Loading…
ILARIS is a brand name for Canakinumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ILARIS® (canakinumab) is an interleukin-1 beta (IL-1β) inhibitor indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes. Cryopyrin-Associated Periodic Syndromes (CAPS) ILARIS is indicated for the ongoing management of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and…
Verbatim from this product's HC label. Tap a section to expand.
Continued treatment with Ilaris in patients without clinical improvement should be reconsidered by the treating health professional. 1 Dosing Considerations Special populations: Renal impairment: No dose adjustment is required in patients with renal impairment.
However, clinical experience in such patients is limited. Hepatic impairment: Ilaris has not been studied in patients with hepatic impairment. Pediatric patients (<18 years of age): CAPS, TRAPS, HIDS/MKD, and FMF: Ilaris is not recommended for use in children below the age of 2 years.
SJIA:
The safety and efficacy of Ilaris in SJIA patients under 2 years of age and with a body weight < 9 kg have not been established. Geriatric patients (> 65 years of age): No dose adjustment is required in geriatric patients. However, clinical experience in such patients is limited.
2 Recommended Dose and Dosage Adjustment Dosage for CAPS The recommended starting dose of Ilaris for CAPS patients is: 150 mg with body weight >40 kg 2 mg/kg with body weight ≥15 kg and ≤40 kg If a satisfactory clinical response (resolution of rash and other generalized inflammatory symptoms) has not been achieved 7 days after the first dose, the dose can be individually adjusted in 150 mg or 2 mg/kg increments with a minimum of 1 week observation period for satisfactory treatment response between increases, to a maximum of 600 mg (body weight > 40 kg) or 8 mg/kg (body weight 15 – 40 kg).
If a full treatment response is subsequently achieved, the intensified dose should be maintained and Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 6 of 68 administered every 8 weeks. Adults and children ≥ 2 years of age ≥ 15 kg Discontinuation of drug should be considered if an unsatisfactory therapeutic effect persists.
Dosage for TRAPS, HIDS/MKD and FMF The recommended starting dose of Ilaris for TRAPS, HIDS/MKD and FMF patients is: 150 mg with body weight >40 kg 2 mg/kg with body weight ≤40 kg Satisfactory clinical response after 7 days? Satisfactory clinical response after 7 days?
150 mg or 2 mg/kg Yes No Maintenance dose: 150 mg or 2 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered Maintenance dose: 300 mg or 4 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks Yes No Satisfactory clinical response after 7 days?
, Serious Infections). 4 DOSAGE AND ADMINISTRATION Continued treatment with Ilaris in patients without clinical improvement should be reconsidered by the treating health professional. 1 Dosing Considerations Special populations: Renal impairment: No dose adjustment is required in patients with renal impairment.
However, clinical experience in such patients is limited. Hepatic impairment: Ilaris has not been studied in patients with hepatic impairment. Pediatric patients (<18 years of age): CAPS, TRAPS, HIDS/MKD, and FMF: Ilaris is not recommended for use in children below the age of 2 years.
SJIA:
The safety and efficacy of Ilaris in SJIA patients under 2 years of age and with a body weight < 9 kg have not been established. Geriatric patients (> 65 years of age): No dose adjustment is required in geriatric patients. However, clinical experience in such patients is limited.
2 Recommended Dose and Dosage Adjustment Dosage for CAPS The recommended starting dose of Ilaris for CAPS patients is: 150 mg with body weight >40 kg 2 mg/kg with body weight ≥15 kg and ≤40 kg If a satisfactory clinical response (resolution of rash and other generalized inflammatory symptoms) has not been achieved 7 days after the first dose, the dose can be individually adjusted in 150 mg or 2 mg/kg increments with a minimum of 1 week observation period for satisfactory treatment response between increases, to a maximum of 600 mg (body weight > 40 kg) or 8 mg/kg (body weight 15 – 40 kg).
If a full treatment response is subsequently achieved, the intensified dose should be maintained and Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 6 of 68 administered every 8 weeks. Adults and children ≥ 2 years of age ≥ 15 kg Discontinuation of drug should be considered if an unsatisfactory therapeutic effect persists.
General Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous injection 150 mg / 1 mL canakinumab solution for injection Mannitol, L-histidine, L-histidine HCl monohydrate, polysorbate 80, water for injection.
No preservatives are present.
Product Monograph Master Template Template Date:
September 2020 ILARIS® (canakinumab) Page 9 of 68 Serious infections Ilaris is associated with an increased incidence of serious infections. Therefore patients should be monitored carefully for signs and symptoms of infections during and after treatment with Ilaris.
Health professionals should exercise caution when administering Ilaris to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Treatment with Ilaris should not be initiated or continued in patients with active infection requiring medical intervention.
4% of the 4-11 year old age group vs. 7% in adult CAPS patients. The severe phenotype and disease severity in young children may have played a role in this difference. Concomitant use of Ilaris with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections (see 9 DRUG INTERACTIONS).
Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during Ilaris treatment however no cases have been confirmed to be opportunistic in CAPS patients.
A causal relationship of Ilaris to these events cannot be excluded. Tuberculosis screening Drugs that affect the immune system by blocking TNF have been associated with an increased risk of reactivation of latent tuberculosis (TB). It is possible that taking drugs such as Ilaris that block IL-1 increases the risk of TB or other atypical or opportunistic infections.
Patients who are hypersensitive to canakinumab or to any ingredient in the formulation of Ilaris or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. A risk for hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded.
Patients who have active, severe infections (see 8 ADVERSE REACTIONS, Serious Infections).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Additional dose of 150 mg or 2 mg/kg can be considered Maintenance dose: 450 mg or 6 mg/kg every 8 weeks Yes No Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 7 of 68 This is administered every four weeks as a single dose via subcutaneous injection.
If a satisfactory clinical response has not been achieved 7 days after the first dose, a second dose of Ilaris at 150 mg or 2 mg/kg can be administered. If a full treatment response (no or minimal disease activity) is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 4 weeks should be maintained.
Dosage for Still’s disease (SJIA and AOSD) The recommended dose of Ilaris for patients with Still’s disease with a body weight >9 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection. 4 Administration Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS, TRAPS, HIDS/MKD, FMF & / or Still’s disease (SJIA and AOSD).
After proper training in injection technique, patients or caregivers may inject Ilaris if their health professional determines that it is appropriate and with medical follow-up as necessary. Ilaris 150 mg/1 mL solution for injection is supplied in a single-use vial for individual use.
Any unused product or waste material should be disposed of in accordance with local requirements. Prior to the injection, the vial containing the solution for injection should be left unopened to allow the content to reach room temperature.
The vial must not be exposed to heat. The solution should be practically free of visible particles and clear to opalescent. The solution should be colorless or may have a slight brownish-yellow tint. The solution should not be used if particles are present.
5” needle. Once Satisfactory clinical response after 7 days? Yes No Maintenance dose: 150 mg or 2 mg/kg every 4 weeks Additional dose of 150 mg or 2 mg/kg can be considered If full treatment response is achieved, maintenance dose: 300 mg or 4 mg/kg every 4 weeks 150 mg or 2 mg/kg Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 8 of 68 the vial is pierced, use the solution immediately.
Injection into scar-tissue should be avoided as this may result in insufficient exposure to Ilaris.
Dosage for TRAPS, HIDS/MKD and FMF The recommended starting dose of Ilaris for TRAPS, HIDS/MKD and FMF patients is: 150 mg with body weight >40 kg 2 mg/kg with body weight ≤40 kg Satisfactory clinical response after 7 days? Satisfactory clinical response after 7 days?
150 mg or 2 mg/kg Yes No Maintenance dose: 150 mg or 2 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered Maintenance dose: 300 mg or 4 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks Yes No Satisfactory clinical response after 7 days?
Additional dose of 150 mg or 2 mg/kg can be considered Maintenance dose: 450 mg or 6 mg/kg every 8 weeks Yes No Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 7 of 68 This is administered every four weeks as a single dose via subcutaneous injection.
If a satisfactory clinical response has not been achieved 7 days after the first dose, a second dose of Ilaris at 150 mg or 2 mg/kg can be administered. If a full treatment response (no or minimal disease activity) is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 4 weeks should be maintained.
Dosage for Still’s disease (SJIA and AOSD) The recommended dose of Ilaris for patients with Still’s disease with a body weight >9 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection. 4 Administration Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS, TRAPS, HIDS/MKD, FMF & / or Still’s disease (SJIA and AOSD).
After proper training in injection technique, patients or caregivers may inject Ilaris if their health professional determines that it is appropriate and with medical follow-up as necessary. Ilaris 150 mg/1 mL solution for injection is supplied in a single-use vial for individual use.
Any unused product or waste material should be disposed of in accordance with local requirements. Prior to the injection, the vial containing the solution for injection should be left unopened to allow the content to reach room temperature.
The vial must not be exposed to heat. The solution should be practically free of visible particles and clear to opalescent. The solution should be colorless or may have a slight brownish-yellow tint. The solution should not be used if particles are present.
5” needle. Once Satisfactory clinical response after 7 days? Yes No Maintenance dose: 150 mg or 2 mg/kg every 4 weeks Additional dose of 150 mg or 2 mg/kg can be considered If full treatment response is achieved, maintenance dose: 300 mg or 4 mg/kg every 4 weeks 150 mg or 2 mg/kg Product Monograph Master Template Template Date: September 2020 ILARIS® (canakinumab) Page 8 of 68 the vial is pierced, use the solution immediately.
Injection into scar-tissue should be avoided as this may result in insufficient exposure to Ilaris. 5 OVERDOSAGE There is limited experience with overdosage. In early clinical trials, patients and healthy volunteers received doses as high as 10mg/kg administered intravenously or subcutaneously without evidence of acute toxicity.
In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted as necessary. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table – Dosage […]
Prior to initiating immunomodulatory therapies, including Ilaris, patients should be tested for latent tuberculosis infection. Ilaris has not been studied in patients with a positive tuberculosis screen, and the safety of Ilaris in individuals with latent tuberculosis infection is unknown.
Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with Ilaris. In approximately 12% of CAPS patients tested with a PPD skin test in clinical trials, follow-up testing yielded a positive test result while treated with Ilaris without clinical evidence of a latent or active tuberculosis infection.
Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection. Particularly in adult patients, this evaluation should include a detailed medical history and appropriate screening tests.
Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with Ilaris. In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection should be considered.
Cardiovascular In clinical trials for CAPS, notable changes from baseline in systolic and diastolic blood pressure values were more frequently seen in patients in the canakinumab group than in patients in the placebo group. Blood pressure should be monitored in patients on Ilaris treatment (see