Canakinumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of canakinumab.
These products have been produced by recombinant technology using murine hybridoma cell lines.
Drugs List
Therapeutic Indications
Uses
Cryopyrin-associated periodic syndromes
Familial Mediterranean fever
Gouty arthritis
Hyperimmunoglobulin D syndrome
Still's disease
Systemic juvenile idiopathic arthritis
Tumour necrosis factor receptor associated periodic syndrome
Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
In adults, adolescents and children aged 2 years and older with body weight of 7.5 kg and above, including:
Muckle-Wells Syndrome (MWS)
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
Treatment of Familial Mediterranean fever
In adults, adolescents and children aged 2 years and older with body weight of 7.5 kg and above, canakinumab may be used for the treatment of Familial Mediterranean fever, either alone or in combination with colchicine.
Hyperimmunoglobulin D syndrome/mevalonate kinase deficiency
In adults, adolescents and children aged 2 years and older with body weight of 7.5 kg and above.
Tumour necrosis factor receptor associated periodic syndrome
In adults, adolescents and children aged 2 years and older with body weight of 7.5 kg and above.
Treatment of gouty arthritis
In adults with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, are not tolerated, or do not provide adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Treatment of Still's Disease
For the treatment of active still's disease 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 previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Canakinumab can be given as monotherapy or in combination with methotrexate.
Dosage
Adults
Treatment of Cryopyrin-Associated Periodic Syndromes
Body weight greater than 40kg
Initially, 150mg as a single dose, then after seven days:
If there is a satisfactory response continue with a maintenance dose of 150mg every eight weeks.
If there is a non-satisfactory response, consider a second single dose of 150mg, then after seven days:
If there is a satisfactory response, continue with a maintenance dose of 300mg every eight weeks.
If there is a non-satisfactory response, consider a third single dose of 300mg, then after seven days if there is a full treatment response continue with a maintenance dose of 600mg every eight weeks.
Body weight 15kg to 40kg
Initially 2mg/kg as a single dose, then after seven days:
If there is a satisfactory response, continue with a maintenance dose of 2mg/kg every eight weeks.
If there is a non-satisfactory response, consider a second single dose of 2mg/kg, then after seven days:
If there is a satisfactory response, continue with a maintenance dose of 4mg/kg every eight weeks.
If there is a non-satisfactory response, consider a third single dose of 4mg/kg, then after seven days if there is a full treatment response continue with a maintenance dose of 8mg/kg every eight weeks.
Hyperimmunoglobulin D syndrome/mevalonate kinase deficiency, Tumour necrosis factor receptor associated periodic syndrome and Familial Mediterranean fever
Bodyweight greater than 40kg
Initially, 150mg as a single dose.
If a satisfactory clinical response after seven days, continue with a maintenance dose of 150mg every four weeks.
If a satisfactory response has not been seen after seven days, consider a second dose of 150mg.
If there is a satisfactory response after two initial doses of 150mg (on day 0 and day 7), the maintenance dose should be 300mg every four weeks.
Bodyweight greater than or equal to 7.5kg and less than or equal to 40kg
Initially, 2mg/kg to be given.
If a satisfactory clinical response after seven days, continue with a maintenance dose of 2mg/kg every four weeks.
If a satisfactory response has not been seen after seven days, consider a second dose of 2mg/kg.
If there is a satisfactory response after two initial doses of 2mg/kg (on day 0 and day 7), the maintenance dose should be 4mg/kg every four weeks.
Gouty arthritis
150mg as a single dose during an attack.
For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack. Patients who do not respond to initial treatment should not be re-treated. In patients who respond and require re-treatment, there should be an interval of at least twelve weeks before a new dose is administered.
Still's disease (AOSD and SJIA)
Body weight greater than or equal to 7.5kg
4mg/kg (up to a maximum of 300mg) administered every four weeks.
Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.
Children
Treatment of Cryopyrin-Associated Periodic Syndromes
Children with a body weight over 40kg: (See Dosage; Adults)
Children aged 4 years and over with body weight 15kg to 40kg: (See Dosage; Adults)
Children aged 2 years and over with body weight 7.5kg to 15kg:
Initially 4mg/kg as a single dose, then after seven days:
If there is a satisfactory response continue with a maintenance dose of 4mg/kg every eight weeks.
