Gemtuzumab Pregnancy and Breastfeeding Warnings

Brand names: Mylotarg

Medically reviewed by Drugs.com. Last updated on Sep 13, 2024.

Gemtuzumab Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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

Risk summary: Based on animal studies and its mechanism of action, this drug can cause embryofetal harm when administered to a pregnant woman; no data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnant patients, patients who become pregnant while taking this drug, or treated male patients as partners of pregnant women, should be apprised of the potential harm to the fetus.
-Pregnancy status should be verified in patients of childbearing potential before starting this drug.
-Patients of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception during therapy and for at least 6 or 7 months after the last dose; male patients with partners of childbearing potential should be advised to use effective contraception during therapy and for at least 3 or 4 months after the last dose.
---Local protocol should be consulted regarding contraception timing.
---According to some authorities, 2 methods of effective contraception should be used.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. In pregnant rats administered IV doses up to 1.2 mg/m2/day during organogenesis, embryofetal toxicities (including fetal growth retardation, fetal wavy ribs, and delayed skeletal ossification), increased embryofetal lethality, and fetal morphological anomalies (digital malformations, missing aortic arch, forelimb long bone anomalies, misshapen scapula, missing vertebral centrum, fused sternebrae) were observed; maternal toxicity (including decreased gestational body weight gain, food intake, and gravid uterine weight) was observed at all doses with embryofetal effects. The lowest dose at which embryofetal effects were seen in rats (0.15 mg/m2/day) was 0.4 times the exposure in patients at the maximum recommended human dose (based on AUC). There are no controlled data in human pregnancy.

Based on animal studies, this drug may impair female and male fertility. According to some authorities, both men and women should seek advice on fertility preservation before treatment.

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

Gemtuzumab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 month after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in the breastfed child.

Since gemtuzumab is a large protein molecule (molecular weight about 152 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption of gemtuzumab by the infant is probably minimal. Ozogamicin (N-acetyl gamma calicheamicin) is a small molecule that causes double-stranded DNA breaks that may enter milk and be absorbed by the infant.

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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