Is Etanercept safe while breastfeeding?

Effects on the breastfed infant

A woman with rheumatoid arthritis began etanercept 25 mg subcutaneously twice a week at 3 months postpartum and later switched to a dose of 50 mg subcutaneously once a week. Her infant was breastfed (extent not stated) until 6 months of age. The infant was reportedly healthy at 3 years of age.[ 12 ] A case-control study of women with chronic arthritic conditions found 5 women who received etanercept during pregnancy and lactation (extent not stated). No differences were observed in the 5 infants' growth parameters, developmental milestones, vaccinations and diseases in the first year of life compared to those not exposed to the drugs with lactation.[ 14 ] Six infants were breastfed (2 fully, 4 partially) by mothers with rheumatoid arthritis or ankylosing spondylitis who were receiving etanercept during pregnancy and up to the time they were enrolled in the study. One mother reported a nonserious rash and high-pitched crying in her infant, both of which resolved without intervention. All infants had growth measures within normal range at their 6-month well-child visit.[ 13 ] A national prospective registry of patients with rheumatic diseases who were treated with biological DMARDs was conducted in Spain. Three infants whose mothers were taking etanercept were breastfed (extent not stated) with no mild or severe adverse events reported in the infants.[ 15 ] A woman with ankylosing spondylitis was breastfeeding her infant when subcutaneous etanercept 25 mg weekly was begun at 11 weeks postpartum because of increased disease activity. Her infant developed somnolence, prolonged sleep, feeding difficulty, and hypotonia the day after the first dose. These neurologic symptoms persisted, with some fluctuation in intensity, over the following weeks. About 1 week after their onset, the infant also began to experience intermittent low-grade fever, cough, and nasal congestion. Etanercept was then discontinued. Approximately 4 weeks after the onset of the initial symptoms, the in

Effects on milk supply

An analysis of the US Food and Drug Administration s FAERS database of 7,022 spontaneous adverse reaction reports of anti-TNF drugs found that they may cause an increased risk of lactation insufficiency and disorders. Drugs that were studied included adalimumab, infliximab, golimumab, certolizumab, and etanercept. The authors noted that TNF alpha is involved in milk production, adding biological plausibility to the findings.[ 17 ]

Levels in milk

Maternal Levels. One woman was receiving etanercept 25 mg subcutaneous injections twice weekly. The mother was secreting small amounts of milk, but not breastfeeding. On day 44 after delivery the trough milk etanercept level before the fifth dose was 50 mcg/L. A milk etanercept level one day after the fifth injection was 75 mcg/L and milk levels declined thereafter.[ 1 ] A woman received etanercept 25 mg subcutaneously twice weekly during pregnancy and lactation. At 12 weeks postpartum, a breastmilk sample taken at an unspecified time after a dose was 3.5 mcg/L. Her serum etanercept concentration at the same time was 2872 mcg/L.[ 10 ] A woman with ankylosing spondylitis received etanercept 25 mg subcutaneously once weekly during pregnancy and postpartum. Breastmilk concentrations were measured daily from day 40 to day 47 postpartum following a dose on day 40. Breastmilk concentrations ranged from 2 to 5 mcg/L; the high concentration of 5 mcg/L occurred on day 43 and corresponded with the highest maternal serum etanercept concentration. By day 47, etanercept was not detectable in breastmilk ( 2 mcg/L).[ 11 ] A woman with rheumatoid arthritis began etanercept 25 mg subcutaneously twice a week at 3 months postpartum and later switched to a dose of 50 mg subcutaneously once a week. Breastmilk samples were collected over a 2-month period. Before the first dose, the milk level was 1.5 mcg/L. Etanercept milk levels 24 and 48 hours after 25 mg doses were 4.48 and 5.25 mcg/L, respectively. Etanercept milk levels 24 and 72 hours after 50 mg doses were 4.48 and 7.5 mcg/L.[ 12 ] Six women who were receiving etanercept 50 mg per week donated milk samples to a human milk repository. Samples were taken between 5.14 hours (range 1.5 to 10.5 hours) after the last milk expression The median milk etanercept concentration was 12.9 ng/mL (IRQ 6.0 to 46.9 ng/mL). The level in milk was correlated with both the infant and maternal age, but not with any other variable. The estimated average

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