Durvalumab

The Basics

What is Durvalumab?

Used to treat urothelial cancer.

Brand names for Durvalumab

Imfinzi

How Durvalumab is classified

Antineoplastic Agents, Biological Response Modifiers, Immunologic Adjuvants, Immune Checkpoint Inhibitors, Antibodies – Monoclonal

Durvalumab During Pregnancy

Durvalumab pregnancy category

Category Not AssignedNote 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 Durvalumab while pregnant

Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no data on the use of IMFINZI in pregnant women. In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery resulted in an increase in premature delivery, fetal loss, and premature neonatal death (see Data). Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, durvalumab has the potential to be transmitted from the mother to the developing fetus. Apprise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Durvalumab While Breastfeeding

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

No information is available on the clinical use of durvalumab during breastfeeding. Because durvalumab is a large protein molecule with a molecular weight of about 146,000, 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, durvalumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for at least 3 months after the last dose of durvalumab. Durvalumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of durvalumab during breastfeeding. Because durvalumab is a large protein molecule with a molecular weight of about 146,000, 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, durvalumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for at least 3 months after the last dose of durvalumab. Durvalumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Possible effects of Durvalumab on milk supply

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

Possible alternatives to Durvalumab

None listed