Cryopyrin-associated periodic syndromes (CAPS): Patient syndromes included in trials were: Familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), chronic infantile neurological cutaneous articular syndrome/neonatal onset multisystemic inflammatory disease (CINCA/NOMID), and familial cold urticaria (FCU); data has shown that pediatric patients require higher doses than adults (Ref).
Manufacturer's labeling:
Children ≥4 years and Adolescents:
15 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 8 weeks; may increase to 3 mg/kg/dose if response inadequate.
>40 kg: SUBQ: 150 mg/dose every 8 weeks.
Alternate dosing: Limited data available:
Children 2 to <4 years and weighing ≥7.5 kg: SUBQ: 4 mg/kg/dose every 8 weeks; if no response after 7 days, may repeat 4 mg/kg dose; if response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref).
Children ≥4 years and Adolescents:
7.5 to <15 kg: SUBQ: 4 mg/kg/dose every 8 weeks. If no response after 7 days, may administered a second 4 mg/kg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref).
15 to 40 kg: SUBQ: 2 mg/kg/dose every 8 weeks. If response not satisfactory after 7 days, may repeat 2 mg/kg dose; if full treatment response achieved then may continue patient on intensified maintenance of 4 mg/kg/dose every 8 weeks. If after 7 days (ie, day 14) a satisfactory response still not achieved, may administer another 4 mg/kg dose; if full treatment response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref). Another dose-escalation regimen describes titration in 2 mg/kg/dose increments every 7 days up to a maximum dose of 8 mg/kg/dose (Ref).
>40 kg: SUBQ: 150 mg every 8 weeks. If response not satisfactory after 7 days, may repeat 150 mg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 300 mg every 8 weeks. If after 7 days (ie, day 14) a satisfactory response still not achieved, may administer another 300 mg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 600 mg every 8 weeks (Ref). Another dose-escalation regimen describes titration in 150 mg increments every 7 days up to a maximum dose of 600 mg (Ref).
Familial Mediterranean fever (FMF): Note: In trials, canakinumab was used as monotherapy and in combination with daily colchicine.
Children ≥2 years and Adolescents:
7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).
>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD):
Children ≥2 years and Adolescents:
7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).
>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).
Juvenile idiopathic arthritis, systemic: Children ≥2 years weighing at least 7.5 kg and Adolescents: SUBQ: 4 mg/kg/dose every 4 weeks; maximum dose: 300 mg/dose.
Tumor necrosis factor receptor associated periodic syndrome (TRAPS):
Children ≥2 years and Adolescents:
7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).
>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Children ≥2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
(For additional information see "Canakinumab: Drug information")
Cryopyrin-associated periodic syndromes (CAPS): SUBQ: 150 mg (>40 kg) or 2 mg/kg (15 to 40 kg) every 8 weeks; in clinical trials, dosage adjustments up to 600 mg (>40 kg) or 8 mg/kg (≤40 kg) and/or increased dosing frequency were allowed for residual symptoms (Ref). For inadequate response, a dose titration schedule of 150 mg or 2 mg/kg every 7 days up to a maximum dose of 600 mg or 8 mg/kg (15 to 40 kg) has been recommended (Ref).
Familial Mediterranean fever (FMF), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), tumor necrosis factor receptor associated periodic syndrome (TRAPS): SUBQ: Initial: 150 mg (>40 kg) or 2 mg/kg (≤40 kg) every 4 weeks; may increase to 300 mg (>40 kg) or 4 mg/kg (≤40 kg) every 4 weeks if response to the initial dose was not adequate or if an early supplemental dose was used (Ref).
Early inadequate response (off-label dosing): SUBQ: If inadequate response to initial dose occurs between days 8 and 28 (eg, baseline flare persists), an additional 150 mg (>40 kg) or 2 mg/kg (≤40 kg) may be given (Ref).
