A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag
- Mother is registered with the PROMACTA Pregnancy Registry and meets all the
enrollment criteria defined in the PROMACTA Pregnancy Registry study (113327).
- Mother is continuing to take eltrombopag.
- Mother has received 7 consecutive eltrombopag doses prior to the milk sample
- Infant is 4 weeks to 26 weeks of age at the time of milk sampling.
- Exclusively breastfeeding mother-infant pair; either via breast or with expressed
milk from the mother.
- Mother is capable of giving written informed consent, which includes compliance with
the requirements and restrictions listed in the consent form.
- Infant was born with complications that could impact ability to participate in this
- Breastfeeding is not well established in the mother-infant pair (e.g., poor latching
of the infant or low milk supply).
- Infants who are supplemented with formula or are consuming solid foods.
- Unwillingness or inability of mother to follow the procedures outlined in the
- Mother is mentally or legally incapacitated