Efbemalenograstim alfa Pregnancy and Breastfeeding Warnings

Brand names: Ryzneuta

Efbemalenograstim alfa Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no adequate studies of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of maternal toxicity (decreased weight gain, weight loss, and/or death) with higher cumulative doses of this drug. There was no reproductive or developmental toxicity in the offspring of pregnant rats and rabbits who received cumulative doses of 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area). There are no controlled data in human pregnancy.

The estimated risk of major birth defects and miscarriage for the indicated population is unknown.

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

Efbemalenograstim alfa Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

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

Comments:
-The effects in the nursing infant or on milk production are unknown.
-The benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the nursing infant from this drug or from the underlying maternal condition.

See references

Further information

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