Guselkumab (TREMFYA®)

Selected References:

  • Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeed Med. 16(8): 591-593. 
  • Dernoncourt A., et al. 2023. Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase®). BioDrugs. 37(1):73-87.  
  • Jeong YD, et al. 2025. Biologics Use for Psoriasis during Pregnancy and Its Related Adverse Outcomes in Pregnant Women and Newborns: Findings from WHO Pharmacovigilance Study. Int Arch Allergy Immunol. 186(6):579-593.  
  • Kimball AB. 2020. Pregnancy outcomes in women exposed to guselkumab: Experience from the clinical development program. J Am Acad Dermatol. 83(6):AB27.  
  • Lin CB, Geldhof A, Ballina MR, Patel H. Fakharzadeh S, Li H. Pregnancy outcomes in women exposed to guzelkumab: Review of cases reported to the manufacturer’s global safety database. BJD 2024;191[Suppl 3]:iii38-iii39 https://academic.oup.com/bjd/article/191/Supplement_3/ljae360.077/7916181 
  • Mahadevan U, et al. 2025. Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 23(11S):S1-S60.  
  • McMullan P et al. 2024. Safety of dermatologic medications in pregnancy and lactation: An Update-Part I: Pregnancy. Journal of the American Academy of Dermatology. 
  • Owczarek W, et al. 2020. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 37(6):821-830.  
  • Tremfya® Prescribing Information. Available online at http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed on May 28, 2024. 
  • Wolfe C et al., 2024. A Retrospective Review of Pregnancies in our Psoriasis Biologics Cohort. Clinical and Experimental Dermatology. llae106.  
  • Yeung J, et al. 2020. Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper. J Cutan Med Surg. 24(1_suppl):3S-14S.  

 

Guselkumab (TREMFYA®)

Selected References:

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  • Chang JJ, Lathi RB, Kim SH. 2020. A retrospective study examining phentermine on preconception weight loss and pregnancy outcomes. Endocrine Practice;26(9):990-996. https://doi.org/10.4158/EP-2019-0609 
  • Food and Drug Administration. 2012. Prescribing information for ADIPEX-P®. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf . Accessed 21 July 2026. 
  • Food and Drug Administration. 2013. Prescribing information for SUPRENZATM. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf. Accessed 21 July 2026. 
  • Food and Drug Administration. 2023. Prescribing information for Qsymia®. Available at https://qsymia.com/patient/include/media/pdf/prescribing-information.pdf. Accessed 21 July 2026. 
  • Hale TW. 2008. Medications and Mothers’ Milk, 13th ed. Amarillo, TX: Hale Publishing.  
  • Johnson KA, et al. 1998. Pregnancy outcome of women exposed to Fen/Phen [abstract]. Organization of Teratology Information Specialists Annual Meeting, June 1998.  
  • Jones KL, et al. 2002. Pregnancy outcomes after first trimester exposure to phentermine/fenfluramine. Teratology 65:125-130.  
  • No authors listed. 2013. Topiramate + phentermine. An excessively dangerous appetite-suppressant combination. Prescrire Int 22(136):61-4. 
  • Robert E, et al. 1995. Neural tube defects and maternal weight reduction in early pregnancy. Reprod Toxicol 9(1):57-59.  
  • Silverstone, T. 1982. Drugs and Appetite. New York: Academic Press.  
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  • Winick M. 1989. Nutrition, Pregnancy, and Early Infancy. Baltimore: Williams & Wilkins.  

