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Rilonacept Regeneron (Previously Arcalyst) is a brand name for Rilonacept. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS. After proper training in the correct injection technique, patients may self-inject Rilonacept Regeneron if their physician determines that it is appropriate and with medical follow-up as necessary.
Posology Adults Treatment in adults should be initiated with a loading dose of 320 mg. Dosing should be continued with a once-weekly injection of 160 mg. Rilonacept Regeneron should not be given more often than once weekly. 4 mg/kg, up to a maximum of 320 mg.
2 mg/kg, up to a maximum of 160 mg (see Table 1). Dosing in children must be adjusted as the child grows. The patient or care giver should be advised to speak to the treating physician before adjusting the dose. The experience in children is limited.
In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months. Medicinal product no longer authorised3 Paediatric population (up to 12 years old) No data are available on the use of Rilonacept Regeneron in children with CAPS under 12 years of age, therefore it is not recommended in this paediatric age group.
Elderly (65 years old or older) Available data indicate that dose modification is not required based on advanced age. 1). Renal impairment No dose adjustment is required in patients with mild, moderate, or severe renal impairment, or end stage renal disease.
However, clinical experience in such patients is limited. Hepatic impairment Rilonacept Regeneron has not been studied in patients with hepatic impairment. Method of administration Rilonacept Regeneron is for subcutaneous use only. It is not intended for intravenous or intramuscular use.
6. The adult loading dose should be administered as two 2 ml subcutaneous injections (320 mg of rilonacept in total) given on the same day at different sites. The subsequent doses are administered as a 2 ml (160 mg of rilonacept) subcutaneous injection once a week.
For paediatric patients, the dose is delivered as one or two (for loading dose) subcutaneous injections with a maximum single-injection volume of 2 ml. For convenience, the corresponding dose volume for weekly injection in paediatric patients is presented in Table 1 below.
9 or greater 2 Medicinal product no longer authorised4
The majority of the related adverse events in the clinical trials were classified as injection site reactions, experienced by approximately 50% of the patients in the Phase 3 study. Reported ISRs were generally mild to moderate in severity.
No patients withdrew from the study due to ISRs. ADRs to Rilonacept Regeneron reported during the Phase 2/3 program in a total of 109 patients, some treated for longer than 2 years, are listed below using the following categories of frequency: very common (≥1/10); common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100).
1), the incidence of patients reporting infections and considered by the investigator as related to treatment was greater with Rilonacept Regeneron (9%) than with placebo (0%). In Part B, randomised withdrawal, the incidence of infections were similar in the Rilonacept Regeneron (0%) and the placebo patients (4%).
Part A of the trial was initiated in the winter months, while Part B was predominantly performed in the summer months. 19 per patient-exposure year), respectively, for rilonacept and placebo. Serious infections One patient in an open-label study of CAPS died after developing sinusitis and bacterial (Streptococcus pneumoniae) meningitis.
In a study in patients with adult Still’s disease, one patient developed an infection in his elbow with Mycobacterium intracellulare after an intraarticular glucocorticoid injection and subsequent local exposure to a suspected source of mycobacteria.
In a study in patients with polymyalgia rheumatica, one patient developed bronchitis and sinusitis, which resulted in hospitalization. Blood and lymphatic system disorder During the initial placebo-controlled portion of the pivotal trial, mean values increased for haemoglobin and decreased for neutrophils and platelets in the patients treated with Rilonacept Regeneron.
Serious infections Interleukin-1 (IL-1) blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported uncommonly in patients taking Rilonacept Regeneron. In an open-label extension study, one patient developed bacterial meningitis and died.
Rilonacept Regeneron should be discontinued if a patient develops a serious infection. 3) and physicians should exercise caution when administering Rilonacept Regeneron to patients with a history of recurring infections or with underlying conditions that may predispose them to infections.
Because Rilonacept Regeneron dampens an inflammatory response, vigilance in excluding underlying infection in unwell patients is required. Tumour necrosis factor (TNF) inhibitors have been associated with an increased risk of reactivation of latent tuberculosis (TB).
