Commentary

2011 FDA Approvals


 

The five antineoplastics are: brentuximab (Adcetris; D), approved for Hodgkin’s disease and systemic anaplastic large cell lymphoma; crizotinib (Xalkori; D), for metastatic non–small cell lung cancer; ipilimumab (Yervoy; C), for metastatic melanoma; vandetanib (Caprelsa; D), for metastatic medullary thyroid cancer; and vemurafenib (Zelboraf; D) for metastatic melanoma. The properties (molecular weight, plasma elimination half-life) of these agents suggest that they will probably cross the placenta. The combination of these properties, their mechanisms of action, and/or their animal reproduction data suggests that all should be avoided in pregnancy.

Spinosad (Natroba; B) is an insecticide used for head lice infection. The pediculicide is not absorbed systemically, so it is compatible with pregnancy.

Factor XIII Concentrate (Human) (Corifact; C) is a hematologic agent used for the prophylactic treatment of congenital factor XIII deficiency. The product is made from pooled human plasma that has been checked for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. The limited human data suggest that it is low risk in pregnancy. In contrast, the animal data for icatibant (Firazyr; C), the other hematologic agent that is indicated for the treatment of acute attacks of hereditary angioedema, suggest risk. Currently, plasma-derived human C1 inhibitor concentrate is preferred for acute treatment and short- or long-term prophylaxis of hereditary angioedema (J. Allergy Clin. Immunol. 2012;129:308-20). Until human data are available, icatibant is best avoided in pregnancy.

The first of the two immunologic agents is the immunosuppressant belatacept (Nulojix; C), indicated to prevent rejection of a kidney transplant. Although the animal data suggest low risk, it is given in combination with basiliximab induction and two agents known to be teratogenic, mycophenolate and corticosteroids. The absolute risk for major defects with corticosteroids is low, but the risk magnitude is thought to be much higher for mycophenolate. If possible, belatacept should be avoided in pregnancy. The other agent is the immunomodulator belimumab (Benlysta; C), which is indicated for the treatment of systemic lupus erythematosus. The animal data for this monoclonal antibody are reassuring, and the agent is probably compatible with pregnancy.

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.; a clinical professor of pharmacy at the University of California, San Francisco; and an 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 said he had no relevant financial disclosures.

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