Nintedanib

The Basics

What is Nintedanib?

Used to treat idiopathic pulmonary fibrosis. Also used to treat people with a chronic interstitial lung disease.

Brand names for Nintedanib

Ofev

How Nintedanib is classified

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

Nintedanib During Pregnancy

Nintedanib pregnancy category

Category Not AssignedNote 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 Nintedanib while pregnant

Based on findings from animal studies and its mechanism of action [see CLINICAL PHARMACOLOGY], OFEV can cause fetal harm when administered to a pregnant woman. There are no data on the use of OFEV during pregnancy. In animal studies of pregnant rats and rabbits treated during organogenesis, nintedanib caused embryo-fetal deaths and structural abnormalities at less than (rats) and approximately 5 times (rabbits) the maximum recommended human dose . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage in clinically recognized pregnancies is 15% to 20%. Data Animal Data In animal reproduction toxicity studies, nintedanib caused embryo-fetal deaths and structural abnormalities in rats and rabbits at less than and approximately 5 times the maximum recommended human dose (MRHD) in adults (on a plasma AUC basis at maternal oral doses of 2.5 and 15 mg/kg/day in rats and rabbits, respectively). Malformations included abnormalities in the vasculature, urogenital, and skeletal systems. Vasculature anomalies included missing or additional major blood vessels. Skeletal anomalies included abnormalities in the thoracic, lumbar, and caudal vertebrae (e.g., hemivertebra, missing, or asymmetrically ossified), ribs (bifid or fused), and sternebrae (fused, split, or unilaterally ossified). In some fetuses, organs in the urogenital system were missing. In rabbits, a significant change in sex ratio was observed in fetuses (female:male ratio of approximately 71%:29%) at approximately 15 times the MRHD in adults (on an AUC basis at a maternal oral dose of 60 mg/kg/day). Nintedanib decreased post-natal viability of rat pups during the first 4 post-natal days when dams were exposed to less than the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).

Taking Nintedanib While Breastfeeding

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

No information is available on the clinical use of nintedanib during breastfeeding. Because nintedanib is more than 97% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 9.7 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during nintedanib therapy.

Maternal / infant drug levels

No information is available on the clinical use of nintedanib during breastfeeding. Because nintedanib is more than 97% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 9.7 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during nintedanib therapy.

Possible effects of Nintedanib on milk supply

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

Possible alternatives to Nintedanib

None listed