Ilumya

(tildrakizumab)
ILUMYA 100 MG in 1 ML Prefilled Syringe
NO BLACK BOX WARNING

Dosage & administration

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Billing and Coding

drug label

Ilumya prescribing information

prior authorization

Ilumya prior authorization resources

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Updated: Jul 12, 2023Kaiser Permanente - Mid-Atlantic Ilumya Prior Authorization Form Mid-Atlantic States
Updated: Jun 04, 2023Blue Cross Blue Shield of Michigan - FEP Ilumya Prior Authorization Form (Medical Benefit)
Updated: May 31, 2023Blue Cross Blue Shield of North Carolina - Ilumya Prior Authorization Form
Updated: May 31, 2023Blue Cross Blue Shield - Federal Employee Program Ilumya Prior Authorization From
Updated: May 31, 2023Cigna - Ilumya Prior Authorization Form
Updated: May 29, 2023Blue Cross Blue Shield of Michigan - Ilumya Prior Authorization Form (Medical Benefit)
Updated: May 23, 2023Aetna - Medicare Part B Ilumya Prior Authorization Form

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Complete Letter of Medical Necessity

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Coverage Authorization Appeals
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Benefits investigation

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Ilumya Support Enrollment Form
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Reimbursement help (FRM)

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financial assistance

Ilumya financial assistance options

Co-pay savings program

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Ilumya Support Enrollment Form
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Bridge program

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Ilumya Support Enrollment Form

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Ilumya Early Access Program
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Foundation programs

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goverment insurance
65+

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Ilumya Support Enrollment Form
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patient education

Ilumya patient education

Getting started on Ilumya

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Patient toolkit

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About Ilumya
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Receiving Ilumya
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Side Effects
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Patient Stories
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Patient Brochure
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Patient Brochure - Spanish
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people also ask

Ilumya FAQs

What is the risk of ILUMYA use during pregnancy?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.
What is the background risk of birth defects and miscarriage during pregnancy?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.
What does the animal data on ILUMYA use during pregnancy show?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.
What is the risk of ILUMYA use during lactation?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.
What is the safety and effectiveness of ILUMYA in pediatric patients?ILUMYA has not been established as safe and effective in pediatric patients under the age of 18.
What is the geriatric use of ILUMYA?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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