Last update: Feb. 10, 2021

Dimethyl Fumarate

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 Low Risk, is now set to Very Low Risk.

Level of risk reviewed on Jan. 31, 2021

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

Anti-inflammatory and immunomodulator used in the treatment of psoriasis and in relapsing forms of multiple sclerosis.
Topical and oral administration every 12 hours

Its pharmacokinetic data, large volume of distribution and short half-life, explain (Almas 2016) the negligible passage into milk observed (Ciplea 2020).

Possible side effects are rare and generally not serious, with no immunosuppressive effects or higher frequency of infections (EMA 2017, AEMPS 2015).

Various medical societies and / or expert consensus consider the use of this medication probably safe during breastfeeding (Hale, Alroughani 2016, Briggs 2015), although others differ (Langer 2019).

Exposure can be minimized by 90% waiting 3 hours to breastfeed again after taking the medication.

Until there is more published data on this drug in relation to breastfeeding, known safer alternatives may be preferable (Langer 2019, Cree 2013), especially during the neonatal period and in case of prematurity.

Given the strong existing evidence regarding the benefits of breastfeeding for the development of babies and the health of mothers, it is advisable to evaluate the risk-benefit of any maternal treatment, including chemotherapy, individually advising each mother who wishes to continue with breastfeeding (Koren 2013).


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Dimethyl Fumarate is also known as


Dimethyl Fumarate in other languages or writings:

Groups

Dimethyl Fumarate belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Dimethyl Fumarate in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 144 daltons
Protein Binding 27 - 40 %
VD 0,7 - 1,2 l/Kg
Tmax 2 - 3 hours
T1/2 0,75 - 1 hours
Theoretical Dose 0,0004 - 0,001 mg/Kg/d
Relative Dose 0,005 - 0,01 %

References

  1. Ciplea AI, Datta P, Rewers-Felkins K, Baker T, Gold R, Hale TW, Hellwig K. Dimethyl fumarate transfer into human milk. Ther Adv Neurol Disord. 2020 Oct 31;13:1756286420968414. Abstract Full text (link to original source)
  2. Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. Abstract
  3. Brown SM, Aljefri KA, Waas R, Hampton PJ. Systemic medications used in treatment of common dermatological conditions: Safety profile with respect to pregnancy, breast feeding and content in seminal fluid. J Dermatolog Treat. 2017 Abstract
  4. EMA. Dimetilfumarato. Ficha técnica. 2017 Full text (in our servers)
  5. EMA. Dimethyl fumarate. Drug Summary. 2017 Full text (in our servers)
  6. Alroughani R, Altintas A, Al Jumah M, Sahraian M, Alsharoqi I, AlTahan A, Daif A, Dahdaleh M, Deleu D, Fernandez O, Grigoriadis N, Inshasi J, Karabudak R, Taha K, Totolyan N, Yamout BI, Zakaria M, Bohlega S. Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks. Mult Scler Int. 2016 Abstract Full text (link to original source) Full text (in our servers)
  7. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016;2016:6527458. Abstract Full text (link to original source) Full text (in our servers)
  8. AEMPS. Informe de Posicionamiento Terapéutico de dimetilfumarato (Tecfidera®). V1/22042015. 2015 Full text (in our servers)
  9. AEMPS. Informe de Posicionamiento Terapéutico de dimetilfumarato (Tecfidera). 2015 Full text (in our servers)
  10. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  11. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013 Jun;19(7):835-43. Abstract Full text (link to original source) Full text (in our servers)
  12. 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)
  13. Rostami-Yazdi M, Clement B, Mrowietz U. Pharmacokinetics of anti-psoriatic fumaric acid esters in psoriasis patients. Arch Dermatol Res. 2010 Abstract
  14. Litjens NH, Burggraaf J, van Strijen E, van Gulpen C, Mattie H, Schoemaker RC, van Dissel JT, Thio HB, Nibbering PH. Pharmacokinetics of oral fumarates in healthy subjects. Br J Clin Pharmacol. 2004 Abstract

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