If there is a non-satisfactory response consider a second single dose of 4mg/kg, then after seven days:
If there is a satisfactory response continue with a maintenance dose of 8mg/kg every eight weeks.
Treatment of active systemic juvenile idiopathic arthritis
Children aged 2 years and over with body weight 7.5kg and above:
4mg/kg (up to a maximum of 300mg) administered once every four weeks.
Hyperimmunoglobulin D syndrome/mevalonate kinase deficiency, Tumour necrosis factor receptor associated periodic syndrome and Familial Mediterranean fever
Children aged 2 years and over: (See Dosage; Adult)
Administration
For subcutaneous injection.
The following are suitable injection sites: upper thigh, abdomen, upper arm or buttocks.
Broken skin and areas which are bruised or covered by a rash should be avoided. Injection into scar-tissue should be avoided as this may result in insufficient exposure to canakinumab.
Contraindications
Children under 2 years
Infection
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Breastfeeding
Leucopenia
Pregnancy
Tuberculosis
Precautions and Warnings
Females of childbearing potential
History of recurrent infection
Predisposition to infection
Latent or healed tuberculosis
Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Before starting therapy ensure immunisations are up to date
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Avoid injection into broken or bruised skin
Avoid injection into rash covered skin
Avoid injection into scar tissue
Record name and batch number of administered product
Vary injection site during prolonged therapy
Monitor differential WBC count before and during therapy
Monitor closely patients who develop neutropenia
Monitor for signs of Macrophage Activation Syndrome (MAS)
Monitor neutrophil count before initiation, at 1-2months, then periodically
Advise patient to report symptoms of infection immediately
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Discontinue if active infection develops
Immunosuppressive drugs may increase risk of malignancy
Consider discontinuing if neutrophil count below 1.5 x 10 to the power 9/l
Consider discontinuing if patient becomes leucopenic
Not licensed for all indications in all age groups
Female: Contraception required during and for 3 months after treatment
Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection. This evaluation should include a detailed medical history and appropriate screening tests. Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with canakinumab.
Certain patients tested with PPD skin test may yield a positive result in a follow up test without clinical evidence of a latent or active tuberculosis infection. In the event of a conversion from a negative to a positive PPD test, especially in high risk patients, consider an alternative method of tuberculosis screening.
Macrophage Activation Syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease. Known triggers of MAS include infection and worsening of Still's disease. If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible. Physicians should be attentive to the symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Pregnancy and Lactation
Pregnancy
Canakinumab is contraindicated during pregnancy.
The manufacturer does not recommend using canakinumab during pregnancy unless a thorough benefit/risk evaluation has been performed. At the time of writing there is limited published information regarding the use of canakinumab during pregnancy. Potential risks are unknown.
Lactation
Canakinumab is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking canakinumab unless a thorough benefit/risk evaluation has been performed. Animal data reports using the murine equivalent of canakinumab indicated levels in the breast milk, however presence in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal pain
Arthralgia
Asthenia
Back pain
Bronchitis
Cellulitis
Decrease in creatinine clearance
Dizziness
Ear infection
Elevated triglyceride levels
Fatigue
Gastro-enteritis
Gastroesophageal reflux disease
Hypersensitivity reactions
Increase in haemoglobin
Increase in serum transaminases
Increased susceptibility to infection
Increased uric acid level
Influenza
Injection site reactions
Leucopenia
Macrophage-activation syndrome
Musculoskeletal pain
Nasopharyngitis
Neutropenia
Pharyngitis
Pneumonia
Proteinuria
Reduced neutrophil count
Reduced platelet count
Rhinitis
Serum bilirubin increased
Sinusitis
Tonsillitis
Upper respiratory tract infection
Urinary tract infections
Vaginal candidiasis
Vertigo
Viral infection
Vomiting
White blood cell count decreased
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2020
Reference Sources
Summary of Product Characteristics: Ilaris 150mg solution for injection. Novartis Pharmaceuticals UK Ltd. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 September 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.