Sparsentan Pregnancy Warnings
Animal studies have revealed evidence of embryo-fetal lethality, teratogenicity, and reduced fetal weights; these outcomes were attributed to the antagonism of endothelin type A and angiotensin II type 1 receptors. Animal studies suggest there are no impairments to fertility with this drug. There are insufficient 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.
Use is contraindicated.
US FDA pregnancy category: Not assigned
Risk summary: Based on findings in animals, this drug can cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient. The use of this drug is contraindicated during pregnancy.
Comments:
-Pregnancy testing should be performed before the initiation of treatment, monthly while on treatment, and 1 month after stopping treatment.
-Treatment may be initiated in females of reproductive potential only after a negative pregnancy test.
-Effective methods of contraception should be used to prevent pregnancy prior to start of treatment, during treatment, and for 1 month after discontinuation of treatment.
-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.
-This drug is only available through a restricted access program; prescribers are required to notify Filspari REMS of any pregnancies that occur during treatment or within 1 month of discontinuation.
See references
Sparsentan Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug could potentially harm a nursing infant due to the potential risk for adverse reactions, including hypotension.
-Lactating women are advised not to breastfeed during treatment.
See references
