Tildrakizumab-Asmn
FDA Drug Information • Also known as: Ilumya
- Brand Names
- Ilumya
- Drug Class
- Interleukin-23 Antagonist [EPC]
- Route
- SUBCUTANEOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 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.
What Is Tildrakizumab-Asmn Used For?
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage and Administration
2 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
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS 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 100 mg (N=705) N (%) Placebo (N=355) 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 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 [ 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. 6.2 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies. 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....
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 )
Pregnancy and Breastfeeding
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 or who are exposed to ILUMYA during pregnancy. These patients should be encouraged to 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 Limited available data with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of adverse developmental 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 below]. 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...
Overdosage
10 OVERDOSAGE 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.
How Supplied
16 HOW 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).
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.