Qinlock Pregnancy Warnings
In animal reproduction studies, administration of the small molecule component of this drug, MMAE, to pregnant rats during organogenesis at exposures below the clinical exposure at the recommended dose resulted in abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia. 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.
Use should be avoided.
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 rats during organogenesis resulted in malformations primarily associated with the cardiovascular and skeletal systems, including interrupted or retroesophageal aortic arch and retroesophageal subclavian artery, fusion of the exoccipital bone to the first cervical vertebra, branched and fused ribs, anomalies of the cervical, thoracic, caudal, and sacral vertebrae, absent forepaw phalanges, and absent metacarpals at a dose one-half of the human exposure at the recommended dose. An increased incidence of anatomic variations was also observed. Variations included malpositioned carotid and subclavian artery origins, malpositioned subclavian artery, absent or elongated innominate artery, misshapen and nodulated ribs, bipartite, incompletely ossified, or unossified vertebral centra, small or misshapen vertebral arches, and reductions in ossified forelimb and hindlimb phalanges, hindlimb metatarsals, and caudal vertebrae.
Comments:
-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 females of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-This drug can impair male fertility.
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