Dupilumab

The Basics

What is Dupilumab?

Used to treat moderate-to-severe eczema that cannot be controlled with topical medicines. Also used together with other medications to treat moderate-to-severe asthma.

Brand names for Dupilumab

Dupixent

How Dupilumab is classified

Biological Response Modifiers, Immunologic Adjuvants, Antibodies – Monoclonal

Dupilumab During Pregnancy

Dupilumab 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 Dupilumab while pregnant

Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus. There are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy (see Clinical Considerations). In an enhanced pre- and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha (IL-4Rα) during organogenesis through parturition at doses up to 10-times the maximum recommended human dose (MRHD) (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-fetal Risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data In an enhanced pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of homologous antibody against IL-4Rα up to 10 times the MRHD (on a mg/kg basis of 100 mg/kg/week) from the beginning of organogenesis to parturition. No treatment-related adverse effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.

Taking Dupilumab While Breastfeeding

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

No information is available on the clinical use of dupilumab during breastfeeding. Because dupilumab is a large protein molecule with a molecular weight of about 147,000, 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, dupilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Dupilumab is a human immunoglobulin G4 (IgG4) 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 Holder pasteurization having little effect on IgG4 activity.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of dupilumab during breastfeeding. Because dupilumab is a large protein molecule with a molecular weight of about 147,000, 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, dupilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Dupilumab is a human immunoglobulin G4 (IgG4) 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 Holder pasteurization having little effect on IgG4 activity.[3] None of the studies measured IgG activity.

Possible effects of Dupilumab on milk supply

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

Possible alternatives to Dupilumab

None listed