Single Vial Docetaxel Injection - ION Solutions

In 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) and Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category D [See 'Warnings and Precautions' section]
Based on its mechanism of action and findings in animals, Docetaxel Injection can cause fetal
harm when administered to a pregnant woman. If Docetaxel Injection is used during pregnancy, or if the
patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard
to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during
therapy with Docetaxel Injection.
Docetaxel Injection can cause fetal harm when administered to a pregnant woman. Studies in both
rats and rabbits at doses ≥0.3 and 0.03 mg/kg/day, respectively (about 1/50 and 1/300 the daily maximum
recommended human dose on a mg/m 2 basis), administered during the period of organogenesis, have
shown that docetaxel is embryotoxic and fetotoxic (characterized by intrauterine mortality, increased
resorption, reduced fetal weight, and fetal ossification delay). The doses indicated above also caused
maternal toxicity.
8.3 Nursing Mothers
It is not known whether docetaxel is excreted in human milk. Because many drugs are excreted in
human milk, and because of the potential for serious adverse reactions in nursing infants from Docetaxel
Injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
8.4 Pediatric Use
The safety and effectiveness of docetaxel in pediatric patients have not been established.
8.5 Geriatric Use
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly
patients.
Non-Small Cell Lung Cancer
In a study conducted in chemotherapy-naïve patients with NSCLC (TAX326), 148 patients (36%)
in the docetaxel+cisplatin group were 65 years of age or greater. There were 128 patients (32%) in the
vinorelbine+cisplatin group 65 years of age or greater. In the docetaxel+cisplatin group, patients less than
65 years of age had a median survival of 10.3 months (95% CI: 9.1 months, 11.8 months) and patients 65
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