Tafasitamab Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Sep 7, 2022.

Tafasitamab is also known as: Monjuvi

Tafasitamab Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug may cause fetal B-cell depletion when administered to a pregnant woman. It is administered in combination with lenalidomide which can cause embryofetal harm and is contraindicated for use in pregnancy.

Comments:
-Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta.
-Based on its mechanism of action, this drug may cause depletion of fetal CD19 positive immune cells.
-Delay administration of live vaccines to neonates and infants exposed to this drug in utero until a hematology evaluation is completed.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-Refer to the lenalidomide prescribing information for additional recommendations for contraception.

Animal reproductive studies have not been conducted with this drug. It is an IgG antibody with the potential to cross the placental barrier permitting direct fetal exposure and depleting fetal B lymphocytes. 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

Tafasitamab Breastfeeding Warnings

Use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-Maternal immunoglobulin G is known to be present in human milk.
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for at least 3 months after.

See references

Further information

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