Ponatinib

The Basics

What is Ponatinib?

Used to treat a certain type of chronic myeloid leukemia (CML).

Brand names for Ponatinib

Iclusig

How Ponatinib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors, Tyrosine Kinase Inhibitors

Ponatinib During Pregnancy

Ponatinib 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 Ponatinib while pregnant

Based on its mechanism of action and findings in animals, Iclusig can cause fetal harm when administered to a pregnant woman . There are no available data on Iclusig use in pregnant women. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposures at the recommended human dose . Advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Taking Ponatinib While Breastfeeding

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

No information is available on the clinical use of ponatinib during breastfeeding. Because ponatinib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 24 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during ponatinib therapy and for 6 days following the last dose.

Maternal / infant drug levels

No information is available on the clinical use of ponatinib during breastfeeding. Because ponatinib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 24 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during ponatinib therapy and for 6 days following the last dose.

Possible effects of Ponatinib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ponatinib

None listed