Ilumya (tildrakizumab-asmn): Uses, Dosage, Side Effects & Warnings

Q: Who makes Ilumya?

Ilumya is listed by 1 labeler in the FDA NDC directory, including Sun Pharmaceutical Industries, Inc..

Uses

1 INDICATIONS AND USAGE ILUMYA ® is indicated for the treatment of moderate-to-severe plaque psoriasis in aduts who are candidates for systemic therapy or phototherapy. ILUMYA is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1 )

Dosage and administration

See the full prescribing information for recommended evaluations and immunizations prior to treatment. ( 2.1 ) Administer by subcutaneous injection. ( 2.2 ) Recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. ( 2.2 ) 2.1 Recommended Evaluation and Immunization Prior to Treatment Initiation Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA [see Warnings and Precautions ( 5.3 )] . Consider completion of all age appropriate immunizations according to current immunization guidelines. [see Warnings and Precautions ( 5.4 )] 2.2 Dosage ILUMYA is administered by subcutaneous injection. The recommended dosage is 100 mg at Weeks 0, 4, and every 12 weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn. 2.3 Important Administration Instructions ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled interval. 2.4 Preparation and Administration of ILUMYA Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes. Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject. Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them. Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Also, do not inject into scars, stretch marks, or blood vessels. While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard. Inject ILUMYA subcutaneously as recommended [see Dosage and Administration (2.3) ] . Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given. Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safety lock will draw the needle inside the needle guard. Discard any unused portion. Dispose of used syringe. image-1 image-2 image-3

Dosage 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. Injection: 100 mg/mL solution in a single-dose prefilled syringe. ( 3 )

Contraindications

4 CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients [see Warnings and Precautions (5.1) ]. Serious hypersensitivity reaction to tildrakizumab or to any of the excipients. ( 4 )

Warnings and precautions

Hypersensitivity: If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. ( 5.1 ) Infections : ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, consider discontinuing ILUMYA until the infection resolves. ( 5.2 ) Pretreatment Evaluation for Tuberculosis (TB): Evaluate for TB prior to initiating treatment. ( 5.3 ) Immunizations : Avoid use of live vaccines. ( 5.4 ) 5.1 Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy [see Adverse Reactions (6.1) ]. 5.2 Infections ILUMYA may increase the risk of infection. Although infections were more common in the ILUMYA group (23%), the difference in frequency of infections between the ILUMYA group and the placebo group (22%) was less than 1% during the placebo-controlled period. However, subjects with active infections or a history of recurrent infections were not included in clinical trials. Upper respiratory infections occurred more frequently in the ILUMYA group than in the placebo group [see Adverse Reactions (6.1) ] . The rates of serious infections for the ILUMYA group and the placebo group were ≤0.3%. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves [see Adverse Reactions (6.1) ] . 5.3 Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Initiate treatment of latent TB prior to administering ILUMYA. In clinical trials, of 55 subjects with latent TB who were concurrently treated with ILUMYA and appropriate TB prophylaxis, no subjects developed active TB (during the mean follow-up of 56.5 weeks). One other subject developed TB while receiving ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer ILUMYA to patients with active TB infection. 5.4 Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA. No data are available on the response to live or inactive vaccines.

Side effects

The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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]) [see Clinical Studies (14) ] . 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. Table 1: Adverse Reactions Occurring in ≥1% of Subjects in the ILUMYA Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Trials 1, 2, and 3 * Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, and pharyngitis. † Injection site reactions include injection site urticaria, pruritus, pain, reaction, erythema, inflammation, edema, swelling, bruising, hematoma, and hemorrhage. Adverse Reaction ILUMYA Placebo 100 mg (N=705) (N=355) N (%) N (%) Upper respiratory infections* 98 (14) 41 (12) Injection site reactions † 24 (3) 7 (2) Diarrhea 13 (2) 5 (1) 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 260 The safety profile of ILUMYA through Week 260 of the open-label extension periods of Trial 2 and Trial 3 was consistent with the safety profile observed during the double-blind periods . 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 [ see Clinical Studies (14) ]. No new safety signals were identified through follow-up to Week 72. Psoriasis of the Nail The safety of ILUMYA was assessed in a multicenter, randomized, double-blind, placebo-controlled trial (Trial 5) in 99 subjects with psoriasis of the nail [ see Clinical Studies (14) ]. No new safety signals were identified through Week 28.

Use in specific populations

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with ILUMYA during pregnancy. These patients can enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn. Risk Summary Available data from clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). 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, an increase in neonatal death was observed at 59 times the MRHD (see Data). The clinical significance of this nonclinical finding is unknown. 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed in utero . The potential clinical impact of tildrakizumab exposure in infants exposed in utero should be considered. Data Animal Data 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 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). 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 (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD 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 of age. 8.2 Lactation Risk Summary 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 [ see Data ] . 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. Data Animal Data Tildrakizumab was detected in breast milk of monkeys in the pre- and postnatal developmental study described in 8.1. The mean tildrakizumab concentrations in milk were approximately 0.09 – 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 been established. 8.5 Geriatric Use A total of 1083 subjects were exposed to ILUMYA 100 mg during Phase 2 and 3 trials. A total of 92 subjects were 65 years or older, and 17 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they responded differently from younger subjects [see Clinical Pharmacology (12.3) ] .

Pregnancy

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with ILUMYA during pregnancy. These patients can enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn. Risk Summary Available data from clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). 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, an increase in neonatal death was observed at 59 times the MRHD (see Data). The clinical significance of this nonclinical finding is unknown. 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed in utero . The potential clinical impact of tildrakizumab exposure in infants exposed in utero should be considered. Data Animal Data 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 (22 days from parturition). No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). 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 (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD 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 of age.

Pediatric use

8.4 Pediatric Use Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not been established.

Geriatric use

8.5 Geriatric Use A total of 1083 subjects were exposed to ILUMYA 100 mg during Phase 2 and 3 trials. A total of 92 subjects were 65 years or older, and 17 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they responded differently from younger subjects [see Clinical Pharmacology (12.3) ] .

Description

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.

Mechanism of action

12.1 Mechanism of Action Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.

How supplied

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).

Patient 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 [see Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.4) ]. Pregnancy Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ILUMYA during pregnancy [ see Use in Specific Populations, Pregnancy (8.1) ]. Manufactured by: Sun Pharmaceutical Industries Limited Mumbai, Maharashtra India 400 063 U.S. License No. 2092 U.S. Patent No. 8,404,813; 8,293,883 and 9,809,648 Tildrakizumab-asmn (active ingred.) Product of South Korea. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 ILUMYA is a registered trademark of Sun Pharmaceutical Industries Limited ©2026 Sun Pharmaceutical Industries Limited All rights reserved Rev. 07 2026 10009296-09

Active ingredients

Tildrakizumab in 1 product

Ilumya NDC products (1)

NDC	Strength & form	Labeler	Type
47335-177	Tildrakizumab 100 mg/mL Injection, Solution	Sun Pharmaceutical Industries, Inc.	BLA

Frequently asked questions

What is Ilumya used for?

1 INDICATIONS AND USAGE ILUMYA ® is indicated for the treatment of moderate-to-severe plaque psoriasis in aduts who are candidates for systemic therapy or phototherapy. ILUMYA is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1 )

What are the side effects of Ilumya?

The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun… See the full label for the complete list.

Who makes Ilumya?

Ilumya is listed by 1 labeler in the FDA NDC directory, including Sun Pharmaceutical Industries, Inc..