Most recent update(s): The National Institute of Health’s COVID-19 guidelines state there are insufficient data to recommend for or against the use of interleukin (IL)-1 inhibitors, such as anakinra, for the treatment of COVID-19.
As part of our response to the evolving COVID-19 pandemic, published literature and guidelines from major health organizations are continuously monitored for potential content updates. At this time, only investigational medications with data determined to be of relatively high quality and/or consistently showing positive clinical outcomes to support dosing recommendations will be included in the Lexicomp monograph, outside of this Special Alert field.
Further information may be found at:
NIH COVID-19 Treatment Guidelines: https://www.covid19treatmentguidelines.nih.gov/
IDSA COVID-19 Treatment Guidelines: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/
Clinicaltrials.gov: https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=anakinra&cntry=&state=&city=&dist=
Deficiency of interleukin-1 receptor antagonist: SUBQ: Initial: 1 to 2 mg/kg daily; adjust dose in 0.5 to 1 mg/kg increments as needed to a maximum of 8 mg/kg daily.
Neonatal-onset multisystem inflammatory disease: SUBQ: Initial: 1 to 2 mg/kg daily in 1 to 2 divided doses; adjust dose in 0.5 to 1 mg/kg increments as needed; usual maintenance dose: 3 to 4 mg/kg daily (maximum: 8 mg/kg daily). Note: Once-daily administration is preferred; however, the dose may also be divided and administered twice daily.
Familial Mediterranean fever (off-label use): SUBQ: 100 mg once daily (Ben-Zvi 2017)
Gout, treatment (acute flares) (alternative agent) (off-label use):
Note: Reserve use for patients in whom first-line therapies are ineffective, contraindicated, or not tolerated (ACR [FitzGerald 2020]; EULAR [Richette 2017]).
SUBQ: 100 mg once daily until symptom improvement; usual duration: 3 to 5 days (EULAR [Richette 2017]; Ghosh 2013; Janssen 2019; Saag 2021; So 2007).
Pericarditis (recurrent) (off-label use): SUBQ: 100 mg once daily. Dosing based on limited data with treatment periods up to 6 months (Brucato 2016; Cantarini 2010). Additional data is necessary to further define the role of anakinra in the treatment of this condition.
Rheumatoid arthritis: SUBQ: 100 mg once daily (administer at approximately the same time each day).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute or end-stage renal disease (ESRD): Consider administering the prescribed dose every other day.
Hemodialysis: Not dialyzable (<2.5%)
Continuous ambulatory peritoneal dialysis (CAPD): Not dialyzable (<2.5%)
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Anakinra: Pediatric drug information")
Deficiency of interleukin-1 receptor antagonist (DIRA): Infants, Children, and Adolescents: SubQ: Initial: 1 to 2 mg/kg/dose once daily; may titrate in 0.5 to 1 mg/kg increments up to a maximum dose of 8 mg/kg/dose to achieve control of active inflammation (Aksentijevich 2009; Reddy 2009; manufacturer's labeling).
Familial Mediterranean Fever; colchicine-resistant: Limited data available: Children ≥2 years and Adolescents: SubQ: 1 to 2 mg/kg/dose once daily; dose, frequency, and duration of therapy were adjusted as needed based on clinical response; reported range: 1 to 5 mg/kg/dose; maximum dose: 100 mg/dose. One center has reported transitioning to less frequent doses (every other day) in patients who remain attack-free for 6 months; on-demand treatment during times of specific triggers (eg, menstrual cycle) has also been reported (Eroglu 2015; Kurt 2020; Sag 2020).
Juvenile idiopathic arthritis (JIA): Limited data available:
Systemic-onset JIA (SOJIA): Children and Adolescents: SubQ: Initial: 1 to 2 mg/kg/dose once daily; maximum initial dose: 100 mg; if no response, may titrate typically at 2-week intervals by doubling dose up to 4 mg/kg/dose once daily; maximum dose: 200 mg (Dewitt 2012; Gattorno 2006; Hedrich 2012; Irigoyen 2006; Lequerré 2008; Nigrovi 2011; Quartier 2011). Anakinra was shown efficacious as first-line monotherapy in single-center, prospective cohort trial including 42 pediatric patients (median age: 7.1 years); dosing was initiated at 2 mg/kg/dose if after 3 days fever remained the dose was increased to 4 mg/kg/dose (Ter Haar 2019).
Polyarticular course JIA: Children ≥2 years and Adolescents: SubQ: 1 mg/kg once daily; maximum dose: 100 mg (Ilowite 2009; Reiff 2005).
