rilonacept (Rx)

Brand and Other Names:Arcalyst
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 220mg/vial

Cryopyrin Associated Periodic Syndromes

Indicated for cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)

Loading dose: 320 mg SC x 1 dose

Maintenance: 160 mg SC qWeek

Deficiency of Interleukin-1 Receptor Antagonist

Indicated for maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA)

4.4 mg/kg (not to exceed 320 mg) SC once weekly

Pericarditis

Indicated to treat recurrent pericarditis and to reduce risk for recurrence

Loading dose: 320 mg SC x 1 dose

Maintenance: 160 mg SC qWeek

Dosage Modifications

Renal or hepatic impairment

  • No formal studies conducted

Dosing Considerations

DIRA

  • When switching from another IL-1 blocker, discontinue IL-1 blocker and begin rilonacept at next scheduled dose

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 220mg/vial

Cryopyrin Associated Periodic Syndromes

Indicated for cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) in adults and children aged ≥12 yr

<12 years: Safety and efficacy not established

12-17 years

  • Loading dose: 4.4 mg/kg SC; not to exceed 320 mg total dose  
  • Maintenance: 2.2 mg/kg SC; not to exceed 160 mg/dose and 2 mL/injection

≥18 years

  • Loading dose: 320 mg SC once
  • Maintenance: 160 mg SC qWeek

Deficiency of Interleukin-1 Receptor Antagonist

Indicated for maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA) in adults and pediatric patients weighing ≥10 kg

≥10 kg

  • 4.4 mg/kg not to exceed 320 mg) SC once weekly

Pericarditis

Indicated to treat recurrent pericarditis and to reduce risk for recurrence in adults and children aged ≥12 yr

<12 years: Safety and efficacy not established

12-17 years

  • Loading dose: 4.4 mg/kg SC; not to exceed 320 mg total dose  
  • Maintenance: 2.2 mg/kg SC; not to exceed 160 mg/dose and 2 mL/injection

≥18 years

  • Loading dose: 320 mg SC x 1 dose
  • Maintenance: 160 mg SC qWeek

Dosage Modifications

Renal or hepatic impairment

  • No formal studies conducted

Dosing Considerations

DIRA

  • When switching from another IL-1 blocker, discontinue IL-1 blocker and begin rilonacept at next scheduled dose
Next:

Interactions

Interaction Checker

and rilonacept

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (64)

              • adalimumab

                adalimumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • alefacept

                alefacept and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anakinra

                anakinra and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • anthrax vaccine

                rilonacept 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 rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • antithymocyte globulin rabbit

                antithymocyte globulin rabbit and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • azathioprine

                azathioprine and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • baricitinib

                baricitinib, rilonacept. 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 rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • BCG vaccine live

                rilonacept decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • canakinumab

                canakinumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • certolizumab pegol

                rilonacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

              • cyclosporine

                cyclosporine and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • diphtheria & tetanus toxoids

                rilonacept decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • diphtheria & tetanus toxoids/ acellular pertussis vaccine

                rilonacept 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

                rilonacept 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

                etanercept and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • everolimus

                everolimus and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • glatiramer

                glatiramer and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • golimumab

                golimumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • hepatitis A vaccine inactivated

                rilonacept 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

                rilonacept 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

                rilonacept decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • hepatitis b vaccine

                rilonacept decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • human papillomavirus vaccine, nonavalent

                rilonacept 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

                rilonacept 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

                hydroxychloroquine sulfate and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • infliximab

                infliximab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza virus vaccine quadrivalent

                rilonacept 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

                rilonacept 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

                rilonacept 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

                rilonacept 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

                rilonacept 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

                rilonacept 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

                rilonacept decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • leflunomide

                leflunomide and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • measles (rubeola) vaccine

                rilonacept 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

                rilonacept 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

                rilonacept 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

                rilonacept 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

                muromonab CD3 and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • mycophenolate

                mycophenolate and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • pneumococcal vaccine 13-valent

                rilonacept decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine heptavalent

                rilonacept decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • pneumococcal vaccine polyvalent

                rilonacept decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rabies vaccine

                rilonacept decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

              • rabies vaccine chick embryo cell derived

                rilonacept decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rotavirus oral vaccine, live

                rilonacept decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • rubella vaccine

                rilonacept decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • sirolimus

                rilonacept and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • smallpox (vaccinia) vaccine, live

                rilonacept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tacrolimus

                rilonacept and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • temsirolimus

                rilonacept and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tetanus toxoid adsorbed or fluid

                rilonacept 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

                rilonacept decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • tocilizumab

                tocilizumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tongkat ali

                rilonacept and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • travelers diarrhea and cholera vaccine inactivated

                rilonacept 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

                rilonacept decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • typhoid vaccine live

                rilonacept decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • ustekinumab

                rilonacept and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • varicella virus vaccine live

                rilonacept decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • yellow fever vaccine

                rilonacept decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              • zoster vaccine live

                rilonacept decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

              Monitor Closely (22)

