ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Anakinra: Drug information

Anakinra: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Anakinra: Patient drug information" and "Anakinra: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Kineret
Brand Names: Canada
  • Kineret
Pharmacologic Category
  • Antirheumatic, Disease Modifying;
  • Interleukin-1 Receptor Antagonist
Dosing: Adult
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 syndromes

Cytokine storm syndromes (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: 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: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Anakinra: Pediatric drug information")

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).

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: Hepatic Impairment: Pediatric

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 transferase (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 (NOMAD):

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, 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%:

Dermatologic: Malignant melanoma

Hematologic & oncologic: Malignant lymphoma, 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 (any indication):

Dermatologic: Pruritus, urticaria

Hepatic: Hepatitis (noninfectious), increased serum transaminases

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

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. 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 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): $236.28

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: Adult

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.

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).

Use: Labeled Indications

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 in whom 1 or more disease-modifying antirheumatic drugs have failed.

Use: Off-Label: Adult

Behçet disease, mucocutaneous, refractory; Calcium pyrophosphate crystal deposition disease (ie, pseudogout); COVID-19, hospitalized patients; Cytokine storm syndromes; Familial Mediterranean fever; Gout, treatment (acute flares); Pericarditis, recurrent; Still disease, adult onset

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.

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

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

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). 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 (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

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Canakinumab: Interleukin-1 Receptor Antagonist may enhance the adverse/toxic effect of Canakinumab. Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). 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). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

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: 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). 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

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

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

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- 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 Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

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

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

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 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 enhance the immunosuppressive effect of Ritlecitinib. 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

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

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

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 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

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]).

Breastfeeding Considerations

It is not known if anakinra is present in breast milk.

Adverse events have not been observed in breastfeeding infants following maternal use of anakinra (Berger 2009; Chang 2014; Duman 2019; Negro 2023; 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 patients with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]).

Monitoring Parameters

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; injection site reactions.

