Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

The purpose of this study is to understand if the study drugs of interest are found in
breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants
and what effect this may have on infants; and to share what we learn with other researchers.
The study drugs of interest have Food and Drug Administration (FDA) approval, but there is
little or no information about the amount of drug found in the breastmilk of mothers who take
them; the amount of drug that may be transferred to their infant's through breastmilk; or the
effects this transfer may have on their infants. During this study we will ask to collect
breastmilk and blood from mothers, and blood from infants, to measure the amount of study
drug of interest in these body fluids. Results from this study will help researchers better
understand how much of the study drug of interest is in your blood and breastmilk, and how
much of the study drug of interest may be in your infant's blood because of breastfeeding.

Inclusion Criteria:

- Lactating women who are receiving at least one DOI per SOC who are ≤180 days
postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.

- Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to
any study-related procedures. Lactating women who are not legal adults and their
breastfed infants may be enrolled if they assent to participate in the study and
consent is obtained from their legal guardian according to local IRB/REB/IEC
guidelines.

Exclusion Criteria:

- Any concomitant condition which, in the opinion of the physicians providing patient
care or the principal investigator conducting the study, would preclude a subject's
participation in the study.

- Known pregnancy during PK sampling.