Still disease, adult onset: SUBQ: 4 mg/kg every 4 weeks (maximum: 300 mg/dose).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
>10%:
Endocrine & metabolic: Increased uric acid (gout flares: 44%), weight gain (11%)
Gastrointestinal: Diarrhea (20%), gastroenteritis (3% to 11%), nausea (14%), upper abdominal pain (7% to 16%)
Hematologic & oncologic: Neutropenia (16%), thrombocytopenia (16%)
Infection: Infection (including upper respiratory tract infection, urinary tract infection, and viral upper respiratory tract infection: ≤55%; serious infection: 2% to 5%), influenza (17%)
Local: Injection-site reaction (1% to 12%)
Nervous system: Headache (14%), vertigo (9% to 14%)
Neuromuscular & skeletal: Musculoskeletal pain (11%)
Respiratory: Bronchitis (11%), nasopharyngitis (11% to 34%), pharyngitis (3% to 11%), rhinitis (5% to 17%)
1% to 10%:
Endocrine & metabolic: Decreased serum calcium (8%) (Lachmann 2009), hypertriglyceridemia (3% to 6%)
Genitourinary: Proteinuria (8%) (Lachmann 2009)
Hematologic & oncologic: Eosinophilia (7%) (Lachmann 2009), leukopenia (6%)
Hepatic: Increased serum alanine aminotransferase (≤4%), increased serum aspartate aminotransferase (≤4%), increased serum bilirubin (7%) (Lachmann 2009)
Immunologic: Antibody development (non-neutralizing: 1% to 4%; neutralizing: <1%)
Nervous system: Dizziness (2%)
Neuromuscular & skeletal: Back pain (3%)
Renal: Decreased creatinine clearance (8%) (Lachmann 2009)
Postmarketing:
Hypersensitivity: Hypersensitivity reaction
Infection: Opportunistic infection
Hypersensitivity to canakinumab or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Active, severe infections
Concerns related to adverse effects:
• Hematologic effects: A decrease in WBC, neutrophils, and platelets was observed in clinical trials; some changes were transient and/or mild (eg, thrombocytopenia). One case of neutropenia (ANC <1,500/mm3) was reported; monitor blood counts as indicated.
• Hypersensitivity: Hypersensitivity reactions (excluding anaphylactic reactions) have been reported with use; symptoms may be similar to those that are disease related. Discontinue therapy and initiate appropriate therapy if severe hypersensitivity occurs.
• Infections: Caution should be exercised when considering use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with latent or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Therapy should not be initiated in patients with active or chronic infections.
• Macrophage activation syndrome: Macrophage activation syndrome (MAS) may develop in patients with Still disease and should be treated aggressively. Infection or worsening Still disease may be triggers for MAS.
• Malignancy: Use may impair defenses against malignancies; impact on the development and course of malignancies is not fully defined.
• Tuberculosis: Avoid use in patients with tuberculosis (TB) disease (active TB). Patients should be evaluated for TB infection (latent TB) with a tuberculin skin test prior to starting therapy. Treat TB infection prior to initiating canakinumab therapy. During and following treatment, monitor for signs/symptoms of TB disease.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Other warnings/precautions:
• Immunizations: All patients should be brought up to date with all immunizations including pneumococcal and influenza vaccines before initiating therapy. Live vaccines should not be given concurrently; no data available on either the efficacy or on the risks concerning secondary transmission of infection by live vaccines in patients receiving therapy. Administration of inactivated (killed) vaccines while on therapy may not be effective.
Reactivation of TB has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test, and ≥5 years of age: IGRA [interferon gamma release assay]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016])
Influenza reported in 17% of patients during clinical trials. Vertigo has been reported exclusively in patients with MWS (9% to 14%); events appear self-resolving with continued therapy. Infection reported more frequently in children than adults (Kuemmerle-Deschner 2011) for both CAPS and JIA. Treatment for CAPS has been associated with higher incidence of reported adverse reactions including diarrhea (20%), nasopharyngitis (34%), and rhinitis (17%).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Ilaris: 150 mg/mL (1 mL) [contains polysorbate 80]
No
Solution (Ilaris Subcutaneous)
150 mg/mL (per mL): $21,806.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous:
Ilaris: 150 mg/mL (1 mL) [contains polysorbate 80]
SubQ: Do not shake; administer subcutaneously at a concentration of 150 mg/mL by a health care provider; avoid sites with scar tissue
SUBQ: For subcutaneous injection only by a health care provider. Do not shake solution. Do not inject into scar tissue.
