Ilumya

Question 1

What is the risk of ILUMYA use during pregnancy?

Accepted Answer

Limited available data on the use of ILUMYA during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier; therefore, ILUMYA may be transferred from the mother to the fetus. An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD). When dosing was continued until parturition, a small increase in neonatal death was observed at 59 times the MRHD.

Question 2

What is the background risk of birth defects and miscarriage during pregnancy?

Accepted Answer

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The 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 2-4% and 15-20%, respectively.

Question 3

What does the animal data on ILUMYA use during pregnancy show?

Accepted Answer

In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118. No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg. Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose, and four monkeys at 100 mg/kg dose. The clinical significance of these nonclinical findings is unknown.

Question 4

What is the risk of ILUMYA use during lactation?

Accepted Answer

There are no data on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. Tildrakizumab was detected in the milk of monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ILUMYA and any potential adverse effects on the breastfed child from ILUMYA or from the underlying maternal condition.

Question 5

What is the safety and effectiveness of ILUMYA in pediatric patients?

Accepted Answer

ILUMYA has not been established as safe and effective in pediatric patients under the age of 18.

Question 6

What is the geriatric use of ILUMYA?

Accepted Answer

During Phase 2 and 3 trials, 92 subjects aged 65 or older and 17 subjects aged 75 or older were exposed to ILUMYA 100mg. Although there were no observed differences in safety or efficacy between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.

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