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;
  • (NL) Netherlands: Kineret;
  • (NO) Norway: Anakinra amgen | Kineret;
  • (NZ) New Zealand: Kineret;
  • (PL) Poland: Kineret;
  • (PR) Puerto Rico: Kineret;
  • (PT) Portugal: Kineret;
  • (RO) Romania: Kineret;
  • (RU) Russian Federation: Kineret;
  • (SE) Sweden: Kineret;
  • (SG) Singapore: Kineret;
  • (SK) Slovakia: Kineret;
  • (TN) Tunisia: Kineret
  1. Adler Y, Charron P, Imazio M, et al; European Society of Cardiology (ESC). 2015 ESC guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC) endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015;36(42):2921-2964. [PubMed 26320112]
  2. Aksentijevich I, Masters SL, Ferguson PJ, et al. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist. N Engl J Med. 2009;360(23):2426-2437. [PubMed 19494218]
  3. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  4. American Academy of Pediatrics (AAP). What is the case definition of multisystem inflammatory syndrome in children (MIS-C)? Updated November 15, 2021. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/multisystem-inflammatory-syndrome-in-children-mis-c-interim-guidance/
  5. Aouba A, Deshayes S, Frenzel L, et al. Efficacy of anakinra for various types of crystal-induced arthritis in complex hospitalized patients: a case series and review of the literature. Mediators Inflamm. 2015;2015:792173. doi:10.1155/2015/792173 [PubMed 25922564]
  6. Baverez C, Grall M, Gerfaud-Valentin M, et al. Anakinra for the treatment of hemophagocytic lymphohistiocytosis: 21 cases. J Clin Med. 2022;11(19):5799. doi:10.3390/jcm11195799 [PubMed 36233667]
  7. Ben-Zvi I, Kukuy O, Giat E, et al. Anakinra for colchicine-resistant familial Mediterranean fever: a randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2017;69(4):854‐862. doi:10.1002/art.39995 [PubMed 27860460]
  8. Berger CT, Recher M, Steiner U, Hauser TM. A patient's wish: anakinra in pregnancy [published correction appears in Ann Rheum Dis. 2010;69(1):28]. Ann Rheum Dis. 2009;68(11):1794‐1795. doi:10.1136/ard.2008.105833 [PubMed 19822718]
  9. Blonz G, Lacroix S, Benbrik N, et al. Severe late-onset Kawasaki disease successfully treated with anakinra. J Clin Rheumatol. 2020;26(2):e42-e43. [PubMed 32073531]
  10. Brien ME, Gaudreault V, Hughes K, Hayes DJL, Heazell AEP, Girard S. A systematic review of the safety of blocking the IL-1 system in human pregnancy. J Clin Med. 2021;11(1):225. doi:10.3390/jcm11010225 [PubMed 35011965]
  11. Brucato A, Imazio M, Gattorno M, et al. Effect of anakinra on recurrent pericarditis among patients with colchicine resistance and corticosteroid dependence: the AIRTRIP randomized clinical trial. JAMA. 2016;316(18):1906-1912. [PubMed 27825009]
  12. Callejas JL, Oliver J, Martín J, et al. Anakinra in Mutation-Negative CINCA Syndrome. Clin Rheumatol. 2007;26(4):576-577. [PubMed 16440135]
  13. Cantarini L, Lucherini OM, Cimaz R, Galeazzi M. Recurrent pericarditis caused by a rare mutation in the TNFRSF1A gene and with excellent response to anakinra treatment. Clin Exp Rheumatol. 2010;28(5):802. [PubMed 21029567]
  14. Cantarini L, Vitale A, Scalini P, et al. Anakinra treatment in drug-resistant Behcet's disease: a case series. Clin Rheumatol. 2015;34(7):1293-1301. doi:10.1007/s10067-013-2443-8 [PubMed 24305945]
  15. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm [PubMed 6423951]
  16. Chang Z, Spong CY, Jesus AA, et al. Anakinra use during pregnancy in patients with cryopyrin-associated periodic syndromes (CAPS). Arthritis Rheumatol. 2014;66(11):3227-3232. doi:10.1002/art.38811 [PubMed 25223501]
  17. Cipolletta E, Di Matteo A, Scanu A, et al. Biologics in the treatment of calcium pyrophosphate deposition disease: a systematic literature review. Clin Exp Rheumatol. 2020;38(5):1001-1007. [PubMed 32359034]
