Guselkumab

The Basics

What is Guselkumab?

Used to treat moderate to severe plaque psoriasis.

Brand names for Guselkumab

Tremfya

How Guselkumab is classified

Antibodies – Monoclonal, Dermatologic Agents

Guselkumab During Pregnancy

Guselkumab 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 Guselkumab while pregnant

There are no available data on TREMFYA use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, TREMFYA may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of guselkumab during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal deaths were observed at 6- to 30-times the MRHD (see Data). The clinical significance of these nonclinical findings is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Data Animal Data In a combined embryofetal development and pre- and post-natal development study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of guselkumab up to 50 mg/kg (30 times the MRHD based on a mg/kg comparison) from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of one control monkey, three monkeys administered guselkumab at 10 mg/kg/week (6 times the MRHD based on a mg/kg comparison) and three monkeys administered guselkumab at 50 mg/kg/week (30 times the MRHD based on a mg/kg comparison). The clinical significance of these findings is unknown. No guselkumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age.

Taking Guselkumab While Breastfeeding

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

No information is available on the clinical use of guselkumab during breastfeeding. Because guselkumab is a large protein molecule with a molecular weight of , 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, guselkumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Guselkumab is a human immunoglobulin G1 (IgG1) lambda 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 guselkumab during breastfeeding. Because guselkumab is a large protein molecule with a molecular weight of , 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, guselkumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Guselkumab is a human immunoglobulin G1 (IgG1) lambda 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 Guselkumab on milk supply

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

Possible alternatives to Guselkumab

(Psoriasis) Adalimumab, Etanercept, Infliximab, Phototherapy, Tretinoin.