Brand Name
Ilumya
Generic Name
Tildrakizumab-Asmn
View Brand Information FDA approval date: August 06, 2018
Classification: Interleukin-23 Antagonist
Form: Injection
What is Ilumya (Tildrakizumab-Asmn)?
ILUMYA ® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYA is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Approved To Treat
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A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of Moderate to Severe Plaque Psoriasis.
Summary: Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
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Brand Information
ILUMYA (tildrakizumab-asmn)
1INDICATIONS AND USAGE
ILUMYA
2DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose prefilled syringe. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution.
3CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity Reactions
- Infections
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Plaque Psoriasis
In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA, of which 1083 subjects were treated with ILUMYA 100 mg. Of these, 672 subjects were exposed for at least 12 months, 587 for 18 months, and 469 for 24 months.
Data from three placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years, 71% males, 81% white) were pooled to evaluate the safety of ILUMYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W])
Placebo-Controlled Period (Weeks 0-16 of Trial 1 and Weeks 0-12 of Trials 2 and 3)
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the ILUMYA group than in the placebo group.
During the placebo-controlled period of Trials 1, 2, and 3, adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity.
Cases of angioedema and urticaria were reported in ILUMYA-treated subjects in clinical trials
Safety through Week 52/64
Through Week 52 (Trials 1 and 3) and Week 64 (Trial 2), no new adverse reactions were identified with ILUMYA use and the frequency of the adverse reactions was similar to that observed during the placebo-controlled period.
Psoriasis of the Scalp
The safety of ILUMYA was assessed in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 4) in 231 subjects with psoriasis of the scalp [
4.2Immunogenicity
As with all therapeutic proteins there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to tildrakizumab in the studies described below with the incidences of antibodies in other studies or to other products may be misleading.
Up to Week 64, approximately 6.5% of subjects treated with ILUMYA 100 mg developed antibodies to tildrakizumab. Of the subjects who developed antibodies to tildrakizumab, approximately 40% (2.5% of all subjects receiving ILUMYA) had antibodies that were classified as neutralizing. Development of neutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrations and reduced efficacy.
5OVERDOSAGE
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions, administer appropriate symptomatic treatment immediately, and contact Poison Control at 1-800-222-1222.
6DESCRIPTION
Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23).
Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and has an approximate molecular mass of 147 kilodaltons.
ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1/2-inch needle.
The syringe is fitted with a passive needle guard and a needle cover.
Each 1 mL single-dose prefilled syringe contains 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.
7CLINICAL STUDIES
Plaque Psoriasis
In two multicenter, randomized, double-blind, placebo-controlled trials (Trial 2 [NCT01722331] and Trial 3 [NCT01729754]), 926 subjects were treated with ILUMYA 100 mg (N=616) or placebo (N=310). Subjects had a Physician Global Assessment (PGA) score of ≥3 (moderate) on a 5-point scale of overall disease severity, Psoriasis Area and Severity Index (PASI) score ≥12, and a minimum body surface area (BSA) involvement of 10%. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded.
In both trials, subjects were randomized to either placebo or ILUMYA (100 mg at Week 0, Week 4, and every twelve weeks thereafter [Q12W]) up to 64 weeks.
Trials 2 and 3 assessed the changes from baseline to Week 12 in the two co-primary endpoints:
- PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score.
- PGA of 0 (“cleared”) or 1 (“minimal”), the proportion of subjects with a PGA of 0 or 1 and at least a 2-point improvement.
Other evaluated outcomes in Trials 2 and 3 included the proportion of subjects who achieved a reduction from baseline in PASI score of at least 90% (PASI 90) and a reduction of 100% in PASI score (PASI 100) at Week 12 and maintenance of efficacy up to Week 64.
In both trials, subjects in the ILUMYA 100 mg and placebo treatment groups were predominantly men (69%) and White (80%), with a mean age of 46 years. At baseline, these subjects had a median affected BSA of 27%, a median PASI score of 17.8, and approximately 33% had a PGA score of 4 (“marked”) or 5 (“severe”). Approximately 34% had received prior phototherapy, 39% had received prior conventional systemic therapy, and 18% had received prior biologic therapy for the treatment of psoriasis. Approximately 16% of subjects had a history of psoriatic arthritis.
Clinical Response at Week 12
The results of Trials 2 and 3 are presented in Table 2.
Examination of age, gender, race, and previous treatment with a biologic did not identify differences in response to ILUMYA among these subgroups at Week 12.
