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Gemtuzumab Pregnancy and Breastfeeding Warnings

Gemtuzumab is also known as: Mylotarg

Gemtuzumab Pregnancy Warnings

Animal studies revealed fetal growth retardation, fetal wavy ribs, delayed skeletal ossification, increased embryofetal lethality, and fetal morphological anomalies (digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae). The lowest dose at which embryofetal adverse effects were observed was 0.4 times the exposure in patients at the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause embryofetal harm when administered to a pregnant woman based on its mechanism of action and animal studies. There are no data on its use in pregnant women; however, in animal studies, it caused embryofetal toxicity at maternal systemic exposures that were greater than or equal to 0.4 times the exposure in patients at the maximum recommended human dose (MRHD).

Comments:
-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.
-Women of childbearing potential should be advised to avoid pregnancy.
-Females of reproductive potential should use effective contraception during therapy and for at least 6 months following the last dose.
-Males with female partners of reproductive potential should use effective contraception during therapy and for at least 3 months following the last dose.
-Based animal studies, this drug may impair fertility in both males and females of reproductive potential.

See references

Gemtuzumab Breastfeeding Warnings

Use should be avoided.

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

Comments:
-Because of the potential for adverse reactions in breastfed infants, women should not breastfeed during therapy and for at least one month following the final dose.

See references

References for pregnancy information

  1. "Product Information. Mylotarg (gemtuzumab)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. "Product Information. Mylotarg (gemtuzumab)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

Further information

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

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