5-Aminolevulinic Acid (ALA, 5-ALA)

Aminolevulinic acid is a precursor of porphyrin that is metabolized in the body to protoporphyrin IX, a photosensitizer that accumulates in malignant cells. 5-aminolevulinic acid and its derivatives (aminolevulinic acid hydrochloride and methylaminolevulinate) are used in photodynamic therapy to treat actinic keratosis and basal cell carcinoma, and in the diagnosis of gliomas and bladder cancer. Topical or oral administration.

At latest update, relevant information on excretion into breast milk was not found.

Absorption through the skin is very low (0.26% of the administered dose), so plasma and breast milk levels will be nil or negligible and it will not be necessary to interrupt lactation. ^(LactMed)

In case of oral administration: 

It is known from Pharmacokinetics that after 3 elimination half-lives (T½) 87.5% of the drug is eliminated from the body; after 4 T½ 94%, after 5 T½ 96.9%, after 6 T½ 98.4% and after 7 T½ 99%. After 7 T½ the plasma concentrations of drug in the body are negligible. In general, a period of at least five half-lives can be considered a safe waiting period to resume breastfeeding. ^{(Anderson 2016)}

Taking the longest published T½ of all active metabolites as a reference, these 7 T½ would correspond to 14 hours. In the meantime, express and discard breast milk regularly.

Expert authors recommend waiting 24 hours after the last oral dose to restart breastfeeding.^(LactMed)

It has been used to topically and conservatively treat various nipple lesions (condyloma, erosive adenomatosis and Paget's disease). ^{(Berger 2024, Ye 2022, Nardelli 2011)}

See below the information of this related product:

• Maternal Cancer (Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.)