Skip to Content
Not all colorectal cancer treatments are the same. Find out more >

Dinutuximab Pregnancy and Breastfeeding Warnings

Dinutuximab is also known as: Unituxin

Dinutuximab Pregnancy Warnings

Use is not recommended. US FDA pregnancy category: Not formally assigned to a pregnancy category. Comments: -This drug may cause fetal harm. -Females of reproductive potential should be advised to use effective contraception during treatment and for two months after the last dose of this drug.

-This drug may cause fetal harm when administered to a pregnant woman based on its mechanism of action. There are no studies in animals or human pregnant women to assess the drug-associated risk. -Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Pregnant women should be advised of the potential risk to a fetus. The background risk of major birth defects and miscarriage pregnant women is unknown; however, the background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

See references

Dinutuximab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown; however, human IgG is present in human milk Excreted into animal milk: Data not available Comments: -There is no information on the effects of the drug on the breastfed infant. -There is no information on the effects of the drug on milk production.

See references

References for pregnancy information

  1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation, Silver Spring, MD.

References for breastfeeding information

  1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation, Silver Spring, MD.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com 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.

Hide