Docetaxel 80 mg/4mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Microtubule Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Docetaxel is a chemotherapy drug used for several types of cancer — most commonly breast cancer, non-small cell lung cancer, prostate cancer that no longer responds to hormone ther...
- What exactly is docetaxel being used to treat me for?
- You'll get docetaxel as an IV infusion — a drip into a vein — that takes about one hour. Treatments are usually given once every three weeks at your cancer center or hospital. Befo...
- How will I receive my docetaxel treatment, and how often?
Patient education
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Some supplements/herbs that may interact with Docetaxel — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $13.64 | $13.64 / 1 vial |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9171 | $0.456 / J9171 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Docetaxel 20 mg/mL 00143-9205-01 | Hikma | 1 vial | — | AP | FDA listed | — |
| Docetaxel 80 mg/4mL 00955-1021-04 | Sanofi-Aventis | 1 vial | — | — | FDA listed | — |
| Docetaxel 80 mg/4mLthis 23155-0904-31 | Heritage | 1 vial | — | AP | FDA listed | — |
| Docetaxel 20 mg/mL 25021-0245-01 | Sagent | 1 vial | — | AP | FDA listed | — |
| Docetaxel 80 mg/4mL 43598-0259-40 | Dr. | 4 ml | — | AP | FDA listed | — |
| Docetaxel 80 mg/4mL 43598-0610-40 | Dr. | 4 ml | — | AP | FDA listed | — |
| Docetaxel 20 mg/mL 45963-0765-52 | Actavis | 1 vial | — | AP | FDA listed | — |
| Docetaxel 80 mg/4mL 47335-0895-40 | Sun | 1 vial | — | — | FDA listed | — |
| Docetaxel 80 mg/4mL 57884-3042-01 | Jiangsu | 1 vial | — | AP | FDA listed | — |
| Docetaxel 80 mg/4mL 70121-1222-01 | Amneal | 1 vial | — | AP | FDA listed | — |
| Beizray 20 mg/mL 70710-2152-01 | Zydus | 1 vial | — | — | FDA listed | — |
| Docetaxel 20 mg/mL 71288-0152-04 | Meitheal | 1 vial | — | — | FDA listed | — |
| Beizray 20 mg/mL 83513-0009-01 | Zhuhai | 4 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 23155-0904-31 You're viewing this | 1 VIAL in 1 CARTON (23155-904-31) / 4 mL in 1 VIAL | 2024-12-15 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with Docetaxel Injection 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 Injection 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 <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection. [see Warnings and Precautions (5.3)] . Do not administer Docetaxel Injection to patients who have a history of severe hypersensitivity reactions to Docetaxel Injection or to other drugs formulated with polysorbate 80 [see Contraindications (4)] .
Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the Docetaxel Injection infusion and administration of appropriate therapy [see Warnings and Precautions (5.5)] . Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication.
It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions (5.6)] WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m 2 (5.1) Avoid use of docetaxel if bilirubin > 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 to patients with neutrophil counts <1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia (4, 5.3) Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication.
Severe reactions require immediate discontinuation of docetaxel and administration of appropriate therapy (5.5) Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4) Severe fluid retention may occur despite dexamethasone (5.6)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Docetaxel Injection is a microtubule inhibitor indicated for: Br e a st Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1) N o n- small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2) C a stration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer (1.3) Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4) Squ a m o u s Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1Breast Cancer Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2Non-small Cell Lung Cancer Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3Prostate Cancer Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4Gastric Adenocarcinoma Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5Head and Neck Cancer Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration ( 2.7)] . Administer in a facility equipped to manage possible complications (e.g. anaphylaxis). Administer in a facility equipped to manage possible complications (e.g., anaphylaxis).
Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw Docetaxel Injection from the vial.
BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent (2.1) BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles (2.1) NSCLC: after platinum therapy failure: 75 mg/m 2 single agent (2.2) NSCLC: chemotherapy naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (2.2) HRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously (2.3) GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion (2.4) SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion; for 4 cycles (2.5) SCCHN: 75 mg/m 2 followed by cisplatin 100 mg/m 2 IV (day 1), followed by fluorouracil 1000 mg/m 2 per day as a 24-hr IV (days 1-4); for 3 cycles (2.5) For all patients: Premedicate with oral corticosteroids (2.6) Adjust dose as needed (2.7)
2.1Breast Cancer • For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of Docetaxel Injection is 60 mg/m 2 to 100 mg/m 2 administered intravenously over 1 hour every 3 weeks. • For the adjuvant treatment of operable node-positive breast cancer, the recommended Docetaxel Injection dose is 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities [see Dosage and Administration (2.7)] .
