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Medications and More during pregnancy and breastfeeding

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Ustekinumab (Stelara®)

Selected References:

  • Alsenaid A, Prinz JC. 2016. Inadvertent pregnancy during ustekinumab therapy in a patient with plaque psoriasis and impetigo herpetiformis. J Eur Acad Dermatol Venereol. 30(3):488-90.
  • American Academy of Pediatrics. 2018. Report of the Committee of Infectious Disease. RedBook. p704.
  • Andrulonis R, Ferris LK. 2012 Treatment of severe psoriasis with ustekinumab during pregnancy. J Drugs Dermatol. 11(10):1240.
  • Beaulieu D, et al. 2018. Use of Biologic Therapy by Pregnant Women with Inflammatory Bowel Disease does Not affect Infant Response to Vaccines. Clin Gast & Hep; 16:99-105.
  • Fotiadou C, et al. 2012. Spontaneous abortion during ustekinumab J Dermatol Case Rep. 6(4):105-107.
  • Galli-Novak E, et al. 2016. Successful pregnancy outcome under prolonged ustekinumab treatment in a patientwith Crohn’s disease and paradoxical psoriasis. J Eur Acad Dermatol Venereol. 30(12):e191-e192.
  • Galluzzo M, et al. 2019. Psoriasis in pregnancy: case series and literature review of data concerning exposure during pregnancy to ustekinumab. J Dermatolog Treat. 2019 Feb;30(1):40-44.
  • Gotestam Skorpen C, et al. 2016. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 75:795-810.
  • Klenske E, et al. 2019. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn’s Disease. J Crohns Colitis. 2019 Feb 1;13(2):267-269.
  • Lund T and Thomsen SF. 2017. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: a patient series. Dermatologic Therapy 30:e12454.
  • Mahadevan U, et al. 2017. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 152(2):451-462.e2.
  • Martin PL, et al. 2010. Development in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation.Birth Defects Res B Dev Reprod Toxicol. 89(5):351-363.
  • Matro R, et al. 2018. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel disease and effects of breastfeeding on infections and development. Gastroenterology 155;696-704.
  • Rocha K, et al. 2015. Pregnancy during ustekinumab treatment for severe psoriasis. Dermatology; 231:103-104.
  • Rosen M, et al. 2012. A case of ustekinumab for the treatment of Crohn’s disease during pregnancy [abstract]. Amer J Gastroenterol. 107(suppl 1):S516.
  • Rowan CR, et al. 2018. Ustekinumab drug levels in maternal and cord blood in a woman with Crohn’s Disease treated until 33 weeks of gestation. Journal of Crohn’s and Colitis;376-378
  • Sheeran C, Nicolopoulos J. 2014. Pregnancy outcomes of two patients exposed to ustekinumab in the first trimester. Australasian J of Dermatology; 55(3);235-236.
  • Stelara® Prescribing Information. Available online at https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf accessed May, 2019.
  • Venturin C, et al. 2017. Fetal death in utero and miscarriage in a patient with Crohn’s disease under therapy with ustekinumab: case-report and review of the literature. BMC Gastroenterology 17;80.
  • Watson N, et al. 2019. Ustekinumab exposure during conception and pregnancy in patients with chronic plaque psoriasis: a case series of 10 pregnancies. British Journal of Dermatology 180;195-196.