              • astragalus

                rilonacept increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • belatacept

                belatacept and rilonacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • denosumab

                rilonacept, 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

                rilonacept increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fingolimod

                rilonacept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • haemophilus influenzae type b vaccine

                rilonacept 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

                rilonacept 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

                rilonacept decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

              • isavuconazonium sulfate

                rilonacept and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • maitake

                rilonacept increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • meningococcal group B vaccine

                rilonacept 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.

              • methotrexate

                methotrexate and rilonacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Combination may increase risk of myelosuppression.

              • ocrelizumab

                rilonacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.

              • ofatumumab SC

                ofatumumab SC, rilonacept. 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

                rilonacept 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.

              • ozanimod

                ozanimod, rilonacept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

              • poliovirus vaccine inactivated

                rilonacept decreases effects of poliovirus vaccine inactivated 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. .

              • siponimod

                siponimod and rilonacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                rilonacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, rilonacept. 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, rilonacept. 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

                rilonacept decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

                Previous
                Next:

                Adverse Effects

                >10%

                Injection site reactions (48%)

                Infections (34-48%)

                Upper respiratory tract infections (26%)

                1-10%

                Cough (9%)

                Hypoesthesia (9%)

                Sinusitis (9%)

                <1%

                Hypersensitivity reaction

                Neutropenia

                Previous
                Next:

                Warnings

                Contraindications

                None

                Cautions

                Hypersensitivity reactions reported but rare; if hypersensitivity reaction occurs, discontinue treatment and initiate appropriate therapy

                Monitor for changes in lipid profiles and treat appropriately

                Immunosuppressants increase the risk of malignancies

                Increases in non-fasting lipid profile parameters reported; monitor patients’ lipid profiles and consider lipid-lowering therapies if needed, based on cardiovascular risk factors and current guidelines

                Infections

                • Interleukin-1 blockade may interfere with immune response to infections
                • Serious, life-threatening infections reported
                • Discontinue treatment with if serious infection develops
                • Do not initiate in patients with active or chronic infections

                Drug interaction overview

                • Live vaccines
                  • Do not give live vaccines concurrently with rilonacept
                  • Before initiation, patients should receive all recommended vaccinations
                • TNF-blocking agent and IL-1 blocking agent
                  • Not recommended
                  • Coadministration of drug that blocks IL-1 with a TNF-blocking agent associated with increased risk of serious infections and neutropenia
                • CYP450 substrates
                  • Monitor therapeutic effect or drug concentration of CYP450 substrates with narrow therapeutic index; adjust dose accordingly
                  • Increased levels of cytokines (eg, IL-1) suppress formation of CYP450 enzymes during chronic inflammation
                  • Rilonacept may normalize the formation of these cytokines
                  • May affect CYP450 substrates with narrow therapeutic indexes
                Previous
                Next:

                Pregnancy & Lactation

                Pregnancy

                Data are insufficient on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

                Animal data

                • Increased incidences of lumbar ribs, a skeletal variation, were observed in fetuses at doses ~2x the maximum recommended human dose (MRHD) and higher that slightly exceeded incidences in both control animals and the historical control database
                • Multiple fusion and absence of the ribs and thoracic vertebral bodies and arches in one fetus of the only pregnant monkey with drug exposure found during the later period of gestation associated with a dose ~6x the MRHD

                Disease-associated maternal and/or embryofetal risk

                Published data suggest that increased maternal levels of interleukin (IL)-1beta, which induces inflammation that occurs in CAPS, may be associated with preterm birth

                Lactation

                There is no information on presence in either human or animal milk, effects on breastfed infants, or effects on milk production

                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.

                Previous
                Next:

                Pharmacology

                Mechanism of Action

                Blocks interleukin-1alpha (IL-1alpha) and IL-1beta signaling by acting as a soluble decoy receptor that binds IL-1 alpha and beta and prevents interactions with cell surface receptors

                CAPS

                • Inflammation in CAPS is associated with mutations in the NLRP-3 gene which encodes the protein cryopyrin, an important component of inflammasome
                • Cryopyrin regulates the protease caspase-1 and controls the activation of IL-1beta; mutations in NLRP-3 result in an overactive inflammasome resulting in excessive release of activated IL-1beta that drives inflammation