Kawasaki disease, refractory to intravenous immunoglobulin (IVIG): Limited data available; optimal dose, timing, and duration of anakinra therapy has not been defined.
Infants ≥3 months weighing ≥5 kg to <8 months weighing <10 kg: SubQ: Initial: 4 mg/kg/dose once daily; if fever persisted or recurred 24 hours after previous anakinra dose, the dose was increased in 2 mg/kg increments; maximum daily dose: 8 mg/kg/day; anakinra was continued for 14 days total of anakinra therapy (Koné-Paut 2021).
Infants ≥8 months, Children, and Adolescents weighing ≥10 kg: SubQ: Initial: 2 mg/kg/dose once daily; if fever persisted or recurred 24 hours after previous anakinra dose, the dose was increased in 2 mg/kg increments; maximum daily dose: 6 mg/kg/day;anakinra was continued for 14 days total of anakinra therapy (Koné-Paut 2021).
Dosing based on the largest trial (KAWAKINRA study), a phase 2, open-labeled, multicenter trial evaluating 16 patients (median age: 31 months; range: 3 to 83 months), which initiated anakinra for recurrent or persistent fever 48 hours after the last dose of IVIG; after the last escalation of dose, 87.5% in the per protocol group were afebrile and 75% in the intent-to-treat group (Koné-Paut 2021).
Reported dosing from smaller case series and reports: 1 to 10 mg/kg/day in 1 to 2 divided doses; in several reports, doses were initiated at the low to mid-range (1 to 6 mg/kg) and titrated based on response and subsequently tapered to discontinued therapy; the duration of therapy variable, up to 180 days has been reported (AHA [McCrindle 2017]; Blonz 2020; Cohen 2012; Ferrara 2020; Gambacorta 2020; Sánchez-Manubens 2017; Shafferman 2014).
Multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2: Very limited data available, optimal regimen and place in therapy not well established:
Note: Use is based on limited experience in patients with MIS-C, extrapolation from other disease states, expert opinion, and case reports in adults (AAP 2020; ACR [Henderson 2020]; Aronoff 2020; Elias 2020; Hennon 2020). As data and experience continue to rapidly evolve, dosing will be updated as appropriate.
Infants, Children, and Adolescents: IV, SubQ: 2 to 10 mg/kg/day in divided doses every 6 to 12 hours; doses up to 13 mg/kg/day have been described (AAP 2020; ACR [Henderson 2020]; Chiotos 2020; Lee 2020); duration dependent upon clinical course, tapering over 3 weeks has been suggested (AAP 2020). Note: While poorly documented, the IV route has been suggested in MIS-C recommendations, particularly in patients requiring high doses or who have bleeding concerns, subcutaneous skin conditions, or neurologic comorbidities (Mehta 2020). Dosing and use of IV route is extrapolated from other disease states (eg, macrophage activation syndrome, Kawasaki disease, secondary hemophagocytic lymphohistiocytosis), limited published experience (pediatric and adult), and expert opinion (AAP 2020; ACR [Henderson 2020]; Cavalli 2020; Dimopopoulos 2020; Eloseily 2020; Halyabar 2019; Mehta 2020; Pontali 2020).
Neonatal-onset multisystem inflammatory disease (NOMID) or chronic infantile neurological, cutaneous, and articular syndrome (CINCA) [cryopyrin-associated periodic syndromes (CAPS)]: Infants, Children, and Adolescents: SubQ: Initial: 1 to 2 mg/kg/day in 1 to 2 divided doses; adjust dose in 0.5 to 1 mg/kg increments as needed to control inflammation; usual maintenance dose: 3 to 4 mg/kg/day; maximum daily dose: 8 mg/kg/day. Note: Once-daily administration is preferred; however, the dose may also be divided and administered twice daily.
Rheumatoid arthritis: Adolescents ≥18 years: SubQ: 100 mg once daily; administer at approximately the same time each day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute:
Deficiency of interleukin-1 receptor antagonist (DIRA), neonatal-onset multisystem inflammatory disease (NOMID) (cryopyrin-associated periodic syndromes [CAPS]; chronic infantile neurological, cutaneous, and articular syndrome [CINCA]):
Infants, Children, and Adolescents: Decrease frequency of administration to every other day.
Rheumatoid arthritis: Adolescents ≥18 years: Consider 100 mg every other day.
