500 cells/mm3758886Leukopenia <4000 cells/mm3969899 <1000 cells/mm3324744Thrombocytopenia <100,000 cells/mm38259Anemia <11 g/dL909294 <8 g/dL9318Febrile NeutropeniaFebrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization112612Septic Death251Non-Septic Death171Infections Any223322 Severe6166Fever in Absence of Infection Any314135 Severe282Hypersensitivity ReactionsRegardless of Premedication Any212018 Severe4103With 3-day Premedicationn=92n=3n=92 Any153315 Severe202Fluid RetentionRegardless of Premedication Any473960 Severe789With 3-day Premedicationn=92

adverse reactions table

Table 4: Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function TestsAdverse ReactionDocetaxel100 mg/m2Docetaxel60mg/m2Normal LFTsNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN n=730 %Elevated LFTsElevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN n=18 %Normal LFTs n=174 %Neutropenia Any <2000 cells/mm39810095 Grade 4 <500 cells/mm3849475Thrombocytopenia Any <100,000 cells/mm3114414 Grade 4 <20,000 cells/mm31171Anemia <11 g/dL959465InfectionIncidence of infection requiring hospitalization and/or intravenous antibiotics was 8.5% (n=62) among the 730 patients with normal LFTs at baseline; 7 patients had concurrent grade 3 neutropenia, and 46 patients had grade 4 neutropenia. Any23391 Grade 3 and 47330Febrile NeutropeniaFebrile Neutropenia: For 100 mg/m2, ANC grade 4 and fever >38°C with intravenous antibiotics and/or hospitalization; for 60 mg/m2, ANC grade 3/4 and fever >38.1°C By Patient12330 By Course290Septic Death261Non-Septic Death1110

adverse reactions table

Table 5: Non-Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function TestsNA = not availableAdverse ReactionDocetaxel100 mg/m2Docetaxel60 mg/m2Normal LFTsNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN n=730 %Elevated LFTsElevated Baseline Liver Function: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN n=18 %Normal LFTs n=174 %Acute Hypersensitivity ReactionRegardless of Premedication Any1361 Severe100Fluid RetentionFluid Retention includes (by COSTART): edema (peripheral, localized, generalized, lymphedema, pulmonary edema, and edema otherwise not specified) and effusion (pleural, pericardial, and ascites); no premedication given with the 60 mg/m2 doseRegardless of Premedication Any566113 Severe8170Neurosensory Any575020 Severe600Myalgia23333Cutaneous Any456131 Severe5170Asthenia Any654466 Severe17220Diarrhea Any4228NA Severe611Stomatitis Any536719 Severe8391

adverse reactions table

Table 6: Clinically Important Treatment-Emergent Adverse Reactions Regardless of Causal Relationship in Patients Receiving Docetaxel in Combination with Doxorubicin and Cyclophosphamide (TAX316)Docetaxel 75 mg/m2 + Doxorubicin 50 mg/m2 + Cyclophosphamide 500 mg/m2 (TAC) n=744 %Fluorouracil 500 mg/m2 + Doxorubicin 50 mg/m2 + Cyclophosphamide 500 mg/m2 (FAC) n=736 %Adverse Reaction AnyGrade 3/4AnyGrade 3/4Anemia924722Neutropenia71668249Fever in absence of infection471170Infection394362Thrombocytopenia392281Febrile neutropenia25N/A3N/ANeutropenic infection12N/A6N/AHypersensitivity reactions13140Lymphedema4010Fluid RetentionCOSTART term and grading system for events related to treatment.351150Peripheral edema27070Weight gain13090Neuropathy sensory260100Neuro-cortical5161Neuropathy motor4020Neuro-cerebellar2020Syncope2110Alopecia98N/A97N/ASkin toxicity271180Nail disorders190140Nausea81588

adverse reactions table

Table 7: Treatment-Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-small Cell Lung Cancer Previously Treated with Platinum-Based ChemotherapyNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULNAdverse ReactionDocetaxel 75 mg/m2 n=176 %Best Supportive Care n=49 %Vinorelbine/Ifosfamide n=119 %Neutropenia Any841483 Grade 3/4651257Leukopenia Any84689 Grade 3/449043Thrombocytopenia Any808 Grade 3/4302Anemia Any915591 Grade 3/491214Febrile NeutropeniaFebrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization6NANot Applicable1Infection Any342930 Grade 3/41069Treatment Related Mortality3NA3Hypersensitivity Reactions Any601 Grade 3/4300Fluid Retention Any34NDNot Done23 Severe33Neurosensory Any231429 Grade 3/4265Neuromotor Any16810 Grade 3/4563Skin Any20617 Grade 3/4121Gastrointestinal

adverse reactions table

Table 8: Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer Patients Receiving Docetaxel in Combination with CisplatinAdverse ReactionDocetaxel 75 mg/m2 + Cisplatin 75 mg/m2 n=406 %Vinorelbine 25 mg/m2 + Cisplatin 100 mg/m2 n=396 %Neutropenia Any9190 Grade 3/47478Febrile Neutropenia55Thrombocytopenia Any1515 Grade 3/434Anemia Any8994 Grade 3/4725Infection Any3537 Grade 3/488Fever in absence of infection Any3329 Grade 3/4<11Hypersensitivity ReactionReplaces NCI term "Allergy" Any124 Grade 3/43<1Fluid RetentionCOSTART term and grading system Any5442 All severe or life-threatening events22Pleural effusion Any2322 All severe or life-threatening events22Peripheral edema Any3418 All severe or life-threatening events<1<1Weight gain Any159 All severe or life-threatening events<1<1Neurosensory Any4742 Grade 3/444Neuromotor Any1917 Grade 3/436Skin Any1614 Grade 3/4<11Nausea Any7276 Grade 3/41017Vomiting Any5561

adverse reactions table

Table 9: Clinically Important Treatment-Emergent Adverse Reactions (Regardless of Relationship) in Patients with Prostate Cancer who Received Docetaxel in Combination with Prednisone (TAX327)Docetaxel 75 mg/m2 every 3 weeks + prednisone 5 mg twice daily n=332 %Mitoxantrone 12 mg/m2 every 3 weeks + prednisone 5 mg twice daily n=335 %Adverse ReactionAnyGrade 3/4AnyGrade 3/4Anemia675582Neutropenia41324822Thrombocytopenia3181Febrile Neutropenia3N/A2N/AInfection326204Epistaxis6020Allergic Reactions8110Fluid RetentionRelated to treatment24150Weight Gain8030Peripheral Edema18020Neuropathy Sensory30270Neuropathy Motor7231Rash/Desquamation6031Alopecia65N/A13N/ANail Changes30080Nausea413362Diarrhea322101Stomatitis/Pharyngitis20180Taste Disturbance18070Vomiting172142Anorexia171140