Blinatumomab Pregnancy and Breastfeeding Warnings

Brand names: Blincyto

Blinatumomab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug may cause fetal harm including B-cell lymphocytopenia when administered to a pregnant woman. In animal reproduction studies, a murine surrogate molecule crossed the placental barrier.

Comments:
-Due to the potential for depletion of B lymphocytes in infants following exposure to this drug during pregnancy, the infant's B lymphocytes should be monitored before the initiation of live virus vaccination. Live virus vaccines can be administered when the B lymphocytes are within the normal range.
-Women of childbearing potential should use effective contraception during and for at least 48 hours after therapy with this drug.

In animal studies, a murine surrogate molecule administered IV to the mother during organogenesis crossed the placental barrier but did not cause embryofetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the mother, but hematological effects were not assessed in fetuses. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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Blinatumomab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother; according to some experts, use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-Nursing should be discontinued during and for at least 48 hours after the last dose.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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