ntil parturition, a small increase in neonatal death was observed at 59 times the MRHD [seeData]. The clinical significance of this nonclinical finding is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Thebackground risk of major birth defects and miscarriage for the indicated population is unknown. In theU.S. general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2-4% and 15-20%, respectively.
Data
Animal Data
In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab wereadministered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestationday 118 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). Tildrakizumab crossed theplacenta in monkeys.
In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumabwere administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 toparturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kgdose (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times theMRHD based on AUC comparison). The clinical significance of these nonclinical findings is unknown. No
tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months ofage.
8.2 Lactation
Risk Summary
There are no data on the presence of tildrakizumab in human milk, the effects on the breastfedinfant, or the effects on milk production. Human IgG is known to be present in human milk. Tildrakizumabwas detected in the milk of monkeys [see Data].
The developmental and health benefits of breastfeeding should be considered along with themother’s clinical need for ILUMYA and any potential adverse effects on the breastfed child from ILUMYAor from the underlying maternal condition.
Data
Animal Data
Very low levels of tildrakizumab were detected in breast milk of monkeys in the pre- and postnataldevelopmental study described in 8.1. The mean tildrakizumab concentrations in milk were approximately0.09 – 0.2% of that in serum on postpartum days 28 and 91.
8.4 Pediatric Use
Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not beenestablished.
8.5 Geriatric Use
A total of 1083 subjects were exposed to ILUMYA 100 mg during Phase 2 and 3 trials. A total of 92subjects were 65 years or older, and 17 subjects were 75 years or older. Although no differences in safetyor efficacy were observed between older and younger subjects, the number of subjects aged 65 and overis not sufficient to determine whether they respond differently from younger subjects [see ClinicalPharmacology (12.3)].
10 OVERDOSAGE
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions andadminister appropriate symptomatic treatment immediately.
11 DESCRIPTION
Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit ofinterleukin-23 (IL-23).
Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and hasan approximate molecular mass of 147 kilodaltons.
ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightlyopalescent, colorless to s |
