Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 180mg/vial (150mg/mL after reconstitution)
Cryopyrin-Associated Periodic Syndrome
Indicated for treatment of cryopyrin-associated periodic syndrome (CAPS), including familial old autoinflammatory syndrome and Muckle-Wells syndrome in adults and children
>40 kg: 150 mg SC q8wk
15-40 kg: 2 mg/kg SC q8wk; may increase to 3 mg/kg if inadequate response
Tumor Necrosis Factor Receptor-Associated Periodic Syndrome
Indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency
Indicated for the treatment of hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS) (HIDS)/mevalonate kinase deficiency (MKD) in adult and pediatric patients
150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Familial Mediterranean Fever
Indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Still Disease
Indicated for the treatment of active Still disease, including adult-onset Still disease (AOSD)
4 mg/kg SC q4Weeks; not to exceed 300 mg/dose
Gout Flares
Indicated for gout flares in adults in whom NSAIDs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate
150 mg SC
Allow ≥12 weeks between doses if patient requires retreatment
Dosage Forms & Strengths
powder for injection
- 180mg/vial (150mg/mL after reconstitution)
Cryopyrin-Associated Periodic Syndrome
Indicated for treatment of cryopyrin-associated periodic syndrome, including familial old autoinflammatory syndrome and Muckle-Wells syndrome in adults and children
<4 years
- Safety and efficacy not established
≥4 Years
Tumor Necrosis Factor Receptor-Associated Periodic Syndrome
Indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate
>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency
Indicated for the treatment of hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS) (HIDS)/mevalonate kinase deficiency (MKD) in adult and pediatric patients
≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate
>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Familial Mediterranean Fever
Indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
≤40 kg: 2 mg/kg SC q4wk; may increase to 4 mg/kg q4wk if the clinical response is not adequate
>40 kg: 150 mg SC q4wk; may increase to 300 mg q4wk if the clinical response is not adequate
Systemic Juvenile Idiopathic Arthritis
Indicated for Still disease and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older
<2 years: Safety and efficacy not established
≥2 years and weight ≥7.5 kg: 4 mg/kg SC q4Weeks; not to exceed 300 mg/dose
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
canakinumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (69)
- adalimumab
adalimumab and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anthrax vaccine
canakinumab decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
antithymocyte globulin equine and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
canakinumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, canakinumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- basiliximab
basiliximab and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
canakinumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
canakinumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
canakinumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
canakinumab and cyclosporine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, canakinumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of canakinumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- diphtheria & tetanus toxoids
canakinumab decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
canakinumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
canakinumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- etanercept
canakinumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- everolimus
canakinumab and everolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
canakinumab and glatiramer both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
canakinumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
canakinumab decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/b vaccine
canakinumab decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/typhoid vaccine
canakinumab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
canakinumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
canakinumab decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- human papillomavirus vaccine, quadrivalent
canakinumab decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- hydroxychloroquine sulfate
canakinumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
canakinumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
canakinumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
canakinumab decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, adjuvanted
canakinumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine quadrivalent, cell-cultured
canakinumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, intranasal
canakinumab decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent
canakinumab decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent, adjuvanted
canakinumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- Japanese encephalitis virus vaccine
canakinumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
canakinumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
canakinumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
canakinumab decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles mumps and rubella vaccine, live
canakinumab decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles, mumps, rubella and varicella vaccine, live
canakinumab decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
canakinumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- muromonab CD3
canakinumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
canakinumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pneumococcal vaccine 13-valent
canakinumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine heptavalent
canakinumab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine polyvalent
canakinumab decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rabies vaccine
canakinumab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressant may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
canakinumab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
canakinumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
canakinumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
canakinumab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- sirolimus
canakinumab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
canakinumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
canakinumab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
canakinumab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
canakinumab decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tick-borne encephalitis vaccine
canakinumab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
canakinumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
canakinumab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
canakinumab decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid polysaccharide vaccine
canakinumab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
canakinumab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ustekinumab
canakinumab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
canakinumab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- yellow fever vaccine
canakinumab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- zoster vaccine live
canakinumab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (24)
- astragalus
canakinumab increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- belatacept
belatacept and canakinumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- denosumab
canakinumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- echinacea
canakinumab increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of canakinumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of canakinumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- haemophilus influenzae type b vaccine
canakinumab decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored.
