Ublituximab Pregnancy and Breastfeeding Warnings

Brand names: Briumvi

Medically reviewed by Drugs.com. Last updated on Apr 18, 2023.

Ublituximab Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary:
-The available clinical data on the use of this drug in pregnant women is insufficient to inform a drug-related risk.
-Monoclonal antibodies are known to cross the placental barrier; therefore, this drug is likely to be transferred from the mother to the developing fetus.
-Based on animal studies, this drug has the potential to harm a developing fetus when administered to a pregnant woman.

Comments:
-Verify pregnancy status in females of childbearing potential prior to each infusion.
-Advise patients to notify their healthcare provider if they are pregnant during treatment with this drug, as it has the potential to harm the fetus.
-Use effective contraception during treatment and for 6 months after the last dose.
-Monoclonal antibodies are known to cross the placental barrier; therefore, this drug is likely to be actively transported across the placenta and cause immunosuppression in the in-utero exposed infant.
-The transport of endogenous IgG antibodies across the placenta increases throughout pregnancy, peaking in the third trimester.
-Do not administer live vaccines to infants and neonates who are exposed to this drug in-utero before confirming B-cell recovery.

In animal studies, weekly intravenous administration of this drug to pregnant monkeys produced a severe immunogenic response, resulting in maternal morbidity and death and embryofetal loss, resulting in dose termination. Administration during the second trimester resulted in external, skeletal, and visceral abnormalities in two infants; histopathology examination revealed minimal to moderate degeneration or necrosis in the brain. There are no controlled data in human pregnancy; however, infants born to mothers who were exposed to other anti-CD20 B-cell depleting antibodies during pregnancy had temporary peripheral B-cell depletion and lymphocytopenia.

Abnormalities reported in animal studies included, contractures and abnormal flexion of multiple limbs and the tail, shortened mandible, elongate calvarium, enlargement of the ears, and/or craniomandibular abnormalities, which were attributed to brain necrosis in infants exposed to this drug in-utero.

No abnormalities were present in the infants of dams exposed to this drug during the first trimester of pregnancy. A no-effect dose for adverse effects on embryofetal development in monkeys was not identified.

Last paragraph:
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

Ublituximab Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

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

Comments:
-The effects of this drug on the breastfed infant or milk production are unknown.
-Maternal immunoglobulin (IgG) is known to be secreted into human milk.
-A risk to the newborn or infant cannot be excluded.

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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