  18. Cohen S, Hurd E, Cush J, et al. Treatment of Rheumatoid Arthritis With Anakinra, a Recombinant Human Interleukin-1 Receptor Antagonist, in Combination With Methotrexate: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheum. 2002;46(3):614-624. [PubMed 11920396]
  19. Cohen S, Tacke CE, Straver B, Meijer N, Kuipers IM, Kuijpers TW. A child with severe relapsing Kawasaki disease rescued by IL-1 receptor blockade and extracorporeal membrane oxygenation. Ann Rheum Dis. 2012;71(12):2059-2061. [PubMed 22689319]
  20. Colafrancesco S, Priori R, Valesini G, et al. Response to interleukin-1 inhibitors in 140 Italian patients with adult-onset Still's disease: a multicentre retrospective observational study. Front Pharmacol. 2017;8:369. doi:10.3389/fphar.2017.00369 [PubMed 28659802]
  21. Davies HD, Committee on Infectious Disease. Infectious complications with the use of biologic response modifiers in infants and children. Pediatrics. 2016;138(2):e20161209. [PubMed 27432853]
  22. Dernoncourt A, Liabeuf S, Bennis Y, et al. Fetal and neonatal adverse drug reactions associated with biologics taken during pregnancy by women with autoimmune diseases: insights from an analysis of the World Health Organization Pharmacovigilance Database (VigiBase®). BioDrugs. 2023;37(1):73-87. doi:10.1007/s40259-022-00564-4 [PubMed 36401769]
  23. Desmarais J, Chu CQ. Utility of anakinra in acute crystalline diseases: a retrospective study comparing a university hospital with a veterans affairs medical center. J Rheumatol. 2019;46(7):748-750. doi:10.3899/jrheum.180393 [PubMed 30442822]
  24. Dewitt EM, Kimura Y, Beukelman T, et al; Juvenile Idiopathic Arthritis Disease-specific Research Committee of Childhood Arthritis Rheumatology and Research Alliance. Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2012;64(7):1001-1010. [PubMed 22290637]
  25. Diamantopoulos AP, Brodin C, Hetland H, Haugeberg G. Interleukin 1β blockade improves signs and symptoms of chronic calcium pyrophosphate crystal arthritis resistant to treatment. J Clin Rheumatol. 2012;18(6):310-311. doi:10.1097/RHU.0b013e31826149a2 [PubMed 22832289]
  26. Doaré E, Robin F, Racapé H, et al. Features and outcomes of microcrystalline arthritis treated by biologics: a retrospective study. Rheumatol Ther. 2021;8(3):1241-1253. doi:10.1007/s40744-021-00335-7 [PubMed 34218418]
  27. Duman NC, Goren MZ, Karaalp A. Anakinra use during pregnancy and lactation: A case report. Reprod Toxicol. 2019;88:139-40. doi:10.1016/j.reprotox.2019.05.029
  28. Eroglu FK, Beşbaş N, Topaloglu R, Ozen S. Treatment of colchicine-resistant Familial Mediterranean fever in children and adolescents. Rheumatol Int. 2015;35(10):1733-1737. [PubMed 26001859]
  29. Ferrara G, Giani T, Caparello MC, Farella C, Gamalero L, Cimaz R. Anakinra for treatment-resistant Kawasaki disease: evidence from a literature review. Paediatr Drugs. 2020;22(6):645-652. [PubMed 32885390]
  30. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care Res (Hoboken). 2020;72(6):744-760. doi:10.1002/acr.24180 [PubMed 32391934]
  31. Fleischmann RM, Schechtman J, Bennett R, et al. Anakinra, a Recombinant Human Interleukin-1 Receptor Antagonist (r-metHuIL-1ra), in Patients With Rheumatoid Arthritis: A Large, International, Multicenter, Placebo-Controlled Trial. Arthritis Rheum. 2003;48(4):927-934. doi:10.1002/art.10870 [PubMed 12687534]
  32. Fleischmann RM, Tesser J, Schiff MH, et al. Safety of Extended Treatment With Anakinra in Patients With Rheumatoid Arthritis. Ann Rheum Dis. 2006,65(8):1006-1012. [PubMed 16396977]
  33. Galozzi P, Bindoli S, Doria A, Sfriso P. Progress in biological therapies for adult-onset Still's disease. Biologics. 2022;16:21-34. doi:10.2147/BTT.S290329 [PubMed 35481241]