                DIRA

                • Autoinflammatory, autosomal recessive disorder caused by loss of function mutations in the IL1RN gene, which encodes IL-1 receptor antagonist, resulting in unopposed signaling of the proinflammatory cytokines IL-1alpha and IL-1beta through the IL-1 receptor
                • Blocks IL-1beta signaling by acting as a soluble decoy receptor that binds IL-1beta and prevents its interaction with cell surface receptors
                • Also binds IL-1alpha and IL-1ra with reduced affinity

                Pericarditis

                • Interleukin-1 (IL-1) is a key cytokine that mediates the pathophysiology of many inflammatory processes, and it has been implicated as a causative factor in pericarditis
                • IL-1alpha and IL-1beta bind to the universally expressed cell surface receptor, IL-1 Receptor type-1, triggering a cascade of inflammatory mediators
                • Preformed IL-1alpha is released by damaged/inflamed pericardial cells and may contribute to the maintenance and amplification of inflammation via activation of the NLRP3 inflammasome, which then augments the inflammatory response by production of IL-1beta in a cascade amplification system

                Absorption

                Steady-state reached at 6 weeks

                Mean trough levels (steady-state) in pediatric patients with DIRA: 63.5-74 mg/mL

                Previous
                Next:

                Administration

                SC Preparation

                Reconstitute with 2.3 mL sterile water for injection yielding 80 mg/mL solution

                Shake reconstituted vial for ~1 minute and then allow it to sit for 1 minute

                Use within 3 hr of reconstitution

                SC Administration

                SC use only

                Visually inspect reconstituted vial(s) for any discoloration or particulate matter; solution is viscous, clear, and colorless to pale yellow

                Withdraw dose, up to 160 mg (2 mL); with a new 27-gauge, 0.5-inch needle attached to a new 3-mL syringe

                For a 320-mg dose, deliver dose as 2 SC injections of 160-mg each on the same day at 2 different sites

                Do not administer more often than once weekly

                Single-use only vials; discard vial after withdrawal of drug

                Rotate injection sites (eg, abdomen, thigh, upper arm)

                Do not inject in area that is bruised, red, tender, or hard

                Storage

                Does not contain preservatives

                Unopened vials

                • Refrigerate at 2-8ºC (36-46ºF) in original container to protect from light
                • Do not use beyond stamped date on vial

                Reconstituted vials

                • Store at room temperature for up to 3 hr
                • Protect from light
                • Discard any unused portions
                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Arcalyst subcutaneous
                -
                220 mg vial

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                Patient Education
                rilonacept subcutaneous

                RILONACEPT - INJECTION

                (ri-LON-a-sept)

                COMMON BRAND NAME(S): Arcalyst

                USES: This medication is used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Rilonacept works by blocking a certain natural protein in your body (interleukin-1) that may worsen the symptoms of CAPS. Rilonacept does not cure CAPS, but it can help lessen the symptoms, including rash, joint pain, fever, and tiredness.This medication is also used to treat a condition of a lack of the natural protein interleukin-1 receptor antagonist (Deficiency of Interleukin-1 Receptor Antagonist-DIRA).Rilonacept is also used to treat a certain type heart disease (recurrent pericarditis). This medication reduces the risk of the heart disease from coming back.

                HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using rilonacept and each time you get a refill.Inject this medication under the skin, usually once weekly or as directed by your doctor. Dosage is based on your age, weight, medical condition, and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. The mixed medication should be thick, clear, and colorless to pale yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. 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.Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor promptly if you develop any signs of an infection, such as worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, or cold/flu symptoms. (See also Precautions section.)This medication can affect the amount of cholesterol and other fats (lipids) in your blood. Your doctor may periodically order laboratory tests to monitor this side effect and prescribe treatment if needed.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 rilonacept, 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: breathing problems (e.g., asthma), cancer, cuts or open sores, diabetes, immune system problems (e.g., HIV infection), current/recent/returning infection (including hepatitis and tuberculosis).Rilonacept can make you more likely to get infections or may worsen any current infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (e.g., chickenpox, flu).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: anti-cancer drugs, corticosteroids, live vaccines (e.g., polio vaccine taken by mouth, flu vaccine inhaled through the nose), drugs that block tumor necrosis factor-TNF (e.g., adalimumab, etanercept, infliximab), other drugs that block interleukin-1 (e.g., anakinra).

                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 (e.g., cholesterol, C-reactive protein, serum amyloid A) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, use it as soon as you remember if it is more than 24 hours before your next scheduled dose. If it is less than 24 hours before the next scheduled dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store the unmixed drug in the original container in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. After mixing, store at room temperature away from light. Use within 3 hours of mixing, and discard any unused portion. Do not store in the bathroom. Keep all medications away from children and pets.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.

                Information last revised September 2021. 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.

                Previous
                Next:

                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.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.