It is unknown whether the use of IL-1 inhibitors like rilonacept increases the risk of reactivation of TB or of opportunistic infections. Before starting treatment with Rilonacept Regeneron, all patients should be evaluated for both active and inactive (latent) tuberculosis.
Combinations not recommended The combination of Rilonacept Regeneron with TNF inhibitors has not been evaluated in clinical studies. An increased incidence of serious infections has been associated with administration of another IL-1 inhibitor, in combination with a TNF inhibitor.
5). 5). Hypersensitivity Although hypersensitivity reactions related to treatment with Rilonacept Regeneron were not seen in the initial clinical program, if a hypersensitivity reaction occurs, administration should be stopped immediately and permanently, and appropriate therapy initiated.
3). Immunogenicity Antibodies directed against the receptor domains of rilonacept were detected by an ELISA assay in 35% of patients (19 out of 55) treated for at least 6 weeks in the clinical study. There was no correlation of antibody activity with either clinical efficacy or safety.
Hypersensitivity to rilonacept or to any of the excipients. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These Medicinal product no longer authorised8 changes were not deemed as clinically significant and were potentially due to a decrease in the chronic inflammatory state present in CAPS with an attendant decrease in acute-phase response.
General disorders and administration site conditions In patients with CAPS, the most common and consistently reported adverse event associated with treatment was injection-site reaction (ISR). The ISRs included erythema, swelling, pruritus, and bruising.
Most ISRs lasted for one to two days. In studies of patients with CAPS, no ISRs were assessed as severe, and no patient discontinued study participation due to an ISR. Immunogenicity Antibodies directed against the receptor domains of rilonacept were detected by an ELISA assay in patients with CAPS after treatment with Rilonacept Regeneron in clinical studies.
Nineteen of 55 patients (35%) who had received Rilonacept Regeneron for at least 6 weeks tested positive for treatment-emergent binding antibodies on at least one occasion. Of the 19 patients, 7 tested positive at the last assessment (Week 18 or 24 of the open-label extension period), and 5 patients tested positive for neutralising antibodies on at least one occasion.
There was no correlation of antibody activity and either clinical efficacy or safety. The data reflect the percentage of patients whose test results were positive for antibodies to rilonacept in specific assays, and are highly dependent on the sensitivity and specificity of the assays.
The observed incidence of antibody positivity in an assay may be influenced by several factors including assay sensitivity and specificity, sample handling, concomitant medicinal products, and underlying disease. For these reasons, comparison of the incidence of antibodies to rilonacept with the incidence of antibodies to other products may be misleading.
Changes in lipid parameters Cholesterol and lipid levels may be reduced in patients with chronic inflammation. Patients with CAPS treated with Rilonacept Regeneron experienced mean increases from baseline for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides of 19 mg/dl, 2 mg/dl, 10 mg/dl, and 57 mg/dl respectively after 6 weeks of open-label therapy.
Physicians should monitor the lipid profiles of their patients (for example after 2-3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines.
5 x 109/l) has been observed commonly with another medicinal product that inhibits IL-1 used in a patient population (rheumatoid arthritis) other than CAPS. Neutropenia was observed commonly in patients with rheumatoid arthritis (not an approved use) who were administered Rilonacept Regeneron subcutaneously in clinical studies.
None of these patients had serious infections associated with the neutropenia. Although neutropenia was observed uncommonly in CAPS patients, the numbers studied are small. Treatment with Rilonacept Regeneron should not be initiated in patients with neutropenia.
It is recommended that neutrophil counts be assessed prior to initiating treatment, after 1 to 2 months, and periodically thereafter while receiving Rilonacept Regeneron. If a patient becomes neutropenic the ANC should be monitored closely and treatment discontinuation should be considered.
Malignancies The impact of treatment with Rilonacept Regeneron on the development of malignancies is not known. However, treatment with immunosuppressants, including Rilonacept Regeneron, may result in an increase in the risk of malignancies.
5). Prior to initiation of Rilonacept Regeneron therapy, adult and paediatric patients should receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine. 8). Mutation in NLRP3 gene All cases in the clinical trials had a confirmed mutation in the NLRP3 gene.
The efficacy was not evaluated in patients without a confirmed NLRP3 gene mutation.