Therapeutic Canakinumab antibody from the original Ilaris® commercial drug.
Product Batch | Therapeutic Expiry Date | Brand & Origin | Amount per Aliquot | Select Quantity | Discount | Price per Aliquot | |
|---|---|---|---|---|---|---|---|
2025.07 |
Ilaris® DE |
4.5 mg |
Max: 10
Min: 1
Step: 1
|
2.512,00 €
/aliquot
|
|||
2025.07 |
Ilaris® DE |
4.5 mg |
Max: 10
Min: 1
Step: 1
|
2.512,00 €
/aliquot
|
Evidentic’s Analytical Data Service includes a comprehensive array of methods to support the drug development process, including structure, aggregation, degree of isomerization, and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Ilaris® |
| INN | Canakinumab |
| API type | Monoclonal antobody |
| Pharmacotherapeutic group | Immunosuppressants, interleukin inhibitors |
| ATC code | L04AC08 |
| Target of antibody | IL-1 beta |
| General function | |
| Short description | Canakinumab is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes (CAPS), Tumour necrosis factor receptor-associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), Familial Mediterranean fever (FMF), Still’s disease, Gouty arthritis. |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype. Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The peak serum canakinumab concentration (Cmax) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients. The mean terminal half-life was 26 days. Mean values for Cmax and AUCinf after a single subcutaneous dose of 150 mg in a typical adult CAPS patient (70 kg) were 15.9 µg/ml and 708 µg*d/ml. Canakinumab binds to serum IL-1 beta. The distribution volume (Vss) of canakinumab varied according to body weight. It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg. The apparent clearance (CL/F) of canakinumab increases with body weight. It was estimated to be 0.17 l/d in a CAPS patient of body weight 70 kg and 0.11 l/d in a SJIA patient of body weight 33 kg. After accounting for body weight differences, no clinically significant differences in the pharmacokinetic properties of canakinumab were observed between CAPS and SJIA patients. |
| Original license holder | Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland |
| Marketing authorisation numbers | EU/1/09/564/001-002 |
| Marketing authorisation holder | Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland |
| Name of the manufacturer of the biological active substance | Novartis Pharma S.A.S. Centre de Biotechnologie 8, rue de l’Industrie 68330 Huningue France |
| Name and address of the manufacturer(s) responsible for batch release | Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany |
| Max shelf life | 3 years |
| Storage conditions | 2-8 °C |
| List of excipients | Sucrose Histidine Histidine hydrochloride monohydrate Polysorbate 80 |
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