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Vorinostat Pregnancy and Breastfeeding Warnings

Vorinostat is also known as: Zolinza

Medically reviewed on August 6, 2018

Vorinostat Pregnancy Warnings

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

AU TGA pregnancy category: D
US FDA pregnancy category:

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Adequate methods of contraception should be encouraged.
-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.

Animal studies have revealed evidence of decreased fetal weights, incomplete ossifications of the skull, thoracic vertebra, sternebra, and skeletal variations (e.g., cervical ribs, supernumerary ribs, vertebral count, sacral arch variations) at the highest dose tested. Reductions in mean live fetal weight, an elevated incidence of incomplete ossification of the metacarpals, and malformations of the gall bladder were also reported. There are no controlled data in human pregnancy.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Vorinostat Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Zolinza (vorinostat)." Merck & Company Inc, West Point, PA.

References for breastfeeding information

  1. "Product Information. Zolinza (vorinostat)." Merck & Company Inc, West Point, 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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