Nerlynx Pregnancy Warnings
Administration of this drug in animals during organogenesis caused maternal toxicity, abortions, embryofetal death (increased resorptions), effects on long-term memory in male offspring, and fetal abnormalities (e.g., domed head, dilation of the brain ventricles, ventricular septal defect, misshapen and enlarged anterior fontanelles, enlarged posterior fontanelles) at maternal AUCs approximately 0.2 to 0.5 times the AUC in patients at the recommended human dose (RHD). Findings in animals also revealed tubular hypoplasia of the testes at approximately 0.4 times the RHD AUC; however, doses approximately 0.5 times the RHD AUC caused no effects on mating or the ability to become pregnant. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant rabbits during organogenesis resulted in abortions, embryofetal death, and fetal abnormalities at maternal exposures approximately 0.2 times the recommended human dose.
Comments:
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 1 month after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-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.
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