Paclitaxel

The Basics

What is Paclitaxel?

A chemotherapy medication used to treat a number of types of cancer.

Brand names for Paclitaxel

Paclitaxel

How Paclitaxel is classified

Antineoplastic Agents

Paclitaxel During Pregnancy

Paclitaxel pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Paclitaxel while pregnant

Paclitaxel Injection can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3.0 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m² basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1.0 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m² basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality. There are no adequate and well-controlled studies in pregnant women. If paclitaxel 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.

Taking Paclitaxel While Breastfeeding

What are recommendations for lactation if you're taking Paclitaxel?

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.[1] Based on limited data, paclitaxel appears to be excreted into milk in relatively large amounts. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence, but the duration abstinence is not clear. In one case, paclitaxel was detectable in milk for at least a week, but not at 13 days after a dose of 30 mg per square meter. The manufacturer recommends that breastfeeding be discontinued during paclitaxel therapy and for 2 weeks after the last dose. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[2] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Maternal / infant drug levels

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.[1] Based on limited data, paclitaxel appears to be excreted into milk in relatively large amounts. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence, but the duration abstinence is not clear. In one case, paclitaxel was detectable in milk for at least a week, but not at 13 days after a dose of 30 mg per square meter. The manufacturer recommends that breastfeeding be discontinued during paclitaxel therapy and for 2 weeks after the last dose. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[2] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Possible effects of Paclitaxel on milk supply

A telephone follow-up study was conducted on 74 women who received cancer chemotherapy at one center during the second or third trimester of pregnancy to determine if they were successful at breastfeeding postpartum. Only 34% of the women were able to exclusively breastfeed their infants, and 66% of the women reported experiencing breastfeeding difficulties. This was in comparison to a 91% breastfeeding success rate in 22 other mothers diagnosed during pregnancy, but not treated with chemotherapy. Other statistically significant correlations included: 1. mothers with breastfeeding difficulties had an average of 5.5 cycles of chemotherapy compared with 3.8 cycles among mothers who had no difficulties; and 2. mothers with breastfeeding difficulties received their first cycle of chemotherapy on average 3.4 weeks earlier in pregnancy. Of the 9 women who received a taxane-containing regimen, 7 had breastfeeding difficulties.[4]

Possible alternatives to Paclitaxel