2.2Non-small Cell Lung Cancer • For treatment after failure of prior platinum-based chemotherapy, Docetaxel Injection was evaluated as monotherapy, and the recommended dose is 75 mg/m 2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m 2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)] .
For chemotherapy-naive patients, Docetaxel Injection was evaluated in combination with cisplatin. The recommended dose of Docetaxel Injection is 75 mg/m 2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m 2 over 30-60 minutes every 3 weeks [see Dosage and Administration (2.7)] .
2.3Prostate Cancer For metastatic castration-resistant prostate cancer, the recommended dose of Docetaxel Injection is 75 mg/m 2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously [see Dosage and Administration (2.7)] .
2.4Gastric Adenocarcinoma For gastric adenocarcinoma, the recommended dose of Docetaxel Injection is 75 mg/m 2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m 2 , as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m 2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration [see Dosage and Administration (2.7)] .
2.5Head and Neck Cancer Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infecti…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS One-vial Docetaxel Injection Docetaxel Injection 20 mg/mL Docetaxel Injection 20 mg/1mL single-dose vial: 20 mg docetaxel in 1 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection 80 mg/4 mL Docetaxel Injection 80 mg/4 mL single-dose vial: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel Injection 160 mg/8 mL Docetaxel Injection 160 mg/8 mL single-dose vial: 160 mg docetaxel in 8 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
Injection: One-vial Docetaxel Injection: Single-dose vials 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Docetaxel Injection is contraindicated in patients with: neutrophil counts of <1500 cells/mm 3 [ see Warnings and Precautions (5.3)]. a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred [see Warnings and Precautions (5.5)] . Hypersensitivity to docetaxel or polysorbate 80 (4) Neutrophil counts of <1500 cells/mm 3 (4)
⚠️ 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)
5.1Toxic Deaths B r ea st Cancer Docetaxel Injection 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/m2, 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 Injection administered at a dose of 100 mg/m2 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 randomized, controlled studies).
There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m2 dose level, 3 of 5 patients had an ECOG PS of 2 at study entry [see Dosage and Administration (2.2), Clinical Studies (14)].
5.2Hepatic Impairment 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. Avoid 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 [see Warnings and Precautions (5.1)].
For patients with isolated elevations of transaminase >1.5 × ULN, consider Docetaxel Injection dose modifications [see Dosage and Administration (2.7)] . Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of Docetaxel Injection therapy.
5.3Hematologic Effects Perform frequent peripheral blood cell counts on all patients receiving Docetaxel Injection. Do not retreat patients with subsequent cycles of Docetaxel Injection until neutrophils recover to a level >1500 cells/mm3 [see Contraindications (4)]. Avoid retreating patients until platelets recover to a level >100,000 cells/mm3.
A 25% reduction in the dose of Docetaxel Injection is recommended during subsequent cycles following severe neutropenia (<…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most serious adverse reactions from Docetaxel Injection 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 Injection 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 Injection 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 Avet Pharmaceuticals Inc. at 1-888-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Breast Cancer Monotherapy with Docetaxel Injection for locally advanced or metastatic breast cancer after failure of prior chemotherapy Docetaxel Injection 100 mg/m 2 : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received Docetaxel Injection administered at 100 mg/m 2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline.
These reactions were described using COSTART terms and were considered possibly or probably related to Docetaxel Injection. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving Docetaxel Injection for the treatment of breast cancer and in patients with other tumor types.
(See Table 3.) Table 3: Summary of Adverse Reactions in Patients Receiving Docetaxel Injection at 100 mg/m 2 A dverse Reaction A l l Tumor Types Normal LFTs* n=2045 % A l l Tumor Types Elevated LFTs** n=61 % B reast Cancer Normal LFTs* n=965 % H e m atologic Neutropenia <2000 cells/mm 3 <500 cells/mm 3 Leukopenia <4000 cells/mm 3 <1000 cells/mm 3 Thrombocytopenia <100,000 cells/mm 3 Anemia <11 g/dL <8 g/dL Febrile Neutropenia*** 96 75 96 32 8 90 9 11 96 88 98 47 25 92 31 26 99 86 99 44 9 94 8 12 Septic Death N on-Septic Death 2 1 5 7 1 1 Infections Any Sever…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. I n vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4.
Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of Docetaxel Injection and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with Docetaxel Injection, close monitoring for toxicity and a Docetaxel Injection dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see Dosage and Administration (2.7), Clinical Pharmacology (12.3)].
Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. (7)
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. (8.2) Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of Docetaxel Injection. (8.3) See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling.
8.1Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action, Docetaxel Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Docetaxel Injection contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations].
In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [see Data]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Docetaxel Injection contains alcohol [see Warnings and Precautions (5.13)].
Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal data Intravenous administration of ≥0.3 and 0.03 mg/kg/day docetaxel to pregnant rats and rabbits, respectively, during the period of organogenesis caused an increased incidence of intrauterine mortality, resorptions, reduced fetal weights, and fetal ossification delays. Maternal toxicity was also observed at these doses, which were approximately 0.02 and 0.003 times the daily maximum recommended human dose based on body surface area, respectively.
8.2Lactation Risk Summary There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Docetaxel Injection and for 1 week after the last dose.
8.3Females and Males of Reproductive Potential Based on findings in animals, Docetaxel Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. P r e g nan cy Testing Verify pregnancy status in females of reproductive potential prior to initiating Docetaxel Injection. Contraception Females Based on genetic toxicity findings, advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of Docetaxel Injection.
Males Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of Docetaxel Injection. Infertility Based on findings in animal studies, Docetaxel Injection may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)] .
8.4Pediatric Use The alcohol content of Docetaxel Injection should be taken into account when given to pediatric patients [see Warnings and Precautions (5.13)] . The efficacy of Docetaxel Injection in pediatric patients as monotherapy or in combi…
🆘 Overdosage ▾
10 OVERDOSAGE There is no known antidote for Docetaxel Injection overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions.
Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m2 basis) and was associated with abnormal mitosis and necrosis of multiple organs.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells.
Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.
12.3Pharmacokinetics Ab sorption The pharmacokinetics of docetaxel has been evaluated in cancer patients after administration of 20 mg/m 2 to 115 mg/m 2 in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m 2 to 115 mg/m 2 with infusion times of 1 to 2 hours. Docetaxel’s pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with initial rapid distribution phase and the late (terminal) phase.
Distribution Mean steady state volume of distribution was 113 L. Docetaxel is approximately 94% protein bound in vitro , mainly to α1-acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was approximately 97%.
Dexamethasone does not affect the protein binding of docetaxel. E limination With extended plasma sampling up to 8 to 22 days post infusion, the estimated mean total body clearance was 18 L/h/m 2 (range of means: 14 to 23) and mean terminal elimination half-life was 116 hours (range of means: 92 to 135). Metabolism Docetaxel is metabolized by the CYP3A4 isoenzyme in vitro [see Drug Interactions (7)].
Excretion In three cancer patients urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively, within 7 days. About 80% of the radioactivity recovered in feces was excreted during the first 48 hours as 1 major and 3 minor metabolites with less than 8% as unchanged drug. Spe cific Populations Effect of Age: A population pharmacokinetic analysis was carried out after Docetaxel Injection treatment of 535 patients dosed at 100 mg/m 2 .
Pharmacokinetic parameters estimated by this analysis were very close to those estimated from phase 1 studies. The pharmacokinetics of docetaxel was not influenced by age. Effect of Gender: The population pharmacokinetics analysis described above also indicated that gender did not influence the pharmacokinetics of docetaxel.
Hepatic Impairment: The population pharmacokinetic analysis described above indicated that in patients with clinical chemistry data suggestive of mild to moderate liver impairment (AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN), total body clearance was lowered by an average of 27%, resulting in a 38% increase in systemic exposure (AUC). This average, however, includes a substantial range and there is, at present, no measurement that would allow recommendation for dose adjustment in such patients.
