Last update: Feb. 10, 2021
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
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).
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.
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