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Docetaxel Anhydrous

Also known as: Docetaxel

Microtubule Inhibitor

Route: Intravenous

Check Docetaxel Anhydrous Interactions →

2 interactions on record⛔ Black Box Warning

Docetaxel Anhydrous has 2 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Ketoconazole, Ritonavir. Patients taking Docetaxel Anhydrous should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 2

Major (2)

Docetaxel Anhydrous + Ketoconazole— Potent CYP3A4 inhibitor that increased docetaxel exposure 2.2-fold in vivo. Concomitant use should be avoided; if unavoi…
Docetaxel Anhydrous + Ritonavir— Protease inhibitor and potent CYP3A4 inhibitor that may increase docetaxel exposure. Concomitant use should be avoided; …

Docetaxel Anhydrous + Ketoconazole⚠️Major

Potent CYP3A4 inhibitor that increased docetaxel exposure 2.2-fold in vivo. Concomitant use should be avoided; if unavoidable, close monitoring for toxicity and dose reduction considered.

Docetaxel Anhydrous + Ritonavir⚠️Major

Protease inhibitor and potent CYP3A4 inhibitor that may increase docetaxel exposure. Concomitant use should be avoided; if unavoidable, close monitoring and dose reduction considered.

⛔ FDA Black Box 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 <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 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

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 )

Pregnancy & Breastfeeding

8.1 Pregnancy 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

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.