Patients with combined abnormalities of transaminase and alkaline phosphatase should not be treated with Docetaxel Injection. Patients with severe hepatic impairment have not been studied [see Warnings and Precautions (5.2), Use in Specific Populations (8.6)]. Effect of Race: Mean total body clearance for Japanese patients dosed at the range of 10 mg/m2 to 90 mg/m2 was similar to that of European/American populations dosed at 100 mg/m2, suggesting no significant difference in the elimination of docetaxel in the two populations.
Drug Interaction Studies Effect of Ketoconazole: The effect of ketoconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of docetaxel was investigated in 7 cancer patients. Patients were randomized to receive either docetaxel (100 mg/m2 intrav…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied One-vial Docetaxel Injection Docetaxel Injection is supplied in a single-dose vial as a sterile, pyrogen-free and colourless to brownish yellow clear non-aqueous solution. Discard unused portion. Docetaxel Injection 20mg/mL (NDC 23155-903-31) Docetaxel Injection 20 mg/1 mL: 20 mg docetaxel in 1 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
The vial is a single-dose vial packed in one carton. Discard unused portion. Docetaxel Injection 80 mg/4 mL (NDC 23155-904-31) Docetaxel Injection 80 mg/4 mL: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
The vial is a single-dose vial packed in one carton. Discard unused portion. Docetaxel Injection 160 mg/8 mL (NDC 23155-905-31) Docetaxel Injection 160 mg/8 mL: 160 mg docetaxel in 8 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.
The vial is a single-dose vial packed in one carton. Discard unused portion.
16.2Storage Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.
16.3Handling and Disposal Docetaxel Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1
📋 Description ▾
11 DESCRIPTION Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N- tert -butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate.
Docetaxel has the following structural formula: Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. One-vial Docetaxel Injection Docetaxel Injection is a sterile, non-pyrogenic, and colourless to brownish yellow clear solution at 20 mg/mL concentration.
Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol (50% v/v) solution, with 0.7 mg anhydrous citric acid for pH adjustment. Docetaxel Injection is available in single-dose vials containing 20 mg (1 mL), 80 mg (4 mL) or 160 mg (8mL). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution for injection. structural formula
💬 Information for Patients ▾
Patient Information Docetaxel (doe” se tax' el) Injection for intravenous use What is the most important information I should know about Docetaxel Injection? Docetaxel Injection can cause serious side effects, including death. The chance of death in people who receive Docetaxel Injection is higher if you: ○ have liver problems ○ receive high doses of Docetaxel Injection ○ have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum Docetaxel Injection can affect your blood cells.
Your healthcare provider should do routine blood tests during treatment with Docetaxel Injection. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your healthcare provider may not treat you with Docetaxel Injection until you have enough white blood cells.
People with low white blood cell counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your healthcare provider's instructions for how often to take your temperature during treatment with Docetaxel Injection.
Call your healthcare provider right away if you have a fever. Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms.
Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever. Severe allergic reactions are medical emergencies that can happen in people who receive Docetaxel Injection and can lead to death. You may be at higher risk of developing a severe allergic reaction to Docetaxel Injection if you are allergic to paclitaxel.
Your healthcare provider will monitor you closely for allergic reactions during your Docetaxel Injection infusion. Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction: ○ trouble breathing ○ sudden swelling of your face, lips, tongue, throat, or trouble swallowing ○ hives (raised bumps), rash, or redness all over your body Your body may hold too much fluid (severe fluid retention) during treatment with Docetaxel Injection. This can be life threatening.
To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each Docetaxel Injection treatment. You must take the corticosteroid exactly as your healthcare provider tells you. Tell your healthcare provider or nurse before your Docetaxel Injection treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you.
Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath. Risk of new cancers. An increase in new (second) cancers has happened in people treated with Docetaxel Injection together with certain other anticancer treatments.
This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin's Lymphoma (NHL), and kidney cancer. ○ Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection. Your healthcare provider will check you for new cancers during and after your treatment with Docetaxel Injection. Severe skin problems.
Tell your healthcare provider right away if you have any of these signs of a severe skin reaction: ○ redness and swelling of your arms and legs. ○ blistering, peeling, or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches. red, scaly rash all over your body with blisters, small red or white bumps under the skin that contain pus (pustules) and fever. What is Docetaxel Injection?
Docetaxel Injection is a prescription anticancer medicine used to treat certain people with:…