Brand Name, Dosage Format and Strength
STATEMENT ON USAGE FOR HIGH RISK GROUPS
Pregnancy and Lactation
Pregnancy Category D
Paclitaxel can cause fetal harm when administered to pregnant women. Women who are pregnant or those wanting to become pregnant should be advised to avoid becoming pregnant during paclitaxel therapy. Paclitaxel should be used only when clearly needed and when potential benefits outweigh the unknown hazards to the baby.
Breastfeeding: It is not known whether paclitaxel is distributed to human milk. Breastfeeding is not recommended during chemotherapy because of the potential serious adverse reactions to paclitaxel by the breastfeeding infant.
The safety and efficacy of paclitaxel in elderly patients have not been clearly established. However, most of the patients treated for refractory metastatic ovarian carcinoma are older than 60 yrs. There is no evidence of age-related differences in the safety or dose tolerance between young and old patients. However, the possibility of increased sensitivity in some older patients cannot be ruled out.
The safety and efficacy of paclitaxel in children have not been established. In a clinical trial in children, high dose paclitaxel (350 to 420 mg/m2 or more than two times the recommended dose) infused over 3 hrs caused CNS toxicity (rarely associated with death). The toxicity is attributed to the high dose alcohol content (vehicle) given over a short infusion time. Concomitant use of antihistamines may intensify this effect.
Hepatic and Renal Impairment
The use of paclitaxel in patients with impaired renal and hepatic function has not been fully established. Since paclitaxel is metabolized in the liver, dose reduction is recommended in patients with moderate to severe liver failure. Dose reduction may not be necessary in patients with renal failure.