Considerations for the Use of Long-Acting and Extended-Release Agents During Pregnancy and Lactation

被引:4
作者
Olagunju, Adeniyi [1 ,8 ]
Mathad, Jyoti [2 ]
Eke, Ahizechukwu [3 ]
Delaney-Moretlwe, Sinead [4 ]
Lockman, Shahin [5 ,6 ,7 ]
机构
[1] Univ Liverpool, Ctr Excellence Long Acting Therapeut, Dept Pharmacol & Therapeut, Liverpool, England
[2] Weill Cornell Med, Ctr Global Hlth, Dept Med & Obstet & Gynecol, New York, NY USA
[3] Johns Hopkins Univ, Dept Gynecol & Obstet, Div Maternal Fetal Med, Sch Med, Baltimore, MD USA
[4] Univ Witwatersrand, Wits Reprod Hlth & HIV Inst, Johannesburg, South Africa
[5] Brigham & Womens Hosp, Div Infect Dis, Boston, MA USA
[6] Harvard TH Chan Sch Publ Hlth, Dept Immunol & Infect Dis, Boston, MA USA
[7] Botswana Harvard AIDS Inst Partnership, Gaborone, Botswana
[8] Inst Syst Mol & Integrat Biol, Ctr Excellence Long Acting Therapeut, Dept Pharmacol & Therapeut, William Henry Duncan Bldg,6 West Derby St, Liverpool L7 8TX, England
基金
英国惠康基金;
关键词
long-acting agents; pregnancy; lactation; pharmacokinetics; modeling and simulation; PHARMACOKINETICS; RILPIVIRINE; WOMEN; TUBERCULOSIS; GLUCURONIDATION; MEDICATIONS; INFECTION; TOXICITY; PLASMA; HIV-1;
D O I
10.1093/cid/ciac659
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Long-acting agents hold significant promise for treating and preventing common illnesses, including infections. Pharmacokinetic and safety data during pregnancy and lactation are often unavailable for new drugs; these data are vital to facilitate optimal drug use by pregnant and lactating women and women who may conceive. In this commentary, we summarize the circumstances in which pregnant and lactating women are likely to use and benefit from long-acting agents. We focus on long-acting formulations of small molecules (rather than biologics such as monoclonal antibodies) and on several infections of global importance (human immunodeficiency virus, tuberculosis, malaria, and hepatitis C). We discuss pregnancy pharmacokinetic/pharmacodynamic and potential safety and efficacy considerations pertaining to the use of long-acting agents in pregnancy and lactation. Finally, we summarize existing preclinical and pregnancy pharmacokinetic data that are available (or expected in the near future) for several agents that are under development or approved, and how key research gaps may be addressed.
引用
收藏
页码:S571 / S578
页数:8
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