  34. Gambacorta A, Buonsenso D, De Rosa G, et al. Resolution of giant coronary aneurisms in a child with refractory Kawasaki disease treated with anakinra. Front Pediatr. 2020;8:195. [PubMed 32457855]
  35. Gattorno M, Piccini A, Lasigliè D, et al. The Pattern of Response to Anti-Interleukin-1 Treatment Distinguishes Two Subsets of Patients With Systemic-Onset Juvenile Idiopathic Arthritis. Arthritis Rheum. 2008;58(5):1505-1515. [PubMed 18438814]
  36. Genovese MC, Cohen S, Moreland L, et al. Combination Therapy With Etanercept and Anakinra in the Treatment of Patients With Rheumatoid Arthritis Who Have Been Treated Unsuccessfully With Methotrexate. Arthritis Rheum. 2004;50(5):1412-1519. [PubMed 15146410]
  37. Gerfaud-Valentin M, Maucort-Boulch D, Hot A, et al. Adult-onset still disease: manifestations, treatment, outcome, and prognostic factors in 57 patients. Medicine (Baltimore). 2014;93(2):91-99. doi:10.1097/MD.0000000000000021 [PubMed 24646465]
  38. Ghalandari N, Crijns HJMJ, Bergman JEH, Dolhain RJEM, van Puijenbroek EP, Hazes JMW. Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: a retrospective comparative study in EudraVigilance. Br J Clin Pharmacol. 2022;88(12):5378-5388. doi:10.1111/bcp.15471 [PubMed 35894810]
  39. Ghosh P, Cho M, Rawat G, Simkin PA, et al. Treatment of acute gouty arthritis in complex hospitalized patients with anakinra. Arthritis Care Res (Hoboken). 2013;65(8):1381-1384. doi:10.1002/acr.21989 [PubMed 23650178]
  40. Giampietro C, Ridene M, Lequerre T, et al; CRI (Club Rhumatismes et Inflammation). Anakinra in adult-onset Still's disease: long-term treatment in patients resistant to conventional therapy. Arthritis Care Res (Hoboken). 2013;65(5):822-826. doi:10.1002/acr.21901 [PubMed 23225779]
  41. Goldbach-Mansky R, Dailey NJ, Canna SW, et al. Neonatal-Onset Multisystem Inflammatory Disease Responsive to Interleukin-1Beta Inhibition. N Engl J Med. 2006;355(6):581-592. [PubMed 16899778]
  42. Goodman SM, Springer BD, Chen AF, et al. 2022 American College of Rheumatology/American Association of Hip and Knee Surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty. Arthritis Care Res (Hoboken). 2022;74(9):1399-1408. doi:10.1002/acr.24893 [PubMed 35718887]
  43. Granowitz EV, Porat R, Mier JW, et al. Pharmacokinetics, safety and immunomodulatory effects of human recombinant interleukin-1 receptor antagonist in healthy humans. Cytokine. 1992;4(5):353-360. doi:10.1016/1043-4666(92)90078-6 [PubMed 1420996]
  44. Grayson PC, Yazici Y, Merideth M, et al. Treatment of mucocutaneous manifestations in Behçet's disease with anakinra: a pilot open-label study. Arthritis Res Ther. 2017;19(1):69. doi:10.1186/s13075-017-1222-3 [PubMed 28335798]
  45. Hedrich CM, Bruck N, Fiebig B, Gahr M. Anakinra: a safe and effective first-line treatment in systemic onset juvenile idiopathic arthritis (SoJIA). Rheumatol Int. 2012;32(11):3525-3530. [PubMed 22083619]
  46. Henderson LA, Canna SW, Friedman KG, et al. American College of Rheumatology (ACR) clinical guidance for multisystem inflammatory syndrome in children associated with SARS-CoV-2 and hyperinflammation in pediatric COVID-19: Version 3. Arthritis Rheumatol. Published online February 3, 2022. doi:10.1002/art.42062 [PubMed 35118829]
  47. Hines MR, von Bahr Greenwood T, Beutel G, et al. Consensus-based guidelines for the recognition, diagnosis, and management of hemophagocytic lymphohistiocytosis in critically ill children and adults. Crit Care Med. 2022;50(5):860-872. doi:10.1097/CCM.0000000000005361 [PubMed 34605776]