Store intact vial at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Discard any unused portion.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf#page=24, must be dispensed with this medication.
Treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) (FDA approved in ages ≥4 years and adults); treatment of active systemic juvenile idiopathic arthritis (SJIA) (FDA approved in ages ≥2 years weighing at least 7.5 kg); treatment of tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) (FDA approved in ages ≥2 years and adults); treatment of active adult-onset Still's disease (AOSD) (FDA approved in adults); treatment of gout flares in patients in whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, not tolerated, or do not provide an adequate response and in whom repeated corticosteroid use is not appropriate (FDA approved in adults).
Ilaris may be confused with Ilumya
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Anti-TNF Agents: May enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Interleukin-1 Inhibitors: May enhance the adverse/toxic effect of Canakinumab. Risk X: Avoid combination
Interleukin-1 Receptor Antagonist: May enhance the adverse/toxic effect of Canakinumab. Risk X: Avoid combination
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Fertility may be decreased in males and females with inflammatory diseases such as familial Mediterranean fever. Based on case reports, treatment with canakinumab may improve fertility (Babaoglu 2020; Youngstein 2017).
Canakinumab crosses the placenta; newborn concentrations may be greater than maternal serum concentrations at delivery (Bosshard 2021; Egawa 2017; Weber 2022).
Canakinumab is a recombinant IgG monoclonal antibody; IgG is known to cross the placenta in a linear fashion as pregnancy progresses; potential fetal exposure is likely to be greater during the second and third trimesters.
Outcome data related to the use of canakinumab in pregnancy are limited (Babaoglu 2020; Brien 2021; Dernoncourt 2023; Egawa 2017; İlgen 2022; Youngstein 2017). Other agents are currently preferred for the treatment of adult-onset Still disease (Jamilloux 2014) or familial Mediterranean fever (EULAR [Ozen 2016]) in pregnant patients.
CBC with differential, C-reactive protein (CRP), serum amyloid A; LFTs at baseline; signs or symptoms of infection; latent TB screening (prior to initiating therapy), body weight. Eye examinations for patients with CAPS (Caorsi 2013) and symptoms of disease for patients with CAPS, SJIA, TRAPS, FMF, or HIDS/MKD were also monitored in clinical trials (Arostegui 2015; Brik 2014; Caorsi 2013; Lachmann 2009; Ruperto 2012; Torene 2017).
Canakinumab reduces inflammation by binding to interleukin-1 beta (IL-1beta) (no binding to IL-1 alpha or IL-1 receptor antagonist [IL-1ra]) and preventing interaction with cell surface receptors. Cryopyrin-associated periodic syndromes (CAPS) refers to rare genetic syndromes caused by mutations in the nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3 (NLRP-3) gene or the cold-induced autoinflammatory syndrome-1 (CIAS1) gene. Cryopyrin, a protein encoded by this gene, regulates IL-1beta activation. Deficiency of cryopyrin results in excessive inflammation.
Onset of action: Maximum effect: Within 8 days CRP and serum amyloid normalization.
Distribution: Vdss: Children: 0.097 L/kg (3.2 L in 33 kg); Adults: CAPS: 0.086 L/kg (6.01 L in 70 kg); FMF, HIDS/MKD, TRAPS: 0.09 L/kg (6.34 L in 70 kg); Gout flares: 0.085 L/kg (7.9 L in 93 kg).
Protein binding: Binds to serum IL-1 beta.
Bioavailability: Subcutaneous: 66%.
Half-life elimination: Children ≥4 years: 22.9 to 25.7 days; Adults: 26 days.
Time to peak, serum: Children ≥4 years: 2 to 7 days; Adults: ~7 days.
Clearance: Varies according to body weight:
Children ≤40 kg: SJIA: 0.11 L/day in 33 kg.
Children >40 kg and Adults: CAPS: 0.174 L/day in 70 kg.
Children, Adolescents, and Adults: FMF, HIDS/MKD, TRAPS: 0.17 L/day in 70 kg.
Adults: Gout flares: 0.23 L/day in 93 kg.
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