Hepzato kit Pregnancy Warnings
Animal studies have revealed evidence of embryolethality and teratogenicity. Malformations included alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, as well as hepatocele (exomphaly). 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.
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 should be avoided.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: This drug may cause fetal harm when administered to a pregnant woman. It is embryolethal and teratogenic in animal studies. Malformations resulting include alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, as well as hepatocele (exomphaly).
Comments:
-Women of childbearing potential should be advised to avoid becoming pregnant.
-Women of child-bearing potential should use effective contraception during therapy and for at least 6 months after the last dose.
-Males with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.
-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.
-This drug has been shown to cause chromatid or chromosome damage in IM administration at 6 and 60 mg/m2 produced structural aberrations of the chromatid and chromosomes in bone marrow cells in animal studies.
See references
