Last update Sept. 11, 2022

Apremilast

Likely Compatibility

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

Apremilast is a non-steroidal drug, phosphodiesterase type 4 (PDE-4) inhibitor, used for the treatment of inflammatory conditions such as psoriasis and psoriatic arthritis. Oral administration in two daily doses. (Martindale)

Since the last update we have not found published data on its excretion in breastmilk.

Its low binding to plasma proteins and high pKa facilitates its excretion in breast milk, but its moderately high molecular weight and very large volume of distribution make it difficult.

The most common adverse effects are respiratory infections, diarrhoea, nausea, and headache. (Amgen 2020, EMA 2019)

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives may be preferable (Puchner 2019, Rademaker 2018), especially during the neonatal period and in the event of prematurity.

 

Alternatives

  • Adalimumab (Safe substance and/or breastfeeding is the best option.)
  • Certolizumab (Safe substance and/or breastfeeding is the best option.)
  • Ciclosporin (Safe substance and/or breastfeeding is the best option.)
  • Etanercept (Safe substance and/or breastfeeding is the best option.)
  • Tacrolimus (Safe substance 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

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

Apremilast in other languages or writings:

Group

Apremilast belongs to this group or family:

Tradenames

Main tradenames from several countries containing Apremilast in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 73 %
Molecular weight 461 daltons
Protein Binding 68 %
VD 1.24 l/Kg
pKa 12.98 -
Tmax 2.5 hours
6 - 9 hours

References

  1. Amgen. Apremilast. Drug Summary. 2020 Full text (in our servers)
  2. Puchner A, Gröchenig HP, Sautner J, Helmy-Bader Y, Juch H, Reinisch S, Högenauer C, Koch R, Hermann J, Studnicka-Benke A, Weger W, Puchner R, Dejaco C. Immunosuppressives and biologics during pregnancy and lactation : A consensus report issued by the Austrian Societies of Gastroenterology and Hepatology and Rheumatology and Rehabilitation. Wien Klin Wochenschr. 2019 Jan;131(1-2):29-44. Abstract Full text (link to original source)
  3. EMA. Apremilast. Ficha técnica. 2019 Full text (in our servers)
  4. Rademaker M, Agnew K, Andrews M, Armour K, Baker C, Foley P, Frew J, Gebauer K, Gupta M, Kennedy D, Marshman G, Sullivan J. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018 May;59(2):86-100. Abstract

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