End-stage renal disease: <2.5% of the dose is removed by hemodialysis or CAPD:
Deficiency of interleukin-1 receptor antagonist (DIRA), neonatal-onset multisystem inflammatory disease (NOMID) (cryopyrin-associated periodic syndromes [CAPS]; chronic infantile neurological, cutaneous, and articular syndrome [CINCA]):
Infants, Children, and Adolescents: Decrease frequency of administration to every other day.
Rheumatoid arthritis: Adolescents ≥18 years: 100 mg every other day.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Kineret: 100 mg/0.67 mL (0.67 mL) [contains disodium edta, polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Kineret: 100 mg/0.67 mL (0.67 mL) [contains disodium edta, polysorbate 80]
For patient self-administration, product may be obtained via the Kineret On Track program. Further information is available at https://www.kineretrx.com/hcp/kineret-on-track.php or 1-866-547-0644.
SubQ: Allow solution to warm to room temperature prior to use (30 minutes). Inject into outer area of upper arms, abdomen (do not use within 2 inches of belly button), front of middle thighs, or upper outer buttocks. Rotate injection sites; do not administer into tender, swollen, bruised, red, or hard skin or skin with scars or stretch marks. If dose is separated into 2 injections, a new syringe should be used for each dose. After proper training, patients may self-inject, or the patient's caregiver may administer anakinra.
Parenteral:
SubQ: Rotate injection sites; inject into outer area of upper arms, abdomen (do not use within 2 inches of belly button), front of middle thighs, or upper outer buttocks; injection should be given at least 1 inch away from previous injection site; do not administer into tender, swollen, bruised, red, or hard skin or skin with scars or stretch marks. Allow solution to warm to room temperature prior to use (30 minutes). Do not shake. Provided in single-use, preservative-free syringes with 27-gauge needles; discard any unused portion.
IV: Very limited data available: Administered over 1 to 3 minutes (Tremoulet 2016). Longer administration times (1 to 3 hours) may also be utilized, however, data in pediatric patients are lacking (Granowitz 1992; NIH 2020).
Deficiency of interleukin-1 receptor antagonist: Treatment of deficiency of interleukin-1 receptor antagonist.
Neonatal-onset multisystem inflammatory disease: Treatment of neonatal-onset multisystem inflammatory disease.
Rheumatoid arthritis: Reduction in signs and symptoms and slowing the progression of structural damage of moderately to severely active rheumatoid arthritis in patients 18 years of age and older who have failed 1 or more disease-modifying antirheumatic drugs.
Familial Mediterranean fever; Gout, treatment (acute flares); Pericarditis, recurrent
Anakinra may be confused with amikacin, Ampyra
Kineret may be confused with Amikin
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported for adults, unless otherwise specified.
>10%:
Gastrointestinal: Vomiting (infants, children, and adolescents: 14%)
Immunologic: Antibody development (49%; neutralizing: 2%; no correlation between antibody development and adverse effects)
Infection: Infection (39%; serious infection: 2% to 3%; including cellulitis, pneumonia, and bone and/or joint infections)
Local: Injection site reaction (adults: 71%; infants, children, and adolescents: 16%; including bruising at injection site, erythema at injection site, inflammation at injection site, pain at injection site)
Nervous system: Headache (infants, children, adolescents, and adults: 12% to 14%)
Neuromuscular & skeletal: Arthralgia (infants, children, and adolescents: 12%)
Respiratory: Nasopharyngitis (infants, children, and adolescents: 12%)
Miscellaneous: Fever (infants, children, and adolescents: 12%)
1% to 10%:
Gastrointestinal: Diarrhea (7%), nausea (8%)
Hematologic & oncologic: Decreased platelet count (2%; including severe thrombocytopenia), decreased white blood cell count (8%), eosinophilia (9%), neutropenia (infants, children, adolescents and adults: ≤5%)
<1%: Hematologic & oncologic: Malignant lymphoma, malignant melanoma, malignant neoplasm
Frequency not defined:
Dermatologic: Skin rash
Endocrine & metabolic: Hypercholesterolemia
Gastrointestinal: Gastroenteritis
Infection: Opportunistic infection
Otic: Otitis media
Respiratory: Sinusitis, upper respiratory tract infection
Postmarketing:
Dermatologic: Pruritus, urticaria
Hepatic: Hepatitis (noninfectious), increased serum transaminases
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Hypersensitivity to E. coli-derived proteins, anakinra, or any component of the formulation
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported. Patients with deficiency of interleukin-1 receptor antagonist (DIRA) may have an increased risk of allergic reactions, especially within the first few weeks of initiating therapy; monitor closely. Discontinue use if severe hypersensitivity occurs; medications for the treatment of hypersensitivity reactions should be available for immediate use.
