Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.influenza virus vaccine trivalentSerious - Use Alternative (1)anakinra 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, adjuvantedSerious - Use Alternative (1)anakinra 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.influenza virus vaccine trivalent, recombinantMonitor Closely (1)anakinra 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 sulfateMonitor Closely (1)anakinra and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.Japanese encephalitis virus vaccineSerious - Use Alternative (1)anakinra decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.leflunomideSerious - Use Alternative (1)anakinra and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.lenalidomideContraindicated (1)anakinra increases toxicity of lenalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.lisocabtagene maraleucelSerious - Use Alternative (1)anakinra, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.lomustineMonitor Closely (1)lomustine and anakinra both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.maitakeMonitor Closely (1)anakinra increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.measles (rubeola) vaccineSerious - Use Alternative (1)anakinra 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, liveSerious - Use Alternative (1)anakinra 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, liveSerious - Use Alternative (1)anakinra 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 combinedSerious - Use Alternative (1)anakinra 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.meningococcal group B vaccineMonitor Closely (1)anakinra 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.mercaptopurineMonitor Closely (1)anakinra and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.muromonab CD3Serious - Use Alternative (1)anakinra and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.mycophenolateSerious - Use Alternative (1)anakinra and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.ocrelizumabMonitor Closely (1)anakinra 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 SCMonitor Closely (1)ofatumumab SC, anakinra. 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.olaparibMonitor Closely (1)anakinra 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. ozanimodMonitor Closely (1)ozanimod, anakinra. 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.pneumococcal vaccine 13-valentSerious - Use Alternative (1)anakinra decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.pneumococcal vaccine heptavalentSerious - Use Alternative (1)anakinra decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.pneumococcal vaccine polyvalentSerious - Use Alternative (1)anakinra decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.poliovirus vaccine inactivatedMonitor Closely (1)anakinra 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. .procarbazineSerious - Use Alternative (1)procarbazine, anakinra. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.rabies vaccineSerious - Use Alternative (1)anakinra decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.rabies vaccine chick embryo cell derivedSerious - Use Alternative (1)anakinra decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.rilonaceptSerious - Use Alternative (1)anakinra and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.rotavirus oral vaccine, liveSerious - Use Alternative (1)anakinra decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.rubella vaccineSerious - Use Alternative (1)anakinra decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.siponimodMonitor Closely (1)siponimod and anakinra 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-TMonitor Closely (1)anakinra decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.sirolimusSerious - Use Alternative (1)anakinra and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.smallpox (vaccinia) vaccine, liveSerious - Use Alternative (1)anakinra decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tacrolimusSerious - Use Alternative (1)anakinra and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.temsirolimusSerious - Use Alternative (1)anakinra and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tetanus toxoid adsorbed or fluidSerious - Use Alternative (1)anakinra decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.thalidomideContraindicated (1)anakinra increases toxicity of thalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.tick-borne encephalitis vaccineSerious - Use Alternative (1)anakinra decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tisagenlecleucelSerious - Use Alternative (1)anakinra, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.tongkat aliSerious - Use Alternative (1)anakinra and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.trastuzumabMonitor Closely (1)trastuzumab, anakinra. 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 deruxtecanMonitor Closely (1)trastuzumab deruxtecan, anakinra. 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. .travelers diarrhea and cholera vaccine inactivatedSerious - Use Alternative (1)anakinra 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 vaccineSerious - Use Alternative (1)anakinra decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.typhoid vaccine liveSerious - Use Alternative (1)anakinra decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.ublituximabMonitor Closely (1)ublituximab and anakinra 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 coadministeredupadacitinibSerious - Use Alternative (1)anakinra, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.ustekinumabSerious - Use Alternative (1)anakinra and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.varicella virus vaccine liveSerious - Use Alternative (1)anakinra decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.yellow fever vaccineSerious - Use Alternative (1)anakinra decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.zoster vaccine liveSerious - Use Alternative (1)anakinra decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.zoster vaccine recombinantMonitor Closely (1)anakinra decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant. >10% Rheumatoid arthritis Injection-site reaction (71%) Headache (12%) Neonatal-onset multisystem inflammatory disease Most common during first 6 months of treatment Injection site reaction (16.3%) Headache (14%) Vomiting (14%) Arthralgia (11.6%) Pyrexia (11.6%) Nasopharyngitis (11.6%) COVID-19 Transaminases increased (30.8%) GGT increased (13.8%) 1-10% Nausea (7%) Diarrhea (7%) COVID-19 Hypernatremia (9.6%) Constipation (9.1%) Hyperkalemia (9.1%) Anxiety (8.1%) Hypothermia (7.4%) Acute kidney injury (6.3%) Rash (3.7%) Leukopenia (3.5%) Neutropenia (3%) <1% Neutropenia (0.3%) especially with TNF antagonists Postmarketing Reports Hepatobiliary disorders: Elevated transaminases, noninfectious hepatitis Hematologic events: Thrombocytopenia, including severe thrombocytopenia (platelet count <10x 109/L) Contraindications Hypersensitivity to drug or excipients, including E coli-derived proteins Cautions Impact of treatment on active and/or chronic infections and the development of malignancies is unknown Decrease in neutrophil counts have been reported; assess neutrophil counts before initiation, monthly for 3 months during treatment, and quarterly thereafter for up to 1 year Serious infections Increased incidence of serious infections reported; if serious infection develops in RA patients, discontinue treatment Weigh continued treatment in patients with NOMID or DIRA against potential risks versus benefits Consider risks and benefits of treatment in patients with COVID-19 who have other concurrent infections Do not initiate in patients with RA, NOMID, CAPS, or DIRA who have active infections Safety and efficacy in immunosuppressed patients or in patients with chronic infections have not been evaluated Drugs that affect the immune system by blocking tumor necrosis factor (TNF) have been associated with an increased risk of reactivation of latent tuberculosis (TB); it is possible that taking drugs that block IL-1, such as this medication, increases risk of TB or other atypical or opportunistic infections; health care providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy Hypersensitivity reactions Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported If a severe hypersensitivity reaction occurs, discontinue treatment and initiate appropriate therapy Increased risk of allergic reactions may occur in patients with DIRA, especially in the initial first several weeks of treatment; closely monitor during this time period If severe allergic reaction occurs, initiate appropriate treatment and consider discontinuation Drug interaction overview Immunizations Avoid coadministration of live vaccines Data are unavailable on either effects of live vaccination or secondary transmission of infection by live vaccines in treated patients TNF-blocking agents Use not recommended with anakinra A higher rate of serious infections has been associated with concurrent treatment anakinra and etanercept therapy compared with etanercept alone Pregnancy Insufficient data available on use in pregnant females to identify a drug-associated risks of major birth defects, miscarriage, or maternal and fetal adverse events Clinical consideration Published data suggest the risk of adverse pregnancy outcomes in females with rheumatoid arthritis or CAPS is associated with increased disease activity Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (<2500 grams), and small for gestational age at birth Lactation There are no data on drug presence in either human or animal milk or effects on milk production Limited clinical data during lactation precludes a clear determination of risks to infants during lactationPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no