- influenza virus vaccine quadrivalent, recombinant
canakinumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- influenza virus vaccine trivalent, recombinant
canakinumab decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- isavuconazonium sulfate
canakinumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and canakinumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- maitake
canakinumab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- meningococcal group B vaccine
canakinumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- mercaptopurine
canakinumab and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, canakinumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
canakinumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oxaliplatin
oxaliplatin and canakinumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- poliovirus vaccine inactivated
canakinumab decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. also increase risk of infection with concomitant live vaccines.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of canakinumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- sipuleucel-T
canakinumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, canakinumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, canakinumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and canakinumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- zoster vaccine recombinant
canakinumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
>10%
Nasopharyngitis (34%)
Diarrhea (20%)
Influenza (17%)
Rhinitis (17%)
Headache (14%)
Nausea (14%)
Vertigo (9-14%)
Gastroenteritis (11%)
Pharyngitis (11%)
Weight increase (11%)
Bronchitis (11%)
Musculoskeletal pain (11%)
WBC count ≤0.8x LLN (10.4%)
1-10%
Injection site pain (9%)
Decreased platelets (6.3%)
ANC <1x 109/L (6%)
Increased AST/ALT (4.1%)
Frequency Not Defined
Mild bilirubin elevation
Warnings
Contraindications
Hypersensitivity
Cautions
Hypersensitivity reported postmarketing; disease symptoms may be similar to symptoms of hypersensitivity; if a severe hypersensitivity reaction occurs, therapy should be discontinued and appropriate therapy initiated
May impair defenses against malignancies
Macrophage activation syndrome (MAS) is a life-threatening disorder that may develop with rheumatic conditions, particularly with Still disease or SJIA; it should be aggressively treated; it is important to be attentive to symptoms of infection or worsening of Still’s disease, as these are known triggers for MAS; based on clinical trials, canakinumab did not increase incidence of MAS;
Serious infections
- Risk of serious infections, including opportunistic infections and reactivation of latent hepatitis or TB; interrupt therapy if serious infection develops; infections, predominantly of upper respiratory tract, in some instances serious, reported in isolated cases of unusual or opportunistic infections including aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster; causal relationship of therapy to infections cannot be excluded
- Avoid administering this drug to patients during an active infection requiring medical intervention; discontinue therapy if a patient develops a serious infection
- In clinical trials, this drug has not been administered concomitantly with tumor necrosis factor (TNF) inhibitors; an increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors; coadministration of this drug with TNF inhibitors not recommended; may increase risk of serious infections
- Drugs that affect the immune system by blocking TNF have been associated with an increased risk of new tuberculosis and reactivation of latent tuberculosis (TB); it is possible that use of IL-1 inhibitors, such as this drug, increases risk of reactivation of tuberculosis or of opportunistic infections
- Prior to initiating immunomodulatory therapies, including this drug, evaluate patients for active and latent tuberculosis infection; appropriate screening tests should be performed in all patients
- This drug has not been studied in patients with a positive tuberculosis screen, and the safety of this drug in individuals with latent tuberculosis infection is unknown; treat patients testing positive in tuberculosis screening according to standard medical practice prior to therapy with this drug
- Instruct patients to seek medical advice if signs, symptoms, or high-risk exposure suggestive of tuberculosis (eg, persistent cough, weight loss, subfebrile temperature) appear during or after therapy
- Healthcare providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy with this drug
- Live vaccines: See current recommended immunization schedules at the website of the Centers for Disease Control, http://www.cdc.gov/vaccines/schedules/index.html
Drug interaction overview
-
IL-1 or TNF blockers
- Avoid coadministration
- Coadministration with other IL-1 antagonists or TNF inhibitors increases risk of neutropenia and serious infection
-
Live vaccines
- Avoid coadministration
- Data are not available on effects of live vaccination or secondary infection transmission by live vaccines if administered while on canakinumab
- Recommended to complete immunization before initiating canakinumab
-
CYP450 substrates
- CYP450 enzymes are suppressed by increased levels of cytokines (eg, IL-1) during chronic inflammation
- CYP450 enzymes are expected to normalize once IL-1 levels decrease
- Monitor CYP450 substrates with narrow therapeutic indices, where the dose is individually adjusted (eg, warfarin); dose adjustment may be necessary
Pregnancy & Lactation
Pregnancy
Limited human data from postmarketing reports on use in pregnant women are not sufficient to inform a drug associated risk
Monoclonal antibodies, such as canakinumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential fetal exposure is likely to be greater during the second and third trimesters of pregnancy
Animal data
- Studies with marmoset monkeys showed no evidence of embryotoxicity or fetal malformations with during organogenesis and later in gestation at doses that produced exposures ~11 times the exposure at the maximum recommended human dose (MRHD) and greater
