Females and Males of Reproductive Potential: Based on its mechanism of action, BLINCYTO may cause fetal harm when administered to a pregnant woman (see Pregnancy).
Pregnancy Testing: Verify the pregnancy status of females of reproductive potential prior to initiating BLINCYTO treatment.
Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment and for at least 48 hours after the last dose of BLINCYTO.
Pregnancy: Risk Summary: Based on its mechanism of action, BLINCYTO may cause fetal harm including B-cell lymphocytopenia when administered to a pregnant woman (see Pharmacology: Pharmacodynamics: Mechanism of Action under Actions). There are no data on the use of BLINCYTO in pregnant women. In animal reproduction studies, a murine surrogate molecule administered to pregnant mice crossed the placental barrier (see Data). Advise pregnant women of the potential risk to a fetus.
The background rate of major birth defects and miscarriage is unknown for the indicated population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations: Fetal/Neonatal adverse reactions: Due to the potential for B-cell lymphocytopenia in infants following exposure to BLINCYTO in-utero, the infant's B lymphocytes should be monitored before the initiation of live virus vaccination. (see Precautions).
Data: Animal Data: Animal reproduction studies have not been conducted with blinatumomab. In embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses.
Lactation: Risk Summary: There is no information regarding the presence of blinatumomab in human milk, the effects on the breastfed infant, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from BLINCYTO, including B-cell lymphocytopenia, advise patients not to breastfeed during and for at least 48 hours after treatment with BLINCYTO.