Last update March 20, 2024

Ponesimod

Likely Compatibility

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

Ponesimod is an immunomodulator with similar actions to fingolimod, but has a shorter half-life and a lower risk of cardiac adverse effects from the first dose. Indicated in the treatment of relapsing forms of multiple sclerosis. Oral administration once daily. (Martindale)

At the time of the last update, we found no published data on its excretion in breast milk.

Its pharmacokinetic data (very high percentage of binding to plasma proteins, large volume of distribution and moderately high molecular weight) make passage into breast milk in clinically significant amounts very unlikely.

Pending further published data on this drug in relation to breastfeeding, safer known alternatives may be preferable (Sánchez 2023, Collorone 2023, Ciplea 2020), especially during the neonatal period and in case of prematurity.

If administered during breastfeeding, it is advisable to monitor the appearance of respiratory catarrh, irritability or somnolence in the infant.


See below the information of this related product:

  • Maternal Multiple Sclerosis (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

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

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Other names

Ponesimod in other languages or writings:

  • بونيسيمود (Arabic)
  • Понесимод (Cyrillic)
  • (2Z,5Z)-5-({3-Chloro-4-[(2R)-2,3-dihydroxypropoxy]phenyl}methylidene)-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one (Chemical name)
  • C23H25ClN2O4S (Molecular formula)
  • L04AE04 (ATC Code/s)

Group

Ponesimod belongs to this group or family:

Tradenames

Main tradenames from several countries containing Ponesimod in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 84 %
Molecular weight 461 daltons
Protein Binding > 99 %
VD 2.3 l/Kg
pKa 13.6 -
Tmax 4 hours
T½ 33 hours

References

  1. Sánchez-Velasco S, Midaglia L, Vidal-Jordana A, Castillo F, Horno R, Carreras E, Serrano B, Bosch M, Agustí A, Montalban X, Tintoré M. Fármacos modificadores de la enfermedad en la esclerosis múltiple durante la lactancia: revisión de la evidencia actual. Rev Neurol. 2023 Jan 1;76(1):21-30. Abstract Full text (link to original source)
  2. Janssen. Ponesimod. Drug Summary. 2023 Full text (in our servers)
  3. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: https://www.medicinescomplete.com 2022 Abstract
  4. Collorone S, Kodali S, Toosy AT. The protective role of breastfeeding in multiple sclerosis: Latest evidence and practical considerations. Front Neurol. 2023 Jan 24;13:1090133. Abstract Full text (link to original source)
  5. EMA. Ponesimod. Ficha técnica. 2021 Full text (in our servers)
  6. Ciplea AI, Langer-Gould A, Stahl A, Thiel S, Queisser-Wahrendorf A, Gold R, Hellwig K. Safety of potential breast milk exposure to IFN-β or glatiramer acetate: One-year infant outcomes. Neurol Neuroimmunol Neuroinflamm. 2020 May 20;7(4). pii: e757. Abstract Full text (link to original source)

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