Trisenox Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity. Increased perinatal mortality in pups observed when this drug was administered orally to pregnant rats during pregnancy at doses up to 90 mg/kg/day (less than half the human maintenance dose based on AUC comparisons). Drug administration during organogenesis was associated with dose-related increases in the incidences of rudimentary cervical ribs in rats and rabbits at 30 and 45 mg/kg (doses equal to about 1/5 and 1/10 the clinical exposures based on AUC comparisons), respectively; dose-related increases in the incidences of zygomatic arch fusion and supernumerary ribs/rudimentary supernumerary ribs were also observed in rats at 30 mg/kg and above (equal to 1/5 the human AUC). There are no controlled data in human pregnancy.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.
Risk Summary: Based on the mechanism of action and findings in animal studies, this drug can harm a developing fetus. It was embryolethal and teratogenic in rats when administered on gestation Day 9 at a dose approximately 10 times the equivalent recommended human dose. A related trivalent arsenic, sodium arsenite was teratogenic when administered during gestation in mice at a dose approximately 5 times the equivalent human dose and in hamsters at an IV dose approximately equivalent to the recommended human dose.
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 6 months after.
-Advise males with female sexual partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-Based on testicular toxicities including decreased testicular weight and impaired spermatogenesis observed in animal studies, this drug may impair fertility in males of reproductive potential.
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