Guselkumab (TREMFYA®)

Selected References:  

  • American College of Obstetricians and Gynecologists Committee on Genetics. 2020. Management of women with phenylalanine hydroxylase deficiency (phenylketonuria). Obstet Gynec 135(4): e167-e-170.  
  • Alabdulrazzaq F, Koren G. 2012. Topical corticosteroid use during pregnancy. Can Fam Physician 58(6): 643–644. 
  • Alhussien AH, et al. 2018. Safety of intranasal corticosteroid sprays during pregnancy: an updated review. Eur Arch Otorhinolaryngol 275(2): 325–333. 
  • Battista MC, et al. 2016. Maternal inhaled fluticasone propionate intake during pregnancy is detected in neonatal cord blood. Bioanalysis, 8(14): 1441–1450. 
  • Bjørn AMB, et al. 2015. Use of inhaled and oral corticosteroids in pregnancy and the risk of malformations or miscarriage. Basic Clin Pharmacol Toxicol 116(4): 308–314. 
  • Blais L, et al. 2009. High doses of inhaled corticosteroids during the first trimester of pregnancy and congenital malformations. J Allergy Clin Immunol, 124(6): 1229-1234.e4. 
  • Charlton RA, et al. 2015. Safety of fluticasone propionate prescribed for asthma during pregnancy: A UK population-based cohort study. J Allergy Clin Immunol Pract 3(5): 772-9.e3. 
  • Clifton VL, et al. 2006. Effect of inhaled glucocorticoid treatment on placental 11β‐hydroxysteroid dehydrogenase type 2 activity and neonatal birthweight in pregnancies complicated by asthma. Aust N Z J Obstet Gynaecol 46(2): 136–140. 
  • Cossette B, et al. 2014. Relative perinatal safety of salmeterol vs formoterol and fluticasone vs budesonide use during pregnancy. Ann Allergy Asthma Immunol 112(5): 459–464. 
  • Dombrowski MP, et al. 2008. ACOG practice bulletin: clinical management guidelines for obstetrician-gynecologists number 90, February 2008: asthma in pregnancy. Obstet Gynecol, 111(2 Pt 1): 457-464. 
  • Edwards M J, et.al. 2003. Case-control study of cleft lip or palate after maternal use of topical corticosteroids during pregnancy. Am J Med Genet 120A(4): 459–463. 
  • Ellegård EK, et al. 2001. Fluticasone propionate aqueous nasal spray in pregnancy rhinitis. Clin Otolaryngol Allied Sci 26(5): 394–400. 
  • Källén B, Otterblad Olausson P. 2007. Use of anti-asthmatic drugs during pregnancy. 3. Congenital malformations in the infants. Eur J of Clin Pharmacol, 63(4): 383–388. 
  • Middleton PG ,et al. 2020. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J 55(2): 1901208. 
  • Mygind N, et al. 2001. Mode of action of intranasal corticosteroids. J Allergy Clin Immunol 108(1 Suppl): S16-25. 
  • Park-Wyllie L, et.al. 2000. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratol, 62(6): 385–392. 
  • Pradat P, et al. 2003. First trimester exposure to corticosteroids and oral clefts. Birth Defects Res A Clin Mol Teratol 67(12): 968–970. 
  • Rahimi R, et al. 2006. Meta-analysis finds use of inhaled corticosteroids during pregnancy safe: a systematic meta-analysis review. Hum Exp Toxicol 25(8): 447–452. 
  • Robijn AL, et al. 2019. Inhaled corticosteroid use during pregnancy among women with asthma: A systematic review and meta-analysis. Clin Exp Allergy  49(11): 1403–1417. 
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Guselkumab (TREMFYA®)

Selected References:  

