Cresemba Pregnancy Warnings
This drug should not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections; this drug may be used in such patients if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk summary: Based on results from animal studies, this drug may cause fetal harm when used during pregnancy; no data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Pregnant women should be apprised of the potential harm to the fetus.
-Since this drug may cause embryofetal harm when used during pregnancy, females of reproductive potential should be advised to use effective contraception during therapy and for 28 days after the last dose; local protocol should be consulted regarding contraception timing.
-This drug is not recommended for females of reproductive potential not using contraception.
Animal studies have revealed evidence of perinatal mortality and teratogenicity. Perinatal mortality was increased in pups when this drug was administered orally to pregnant rats during pregnancy at doses up to 90 mg/kg/day (about 0.5 times the clinical exposure based on AUC comparison). 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 0.2 and 0.1 times the clinical exposure 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 0.2 times the human AUC). 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.
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