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Gemtuzumab Pregnancy and Breastfeeding Warnings

Gemtuzumab is also known as: Mylotarg

Gemtuzumab Pregnancy Warnings

Gemtuzumab has been assigned to pregnancy category D. Animal studies have revealed evidence of dose related decreases in fetal weight and fetal skeletal ossification, increased embryo-fetal mortality, digital malformations, absence of the aortic arch, wavy ribs, anomalies of the long bones in the forelimb(s), misshapen scapula, absence of vertebral centrum, and fused sternebrae. There are no controlled data in human pregnancy. Gemtuzumab is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. If gemtuzumab is to be used in pregnancy or if the patient becomes pregnant while receiving gemtuzumab therapy, it is recommended that the patient be consulted regarding the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with gemtuzumab.

See references

Gemtuzumab Breastfeeding Warnings

There are no data on the excretion of gemtuzumab into human milk. Because many drugs are excreted into human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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.

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