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ILUMYA is a brand name for Tildrakizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ilumya® (tildrakizumab injection) is indicated for the treatment of adult patients with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Ilumya (tildrakizumab injection) should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of plaque psoriasis and familiar with the Ilumya efficacy and safety profile.
Patients may self-inject Ilumya if a healthcare professional determines that it is appropriate. 2 Recommended Dose and Dosage Adjustment The recommended dose of Ilumya is 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use. Geriatrics (≥65 years of age) Safety and efficacy data in patients aged 65 years and older are limited. No dose adjustment is required. Duration of treatment Continuation of Ilumya should be reconsidered if a patient has not responded within 28 weeks of treatment onset.
4 Administration Ilumya is administered by subcutaneous injection. Ilumya can be injected by a healthcare professional or, after proper training in subcutaneous injection technique, patients may self- inject Ilumya if a healthcare professional determines that it is appropriate.
However, the physician should ensure appropriate follow-up of patients. Full instructions for use are provided in the package leaflet. Ilumya® (tildrakizumab injection) Product Monograph Page 5 of 36 Injections should not be administered into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
Ilumya does not contain any preservatives. Therefore, discard any unused product remaining in the pre-filled syringes or pre-filled pens (see 11 STORAGE, STABILITY AND DISPOSAL). The full amount of Ilumya 100 mg pre-filled syringe or pre-filled pen should be injected for each dose according to the directions provided in the respective “Instructions for Use” document.
5 Missed Dose Patients who miss a dose of Ilumya should be advised to inject this missed dose as soon as they become aware of it, and then follow with their next scheduled dose.
2%). 0%). 6%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful for identifying and for approximating rates of adverse drug reactions in real-world use. The safety profile of Ilumya in patients with moderate to severe plaque psoriasis is based on pooled data from two phase 3 trials (reSURFACE 1 and reSURFACE 2).
A total of 1255 plaque psoriasis subjects were exposed to Ilumya 100 mg or 200 mg in these 2 trials (see 14 CLINICAL TRIALS). Of these, 642 subjects were exposed for at least 52 weeks, 587 for at least 78 weeks, 469 for at least 104 weeks, and 271 for at least 256 weeks to Ilumya 100 mg.
Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Ilumya 100 mg group than the placebo group during the 12-week, placebo- controlled period of the pooled clinical trials, reSURFACE 1 and reSURFACE 2.
1. 9% in subjects Ilumya® (tildrakizumab injection) Product Monograph Page 9 of 36 treated with Ilumya 100 mg. 3% of subjects treated with placebo. 443 subjects per patient-year of exposure. 009 subjects treated with Ilumya 100 mg per patient-year of exposure.
7% of subjects treated with Ilumya 100 mg. 009 subjects treated with Ilumya 100 mg per patient-years of exposure) occurred in subjects treated in plaque psoriasis clinical trials with Ilumya 100 mg for up to 64 weeks (see 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity).
In the open-label, uncontrolled, extension period of the two Phase 3 clinical trials, no cases of drug-related anaphylaxis were reported. Two cases of drug-related hypersensitivity reactions (urticaria), were reported in subjects treated with 100 mg.
Infections Ilumya is an immunomodulatory agent which has the potential to increase the risk of infection. In clinical trials, there was no increased risk of infection in subjects treated with Ilumya relative to placebo; however, patients with active infections or a history of recurrent infections were not included in clinical trials.
Ilumya should not be given to patients with any clinically important Route of Administration Dosage Form / Strength/Composition Non-Medicinal Ingredients Subcutaneous (SC) injection Sterile solution in a single- dose pre-filled syringe or pre-filled pen (100 mg / 1 mL) L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, water for injection Ilumya® (tildrakizumab injection) Product Monograph Page 6 of 36 active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, the risks and benefits should be considered prior to prescribing Ilumya. Patients should be instructed to seek medical advice if signs or symptoms of a clinically important infection occur.
2 Clinical Trial Adverse Reactions). Pre-treatment Evaluation for Tuberculosis Ilumya must not be given to patients with active tuberculosis (TB). Evaluate patients for TB infection according to the Canadian TB Standards prior to initiating treatment with Ilumya.
Initiate treatment of latent TB prior to initiating treatment with Ilumya. 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.
Patients receiving Ilumya should be monitored closely for signs and symptoms of active TB during and after treatment. Immune Hypersensitivity Non-serious cases of urticaria occurred in Ilumya treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, administration of Ilumya should be discontinued immediately and appropriate therapy initiated.
• Ilumya (tildrakizumab injection) is contraindicated in patients who are hypersensitive to tildrakizumab or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Immunogenicity As with all therapeutic proteins there is the potential for immunogenicity with Ilumya. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of incidence of antibodies between products by different tests may be misleading.
3% (51/615) of subjects developed antibodies to tildrakizumab. Of the subjects who developed anti-drug antibodies, 37% (19/51, or 3% of all subjects receiving Ilumya 100 mg) had neutralizing antibodies. Presence of neutralizing antibodies was associated with lower tildrakizumab concentrations and reduced efficacy.
Adverse Reactions through Weeks 52 and 64 and the extension period Through Week 52 (Phase 2b and reSURFACE 2) and Week 64 (reSURFACE 1), the types and the frequency of the adverse reactions in the Ilumya-treated patients were similar to that observed during the first 12 weeks of treatment.
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As with all therapeutic proteins including Ilumya, there is a potential for anaphylaxis. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue the administration of Ilumya and initiate appropriate medical treatment.
Inform patients/caregivers of the signs and symptoms of anaphylaxis and hypersensitivity reactions, and instruct them to seek immediate medical care if signs and symptoms occur. Vaccinations Prior to initiating therapy with Ilumya, consider completion of appropriate immunizations according to current immunization guidelines.
Patients treated with Ilumya should not receive live vaccines. No data are available on the response to live or inactive vaccines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Ilumya.
Sexual Health Fertility The effect of Ilumya on human fertility has not been evaluated. In addition, no dedicated fertility studies have been conducted in animals. 1 Pregnant Women The use of Ilumya in pregnant women has not been studied.
The effect of Ilumya on human pregnancy is unknown. Human IgG1 is known to cross the placental barrier; therefore, tildrakizumab may be transferred from the mother to the fetus. Ilumya® (tildrakizumab injection) Product Monograph Page 7 of 36 In two developmental studies conducted with pregnant cynomolgus monkeys, tildrakizumab was shown to distribute across the placental barrier as serum concentrations were quantifiable in fetal and neonatal monkeys.
In a pre- and postnatal development study conducted in pregnant cynomolgus monkeys, in utero exposure to tildrakizumab from a maternal subcutaneous dose of 100 mg/kg resulted in incidences of neonatal deaths due to infection (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Animal studies are not always predictive of human response; therefore, it is unknown whether Ilumya can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should use adequate contraception while using Ilumya and for at least 4 months after the last Ilumya dose.
2 Breast-feeding There are no data on the presence of tildrakizumab in human milk, the effects on the breast fed infant, or the effects on human milk production. Because human immunoglobulin G (IgG) is secreted into human milk, precaution should be exercised.
In a pre- and postnatal development study, tildrakizumab was detected at low levels in the breast milk of monkeys dosed with tildrakizumab from gestation day 50 to parturition (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
A decision should be made whether to discontinue breast-feeding or to discontinue Ilumya taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2%) were 75 years or older. The limited safety and efficacy data available from patients aged 65 years and older do not suggest that a dosage adjustment is required in these patients.