canakinumab (Rx)

Brand and Other Names:Ilaris
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Dosing & Uses

AdultPediatric

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

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

  • 15-40 kg: 2 mg/kg SC q8wk  
  • ≥40 kg: 150 mg SC q8wk

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

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Interactions

Interaction Checker

and canakinumab

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (62)

              • 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.

              • 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.

              • 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/ 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.

              • 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.

              • 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.

              • 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 (19)

              • 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.

              • 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.

              • 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.

              • 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. .

              • 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)

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                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

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                Warnings

                Contraindications

                Hypersensitivity

                Cautions

                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

                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;

                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
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                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.

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                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
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                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
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                Images

                No images available for this drug.
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                Patient Handout

                Patient Education
                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 a type of rheumatoid arthritis in children (systemic juvenile idiopathic arthritis-SJIA), as well as Still's Disease in adults.

                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. If you are using this medication to treat CAPS, it is usually given every 8 weeks. If you are using this medication to treat TRAPS, HIDS/MKD, FMF, SJIA, it is usually given every 4 weeks. The dosage is based on your age, weight, medical condition, and response to treatment.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. 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 persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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 worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. 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 not known whether 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.Laboratory and/or medical tests (such as CBC, liver function) should be performed periodically to monitor your progress or check for side effects. 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 2020. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.