Animal studies of intravenous doses up to 20 mcg/kg/day (about 20 times the recommended human starting dose) given during organogenesis showed no evidence of fetotoxicity or other adverse outcomes. Slightly reduce fetal weights were seen at doses of 1 mcg/kg (about equal the recommended human starting dose) and higher with exaggerated pharmacological effects seen in the dams. One animal model showed increased early post-implantation loss at doses of 0.5 mcg/kg three times a week. Doses of 0.5 mg/kg given from implantation throughout pregnancy and lactation had fetal toxicity; doses of 2.5 mg/kg during the same period showed decreased fetal body weights, a slight increase in fetal deaths, delayed eye opening and delayed preputial separation; the F1 generation offspring had no apparent effects from darbepoetin alfa. No significant placental transfer of darbepoetin alfa was seen in the one animal model examined. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


Women who become pregnant during treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call the manufacturer to enroll.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Benefit should outweigh risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-The limited data available on use in pregnant women is insufficient to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal reproduction studies showed increased early post-implantation loss at doses about equal to the usual human starting dose.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Darbepoetin alfa is biologically and immunologically indistinguishable from erythropoietin, a normal component of human milk. IV darbepoetin has been given safely to newborn infants in doses much larger than those expected to appear in breastmilk.

See references