Maintenance of Response and Durability of Response
In Trial 2, subjects originally randomized to ILUMYA and who were responders at Week 28 (i.e., PASI 75) were re-randomized to an additional 36 weeks of either maintaining the same dose of ILUMYA Q12W (every twelve weeks) or placebo.
At Week 28, 229 (74%) subjects treated with ILUMYA 100 mg were PASI 75 responders. At Week 64, 84% of subjects who continued on ILUMYA 100 mg Q12W maintained PASI 75 compared to 22% of subjects who were re-randomized to placebo. In addition, for subjects who were re-randomized and also had a PGA score of 0 or 1 at Week 28, 69% of subjects who continued on ILUMYA 100 mg Q12W maintained this response (PGA 0 or 1) at Week 64 compared to 14% of subjects who were re-randomized to placebo.
For PASI 75 responders at Week 28 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to loss of PASI 75 was approximately 20 weeks.
In addition, for subjects who were re-randomized to placebo and also had a PGA score of 0 or 1 at Week 28, the median time to loss of PGA score of 0 or 1 was approximately 16 weeks.
Psoriasis of the Scalp
In a multicenter, randomized, double-blind, placebo-controlled trial (Trial 4 [NCT03897088]) 231 subjects with moderate to severe psoriasis of the scalp (IGA Scalp score of 3 or 4) were treated subcutaneously with ILUMYA 100 mg (n=117) or placebo (n=114) at Weeks 0 and 4. Of the 231 randomized subjects, 217 subjects completed Part 1 (Day 1 to Week 16). In Part 2 of the trial, subjects previously randomized to placebo were switched to ILUMYA 100 mg at Weeks 16, 20, 32, and 44, and those in the ILUMYA 100 mg arm continued to receive ILUMYA 100 mg at Weeks 16, 28, 40, and 52.
The trial population was 79% White, 8% Black or African American, 6% Asian, 3% Native Hawaiian or Other Pacific Islander, 2% American Indian or Alaska Native, and 2% Other; for ethnicity, 65% of subjects identified as Not Hispanic or Latino. The trial population was 60% male and the mean age was 45 years. At baseline, these subjects had a median affected scalp surface area of 50%, a median PASI score of 16.7, and IGA Scalp score of 3 (“moderate”) or 4 (“severe”) in 81% and 16%, respectively.
The primary endpoint was the proportion of subjects with IGA Scalp score of “clear” and “almost clear” with at least 2-point reduction from Baseline at Week 16.
Other evaluated outcomes included the proportion of subjects achieving a) Psoriasis Scalp Severity Index (PSSI) 90 (≥90% improvement from Baseline in PSSI) at Week 16; b) PSSI 90 at Week 12; and c) IGA Scalp score of “clear” or “almost clear” with at least 2-point reduction from Baseline at Week 12.
The efficacy results from Trial 4 are presented in Table 3.
Table 3: Efficacy Results for Primary and Secondary Endpoints in Subjects with Moderate to Severe Psoriasis of the Scalp in Trial 4 (mITT, NRI*)
8HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ILUMYA (tildrakizumab-asmn) Injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied as one single-dose prefilled syringe per carton that delivers 1 mL of a 100 mg/mL solution.
- NDC 47335-177-95
Each prefilled syringe is equipped with a passive needle guard and a needle cover.
Storage and Handling
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. ILUMYA can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard ILUMYA. Do not store ILUMYA above 25°C (77°F).
9PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).
Instruct patients and/or caregivers to read the Medication Guide before starting ILUMYA therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of ILUMYA.
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
Infections
Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection
Immunizations
Instruct patients to inform the healthcare practitioner that they are taking ILUMYA prior to a potential vaccination since the use of live vaccine is not recommended
Pregnancy
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ILUMYA during pregnancy [see
Manufactured by: Sun Pharmaceutical Industries Limited
Mumbai, Maharashtra India 400 063
U.S. License No. 2092
Distributed by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
ILUMYA is a registered trademark of Sun Pharmaceutical Industries Limited
© 2022 Sun Pharmaceutical Industries Limited
All rights reserved
Rev. NOV 2024
10009296-07
10Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: 08/2022
11Package/Label Display Panel
NDC 47335-177-95
Rx only
Rx only
ILUMYA®
tildrakizumab-asmn injection
tildrakizumab-asmn injection
100 mg/mL
For Subcutaneous Use Only
Dispense the enclosed Medication Guide to each patient.
Single-dose prefilled syringe.
Discard unused portion.
Dispense the enclosed Medication Guide to each patient.
Single-dose prefilled syringe.
Discard unused portion.
Sterile Solution - Contains No Preservative
Sun Pharmaceutical Industries, Inc.
