Ilumya Drug Information

Generic name: TILDRAKIZUMAB-ASMN

Interleukin-23 Antagonist [EPC]

Save on Ilumya at your pharmacy Compare prices near you and start saving today—no enrollment required.

Uses of Ilumya

ILUMYA ® is indicated for the treatment of moderate-to-severe plaque psoriasis in aduts who are candidates for systemic therapy or phototherapy.

Dosage & Administration of Ilumya

Dosage ILUMYA is administered by subcutaneous injection

Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

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.

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.

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

Side Effects of Ilumya

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. 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. 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. No new safety signals were identified through Week 28.

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)

Warnings & Cautions for Ilumya

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.

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.

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.

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.

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.

Pregnancy Safety for Ilumya

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 of Ilumya

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

Contraindications for Ilumya

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

Clinical Studies of Ilumya

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. 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 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.

In Part 2 of the trial, subjects previously randomized to placebo were switched to ILUMYA 100 mg at Weeks and those in the ILUMYA 100 mg arm continued to receive ILUMYA 100 mg at Weeks The trial population was 60% male and the mean age was 45 years. 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 trial population was 71% male and the mean age was 46 years. At baseline, these subjects had a median Modified Nail Psoriasis Severity Index (mNAPSI) score of 34 and a median PASI score of 16. The primary endpoint was the proportion of subjects who achieved at least a 75% improvement from baseline in total mNAPSI at Week 28.

The efficacy results from 13 2

Table 2: Efficacy Results at Week 12 in Adults with Moderate-to-Severe Plaque Psoriasis in Trials 2 and 3 (NRI*)
NRI = Non-Responder Imputation Co-Primary Endpoints PGA score of 0 (“cleared”) or 1 (“minimal”)
	Trial 2 ( NCT01722331)		Trial 3 ( NCT01729754)
	ILUMYA 100 mg (N=309) n (%)	Placebo (N=154) n (%)	ILUMYA 100 mg (N=307) n (%)	Placebo (N=156) n (%)
PGA of 0 or 1,	179 (58)	11 (7)	168 (55)	7 (4)
PASI 75	197 (64)	9 (6)	188 (61)	9 (6)
PASI 90	107 (35)	4 (3)	119 (39)	2 (1)
PASI 100	43 (14)	2 (1)	38 (12)	0 (0)

Table 3: Efficacy Results for Primary and Secondary Endpoints in Adults with Moderate-to-Severe Psoriasis of the Scalp in Trial 4 (mITT, NRI*)
Note: IGA = Investigator Global Assessment. PSSI = psoriasis scalp severity index. NRI = Non-responder imputation; mITT = modified Intent-to-treat, all randomized subjects, excluding subjects enrolled early in the trial evaluated under a different IGA Scalp scale.
	Trial 4 (NCT03897088)
	ILUMYA 100 mg (N=89) n (%)	Placebo (N=82) n (%)
Primary Endpoint
IGA Scalp Response Rate for score 0 or 1 (clear or almost clear) at Week 16 with at least 2-point reduction from baseline score	44 (49)	6 (7)
Secondary Endpoints
PSSI 90 Response Rate at Week 16	54 (61)	4 (5)
IGA Scalp Response Rate for score 0 or 1 (clear or almost clear) at Week 12 with at least 2-point reduction from baseline score	41 (46)	4 (5)
PSSI 90 Response Rate at Week 12	43 (48)	2 (2)

TABLE 4: Efficacy Results for the Modified Nail Psoriasis Severity Index in Adults with Moderate to Severe Psoriasis of the Nail in Trial 5 (ITT, NRI*)
ITT = Intent to Treat. mNAPSI = modified Nail Psoriasis Severity Index NRI = Non-responder Imputation
	Trial 5
	ILUMYA 100mg N=51 n (%)	Placebo N=48 n (%)

Proportion of subjects who achieve at least a 75% improvement from baseline in total mNAPSI at Week 28	13 (26)	2 (4)

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

Ready to save on Ilumya?

Compare prescription prices at over 70,000 pharmacies and start saving today—no enrollment required.

Compare Ilumya Prices