Table 2.

Data from the literature regarding imatinib concentration in human breast milk and breastfeeding

№	Literature source	Main observation	IM concentration in breast milk,	IM metabolite N-desmethyl derivative (CGP74588) concentration in milk	Time after IM maternal dose, hours	Calculated ratio of concentrations of IM and IM metabolite	Calculated daily dose of IM for an infant	Conclusion
1	Russel et al [6]	IM and its metabolite were found in breast milk in high concentrations in a single point measurement	596 ng/ml	1513 ng/ml	15	-	From 1,2 to 2 mg	The risk to an infant consuming the drug at the levels observed in breast milk is probably small. The long-term side effects of IM exposure and the neonatal pharmacokinetics of IM metabolism are not established
2	Gambacorti-Passerini et al [7]	IM and its metabolite were found in breast milk at several time points, IM plasma blood levels were analysed in parallel	3–3,2 μg/ml	0.8–11 μg/ml	1, 2, 3, 4 and 9	Milk/plasma ratio 0.5 for IM and 0.9 for CGP 74588.	< 3mg	The expected exposure for infant is about 10% of a therapeutic dose. The effects of low-dose, chronic exposure of infants to IM are not known
3	Ali et al [8]	IM was found in breast milk in a series of measurements from 7th to 16th day postpartum	From 1430 to 2623 ng/ml	-	From 10 to 16	-	-	Breast feeding during IM therapy seems to be safe; but, the effects of chronic infant exposure to IM are not known. Breastfeeding is not advisable
4	Kronenberg el al [9]	IM and its metabolite were found in breast milk at several time points, IM blood levels were analysed in parallel. The accumulation of a CGP 74588 in milk was observed	From 751 to 1153 ng/ml	From 409 to 1052 ng/ml	3, 27, 51, 171	Milk/plasma ratio nearly 0.5 for IM and nearly 3 for CGP 74588. CGP 74588/IM ratio in milk from 54% to 132%	-	Breastfeeding cannot be recommended during treatment with IM
5	Burwick et al [10]	IM and its metabolite were found in breast milk. IM blood levels were analysed in parallel. The accumulation of a CGP 74588 in milk was observed	18.9 ng/ml	658 ng/ml	99	-	-	Breastfeeding is discouraged. IM and its metabolite concentrate in breast milk. Longer period of drug cessation would be recommended if mother got IM before breastfeeding.