Skip to Content

Vorinostat Pregnancy and Breastfeeding Warnings

Vorinostat is also known as: Zolinza

Vorinostat Pregnancy Warnings

Vorinostat has been assigned to pregnancy category D by the FDA. Animal studies have revealed that vorinostat crosses the placenta and is found in fetal plasma at levels up to 50% of maternal concentrations. Treatment-related developmental effects including decreased mean live fetal weights, incomplete ossifications of the skull, thoracic vertebra, sternebra, and skeletal variations (cervical ribs, supernumerary ribs, vertebral count, and sacral arch variations), reductions in mean live fetal weight, an elevated incidence of incomplete ossification of the metacarpals, and a dose-related increase in the incidence of malformations of the gall bladder have been reported in animal studies. There are no controlled data in human pregnancy. Vorinostat should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Vorinostat Breastfeeding Warnings

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

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.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.