Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Drugline nr 21817

Publicerat 2005-02-16

Query Text

Is the use of TNF-alpha inhibitors (adalimumab, infliximab and etanercept) compatible with breast-feeding? This is a general question from the rheumatology department.

Answer Text

Adalimumab and infliximab are monoclonal antibodies to TNF-alpha and block its ability to bind to TNF-alpha receptors. Adalimumab and infliximab are used in the treatment of rheumatoid arthritis and infliximab is also approved for use in pelvospondylitis and Crohn´s disease. Etanercept is a fusion protein based on the p-75 receptor for TNF-alpha and the Fc portion of human immunoglobulin. Etanercept bind to TNF-alpha and inhibits its interaction with TNF receptors (1).

Availiable documentation about breast-feeding and TNF-alpha inhibitors is sparse. No information about adalimumab and breast-feeding has been found.

One case were a woman, treated with infliximab, breast-fed her child has been found. Milk samples were collected 24 hours and one week after her first infusion of infliximab 5 mg/kg. The infliximab concentration in milk was below the quantification limit of the assay (0.060 ug/ml). No adverse effects were observed in the infant (2).

The concentration of etanercept in breast milk has been measured in the milk of one woman not breast-feeding her child. Etanercept treatment, 25 mg twice weekly, was started four weeks after delivery. After the fifth injection milk was collected. The maximum level of etanercept, measured by ELISA, in milk (75 ng/ml) was observed the day after injection. The concentration declined, but was still above 25 ng/ml on the day for the next injection. The concentration in maternal serum was approximately 2 mg/ml (3).

Maternal antibodies pass from the mother into breast milk (4). Therefore it is also possible that adalimumab and infliximab passes into milk, although this was not observed in the availiable infliximab case.

The uptake of TNF-alpha blockers from the infant's intestine would probably be negligible, although a local effect in the gastro-intestinal channel cannot be excluded.

Since, TNF-alpha blockers have been associated with serious adverse effects and an increased risk of infections (5), breast-feeding cannot be recommended.

Answer Conclusion

Breast-feeding during treatment with TNF-alpha inhibitors cannot be recommended.

Andersson M
Böttiger Y


  1. Fass 2004
  2. Remicade (infliximab). Information from Schering-Plough
  3. Ostensen M, Eigenmann GO. Etanercept in breast milk- J Rheumatol 2004;31(5):1017-8
  4. Bennett PN (ed), Drugs and human lactation. 2nd ed. Amsterdam: Elsevier; 1996
  5. Infliximab (Remicade). EMEA (http://www.emea.eu.int) (cited 2005-02-16)

Senast ändrad 2018-09-20