  48. İlgen U, Küçükşahin O. Anakinra use during pregnancy: Report of a case with Familial Mediterranean Fever and infertility. Eur J Rheumatol. 2017;4(1):66-67. doi: 10.5152/eurjrheum.2017.16075. [PubMed 28293457]
  49. Iliou C, Papagoras C, Tsifetaki N, Voulgari PV, Drosos AA. Adult-onset Still's disease: clinical, serological and therapeutic considerations. Clin Exp Rheumatol. 2013;31(1):47-52. [PubMed 23010097]
  50. Ilowite N, Porras O, Reiff A, et al. Anakinra in the Treatment of Polyarticular-Course Juvenile Rheumatoid Arthritis: Safety and Preliminary Efficacy Results of a Randomized Multicenter Study. Clin Rheumatol. 2009;28(2):129-137. [PubMed 18766426]
  51. Imazio M, Andreis A, De Ferrari GM, et al. Anakinra for corticosteroid-dependent and colchicine-resistant pericarditis: the IRAP (International Registry of Anakinra for Pericarditis) study. Eur J Prev Cardiol. 2020;27(9):956-964. doi:10.1177/2047487319879534 [PubMed 31610707]
  52. Irigoyen P, Olson J, Horn C, et al. Treatment of Systemic Onset Juvenile Idiopathic Arthritis With Anakinra. Ped Rheumatol Online J. 2006;4(2):123-134.
  53. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  54. Janssen CA, Oude Voshaar MAH, Vonkeman HE, et al. Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial. Rheumatology (Oxford). Published online January 2, 2019. doi:10.1093/rheumatology/key402 [PubMed 30602035]
  55. Kaiser C, Knight A, Nordström D, et al. Injection-site reactions upon Kineret (anakinra) administration: experiences and explanations. Rheumatol Int. 2012;32(2):295-299. doi:10.1007/s00296-011-2096-3 [PubMed 21881988]
  56. Karakaş Ö, Erden A, Ünlü S, et al. Can anakinra and corticosteroid treatment be an effective option in pregnant women with severe Covid-19? Women Health. 2021;61(9):872-879. doi:10.1080/03630242.2021.1981517 [PubMed 34551674]
  57. Kashiwagi Y, Kawashima H, Nishimata S, et al. Extreme Efficiency of Anti-Interleukin 1 Agent (Anakinra) in a Japanese Case of CINCA Syndrome. Clin Rheumatol. 2008;27(2):277-279. [PubMed 17891446]
  58. Kineret (anakinra) [prescribing information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB; December 2020.
  59. Koné-Paut I, Tellier S, Belot A, et al. Phase II open label study of anakinra in intravenous immunoglobulin-resistant Kawasaki disease. Arthritis Rheumatol. 2021;73(1):151-161. [PubMed 32779863]
  60. Kucuksahin O, Yildizgoren MT, Ilgen U, et al. Anti-interleukin-1 treatment in 26 patients with refractory familial Mediterranean fever. Mod Rheumatol. 2017;27(2):350-355. doi:10.1080/14397595.2016.1194510 [PubMed 27328763]
  61. Kurt T, Aydın F, Nilüfer Tekgöz P, Sezer M, Uncu N, Çelikel Acar B. Effect of anti-interleukin-1 treatment on quality of life in children with colchicine-resistant familial Mediterranean fever: A single-center experience. Int J Rheum Dis. 2020;23(7):977-981. [PubMed 32558310]
  62. Kyriazopoulou E, Poulakou G, Milionis H, et al. Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial. Nat Med. 2021;27(10):1752-1760. doi:10.1038/s41591-021-01499-z [PubMed 34480127]
  63. Lazaros G, Vasileiou P, Koutsianas C, et al. Anakinra for the management of resistant idiopathic recurrent pericarditis. Initial experience in 10 adult cases. Ann Rheum Dis. 2014;73(12):2215-2217. [PubMed 25165036]
  64. Lequerré T, Quartier P, Rosellini D, et al; Société Francophone pour la Rhumatologie et les Maladies Inflammatoires en Pédiatrie (SOFREMIP); Club Rhumatismes et Inflammation (CRI). Interleukin-1 receptor antagonist (anakinra) treatment in patients with systemic-onset juvenile idiopathic arthritis or adult onset Still disease: preliminary experience in France. Ann Rheum Dis. 2008;67(3):302-308. [PubMed 17947302]
  65. Lovell DJ, Bowyer SL, Solinger AM. Interleukin-1 Blockade by Anakinra Improves Clinical Symptoms in Patients With Neonatal-Onset Multisystem Inflammatory Disease. Arthritis Rheum. 2005;52(4):1283-1286. [PubMed 15818707]