- Delays in fetal skeletal development were observed in marmoset monkeys following prenatal exposure at concentrations ~11 times the MRHD and greater; similar delays in fetal skeletal development were observed in mice administered a murine analog of canakinumab during organogenesis
Lactation
Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production
Human IgG is known to be present in human milk; effects of canakinumab in breast milk and possible systemic exposure in the breastfed infant are unknown; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant, human monoclonal antibody that binds to human interleukin (IL)-1β and neutralizes its activity by blocking its interaction with IL-1 receptors; does not bind IL-1α or IL-1 receptor antagonist (IL-1ra)
Absorption
Absolute bioavailability: 66%
Peak plasma concentration: 16 mcg/mL
Peak plasma time
- Adults: ~7 days
- Pediatric patients: 2-7 days
Distribution
Vd (steady-state)
- CAPS (70-kg patient): 6.01 L
- SJIA (33-kg patient): 3.2 L
- Periodic fever syndrome (70-kg patient): 6.34 L
Elimination
Clearance
- CAPS (70-kg patient): 0.174 L/day
- SJIA (33-kg patient): 0.11 L/day
- Periodic fever syndrome (70-kg patient): 0.17 L/day
Half-life
- Adults, 150-mg dose: 26 days
- Children and adolescents, 150-mg or 2-mg/kg dose: 22.9-25.7 days
Administration
SC Preparation
Reconstitute lyophilized powder with 1 mL sterile water for injection to obtain 150 mg/mL solution
Swirl the vial slowly at an angle of about 45° for ~1 minute and allow to stand for 5 minutes
Do not shake; gently turn the vial upside down and back again 10 times; avoid touching the rubber stopper with your fingers
Allow stand for 15 minutes at room temperature
Do not shake
Do not use if particulate matter is present in the solution
Tap the side of the vial to remove any residual liquid from the stopper
The reconstituted solution should be clear to opalescent, colorless to a slightly brownish yellow tint, and essentially free from particulates
If the solution has a distinctly brown discoloration, do not use
Slight foaming of the product upon reconstitution is not unusual
Protect from light
Reconstituted solution can be kept at room temperature if used within 1 hr; otherwise, refrigerate at 2-8°C (36-46°F) and use within 4 hr
SC Administration
Using a sterile 1-mL syringe and needle, carefully withdraw the required volume depending on the dose to be administered and inject SC using a 27-gauge x 0.5-inch needle
Avoid injecting scar tissue as this may result in insufficient exposure
Discard any unused product or waste material in accordance with local requirements
Storage
Unopened vial
- Refrigerate at 2-8°C (36-46° F)
- Do not freeze
- Store in the original carton to protect from light
Reconstituted vial
- Room temperature if used within 1 hr; otherwise, refrigerate at 2-8°C (36-46°F) and use within 4 hr
Images
Patient Handout
canakinumab (PF) subcutaneous
CANAKINUMAB - INJECTION
(KAN-a-KIN-ue-mab)
COMMON BRAND NAME(S): Ilaris
USES: This medication is used to treat certain types of periodic fever syndromes, which include cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). Canakinumab works by blocking a certain natural protein in your body (interleukin-1 beta) that may worsen the symptoms of these diseases. Canakinumab may help to lessen the symptoms, such as rash, joint/muscle pain, fever, eye redness, and tiredness.Canakinumab is also used to treat gout attacks (flares), Still's disease, and a type of arthritis in children (systemic juvenile idiopathic arthritis-SJIA).
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using canakinumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is injected under the skin as directed by your doctor. The dosage and treatment schedule are based on your medical condition, weight, and response to treatment. Follow your doctor's treatment schedule carefully.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake the vial. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. The liquid should be clear, and either colorless or a pale brownish yellow color. Learn how to store and discard medical supplies safely.Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time to avoid problem areas under the skin. Do not inject into skin that is tender, red, or hard. Never reuse syringes or needles.Use this medication regularly to get the most benefit from it unless your doctor instructs you otherwise. To help you remember, mark your calendar with a reminder when you should get the next dose.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Redness, itching, pain, warmth, or swelling at the injection site may occur. Dizziness, nausea, diarrhea, or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop any signs of an infection, such as fever/chills, cough, or cold/flu symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using canakinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis), cancer.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, you must first be treated for it before you start canakinumab to prevent a serious TB infection.Canakinumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using canakinumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other IL-1 blockers (such as anakinra, rilonacept), TNF-blockers (such as adalimumab, etanercept, infliximab).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store this drug in the original container in the refrigerator away from light and moisture. Do not freeze. Each vial of medication is for single use only. Throw away any unused portion. Keep all medications away from children and pets.After mixing the powdered form of this medication, it may be kept at room temperature for up to 1 hour. If not used within 1 hour, store in the refrigerator and use within the time specified in the product instructions.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised September 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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