Copiktra Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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.
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis caused embryofetal mortality (resorptions, post-implantation loss, and decreased viable fetuses), alterations to growth (lower fetal weights) and structural malformations at maternal doses 10 to 39 times the maximum recommended human dose (MRHD).
Comments:
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during therapy and for at least one month after the last dose.
See references
Copiktra Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug may harm a nursing child.
-Women should not breastfeed while taking this drug and for at least one month after.
No information is available on the use of this drug during breastfeeding. Because it is 98% bound to plasma proteins, the amount in milk is likely to be low; however, because of its potential toxicity in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued.
See references
