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Calaspargase pegol Pregnancy and Breastfeeding Warnings

Calaspargase pegol is also known as: Asparlas

Calaspargase pegol Pregnancy Warnings

Animal reproduction studies have not been conducted to evaluate the effect of this drug on reproduction and fetal development. Studies in which pregnant animals were administered L-asparaginase or were deprived of dietary asparagine showed 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.

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: 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. Studies in pregnant animals suggest asparagine depletion may cause harm to the offspring

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.

See references

Calaspargase pegol Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential for adverse reactions in a breastfed child, lactating women should not to breastfeed during therapy and for 3 months after.

See references

References for pregnancy information

  1. "Product Information. Asparlas (calaspargase pegol)." Servier, Boston, MA.

References for breastfeeding information

  1. "Product Information. Asparlas (calaspargase pegol)." Servier, Boston, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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