Givinostat Pregnancy and Breastfeeding Warnings

Brand names: Duvyzat

Givinostat Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No adequate data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The effect of this drug on reproductive capability in humans is unknown. Animal studies indicate potential adverse effects on reproductive functions.
-This drug is indicated for a disease of predominantly male patients, therefore there are no adequate date available to assess its use in pregnant women.

Animal studies have revealed evidence of decreased fetal body weight and increased structural variations. Oral administration during pregnancy and lactation resulted in increased embryofetal and offspring mortality and neurobehavioral changes in the offspring. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 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.

See references

Givinostat Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant or on milk production are unknown.
-The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.

See references

Further information

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

Medical Disclaimer