Sargramostim Pregnancy and Breastfeeding Warnings

Brand names: Leukine

Medically reviewed by Drugs.com. Last updated on Sep 9, 2024.

Sargramostim Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: The limited available data in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes.

Comments:
-Based on animal studies, this drug may cause embryofetal harm.
-When reconstituted with Bacteriostatic Water for Injection, the solution contains 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants and can cause serious adverse reactions and death. If this drug is needed during pregnancy, reconstitute for injection only with Sterile Water for injection without preservatives.
-Advise pregnant women of the potential risk to a fetus.

Animal studies have revealed evidence of embryolethality and embryotoxicity. Pregnant rabbits received subcutaneous doses of this drug during the period of gestation day (GD) 6 to GD19, GD19 to GD28, or GD19 to parturition at 25, 70, and 200 mcg/kg/day. An increase in spontaneous abortions, late resorptions, and post implantation loss, and a reduction in viable fetuses, mean live litter size, and offspring body weight were evident in rabbits treated with this drug at 200 mcg/kg/day. No adverse effects were observed in those receiving 70 mcg/kg/day or less. There are no controlled data in human pregnancy.

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

Sargramostim Breastfeeding Warnings

Use is not recommended.

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

Comments:
-This drug is a glycosylated form of granulocyte-macrophage colony-stimulating factor (GM-CSF), which is a normal component of breastmilk. However, breastfed infants were not found to have greater serum GM-CSF than formula-fed infants. This may be as GM-CSF is a large molecule and is probably partly digested in the infant's gastrointestinal tract and poorly absorbed by the infant.
-Due to the potential for adverse reactions, the manufacturers advise not to breastfeed during treatment and for at least 2 weeks after the last dose.
-No information is available on the use of this drug intravenously in nursing mothers, but breastmilk levels of GM-CSF were not increased in one nursing mother after receiving this drug inhaled.

There is no data regarding the presence of this drug in rabbit milk. However, in a prenatal and postnatal study, lactating rabbits were administered subcutaneous doses during the period of lactation from day 1 to day 14 at 25, 70, and 200 mcg/kg/day. At doses of 25 mcg/kg/day or greater a reduction in postnatal offspring survival and maternal toxicity were observed.

See references

Further information

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