• Infections: Associated with an increased risk of serious infections in rheumatoid arthritis studies. Anakinra should not be initiated in patients with an active infection. If a patient receiving anakinra for rheumatoid arthritis develops a serious infection, therapy should be discontinued; if a patient receiving anakinra for neonatal-onset multisystem inflammatory disease (NOMID) or DIRA develops a serious infection, the risk of a disease flare should be weighed against the risks associated with continued treatment. Safety and efficacy have not been evaluated in immunosuppressed patients or patients with chronic infections; the impact on active or chronic infections has not been determined. Immunosuppressive therapy (including anakinra) may lead to reactivation of latent tuberculosis or other atypical or opportunistic infections; test patients for latent TB prior to initiation, and treat latent TB infection prior to use.
• Injection site reactions: Injection site reactions commonly occur (within first 4 weeks of therapy) and are generally mild with a duration of 14 to 28 days.
• Malignancy: May affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma.
• Neutropenia: A decrease in neutrophil count may occur during treatment. Assess neutrophil count at baseline, monthly for 3 months, then every 3 months for up to 1 year. In a limited number of patients with NOMID, neutropenia resolved over time with continued anakinra administration.
Disease-related concerns:
• Asthma: Use with caution in patients with asthma; may have increased risk of serious infection.
• Renal impairment: Use caution in patients with renal impairment; extended dosing intervals (every other day) are recommended for severe renal insufficiency (CrCl <30 mL/minute) and ESRD.
Special populations:
• Elderly: Use caution due to the potential higher risk for infections.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy; live vaccines should not be given concurrently. There is no data available concerning the effects of therapy on vaccination or secondary transmission of live vaccines in patients receiving therapy.
Reactivation of TB has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test, and ≥5 years of age: IGRA [interferon gamma release assay]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016])
None known.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Anti-TNF Agents: May enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination
Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Canakinumab: Interleukin-1 Receptor Antagonist may enhance the adverse/toxic effect of Canakinumab. Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Risk D: Consider therapy modification
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Based on limited information, use of anakinra may be continued through conception in women with rheumatic and musculoskeletal diseases who are planning a pregnancy and not able to use alternative therapies; use should be discontinued once pregnancy is confirmed. Conception should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).
Based on limited information, use of anakinra may be continued in males with rheumatic and musculoskeletal diseases who are planning to father a child (ACR [Sammaritano 2020]).
Information related to the use of anakinra during pregnancy is limited (Berger 2009; Chang 2014; Duman 2019; İlgen 2017; Ozdogan 2019; Smith 2018; Youngstein 2017).
Until additional information is available, anakinra is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy. Anakinra should be discontinued once pregnancy is confirmed (ACR [Sammaritano 2020]).
Women exposed to anakinra during pregnancy may contact the Organization of Teratology Information Services (OTIS), Rheumatoid Arthritis and Pregnancy Study at 1-877-311-8972.
It is not known if anakinra is present in breast milk. Endogenous interleukin-1 receptor antagonist can be found in breast milk (Buescher 1996).
Adverse events have not been observed in breastfeeding infants following maternal use of anakinra (Berger 2009; Chang 2014; Duman 2019; Youngstein 2017). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Concentrations of anakinra are expected to be limited in breast milk due to large molecular weight. Also, because anakinra is unlikely to be absorbed by the infant gastrointestinal tract following exposure via breast milk, treatment with anakinra may be initiated in breastfeeding women with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).
CBC with differential (baseline, then monthly for 3 months, then every 3 months for a period up to 1 year); TB test (baseline); serum creatinine; signs/symptoms of infection
Antagonist of the interleukin-1 (IL-1) receptor. Endogenous IL-1 is induced by inflammatory stimuli and mediates a variety of immunological responses, including degradation of cartilage (loss of proteoglycans) and stimulation of bone resorption.
Bioavailability: SubQ: 95%
Half-life elimination: Terminal: 4 to 6 hours; Severe renal impairment (CrCl <30 mL/minute): ~7 hours; ESRD: 9.7 hours (Yang 2003)
Time to peak: SubQ: 3 to 7 hours
Renal function impairment: Mean plasma clearance in patients with mild (CrCl 50 to 80 mL/minute), moderate (CrCl 30 to 49 mL/minute), severe (CrCl <30 mL/minute), and end-stage renal disease (ESRD) was decreased by 16%, 50%, 70%, and 75%, respectively.
Solution Prefilled Syringe (Kineret Subcutaneous)
100 mg/0.67 mL (per 0.67 mL): $204.47
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