Erlotinib

The Basics

What is Erlotinib?

Used to treat certain types of non-small cell lung cancer.

Brand names for Erlotinib

Tarceva

How Erlotinib is classified

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

Erlotinib During Pregnancy

Erlotinib pregnancy category

Category DNote 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 Erlotinib while pregnant

TARCEVA can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while being treated with TARCEVA. Erlotinib has been shown to cause maternal toxicity with associated embryofetal lethality and abortion in rabbits when given at doses that result in plasma drug concentrations of approximately 3 times those in humans (AUCs at 150 mg daily dose). When given during the period of organogenesis to achieve plasma drug concentrations approximately equal to those in humans, based on AUC, there was no increased incidence of embryofetal lethality or abortion in rabbits or rats. However, female rats treated with 30 mg/m2 /day or 60 mg/m2 /day (0.3 or 0.7 times the clinical dose, on a mg/m2 basis) of erlotinib prior to mating through the first week of pregnancy had an increase in early resorptions that resulted in a decrease in the number of live fetuses. No teratogenic effects were observed in rabbits or rats dosed with erlotinib during organogenesis at doses up to 600 mg/m2 /day in the rabbit (3 times the plasma drug concentration seen in humans at 150 mg/day) and up to 60 mg/m2 /day in the rat (0.7 times the clinical dose of 150 mg/day on a mg/m2 basis).

Taking Erlotinib While Breastfeeding

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

No information is available on the clinical use of erlotinib during breastfeeding. Because erlotinib is 93% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 36 hours and it might accumulate in the infant. It is also given in combination with gemcitabine for pancreatic cancer, which may increase the risk to the infant. The manufacturer recommends that breastfeeding be discontinued during erlotinib therapy and for 2 weeks after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of erlotinib during breastfeeding. Because erlotinib is 93% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 36 hours and it might accumulate in the infant. It is also given in combination with gemcitabine for pancreatic cancer, which may increase the risk to the infant. The manufacturer recommends that breastfeeding be discontinued during erlotinib therapy and for 2 weeks after the final dose.

Possible effects of Erlotinib on milk supply

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

Possible alternatives to Erlotinib

None listed