Cancer Home > Ontak and Pregnancy

Because of the unknown risks, Ontak (denileukin diftitox) is considered a pregnancy Category C medicine. This means that this chemotherapy drug may not be safe for use during pregnancy. Although no research has been done on this particular aspect, Ontak is associated with serious side effects that might potentially harm an unborn child.

Can Pregnant Women Receive Ontak?

Ontak® (denileukin diftitox) is a prescription medication approved to treat recurrent or persistent cutaneous T-cell lymphoma, a cancer of the immune system that affects the skin. Ontak may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy. Ontak is classified as a pregnancy Category C drug.
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Very little information is available on the potential effects of using Ontak during pregnancy, as this drug has not been studied in pregnant women or in animals. However, the medication can cause serious reactions, known as infusion reactions, which can occur while a dose is being given or even up to a day later. People who experience infusion reactions may develop low blood pressure, breathing problems, fever, or other potentially dangerous symptoms that could be harmful to an unborn child.
 
Because so little is known about Ontak use in pregnancy, it is probably best to avoid using the drug when pregnant unless absolutely necessary. This may be the case if a safer option does not exist and if the benefits of giving the medication to the mother outweigh the potential harm to an unborn child.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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