Inotuzumab ozogamicin Pregnancy and Breastfeeding Warnings

Brand names: Besponsa

Medically reviewed by Drugs.com. Last updated on May 6, 2024.

Inotuzumab ozogamicin Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause embryofetal harm when administered to a pregnant woman. In animal studies, it caused embryofetal toxicity at maternal systemic exposures starting at 0.4 times the exposure in patients at the maximum recommended human dose (MRHD). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus.

Comments:
-Based on its mechanism of action and findings from animal studies, this drug can cause fetal harm when administered to a pregnant woman.
-Advise women of reproductive potential to avoid becoming pregnant while receiving this drug.
-Advise women of reproductive potential to use effective contraception during therapy and for at least 8 months after the last dose.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 5 months after the last dose.
-This drug may impair the fertility of both females and males of reproductive potential.

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.

See references

Inotuzumab ozogamicin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-Women should not breastfeed during therapy and for at least 2 months after the last dose.

See references

Further information

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

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