Last update Nov. 18, 2024

Tofacitinib

Decreased level of risk

New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Commentary., is now set to Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Level of risk reviewed on Nov. 17, 2024

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Potent and selective inhibitor of Janus kinases 1, 2 and 3. Used in monotherapy or in association with methotrexate in moderate-severe rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. Oral administration twice daily. Its frequent side effects are infections that can be severe, anemia and hypertension. 

It is excreted in breast milk in very low concentration, possibly not clinically significant. (Mitrova 2024, Julsgaard 2023)

No problems have been observed in infants whose mothers took it (Ernest 2024, Mitrova 2024, Julsgaard 2023); one infant even after immunological evaluation was vaccinated with live rotavirus vaccine, without experiencing any problems. (Ernest 2024)

Pending further published data on this drug in relation to lactation, safer known alternatives may be preferable (Mahadevan 2019, Louthrenoo 2017, Götestam 2016), especially during the neonatal period and in case of prematurity.


See below the information of these related products:

Alternatives

  • Adalimumab (Safe product and/or breastfeeding is the best option.)
  • Certolizumab (Safe product and/or breastfeeding is the best option.)
  • Etanercept (Safe product and/or breastfeeding is the best option.)
  • Hydroxychloroquine Sulfate (Safe product and/or breastfeeding is the best option.)
  • Infliximab (Safe product and/or breastfeeding is the best option.)
  • Penicillamine (Safe product and/or breastfeeding is the best option.)
  • Sulfasalazine (Safe product and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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José María Paricio, founder of e-lactancia.
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Other names

Tofacitinib is also known as


Tofacitinib in other languages or writings:

Group

Tofacitinib belongs to this group or family:

Tradenames

Main tradenames from several countries containing Tofacitinib in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 74 %
Molecular weight 312 daltons
Protein Binding 40 %
VD 1.2 l/Kg
pKa 7.13 - 8.46 -
Tmax 0.5 - 1 hours
T½ 3.2 hours
Theoretical Dose 0.0003 - 0.008 mg/Kg/d
Relative Dose 0.16 - 2.9 %

References

  1. Mitrova K, Julsgaard M, Augustijns P, Cerna K, Mahadevan U, Duricova D; Pregnancy Study Group. Tofacitinib in Pregnancy: Assessing Pregnancy and Infant Outcomes, Cord Blood, and Breast Milk Concentrations. Clin Gastroenterol Hepatol. 2024 Feb 1. pii: S1542-3565(24)00096-X. Abstract
  2. Ernest-Suarez K, Murguía-Favela LE, Novak KL, Panaccione R, Constantinescu C, Seow CH. Normal Infant Immunologic Assessment and Uneventful Live Rotavirus Vaccination Despite Continuous Tofacitinib Exposure In Utero and During Breastfeeding. Crohns Colitis 360. 2024 Jan 20;6(1):otae006. Abstract Full text (link to original source)
  3. Julsgaard M, Mahadevan U, Vestergaard T, Mols R, Ferrante M, Augustijns P. Tofacitinib concentrations in plasma and breastmilk of a lactating woman with ulcerative colitis. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):695-697. Abstract
  4. Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Abstract Full text (link to original source)
  5. EMA-Pfizer. Tofacitinib (Xeljanz). Drug Summary. 2017 Full text (in our servers)
  6. EMA-Pfizer. Tofacitinib (Xeljanz). Ficha técnica. 2017 Full text (in our servers)
  7. Louthrenoo W, Kasitanon N, Katchamart W, Aiewruengsurat D, Chevaisrakul P, Chiowchanwisawakit P, Dechanuwong P, Hanvivadhanakul P, Mahakkanukrauh A, Manavathongchai S, Muangchan C, Narongroeknawin P, Phumethum V, Siripaitoon B, Suesuwan A, Suwannaroj S, Uea-Areewongsa P, Ukritchon S, Asavatanabodee P, Koolvisoot A, Nanagara R, Totemchokchyakarn K, et al. 2016 updated Thai Rheumatism Association Recommendations for the use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis. Int J Rheum Dis. 2017 Sep;20(9):1166-1184. Abstract
  8. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  9. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  10. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  11. Koren G, Carey N, Gagnon R, Maxwell C, Nulman I, Senikas V; Society of Obstetricians and Gynaecologists of Canada. Cancer chemotherapy and pregnancy. J Obstet Gynaecol Can. 2013 Mar;35(3):263-278. Abstract Full text (link to original source) Full text (in our servers)

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