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Anakinra: Pediatric drug information

Anakinra: Pediatric drug information
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For additional information see "Anakinra: Drug information" and "Anakinra: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Kineret
Brand Names: Canada
  • Kineret
Therapeutic Category
  • Antirheumatic, Disease Modifying;
  • Interleukin-1 Receptor Antagonist
Dosing: Pediatric
Deficiency of interleukin-1 receptor antagonist

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 (Ref).

Familial Mediterranean fever; colchicine resistant

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 (Ref).

Hemophagocytic lymphohistiocytosis, secondary or macrophage activation syndrome

Hemophagocytic lymphohistiocytosis, secondary or macrophage activation syndrome (sHLH/MAS): Limited data available:

Infants, Children, and Adolescents: IV, SUBQ: 2 to 10 mg/kg/day in divided doses every 6 to 12 hours as part of appropriate combination therapy until clinical response/remission is achieved; IV doses up to 20 mg/kg/day have been described (Ref). Note: Initiation of anakinra therapy soon after hospitalization (ie, within 5 days) was associated with earlier defervescence and decreased mortality in a retrospective review of 44 pediatric patients (Ref).

Juvenile idiopathic arthritis

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 (Ref). 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 (Ref).

Polyarticular course JIA: Children ≥2 years and Adolescents: SUBQ: 1 mg/kg once daily; maximum dose: 100 mg (Ref).

Kawasaki disease, refractory to IVIG

Kawasaki disease, refractory to 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 (Ref).

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 (Ref).

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 (Ref).

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 (Ref).

Multisystem inflammatory syndrome in children associated with SARS-CoV-2

Multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2: Very limited data available: Note: Recommended for intensification therapy in patients who do not improve within 24 hours of initial MIS-C therapy (ie, immune globulin and methylprednisolone); do not use in combination with infliximab (Ref).

Infants, Children, and Adolescents: IV, SUBQ: 5 to 10 mg/kg/day in 1 to 4 divided doses (Ref); duration varies and is dependent upon clinical course; tapering over at least 2 to 3 weeks has been suggested (Ref). Note: While poorly documented, the IV route may be preferred for MIS-C (Ref).

Neonatal-onset multisystem inflammatory disease or chronic infantile neurological, cutaneous, and articular syndrome

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

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.

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adult

(For additional information see "Anakinra: Drug information")

Behçet disease, mucocutaneous, refractory

Behçet disease, mucocutaneous, refractory (adjunctive agent) (off-label use): SUBQ: Initial: 100 mg once daily in combination with other immunosuppressants (eg, corticosteroids); if ulcers persist, may increase to 200 mg once daily after 1 month and further increase to 300 mg once daily after 6 months (Ref).

Calcium pyrophosphate crystal deposition disease

Calcium pyrophosphate crystal deposition disease (ie, pseudogout) (alternative agent) (off-label use): SUBQ: 100 mg once daily. Usual duration of therapy for acute attacks is ~3 to 9 days; however, some patients may require long-term treatment to control symptoms after the acute attack (Ref).

COVID-19, hospitalized patients

COVID-19, hospitalized patients (off-label use): Note: For patients requiring supplemental oxygen who are at risk for progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (Ref).

SUBQ: 100 mg once daily for 10 days (Ref).

Cytokine storm syndrome

Cytokine storm syndrome (adjunctive agent) (off-label use):

Note: The IV route is preferred for doses >2 mg/kg/day or >100 mg/day, or in patients with platelets <20 × 109/L, presence of significant skin edema, or neurological symptoms (Ref).

IV (off-label route): 2 mg/kg/hour as a continuous infusion for up to 72 hours, or 2 to 10 mg/kg/day in 2 to 4 divided doses; use in combination with corticosteroids (Ref).

SUBQ: 2 to 10 mg/kg/day in 2 to 4 divided doses; use in combination with corticosteroids (Ref).

Deficiency of interleukin-1 receptor antagonist

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

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

Familial Mediterranean fever (off-label use): SUBQ : 100 mg once daily (Ref)

Gout, treatment

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 (Ref).

SUBQ: 100 mg once daily until symptom improvement; usual duration: 3 to 5 days (Ref).

Pericarditis, recurrent

Pericarditis, recurrent (off-label use): SUBQ: 100 mg once daily. Usual duration of therapy is ~6 months followed by a taper (Ref).

Rheumatoid arthritis

Rheumatoid arthritis: SUBQ : 100 mg once daily (administer at approximately the same time each day).

Still disease, adult onset

Still disease, adult onset (alternative agent) (off-label use): SUBQ: Initial: 100 mg once daily usually in combination with other immunosuppressants (eg, corticosteroids). In patients with incomplete response, may increase to 200 mg/day in 1 or 2 divided doses (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute or end-stage renal disease:

COVID-19, hospitalized patients: Consider administering 100 mg every other day for a total of 5 doses over 10 days (Ref).

Other indications: Consider administering the prescribed dose every other day.

