Sarclisa Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-The combination of this drug and pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide prescribing information on use during pregnancy. Pomalidomide is only available through a REMS program.
-This drug can harm a developing fetus.
-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 female patients of reproductive potential to use effective contraception during therapy and for at least 5 months after.
Animal reproduction studies have not been conducted with this drug. CD38 knockout mice had reduced bone density which recovered 5 months after birth. Data from studies using CD38 knockout animal models also suggest the involvement of CD38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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
Sarclisa Breastfeeding Warnings
Use should be avoided.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Maternal immunoglobulin G is known to be present in human milk. The effects of local GI exposure and limited systemic exposure in the breastfed infant to this drug are unknown.
-Because of the potential for serious adverse reactions in the breastfed child from this drug in combination with pomalidomide and dexamethasone, advise lactating women not to breastfeed during therapy.
See references