  • ANI Pharmaceuticals. 2024. Fenoprofen product labeling. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm. Accessed 16 June 2026.  
  • Choi E-Y, et al. 2023. Neonatal and maternal adverse outcomes and exposure to nonsteroidal anti-inflammatory drugs during early pregnancy in South Korea: a nationwide cohort study. PLoS Med, 20(2):e1004183.  
  • Dawood MY. 1993. Nonsteroidal antiinflammatory drugs and reproduction. Am J Obstet Gynecol, 169(5):1255-1265.  
  • Daniel S, et al. 2012. Major Malformations Following Exposure to Nonsteroidal Antiinflammatory Drugs During the First Trimester of Pregnancy. J Rhuematol 39(11) 2163-2169.  
  • Daniel S, et al. 2014. Fetal exposure to nonsteroidal anti-inflammatory drugs and spontaneous abortion. Can Med Assoc J 186(5):E177-E182. 
  • Daniel S, et al. 2015. NSAIDs and spontaneous abortions – true effect or an indication bias? Br J Clin Pharmacol, 80(4):750-754. 
  • Dathe K, et al. 2018. No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester—Evaluation of the national Embryotox cohort. Reproductive Toxicology, 79: 32-38. 
  • Ericson A and Kallen BA. 2001. Nonsteroidal anti-inflammatory drugs in early pregnancy. Reprod Toxicol, 15:371-  
  • Janssen NM and Genta MS. 2000. The effects of immunosuppressive and anti-inflammatory medication on fertility, pregnancy, and lactation. Arch Intern Med, 160:610-619.  
  • Nezvalova-Henriksen K et al. 2013. Effects of ibuprofen, diclofenac, naproxen, and piroxicam on the course of pregnancy and pregnancy outcome: a prospective study. BJOG, 120(8):948-959.  
  • Nielsen GL, et al. 2001. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study. BMJ, 322(7281):266-270.  
  • Nielsen GL, et al. 2004. Danish group reanalyses miscarriage in NSAID users. BMJ, 328(7431):109.  
  • U.S. Food and Drug Administration. 2020. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication – Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later. Available at: https://www.fda.gov/safety/medical-product-safety-information/nonsteroidal-anti-inflammatory-drugs-nsaids-drug-safety-communication-avoid-use-nsaids-pregnancy-20. Accessed 16 June 2026. 

Guselkumab (TREMFYA®)

Selected References:  

  • American College of Obstetricians and Gynecologists (ACOG). 2019. ACOG Practice Bulletin No. 203 Summary: Chronic Hypertension in Pregnancy. Obstet Gynecol; 133(1): 215-219.  
  • Davis RL, et al. 2011. Risks of congenital malformations and perinatal events among infants exposed to calcium channel and beta-blockers during pregnancy. Pharmacoepidemiol Drug Saf; 20:138-145. 
  • Kubota K, et al. 2023. Alpha/beta- and beta-blocker exposure in pregnancy and the risk of neonatal hypoglycemia and small for gestational age. Circ J; 87: 569-577. 
  • Lennestal R, et al. 2009. Maternal use of antihypertensive drugs in early pregnancy and delivery outcome, notably the presence of congenital heart defects in the infants. Eur J Clin Pharmacol; 65(6): 615-625. 
  • McCowan LM, et al. 1996. Perinatal morbidity in chronic hypertension. Br J Obstet Gynecol; 103:123–129. 
  • Ray JG, et al. 2001. McMaster outcome study of hypertension in pregnancy. Early Hum Dev; 64:129–143. 
  • Rey E, Couturier A. 1994. The prognosis of pregnancy in women with chronic hypertension. Am J Obst Gynecol; 181:410–416. 
  • Sibal BM, et al. 2000. Preterm delivery in women with pregestational diabetes or chronic hypertension relative to women with uncomplicated pregnancies. The National Institute of Child Health and Human Development – Fetal Medicine Units Network. Am J Obst Gynecol; 183:1520–1524. 
  • Tanaka K, et al. 2016. Beta-blockers and fetal growth restriction in pregnant women with cardiovascular disease. Circ J; 80: 2221-2226. 
  • Waylis Therapeutics LLC. 2025. Coreg Product Label. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm. Accessed 12 June 2026.  
  • Yakoob MY, et al. 2013. The risk of congenital malformations associated with exposures to beta-blockers early in pregnancy: A meta-analysis. Hypertension; 62(2): 375-381. 
Guselkumab (TREMFYA®)
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