1 ML tildrakizumab-asmn 100 MG/ML Prefilled Syringe [Ilumya]
NO BLACK BOX WARNING
Dosage & administration
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Billing and Coding
drug label
Ilumya prescribing information
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Your request will be referred to the appropriate Sun Pharmaceutical Industries, Inc. medical professional, such as a Ilumya pharmaceutical rep; Medical Science Liaison (MSL) or medical affairs.
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You can report a Ilumya adverse event on MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers.
prior authorization
Ilumya Prior authorization resources
Complete Letter of Medical Necessity
NOT PROVIDED BY BRANDCoverage Authorization Request
Coverage Authorization Appeals
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If available, these templates are provided by the brand to help you navigate insurance, especially with newer drugs.
Benefits investigation
Ilumya Support Enrollment Form
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Benefits investigations are conducted to determine whether a therapy is covered under a patient's insurance, if a prior authorization is required, and which specialty pharmacies are preferred.
Reimbursement help (FRM)
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Some brands offer a field reimbursement manager who will work with your clinical staff and preferred pharmacy to help make sure patients don't fall through the cracks.
financial assistance
Ilumya Financial assistance options
Co-pay savings program
commercial only
Ilumya Support Enrollment Form
Enroll in Patient Savings Program
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Overview
Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance
How to sign up
Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bridge program
commercial only
Ilumya Support Enrollment Form
Ilumya Early Access Program
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Overview
Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
Patient benefit
100% free (outside of insurance)
Patient eligibility
HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
Typically HCP assisted enrollment (via form)
Foundation programs
under insured
no insurance
goverment insurance
65+
Ilumya Support Enrollment Form
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Overview
Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted
Patient eligibility
Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
Patients submit proof of out-of-pocket drug costs to charities for reimbursement
patient education
Ilumya Patient education
Getting started on Ilumya
NOT PROVIDED BY BRANDInstructions For Use: Plaque Psoriasis
Patient toolkit
About Ilumya
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Receiving Ilumya
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Side Effects
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Patient Stories
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Before & After
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Patient Resources
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Patient Brochure
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
Patient Brochure - Spanish
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
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Other resources brands publish to help support patients and caregivers.
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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