Oncaspar Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: There are no data on the use of this drug in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the offspring.
Comments:
-This drug can harm a developing fetus.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to avoid becoming pregnant while receiving this drug. Females should use effective contraceptive methods, including a barrier method, during therapy and for at least 3 months after.
-Since there is a potential for an indirect interaction between this drug and oral contraceptives, the concomitant use of this drug and oral contraceptives is not recommended. Another, non-oral contraceptive method should be used in women of childbearing potential.
Animal reproduction studies have not been conducted with this drug. Published literature studies in which pregnant animals were administered L-asparaginase or were deprived of dietary asparagine suggested harm to the animal offspring. 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.
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