Version October 2024
Cryopyrin-associated periodic syndromes: SUBQ:
Initial: 320 mg given as 2 separate injections (160 mg [2 mL] per injection) on the same day at 2 different sites.
Maintenance: 160 mg once weekly. Note: Begin maintenance dose 1 week following loading dose; do not administer more frequently than once weekly.
Missed doses: If a once-weekly dose is missed, administer dose within 7 days from the missed dose and resume original schedule. If dose is not administered within 7 days, start a new schedule based on date administered.
Deficiency of interleukin-1 receptor antagonist: SUBQ: 320 mg once weekly given as 2 separate injections (160 mg [2 mL] per injection) on the same day at 2 different sites.
Switching from another interleukin-1 blocker: Discontinue the interleukin-1 blocker and begin rilonacept at the time of the next scheduled dose.
Pericarditis (recurrent): SUBQ:
Initial: 320 mg given as 2 separate injections (160 mg [2 mL] per injection) on the same day at 2 different sites.
Maintenance: 160 mg once weekly. Note: Begin maintenance dose 1 week following loading dose; do not administer more frequently than once weekly.
Missed doses: If a once-weekly dose is missed, administer dose within 7 days from the missed dose and resume original schedule. If dose is not administered within 7 days, start a new schedule based on date administered.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Rilonacept: Pediatric drug information")
Cryopyrin-associated periodic syndromes (CAPS):
Children ≥12 years and Adolescents ≤17 years:
Initial: SubQ: Loading dose 4.4 mg/kg; maximum dose: 320 mg/dose; Note: Loading dose may be divided into 1 or 2 separate injections administered on same day at different sites; maximum injection volume: 2 mL (160 mg) per injection.
Maintenance dose: Begin 1 week after loading dose: SUBQ: 2.2 mg/kg/dose once weekly; maximum dose: 160 mg/dose; Note: Do not administer more frequently than once weekly.
Adolescents ≥18 years:
Initial: Loading dose: 320 mg administered as 2 separate injections (160 mg each) on the same day at different sites.
Maintenance: Begin 1 week after loading dose: 160 mg once weekly; Note: Do not administer more frequently than once weekly.
Deficiency of interleukin-1 receptor antagonist (DIRA); remission maintenance: Children weighing ≥10 kg and Adolescents: SUBQ: 4.4 mg/kg/dose once weekly administered as 1 or 2 separate injections on the same day at different sites; maximum dose: 320 mg/dose; maximum injection volume: 2 mL (160 mg) per injection.
Switching from another interleukin-1 blocker: Discontinue the interleukin-1 blocker and begin rilonacept at the time of the next scheduled dose.
Pericarditis, recurrent: Note: In clinical trials, patients were weaned off their current standard pericarditis therapy (eg, NSAIDS, oral glucocorticoids, colchicine) over a 9-week period once rilonacept therapy initiated (Klein 2021).
Children ≥12 years and Adolescents ≤17 years:
Initial: SUBQ: Loading dose: 4.4 mg/kg; maximum dose: 320 mg/dose; Note: Loading dose may be divided into 1 or 2 separate injections administered on same day at different sites; maximum injection volume: 2 mL (160 mg) per injection.
Maintenance dose: Begin 1 week after loading dose: SUBQ: 2.2 mg/kg/dose once weekly; maximum dose: 160 mg/dose; Note: Do not administer more frequently than once weekly; maximum injection volume: 2 mL (160 mg) per injection.
Adolescents ≥18 years:
Initial: SUBQ: Loading dose: 320 mg given as 2 separate injections (160 mg each) on the same day at different sites.
