Periodic syndromes dependent on cryopiryna. The drug is indicated for use in adults, adolescents and children from 2 years of age or older with a body weight of 7.5 kg or more in the treatment of periodic syndromes dependent on cryopiryna (CAPS), including: Muckle-Wells syndrome (MWS) ; Neonatal Inflammatory Multidrug Disease (NOMID syndrome) / Chronic Infantile Neurology and Skin-joint Syndrome (CINCA); an acute form of the Family Cold Urticaria (FCAS) / Family Cold Nettle (FCU) with symptoms other than urticar-induced skin rash caused by cold.Systemic juvenile idiopathic arthritis (SJIA). The drug is indicated for the treatment of the active systemic form of juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older who have not sufficiently responded to prior NSAID and systemic corticosteroids. The preparation may be given as monotherapy or in combination with methotrexate.Gouty arthritis. The drug is indicated for use in the symptomatic treatment of adult patients with frequent gonarthritis (at least 3 attacks in the last 12 months) who have contraindications for the use of NSAIDs and colchicine, or whose drug is not tolerated, or they do not provide a sufficient response to treatment, and in which repeated doses of corticosteroids are not appropriate.
Composition:
1 vial contains 150 canakinumab. After reconstitution, 1 ml of solution contains 150 mg of canakinumab.
Action:
Contraindications:
Hypersensitivity to canakinumab or to any of the excipients. Active, severe infections.
Precautions:
Pregnancy and lactation:
Pregnant women or women who plan to become pregnant may be treated with the preparation only after thorough assessment of the benefits and risks of treatment. Women should use effective contraception during treatment with the preparation and up to 3 months after the last dose. The decision to breastfeed when taking the preparation should only be made after thorough assessment of the benefits and risks of treatment.
Side effects:
CAPS Very common: inflammation of the nose and throat, reactions at the site of administration. Common: urinary tract infection, upper respiratory tract infection, viral infection, dizziness. In patients with CAPS, the mean values of hemoglobin increased, while the mean values of white blood cells, neutrophils and platelets decreased, rarely elevated transaminases with asymptomatic and mild elevations of bilirubin in plasma were observed. Infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were reported more often in the 600 mg or 8 mg / kg group. than in groups taking other doses.SJIA Very common: pneumonia, gastroenteritis, urinary tract infection, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, inflammation of the nose and throat, upper respiratory tract infection, epigastric pain, injection site reactions, pain joints, decreased renal clearance of creatinine, proteinuria, leukopenia. Common: muscular-bone pain, neutropenia. A transient decrease in the number of white blood cells to ≤0.8 x DGN (lower limit of normal), transient decrease in absolute neutrophil counts to <1 x 10 was observed in patients with SJIA.9/ l, transient decrease in platelet count (Gouty arthritis Very common: pneumonia, bronchitis, gastroenteritis, urinary tract infection, influenza, cellulitis, sinusitis, otitis, pharyngitis, inflammation of the nose and throat, upper respiratory tract infection. Common: dizziness, injection site reactions, back pain, fatigue / weakness. Uncommon: gastro-oesophageal reflux.In gouty arthritis patients, a reduced white blood cell count ≤0.8 x DGN was reported in 6.7% of patients treated with canakinumab compared with 1.4% of patients treated with triamcinolone acetonide. Reduction of the absolute neutrophil count to <1 x 109/ l was reported in 2% of patients in comparative studies. Single cases of reduction of the absolute neutrophil count to <0.5 x 10 were observed9/ L. A higher incidence of mild ( 75 x 10) has been reported9/ l) and a transient decrease in platelet counts when the preparation was taken in the control group receiving active treatment (12.7%) compared with the reference group (7.7%). Transient increases in uric acid and ALT and AST may occur. An average increase in triglyceride concentration by +33.5 mg / dl was observed in the group of patients treated with the preparation as compared to a slight decrease in triglycerides concentration by -3.1 mg / dl in the group of patients treated with triamcinolone acetonide. The incidence of triglyceride elevation> 5x upper limit of normal (ULN) was 2.4% in the canakinumab group and 0.7% in the triamcinolone acetonide group. Hypersensitivity reactions and opportunistic infections have been reported in patients treated with the preparation. There were no clinically significant differences in the safety and tolerability profile of the preparation in children and adolescents compared to the entire population of CAPS patients, including the overall incidence and severity of infections. In the case of infections, the most frequently observed event was infection of the upper respiratory tract.
Dosage:
Subcutaneously. In the case of CAPS and SJIA, treatment should be initiated and supervised by a specialist experienced in the diagnosis and treatment of the disease. In the case of gouty arthritis, it is necessary for the doctor to have experience in the use of biological medicinal products, and canakinumab should be administered by a medical professional. If the patient or his carers are trained in the proper injection technique, the doctor may decide to inject the preparation by the patient himself. Audit visits may be necessary.CAPS Adults, adolescents and children ≥4 years old. The recommended initial dose is: in patients with a > 40 kg - 150 mg; about mc. ≥15 kg and ≤40 kg - 2 mg / kg; in patients with mc. ≥ 7.5 kg and <15 kg - 4 mg / kg Children aged 2 to <4 years old. ≥ 7.5 kg: 4 mg / kg The dose is given every 8 weeks as a single dose by subcutaneous injection. For patients starting 150 mg or 2 mg / kg when 7 days after the start of treatment no satisfactory clinical response (disappearance of rash and other generalized symptoms of inflammation), a second 150 mg or 2 mg dose may be considered. / kg body If a full response is achieved in this way, a higher dose regimen should be used: 300 mg or 4 mg / kg. every 8 weeks. If a satisfactory clinical response to treatment is not achieved within 7 days of administration of this increased dose, a dose of 300 mg or 4 mg / kg may be considered. If a full response is obtained after this dose, a higher dose regimen of 600 mg or 8 mg / kg should be considered. administered every 8 weeks, based on individual clinical evaluation. If a satisfactory clinical response is not obtained in patients receiving a starting dose of 4 mg / kg within 7 days of starting treatment, a second dose of 4 mg / kg may be considered. If a full response is obtained after this dose, a higher dose regimen of 8 mg / kg should be considered. every 8 weeks, based on individual clinical evaluation. Clinical data for administration at intervals of less than 4 weeks or doses above 600 mg or 8 mg / kg they are limited.SJIA The recommended dose in patients with ≥ 7.5 kg is 4 mg / kg. (up to 300 mg), given every 4 weeks by subcutaneous injection. Continuation of treatment in patients without clinical improvement should be reconsidered by the attending physician.Gouty arthritis. The treatment of hyperuricaemia with agents reducing uric acid should be implemented and optimized. Kanakinumab should be used for the immediate treatment of gouty arthritis seizures. Adults: 150 mg in a single subcutaneous injection during a seizure.For the best therapeutic effect, the preparation should be administered as soon as possible after the onset of gouty arthritis. Patients who have not responded to treatment after the first dose should not be given the medicine again. Patients who have responded to treatment and require re-administration should wait at least 12 weeks before the Next dose. No dosage adjustment is required in elderly patients or patients with renal impairment. However, clinical experience in patients with impaired renal function is limited. No studies have been performed in patients with hepatic impairment.