Hemodialysis: Not dialyzable (<2.5%)

Continuous ambulatory peritoneal dialysis (CAPD): Not dialyzable (<2.5%)

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

COVID-19 infection:

The following adverse drug reactions and incidences are derived from the FDA-issued emergency use authorization (EUA [FDA 2022]). Adverse reactions reported for adults.

>10%: Hepatic: Increased gamma-glutamyl transferase (14%), increased serum transaminases (31%)

1% to 10%:

Dermatologic: Skin rash (4%)

Endocrine & metabolic: Hyperkalemia (9%), hypernatremia (10%)

Gastrointestinal: Constipation (9%)

Hematologic & oncologic: Leukopenia (4%), neutropenia (3%)

Nervous system: Anxiety (8%), hypothermia (7%)

Renal: Acute kidney injury (6%)

Rheumatoid arthritis/neonatal-onset multisystem inflammatory disease (NOMID):

The following adverse drug reactions and incidences are derived from product labeling. Adverse reactions reported for adults unless otherwise specified.

>10%:

Gastrointestinal: Vomiting (infants, children, 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, bone and/or joint infection)

Local: Injection-site reaction (infants, children, adolescents: 16%; adults: 71%; including bruising at injection site, erythema at injection site, inflammation at injection site, pain at injection site)

Nervous system: Headache (infants, children, adolescents, adults: 12% to 14%)

Neuromuscular & skeletal: Arthralgia (infants, children, adolescents: 12%)

Respiratory: Nasopharyngitis (infants, children, adolescents: 12%)

Miscellaneous: Fever (infants, children, adolescents: 12%)

1% to 10%:

Gastrointestinal: Diarrhea (7%), nausea (8%)

Hematologic & oncologic: Decreased platelet count (2%), decreased white blood cell count (8%), eosinophilia (9%), neutropenia (infants, children, adolescents, adults: ≤5%)

<1%:

Dermatologic: Malignant melanoma

Hematologic & oncologic: Malignant lymphoma, malignant neoplasm

Frequency not defined:

Dermatologic: Skin rash

Endocrine & metabolic: Hypercholesterolemia

Gastrointestinal: Gastroenteritis

Hematologic & oncologic: Thrombocytopenia

Infection: Opportunistic infection

Otic: Otitis media

Respiratory: Sinusitis, upper respiratory tract infection

Postmarketing (any indication):

Dermatologic: Pruritus, urticaria

Hepatic: Hepatitis (noninfectious), increased serum transaminases

Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms, hypersensitivity reaction (including anaphylaxis, angioedema)

Contraindications

Hypersensitivity to E. coli-derived proteins, anakinra, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported. Severe cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms, have occurred in patients with autoinflammatory conditions. 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 immediately if severe hypersensitivity occurs; treat promptly and monitor patients until signs and symptoms resolve.

• 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 tuberculosis (TB) infection (latent TB) or other atypical or opportunistic infections; test patients for TB infection prior to initiation, and treat 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. Patients who do not experience an injection site reaction within the first 4 weeks of therapy are not likely to experience one; the incidence of injection site reactions may be lower in patients on concomitant oral corticosteroids (Kaiser 2012).

• 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:

• Renal impairment: Use caution in patients with renal impairment.

• Underlying pulmonary disease: Patients with underlying pulmonary disease (eg, asthma) may have increased risk of serious infection (Fleischmann 2003).

Concurrent drug therapy issues:

• Tumor necrosis factor inhibitors: Anakinra should not be initiated in patients receiving tumor necrosis factor–blocking agents (eg, etanercept) due to increased risk of serious infection.

Special populations:

• Older adult: Use caution due to the potential higher risk for infections.

• Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery: Hold anakinra for at least 1 day prior to surgery to reduce infection risk (ACR/AAHKS [Goodman 2022]).

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 are no data available concerning the effects of therapy on vaccination or secondary transmission of live vaccines in patients receiving therapy.

Warnings: Additional Pediatric Considerations

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])

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Kineret Subcutaneous)

100 mg/0.67 mL (per 0.67 mL): $252.82

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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]

Prescribing and Access Restrictions

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.

Administration: Pediatric

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: Administer over 1 to 3 minutes (Ref) or over 30 minutes (Ref). Longer infusion times (up to 3 hours) have been described in pharmacokinetic studies in adults (Ref).

Administration: Adult

IV (off-label route): Limited data available. Dilute prior to administration. Protect infusion bag and tubing from light during administration (Ref).

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.

Storage/Stability

Store in refrigerator at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake. Protect from light. Discard any unused portion. Extended storage information may be available; contact product manufacturer to obtain current recommendations.

IV: Protect IV bag and tubing from light (Saunders 2023). Information on storage of anakinra diluted for IV infusion is not provided in the manufacturer's labeling; refer to institutional protocols. Limited data suggest that anakinra (diluted in NS) is stable for up to 4 hours at room temperature at concentrations of 4 mg/mL and 36 mg/mL (Nahata 1995; Nahata 1997); one published protocol allows for infusion bags to be prepared for up to an 8-hour infusion when prepared within 1 hour of administration (Monteagudo 2020; Saunders 2023).

