Blinatumomab Pregnancy and Breastfeeding Warnings

Brand names: Blincyto

Blinatumomab Pregnancy Warnings

This drug should not be used during pregnancy unless 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 when administered to a pregnant woman. There are no available data on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Females of childbearing potential should use contraception during use of this drug and for at least 48 hours after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential harm to the fetus.
-This drug causes T-cell activation and cytokine release; pregnancy maintenance may be compromised by immune activation.
-B-cell lymphocytopenia may occur in infants exposed to this drug in-utero.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity after a murine surrogate molecule was administered to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier. Expected depletions of B and T cells were observed in pregnant animals, but hematological effects were not assessed in fetuses. There are no controlled data in human pregnancy.

Newborns exposed to this drug in-utero should be monitored for B-cell depletion before the initiation of live virus vaccination. Live virus vaccines can be administered when B lymphocytes are within the normal range.

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

Until more data become available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is contraindicated (or not recommended) during use of this drug and for at least 48 hours after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-According to some experts: Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant during breastfeeding.
-Because this drug is a large protein molecule, the amount in milk is expected to be very low and absorption is probably minimal due to partial destruction within the infant's gastrointestinal 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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