Last update Jan. 25, 2020

フィンゴリモド塩酸塩

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Immunomodulator agent indicated for the treatment of patients affected with highly active relapsing remitting multiple sclerosis.
Oral administration once a day for prolonged periods.

Since the last update we have not found any published data on its excretion in breast milk.

Pharmacokinetic data (large volume of distribution and high protein binding capacity) make it very unlikely its passage to breast milk in significant amounts, but its long half-life could allow it.

Although generally contraindicated in lactation (Langer 2019, Alroughani 2016, Cree 2013, Houtchens 2013), other expert authors consider the use of this medication during lactation probably safe (Briggs 2017).

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity.

Alternatives

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

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

フィンゴリモド塩酸塩 is Fingolimod in Japanese.

Is written in other languages:

フィンゴリモド塩酸塩 is also known as

Group

フィンゴリモド塩酸塩 belongs to this group or family:

Tradenames

Main tradenames from several countries containing フィンゴリモド塩酸塩 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 93 %
Molecular weight 308 daltons
Protein Binding 99.7 %
VD 17 l/Kg
pKa 9.4 -
Tmax 12 - 16 hours
144 - 216 hours

References

  1. Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. Abstract
  2. EMA. Fingolimod. Ficha técnica. 2016 Full text (in our servers)
  3. 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)
  4. EMA. Fingolimod. Drug Summary. 2016 Full text (in our servers)
  5. 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)
  6. 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
  7. 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)
  8. Houtchens MK, Kolb CM. Multiple sclerosis and pregnancy: therapeutic considerations. J Neurol. 2013 Abstract
  9. David OJ, Kovarik JM, Schmouder RL. Clinical pharmacokinetics of fingolimod. Clin Pharmacokinet. 2012 Abstract

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