Docetaxel

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Docetaxel Prescribing Information

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/m²

[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/mm³. 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)]

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.

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.

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.

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)].

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