11/21/2024

Janusmed fosterpåverkan

Janusmed fosterpåverkan – Infliximab

Janusmed fosterpåverkan tillhandahåller bedömningar av eventuella risker för fostret, när en gravid kvinna använder olika läkemedel. Observera att texterna är generella, och att en bedömning måste göras i varje enskilt fall. Om du inte är medicinskt utbildad, läs först vår information för patienter och allmänhet.

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Infliximab

Infliximab

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  1. Bröms G, Granath F, Ekbom A, Hellgren K, Pedersen L, Sørensen HT et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti-Tumor Necrosis Factor Agents During Pregnancy. Clin Gastroenterol Hepatol. 2016;14:234-41e1-5.

  2. Shihab Z, Yeomans ND, De Cruz P. Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis. J Crohns Colitis. 2016;10:979-88.

  3. Weber-Schoendorfer C, Oppermann M, Wacker E, Bernard N, network of French pharmacovigilance centres, Beghin D et al. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol. 2015;80:727-39.

  4. Fukiko Komaki, Yuga Komaki, Dejan Micic, Akio Ido, Atsushi Sakuraba. Outcome of pregnancy and neonatal complications with anti-tumor necrosis factor-α use in females with immune mediated diseases; a systematic review and meta-analysis. J Autoimmun . 2017 Jan;76(1):38-52.

  5. Carman WJ, Accortt NA, Anthony MS, Iles J, Enger C. Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use. Pharmacoepidemiol Drug Saf. 2017;26(9):1109-1118.

  6. Bröms G, Kieler H, Ekbom A, Gissler M, Hellgren K, Lahesmaa-Korpinen AM et al. Anti-TNF treatment during pregnancy and birth outcomes: A population-based study from Denmark, Finland, and Sweden. Pharmacoepidemiol Drug Saf. 2020;29(3):316-327.

  7. Geldhof A, Slater J, Clark M, Chandran U, Coppola D. Exposure to Infliximab During Pregnancy: Post-Marketing Experience. Drug Saf. 2020;43(2):147-161.

  8. Lichtenstein GR, Feagan BG, Mahadevan U, Salzberg BA, Langholff W, Morgan JG et al. Pregnancy Outcomes Reported During the 13-Year TREAT Registry: A Descriptive Report. Am J Gastroenterol. 2018;113(11):1678-1688.

  9. P Deepak, D J Stobaugh. Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease. Wiley Online Library. 2014 14;40(9):1035-1043.

  10. Ghalandari N, Dolhain RJEM, Hazes JMW, van Puijenbroek EP, Kapur M, Crijns HJMJ. Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review. Drugs. 2020;80(16):1699-1722.

  11. Tsao NW, Rebic N, Lynd LD, De Vera MA. Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: a systematic review and meta-analysis of observational studies. Rheumatology (Oxford). 2020;59(8):1808-1817.

  12. Julsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL, Bibby BM, Uldbjerg N, Connell WR, Rosella O, Grosen A, Brown SJ, Kjeldsen J, Wildt S, Svenningsen L, Sparrow MP, Walsh A, Connor SJ, Radford-Smith G, Lawrance IC, Andrews JM, Ellard K, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology . 2016;151(1):110-119.

  13. Luu M, Benzenine E, Doret M, Michiels C, Barkun A, Degand T et al. Continuous Anti-TNFα Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol. 2018;113(11):1669-1677.

  14. Chaparro M, Verreth A, Lobaton T, Gravito-Soares E, Julsgaard M, Savarino E et al. Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study. Am J Gastroenterol. 2018;113(3):396-403.

  15. Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE et al. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021;160(4):1131-1139.

  16. Vinet É, De Moura C, Pineau CA, Abrahamowicz M, Curtis JR, Bernatsky S. Serious Infections in Rheumatoid Arthritis Offspring Exposed to Tumor Necrosis Factor Inhibitors: A Cohort Study. Arthritis Rheumatol. 2018;70(10):1565-1571.

  17. Bröms G, Kieler H, Ekbom A, Gissler M, Hellgren K, Leinonen MK et al. Paediatric infections in the first 3 years of life after maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther. 2020;52(5):843-854.

  18. Nørgård BM, Nielsen J, Friedman S. In utero exposure to thiopurines/anti-TNF agents and long-term health outcomes during childhood and adolescence in Denmark. Aliment Pharmacol Ther. 2020;52(5):829-842.

  19. Morin M, Frisell T, Stephansson O, Hellgren K. Temporal trends in adverse pregnancy outcomes in axial spondyloarthritis in Sweden: a cohort study. Lancet Rheumatol. 2023;5(3):e121-e129.

  20. Cheent K, Nolan J, Shariq S, Kiho L, Pal A, Arnold J. Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. J Crohns Colitis 2010;4:603-5.

