Spevigo

Question 1

What is the risk of using SPEVIGO during pregnancy?

Accepted Answer

The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. However, human IgG is known to cross the placental barrier, so SPEVIGO may be transmitted from the mother to the developing fetus. In an animal reproduction study, intravenous administration of a surrogate antibody against IL36R in mice during the period of organogenesis did not elicit any reproductive toxicity.

Question 2

What is the estimated background risk of birth defects and miscarriage for the indicated population?

Accepted Answer

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.

Question 3

Is SPEVIGO safe to use during lactation?

Accepted Answer

There are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. However, spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SPEVIGO and any potential adverse effects on the breastfed infant from SPEVIGO or from the underlying maternal condition.

Question 4

Is SPEVIGO safe to use in pediatric patients?

Accepted Answer

The safety and effectiveness of SPEVIGO in pediatric patients have not been established.

Question 5

Is there a difference in safety profile between elderly and younger patients using SPEVIGO?

Accepted Answer

Clinical studies of SPEVIGO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects.