Ilaris® Oman BSS
Ilaris® Oman BSS
Drug Regulatory Affairs
ILARIS® (canakinumab)
150 mg/1 mL Solution for injection
Basic Succinct Statement (BSS)
Version 7.0
Effective CDS date: 17-Feb-2022
Safety Label Change (SLC)N/A – Local Safety: 2021-PSB/GLC-1235-l
Tracking number:
Document status:Final
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Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Important note: Before prescribing, consult full prescribing information.
Composition: Solution for injection, 150 mg/ml canakinumab.
Indication: ILARIS is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes
(CAPS) in adults and children aged 2 years and older, including: Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU), Muckle Wells Syndrome (MWS), Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous,
Articular Syndrome (CINCA).
Patient details must be entered into a CAPS registry specifically designated for ILARIS.
ILARIS is indicated for the treatment of patients with the tumour necrosis factor receptor-associated periodic syndrome (TRAPS). • ILARIS is indicated for the treatment of patients with the hyperimmunoglobulin D syndrome (HIDS) / mevalonate kinase deficiency (MKD). • ILARIS is indicated for the treatment of patients with familial Mediterranean fever (FMF) in whom conventional therapy is contraindicated, is not tolerated or does not provide an adequate response despite the highest tolerable dose being administered. • ILARIS is indicated for the treatment of Still syndrome including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids
Dosage and administration:: CAPS: Adults and children from the age of 2 years (with a body weight (BW) ≥15 kg): 150 mg for patients with a BW >40 kg and 2 mg/kg for patients with a BW ≥15 kg and ≤40 kg. This is administered every 8 weeks as a single dose via subcutaneous injection. If no satisfactory relief has been achieved within 7 days, a second administration of 150 mg or 2 mg/kg may be considered. If this leads to a full response, then subsequently an increased dosage of 300 mg or 4 mg/kg is administered every 8 weeks. If no satisfactory relief has been achieved within 7 days, a third administration of 300 mg or 4 mg/kg may be considered. If this leads to a full response, then subsequently an increased dosage of 600 mg or 8 mg/kg is administered every 8 weeks. • TRAPS, HIDS / MKD and FMF: Adults and children from the age of 2 years: 150 mg for patients with a BW >40 kg and 2 mg/kg for patients with a BW ≤40 kg. Administration is performed every 4 weeks as a single dose via subcutaneous injection. If no appropriate clinical response has been achieved, the dosage may be increased to 300 mg or 4 mg/kg every 4 weeks in patients with a BW ≤ 40 kg. • SJIA and AOSD: The recommended dosage for patients with a body weight ≥7.5 kg is 4 mg/kg (up to a maximum of 300 mg), administered every 4 weeks via subcutaneous injection. Concomitant medication and possible ILARIS dose reduction steps for SJIA were investigated.
Contraindication: Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions: Care is needed in patients with infections, a history of recurrent infections or underlying diseases (especially tuberculosis), which predispose them for infections. Treatment with ILARIS should not be continued or started in an active infection that requires medical treatment. Patients must be examined for a tuberculosis infection before treatment and also closely monitored for symptoms during and after treatment. There have been reports of hypersensitivity reactions, but not of anaphylactoid or anaphylactic reactions. The risk of severe hypersensitivity reactions cannot be ruled out. Live vaccines should not be administered at the same time as ILARIS. The simultaneous administration of ILARIS with TNF inhibitors is not recommended. ILARIS should not be started in patients with neutropenia. The neutrophil count should be determined before starting treatment and regularly thereafter. If a patient develops neutropenia, monitor closely and consider stopping treatment. Macrophage activation syndrome (MAS) (in SIJA patients) is a known, life-threatening disease, which can develop in patients with rheumatic symptoms, especially SJIA, and should be aggressively treated. Doctors should watch out for symptoms of an infection or a deterioration of SJIA, as these are known triggers of MAS. Based on the experience from clinical trials, ILARIS does not seem to increase the incidence of MAS in SJIA and AOSD patients, but no definitive statement can be made. There have been reports of malignant diseases in patients who have been treated with ILARIS. The risk of developing a malignant disease during treatment with ILARIS is unknown. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in rare cases. Patients should be hospitalized if necessary as the condition can be fatal and alternative treatment should be considered.
Pregnancy, lactation, females and males of reproductive potential: ILARIS should not be used in pregnant women unless clearly necessary. Administration of live vaccines to newborn infants exposed to canakinumab in utero is not recommended for 16 weeks following the mother's last dose of ILARIS before childbirth. ILARIS is not recommended during breast-feeding
Interactions: Live vaccines should not be administered simultaneously with ILARIS. The use of ILARIS with TNF inhibitors is not recommended. For CYP450 substrates with a narrow therapeutic range, monitor the efficacy or concentration of the active substance at the beginning of treatment with ILARIS and, if necessary, adjust the individual dosage.
Adverse Events: Possibly severe: Infections (e.g., infection of the upper respiratory tract, pneumonia, viral infection). Other: mild to moderate hypersensitivity reactions, nasopharyngitis, rhinitis, bronchitis, pharyngitis, tonsillitis, sinusitis, urinary tract infection, ear infection, gastroenteritis, vulvovaginal candidiasis, epigastric pain, reaction at the injection site, reduced neutrophil count, reduced platelet count, vomiting, drowsiness/dizziness.