Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are insufficient data in human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; based on animal data, this drug has the potential to cause fetal harm.

Comments:
-Women with sickle cell disease have an increased risk of adverse pregnancy outcomes; maternal risks include vasoocclusive crises, preeclampsia, eclampsia, and maternal mortality; fetal risks include increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality.
-Pregnant women should be advised of the potential risks to their fetus.
-Some authorities advise women of childbearing potential who are not using contraception avoid use of this drug.

Pregnant cynomolgus monkeys receiving this drug from organogenesis through delivery showed a non-dose related increase in fetal loss at doses approximately 2.8 times the expected exposure at the recommended human dose. The increase in fetal loss (abortions or still births) was higher in the third trimester. This drug was shown to cross the placental barrier. All pregnancies have a background risk of birth defect, loss, or other adverse outcome. The estimated background risk of major birth defects and miscarriage for women with sickle cell disease is approximately 14% and up to 43%, respectively. There are no controlled data in human pregnancy.

UK: To allow monitoring through the Pregnancy outcomes Intensive Monitoring programme (PRIM), pregnant women and healthcare professionals are encouraged to report pregnancy (see package leaflet for contact information). Additionally, all adverse pregnancy events should be reported via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

This drug is a large protein molecule and therefore the amount in milk is likely to be very low. If this drug is present in breast milk, it is likely to be partially destroyed in the infant's gastrointestinal tract minimizing potential absorption by the infant. Until more data become available, use caution, especially if considering nursing a newborn or preterm infant.

See references