Dinutuximab

The Basics

What is Dinutuximab?

A chemotherapy drug.

Brand names for Dinutuximab

Unituxin

How Dinutuximab is classified

Antibodies – Monoclonal (Humanized), Antineoplastic Agents

Dinutuximab During Pregnancy

Dinutuximab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dinutuximab while pregnant

Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no studies in pregnant women and no reproductive studies in animals to inform 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. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Taking Dinutuximab While Breastfeeding

What are recommendations for lactation if you're taking Dinutuximab?

No information is available on the clinical use of dinutuximab during breastfeeding. Because dinutuximab is a large protein molecule with a molecular weight of about 150,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, dinutuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during dinutuximab therapy.

Maternal / infant drug levels

No information is available on the clinical use of dinutuximab during breastfeeding. Because dinutuximab is a large protein molecule with a molecular weight of about 150,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, dinutuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during dinutuximab therapy.

Possible effects of Dinutuximab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Dinutuximab