The animal data for the hematologic agent, peginesatide (Omontys; anemia in patients with chronic renal disease) suggest risk. The drug has a high molecular weightthat should limit its passage across the placenta, but it still might cross in the third trimester. Because it stimulates erythropoiesis in human red blood cell precursors, it could do the same in the fetus if it crosses.
The two immunologic drugs are teriflunomide (Aubagio; multiple sclerosis) and tofacitinib (Xeljanz; rheumatoid arthritis). Teriflunomide, the principal active metabolite of leflunomide and responsible for leflunomide’s activity, is contraindicated in pregnancy. If a woman conceives while taking this drug, an 11-day procedure for accelerated elimination is recommended because it takes an average of 8 months (and it may be as long as 2 years) to reach plasma concentrations that are considered minimal risk (see package insert for procedure). The animal data for tofacitinib suggest risk. It is contraindicated if combined with methotrexate.
At first glance, it does not appear that the vasodilator avanafil (Stendra; impotence agent) will be used in pregnancy. However, a similar agent, sildenafil, has been used for the treatment of pulmonary arterial hypertension, a high-risk condition in pregnancy. Based on its indication, mechanism of action, and low-risk animal data, avanafil can be used in pregnancy if indicated.
Aclidinium bromide (Tudorza Pressair; bronchodilator) is a respiratory agent used in chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. The animal data suggest low risk. The low plasma concentrations suggest that the drug represents a low, if any, risk in pregnancy.
The two ophthalmic preparations are ocriplasmin (Jetrea; symptomatic vitreomacular adhesions) and tafluprost (Zioptan; glaucoma). Both are probably compatible in pregnancy because of the undetectable or very low systemic concentrations.
The animal data for mirabegron (Myrbetriq; antispasmodic for overactive bladder) suggest low risk. It is an adrenergic agonist that increases bladder capacity. Although there are no human data, it probably can be used in pregnancy, but avoiding the first trimester should be considered.
As with pregnancy, there are no reports involving the use of the above drugs during breast-feeding. When there are little or no human data, the risk to a nursing infant can be estimated by considering several factors: indication, duration of therapy, molecular weight, plasma protein binding, elimination half-life, presence of the drug in the systemic circulation, and the most common adverse effects observed in adults.
Using these criteria for the drugs discussed above, there are only 10 that are probably compatible with breast-feeding: glucarpidase, ingenol mebutate, sodium picosulfate, taliglucerase alfa, crofelemer, linaclotide, peginesatide, aclidinium bromide, tafluprost, and ocriplasmin. The remaining drugs are either contraindicated (most of the antineoplastics and tofacitinib if combined with methotrexate) or may cause toxicity in a nursing infant.
Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.