Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (71)
- 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.
- axicabtagene ciloleucel
rilonacept, axicabtagene ciloleucel. Either increases effects of the other by 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.
- brexucabtagene autoleucel
rilonacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- ciltacabtagene autoleucel
rilonacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- idecabtagene vicleucel
rilonacept, idecabtagene vicleucel. Either increases effects of the other by 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.
- lisocabtagene maraleucel
rilonacept, lisocabtagene maraleucel. Either increases effects of the other by 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.
- tisagenlecleucel
rilonacept, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- upadacitinib
rilonacept, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- 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 (24)
- 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. .
- rozanolixizumab
rilonacept will decrease the level or effect of rozanolixizumab by plasma protein binding competition. Use Caution/Monitor. Rozanolixizumab may lower systemic exposures and reduce effectiveness of medications that bind to the human neonatal Fc receptor (FcRn). Closely monitor for decreased efficacy of such medications. When long-term use of such medications is required, consider discontinuing rozanolixizumab and using alternative therapies.
- 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.
- ublituximab
ublituximab and rilonacept both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- zoster vaccine recombinant
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)
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
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
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Arcalyst subcutaneous - | 220 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 if available from your pharmacist before you start using rilonacept and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Inject this medication under the skin as directed by your doctor, usually once weekly. The 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 last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).This medication can affect the amount of cholesterol and other fats (lipids) in your blood. Your doctor may periodically order lab 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 (such as asthma), cancer, cuts or open sores, diabetes, immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis).Rilonacept can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using rilonacept before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anti-cancer drugs, corticosteroids, drugs that block tumor necrosis factor-TNF (such as adalimumab, etanercept, infliximab), other drugs that block interleukin-1 (such as 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.Lab and/or medical tests (such as cholesterol, C-reactive protein, serum amyloid A) may be done while you are using this medication. Keep all medical and lab appointments. 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 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 August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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.