  21. Läkemedelsverket. Infliximab (Remicade, Flixabi, Inflectra, Remsima och Zessly): Användning av levande vacciner hos spädbarn som exponerats in utero eller under amning. Nyhet [www]. [updated 2022-03-15, cited 2022-03-15].

  1. Bröms G, Granath F, Ekbom A, Hellgren K, Pedersen L, Sørensen HT et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti-Tumor Necrosis Factor Agents During Pregnancy. Clin Gastroenterol Hepatol. 2016;14:234-41e1-5.
  2. Shihab Z, Yeomans ND, De Cruz P. Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis. J Crohns Colitis. 2016;10:979-88.
  3. Weber-Schoendorfer C, Oppermann M, Wacker E, Bernard N, network of French pharmacovigilance centres, Beghin D et al. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol. 2015;80:727-39.
  4. Fukiko Komaki, Yuga Komaki, Dejan Micic, Akio Ido, Atsushi Sakuraba. Outcome of pregnancy and neonatal complications with anti-tumor necrosis factor-α use in females with immune mediated diseases; a systematic review and meta-analysis. J Autoimmun . 2017 Jan;76(1):38-52.
  5. Carman WJ, Accortt NA, Anthony MS, Iles J, Enger C. Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use. Pharmacoepidemiol Drug Saf. 2017;26(9):1109-1118.
  6. Bröms G, Kieler H, Ekbom A, Gissler M, Hellgren K, Lahesmaa-Korpinen AM et al. Anti-TNF treatment during pregnancy and birth outcomes: A population-based study from Denmark, Finland, and Sweden. Pharmacoepidemiol Drug Saf. 2020;29(3):316-327.
  7. Geldhof A, Slater J, Clark M, Chandran U, Coppola D. Exposure to Infliximab During Pregnancy: Post-Marketing Experience. Drug Saf. 2020;43(2):147-161.
  8. Lichtenstein GR, Feagan BG, Mahadevan U, Salzberg BA, Langholff W, Morgan JG et al. Pregnancy Outcomes Reported During the 13-Year TREAT Registry: A Descriptive Report. Am J Gastroenterol. 2018;113(11):1678-1688.
  9. P Deepak, D J Stobaugh. Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease. Wiley Online Library. 2014 14;40(9):1035-1043.
  10. Ghalandari N, Dolhain RJEM, Hazes JMW, van Puijenbroek EP, Kapur M, Crijns HJMJ. Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review. Drugs. 2020;80(16):1699-1722.
  11. Tsao NW, Rebic N, Lynd LD, De Vera MA. Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: a systematic review and meta-analysis of observational studies. Rheumatology (Oxford). 2020;59(8):1808-1817.
  12. Julsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL, Bibby BM, Uldbjerg N, Connell WR, Rosella O, Grosen A, Brown SJ, Kjeldsen J, Wildt S, Svenningsen L, Sparrow MP, Walsh A, Connor SJ, Radford-Smith G, Lawrance IC, Andrews JM, Ellard K, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology . 2016;151(1):110-119.
  13. Luu M, Benzenine E, Doret M, Michiels C, Barkun A, Degand T et al. Continuous Anti-TNFα Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol. 2018;113(11):1669-1677.
  14. Chaparro M, Verreth A, Lobaton T, Gravito-Soares E, Julsgaard M, Savarino E et al. Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study. Am J Gastroenterol. 2018;113(3):396-403.
  15. Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE et al. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021;160(4):1131-1139.
  16. Vinet É, De Moura C, Pineau CA, Abrahamowicz M, Curtis JR, Bernatsky S. Serious Infections in Rheumatoid Arthritis Offspring Exposed to Tumor Necrosis Factor Inhibitors: A Cohort Study. Arthritis Rheumatol. 2018;70(10):1565-1571.
  17. Bröms G, Kieler H, Ekbom A, Gissler M, Hellgren K, Leinonen MK et al. Paediatric infections in the first 3 years of life after maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther. 2020;52(5):843-854.
  18. Nørgård BM, Nielsen J, Friedman S. In utero exposure to thiopurines/anti-TNF agents and long-term health outcomes during childhood and adolescence in Denmark. Aliment Pharmacol Ther. 2020;52(5):829-842.
  19. Morin M, Frisell T, Stephansson O, Hellgren K. Temporal trends in adverse pregnancy outcomes in axial spondyloarthritis in Sweden: a cohort study. Lancet Rheumatol. 2023;5(3):e121-e129.
  20. Cheent K, Nolan J, Shariq S, Kiho L, Pal A, Arnold J. Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. J Crohns Colitis 2010;4:603-5.
  21. Läkemedelsverket. Infliximab (Remicade, Flixabi, Inflectra, Remsima och Zessly): Användning av levande vacciner hos spädbarn som exponerats in utero eller under amning. Nyhet [www]. [updated 2022-03-15, cited 2022-03-15].