Canakinumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Adult onset Still’s disease; Systemic onset juvenile chronic arthritis Monotherapy or combined with methotrexate: 4 mg/kg every 4 weeks. Max: 300 mg. Neonatal-onset multisystem inflammatory disease; Familial amyloid nephropathy with urticaria and deafness; Familial cold urticaria ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given every 8 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response. Tumour necrosis factor receptor-associated periodic fever syndrome; Hyper-immunoglobulin D periodic fever syndrome/Deficiency of mevalonate kinase ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response. Familial Mediterranean fever Combined with colchicine: ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response. Acute gout 150 mg as a single dose during an attack. Discontinue if no response. If inadequate response, repeat dose after at least 12 weeks.
Dosage Details
Subcutaneous
Adult onset Still’s disease, Systemic onset juvenile chronic arthritis
Adult: As monotherapy or in combination with methotrexate in patients with inadequate response to NSAIDs and corticosteroids: 4 mg/kg as single dose every 4 weeks. Max: 300 mg.
Child: ≥2 years weighing ≥7.5 kg: Same as adult dose.

Subcutaneous
Deficiency of mevalonate kinase, Hyper-immunoglobulin D periodic fever syndrome, Tumour necrosis factor receptor-associated periodic fever syndrome
Adult: ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given as a single dose every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).
Child: ≥2 years weighing 7.5-≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given as single dose every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).

Subcutaneous
Familial amyloid nephropathy with urticaria and deafness, Familial cold urticaria, Neonatal onset multisystem inflammatory disease
Adult: ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given as single dose every 8 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).
Child: 2-<4 years weighing 7.5-<15 kg: 4 mg/kg; ≥4 years weighing 15-≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given as single dose every 8 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).

Subcutaneous
Familial Mediterranean fever
Adult: In combination with colchicine: ≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given as single dose every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).
Child: In combination with colchicine: ≥2 years weighing 7.5-≤40 kg: 2 mg/kg; >40 kg: 150 mg. All doses given every 4 weeks. Dose modification, or discontinuation may be required according to individual safety, tolerability and response (refer to detailed product guideline).

Subcutaneous
Acute gout
Adult: In patient contraindicated to NSAID and colchicine with at least 3 attacks within the last 12 months: 150 mg as a single dose, given as soon as possible after the onset of an attack. Discontinue if no response. If symptoms recur after initial response, repeat dose after at least 12 weeks.
Reconstitution
Reconstitute powder for injection with 1mL sterile water for injection. Swirl slowly, do not shake.
Contraindications
Severe, active infection. Co-administration with live vaccines.
Special Precautions
Patient with infection, history of infection, latent or localised infection, conditions which may predispose to infection. Pregnancy and lactation.
Adverse Reactions
Significant: Infections, opportunistic infections (e.g. mycobacterial infection, herpes zoster), haematologic effects (e.g. decreased WBC, thrombocytopaenia, neutropenia, leucopenia), malignancies, hypersensitivity reactions, serum transaminases and bilirubin elevations.
Gastrointestinal disorders: Diarrhoea, upper abdominal pain, nausea, gastroenteritis.
General disorders and administration site conditions: Injection site reactions, fatigue, asthenia.
Infections and infestations: Influenza, viral infection, ear infection, cellulitis.
Investigations: Weight gain, decreased CrCl.
Metabolism and nutrition disorders: Decreased serum calcium.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, arthralgia, back pain.
Nervous system disorders: Headache, dizziness, vertigo.
Renal and urinary disorders: UTI, proteinuria.
Reproductive system and breast disorders: Vulvovaginal candidiasis.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, rhinitis, bronchitis, pharyngitis, upper respiratory tract infection, pneumonia, sinusitis, tonsillitis.
Potentially Fatal: Serious infection, macrophage activation syndrome.
Patient Counseling Information
This drug may cause dizziness, vertigo or asthenia, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC with differential prior to initiation of treatment, after 1-2 months and periodically thereafter. Monitor C-reactive protein, serum amyloid A protein; signs/symptoms of infection. Perform active or latent TB screening prior to treatment.
Drug Interactions
Increased risk of serious infections with tumour necrosis factor inhibitors.
Potentially Fatal: May enhance the adverse/toxic effect and may diminish the therapeutic effect of live vaccines.
Action
Description: Canakinumab binds with high affinity to interleukin-1β (IL-1β) thereby preventing interaction with cell surface receptors and inhibiting IL-1β-induced gene activation and production of inflammatory mediators.
Onset: Within 8 days.
Pharmacokinetics:
Absorption: Absolute bioavailability: 66%. Time to peak plasma concentration: Approx 7 days.
Excretion: Terminal elimination half-life: Approx 26 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance with local requirements.
MIMS Class
ATC Classification
L04AC08 - canakinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
References
Anon. Canakinumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/04/2018.

Anon. Canakinumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/04/2018.

Buckingham R (ed). Canakinumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/04/2018.

Ilaris Injection, Powder, Lyophilized for Solution; Ilaris Injection, Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/04/2018.

Joint Formulary Committee. Canakinumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/04/2018.

Disclaimer: This information is independently developed by MIMS based on Canakinumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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