Taxotere (docetaxel)

The incidence of mortality associated with docetaxel therapy is higher in patients with hepatic impairment (see Dosage and Administration: Dosage in Renal and Hepatic Impairment) and in patients receiving higher doses of the drug.

Concomitant use of potent inhibitors of cytochrome P-450 (CYP) isoenzyme 3A4 (CYP3A4) (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase docetaxel exposure and should be avoided. If such concomitant use cannot be avoided, a reduction in docetaxel dosage with careful monitoring for toxicity should be considered. Based on limited pharmacokinetic data, the manufacturers state that a 50% reduction in docetaxel dosage may be considered in patients requiring concomitant therapy with a potent CYP3A4 inhibitor; however, there are no clinical data with use of this adjusted docetaxel dosage. (See Drug Interactions: Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes.)

Urinary excretion of docetaxel has been reported to be low (less than 10%), and reduction of dosage in patients with impaired renal function does not appear to be necessary.

Docetaxel clearance appears to be reduced in patients with abnormal liver function, and an increased incidence of adverse effects (including treatment-related mortality) has been reported in patients with moderate to severe hepatic impairment. Therefore, patients with serum total bilirubin exceeding the upper limit of normal, and patients with serum AST and/or ALT exceeding 1.5 times the upper limit of normal concomitant with alkaline phosphatase exceeding 2.5 times the upper limit of normal, generally should not receive docetaxel.

For further information on the handling of antineoplastic agents, see the guidelines at the end of Antineoplastic Agents 10:00.

Adjustment of docetaxel dosage may be required according to toxicity. When docetaxel is used in combination regimens, adjustment of dosage for the other drugs may be necessary. In addition to the dosage adjustments for cisplatin and fluorouracil described here, also see the manufacturers' labelings.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies of docetaxel have not been conducted.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Docetaxel may cause fetal harm when administered to pregnant women, but potential benefits may be acceptable in certain conditions despite possible risks to the fetus. Reproduction studies in rats and rabbits given docetaxel doses greater than or equal to 0.3 and 0.03 mg/kg (about 1/50 and 1/300 the maximum daily recommended human dose on a mg/m2 basis), respectively, during organogenesis revealed evidence of maternal toxicity, embryotoxicity, and fetotoxicity; fetotoxicity was characterized by intrauterine mortality, increased resorption, reduced fetal weight, and fetal ossification delay. There are no adequate and well-controlled studies to date using docetaxel in pregnant women. Docetaxel should be used during pregnancy only in life-threatening situations or in diseases for which safer drugs cannot be used or are ineffective. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with docetaxel. When docetaxel is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential hazard to the fetus.

It is not known whether docetaxel is distributed into milk. Because of the potential for serious adverse reactions to docetaxel in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.