Maintenance: SUBQ: Begin 1 week after loading dose: 160 mg once weekly. Note: Do not administer more frequently than once weekly.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Immunologic: Antibody development (35%; neutralizing: 26%, no correlation of antibody activity was seen on clinical effectiveness or safety)
Infection: Infection (34% to 48%; including serious infection)
Local: Injection site reaction (48%; including bleeding at injection site, bruising at injection site, discomfort at injection site, erythema at injection site, inflammation at injection site, injection site blister formation, injection site pruritus, localized edema, pain at injection site, rash at injection site, residual mass at injection site, swelling at injection site, urticaria at injection site, warm sensation at injection site)
Respiratory: Upper respiratory tract infection (26%)
1% to 10%:
Nervous system: Hypoesthesia (9%)
Respiratory: Cough (9%), sinusitis (9%)
<1%:
Hypersensitivity: Hypersensitivity reaction
Respiratory: Bronchitis
Frequency not defined:
Endocrine & metabolic: Increased HDL cholesterol, increased LDL cholesterol, increased serum cholesterol, increased serum triglycerides
Gastrointestinal: Colitis, gastrointestinal hemorrhage
Infection: Mycobacterium infection (Mycobacterium intracellulare)
Nervous system: Bacterial meningitis (Streptococcus pneumoniae)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: May cause rare hypersensitivity reactions; discontinue use and initiate appropriate therapy if reaction occurs.
• Infections: Serious infections have been reported. 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. May increase risk of reactivation of tuberculosis (TB) infection (latent TB); follow current guidelines for evaluation and treatment of TB infection prior to initiating rilonacept therapy.
• Malignancy: Use may impair defenses against malignancies; impact on the development and course of malignancies is not fully defined.
Disease-related concerns:
• Hyperlipidemia: Use may increase nonfasting total cholesterol, HDL, LDL, and triglycerides. Periodic assessment of lipid profile should occur. Initiation of lipid-lowering therapy may be necessary.
Concurrent drug therapy issues:
• Tumor necrosis factor (TNF)-blocking agents: Should not be used in combination with TNF-antagonists. There is an increased risk of serious infection.
Other warnings/precautions:
• Immunizations: 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; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy. Administration of inactivated (killed) vaccines while on therapy may not be effective.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Subcutaneous:
Arcalyst: 220 mg (1 ea) [contains polyethylene glycol (macrogol)]
Solution Reconstituted, Subcutaneous [preservative free]:
Arcalyst: 220 mg (1 ea [DSC]) [contains polyethylene glycol (macrogol)]
No
Solution (reconstituted) (Arcalyst Subcutaneous)
220 mg (per each): $6,780.86
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.
SUBQ: The initial injection should be performed under the supervision of a health care professional. Rotate injection sites (thigh, abdomen, upper arm); injections should never be made at sites that are bruised, red, tender, or hard. If 2 injections are necessary to complete the dose, administer at different injection sites on the same day. Discard any unused portion.
Parenteral: SUBQ: Administer subcutaneously using a 26-gauge, ½-inch needle; rotate injection sites (thigh, abdomen, upper arm); avoid sites that are bruised, red, tender, or hard. If total dose exceeds 2 mL, dose should be divided into 2 injections administered at different sites on the same day. Discard any unused portion.
Missed dose: Recurrent pericarditis: If a once-weekly dose is missed, administer dose within 7 days from the missed dose and resume original schedule. If dose is not administered within 7 days, administer the dose, and start a new schedule based on date administered.
Cryopyrin-associated periodic syndromes: Treatment of cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome in adults and pediatric patients ≥12 years of age.
Deficiency of interleukin-1 receptor antagonist: Maintenance of remission of deficiency of interleukin-1 receptor antagonist in adults and pediatric patients weighing ≥10 kg.
Pericarditis, recurrent: Treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients ≥12 years of age.
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.
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 Rilonacept. 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
Canakinumab: Interleukin-1 Inhibitors may enhance the adverse/toxic effect of Canakinumab. 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
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
Information related to the use of rilonacept in pregnancy is very limited.
It is not known if rilonacept is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
CBC with differential, lipid profile, C-reactive protein (CRP), serum amyloid A; signs of infection
Rilonacept is an interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) cytokine trap that reduces inflammation by blocking IL-1 signaling by acting as a soluble decoy receptor that binds IL-1α, IL-1β, and interleukin-1 receptor antagonist (IL-1ra).
Onset of action:
Cryopyrin-associated periodic syndromes: Symptomatic improvement within several days; serum amyloid A and C-reactive protein levels decreased to normal range within 6 weeks.
Pericarditis: Median: 5 days (improvement in pain scores and reduction in C-reactive protein).
Half-life elimination:
Cryopyrin-associated periodic syndromes: 8.6 days (Miyamae 2012).
Pericarditis: ~7 days.
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