Use

Treatment of neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological cutaneous and articular syndrome (CINCA), which is a cryopyrin-associated periodic syndrome (CAPS) (FDA approved in pediatric patients [age not specified] and adults); treatment of deficiency of interleukin-1 receptor antagonist (DIRA) (FDA approved in pediatric patients [age not specified] and adults); treatment of moderately to severely active rheumatoid arthritis in patients in whom one or more disease-modifying antirheumatic drugs (DMARDs) have failed; may be used alone or in combination with DMARDs that are not tumor necrosis factor (TNF)-blocking agents (eg, etanercept, adalimumab) (FDA approved in ages ≥18 years and adults); has also been used for reducing signs and symptoms of systemic juvenile idiopathic arthritis (SJIA) and polyarticular-course juvenile idiopathic arthritis (JIA), management of patients with Kawasaki disease refractory to intravenous immunoglobulin (IVIG), treatment of multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2, treatment of Familial Mediterranean Fever, and management of hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS).

Medication Safety Issues
Sound-alike/look-alike issues:

Anakinra may be confused with amikacin, Ampyra

Kineret may be confused with Amikin

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (immunosuppressant agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs may increase immunosuppressive effects of Anifrolumab. Risk X: Avoid

Anti-TNF Agents: May increase adverse/toxic effects of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Belimumab: May increase immunosuppressive effects of Biologic Disease-Modifying Antirheumatic Drugs. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification

Biologic Disease-Modifying Antirheumatic Drugs: May increase immunosuppressive effects of Biologic Disease-Modifying Antirheumatic Drugs. Risk X: Avoid

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Canakinumab: Interleukin-1 Receptor Antagonist may increase adverse/toxic effects of Canakinumab. Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. 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 (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of 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 decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects 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

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Based on limited data, use of anakinra may be continued through conception in patients with rheumatic and musculoskeletal diseases who are planning to become pregnant 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 data, use of anakinra may be continued in patients with rheumatic and musculoskeletal diseases who are planning to father a child (ACR [Sammaritano 2020]).

Pregnancy Considerations

Outcome data related to the use of anakinra during pregnancy are limited (Berger 2009; Brien 2021; Chang 2014; Dernoncourt 2023; Duman 2019; Ghalandari 2022; İlgen 2017; Karakaş 2021; Negro 2023; Ozdogan 2019; Saad Shaukat 2023; Smith 2018; Youngstein 2017).

Until additional data are 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]). Agents other than anakinra are currently recommended for the treatment of familial Mediterranean fever during pregnancy (EULAR [Ozen 2016]).

Monitoring Parameters

Monitor improvement of symptoms and physical function assessments. Latent tuberculosis (TB) screenings prior to initiating and during therapy; signs/symptoms of infection (prior to, during, and following therapy); CBC with differential (baseline, then monthly for 3 months, then every 3 months for a period up to 1 year); serum creatinine; LFTs at baseline; hepatitis B virus (HBV) screening prior to initiating (HBV carriers should also be screened during and for several months following therapy); signs and symptoms of hypersensitivity reaction; symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss); periodic skin examination.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: 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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Kineret;
  • (AT) Austria: Kineret;
  • (AU) Australia: Kineret;
  • (BE) Belgium: Kineret;
  • (BG) Bulgaria: Kineret;
  • (CZ) Czech Republic: Kineret;
  • (DE) Germany: Kineret;
  • (EE) Estonia: Kineret;
  • (ES) Spain: Kineret;
  • (FI) Finland: Kineret;
  • (FR) France: Kineret;
  • (GB) United Kingdom: Kineret;
  • (GR) Greece: Kineret;
  • (HK) Hong Kong: Kineret;
  • (HR) Croatia: Kineret;
  • (HU) Hungary: Kineret;
  • (IE) Ireland: Kineret;
  • (IT) Italy: Kineret;
  • (KR) Korea, Republic of: Kineret;
  • (LT) Lithuania: Kineret;
  • (LU) Luxembourg: Kineret;
  • (LV) Latvia: Kineret;
  • (MY) Malaysia: Kineret;
  • (NL) Netherlands: Kineret;
  • (NO) Norway: Anakinra amgen | Kineret;
  • (NZ) New Zealand: Kineret;
  • (PL) Poland: Kineret;
  • (PR) Puerto Rico: Kineret;
  • (PT) Portugal: Kineret;
  • (QA) Qatar: Kineret;
  • (RO) Romania: Kineret;
  • (RU) Russian Federation: Kineret;
  • (SE) Sweden: Kineret;
  • (SG) Singapore: Kineret;
  • (SK) Slovakia: Kineret;
  • (TN) Tunisia: Kineret
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