  66. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  67. Marko L, Shemer A, Lidar M, et al. Anakinra for colchicine refractory familial Mediterranean fever: a cohort of 44 patients. Rheumatology (Oxford). 2021;60(6):2878-2883. doi:10.1093/rheumatology/keaa728 [PubMed 34144604]
  68. Matsubayashi T, Sugiura H, Arai T, et al. Anakinra Therapy for CINCA Syndrome With a Novel Mutation in Exon 4 of the CIAS1 Gene. Acta Paediatr. 2006;95(2):246-249. [PubMed 16449034]
  69. McCrindle BW, Rowley AH, Newburger JW, et al. Diagnosis, treatment, and long-term management of Kawasaki Disease: a scientific statement for health professionals from the American Heart Association. Circulation. 2017;135(17):e927-e999. [PubMed 28356445]
  70. Mehta P, Cron RQ, Hartwell J, Manson JJ, Tattersall RS. Silencing the cytokine storm: the use of intravenous anakinra in haemophagocytic lymphohistiocytosis or macrophage activation syndrome. Lancet Rheumatol. 2020;2(6):e358-e367. doi:10.1016/S2665-9913(20)30096-5 [PubMed 32373790]
  71. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Therapeutic management of hospitalized pediatric patients with multisystem inflammatory syndrome in children (MIS-C) (with discussion on multisystem inflammatory syndrome in adults [MIS-A]). https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-pediatric-patients--therapeutic-management-of-mis-c/. Updated February 24, 2022. Accessed March 7, 2022.
  72. Naumann L, Feist E, Natusch A, et al. IL1-receptor antagonist anakinra provides long-lasting efficacy in the treatment of refractory adult-onset Still's disease. Ann Rheum Dis. 2010;69(2):466-467. doi:10.1136/ard.2009.108068 [PubMed 20107032]
  73. Naymagon L. Anakinra for the treatment of adult secondary HLH: a retrospective experience. Int J Hematol. 2022;116(6):947-955. doi:10.1007/s12185-022-03430-9 [PubMed 35948764]
  74. Negro E, Costedoat-Chalumeau N, Nivuori M, Gabiati C, Pallini G, Brucato A. Anakinra during pregnancy in a difficult to treat case of recurrent pericarditis. Can J Cardiol. 2023;39(8):1152-1153. doi:10.1016/j.cjca.2022.10.020 [PubMed 36306922]
  75. Neven B, Marvillet I, Terrada C, et al. Long-term efficacy of the interleukin-1 receptor antagonist anakinra in ten patients with neonatal-onset multisystem inflammatory disease/chronic infantile neurologic, cutaneous, articular syndrome. Arthritis and Rheumatism. 2010;62(1): 258-267. [PubMed 20039428]
  76. Nigrovic PA, Mannion M, Prince FH, et al. Anakinra as first-line disease-modifying therapy in systemic juvenile idiopathic arthritis: report of forty-six patients from an international multicenter series. Arthritis Rheum. 2011;63(2):545-555. [PubMed 21280009]
  77. Ohlsson V, Baildam E, Foster H, et al. Anakinra Treatment for Systemic Onset Juvenile Idiopathic Arthritis (SOJIA). Rheumatology (Oxford). 2008;47(4):555-556. [PubMed 18321945]
  78. Ortiz-Sanjuán F, Blanco R, Riancho-Zarrabeitia L, et al. Efficacy of anakinra in refractory adult-onset Still's disease: multicenter study of 41 patients and literature review. Medicine (Baltimore). 2015;94(39):e1554. doi:10.1097/MD.0000000000001554 [PubMed 26426623]
  79. Ottaviani S, Moltó A, Ea HK, et al. Efficacy of anakinra in gouty arthritis: a retrospective study of 40 cases. Arthritis Res Ther. 2013;15(5):R123. [PubMed 24432362]
  80. Ozen S, Demirkaya E, Erer B, et al. EULAR recommendations for the management of familial Mediterranean fever. Ann Rheum Dis. 2016;75(4):644-651. doi:10.1136/annrheumdis-2015-208690 [PubMed 26802180]
  81. Pascual V, Allantaz F, Arce E, et al. Role of Interleukin-1 (IL-1) in the Pathogenesis of Systemic Onset Juvenile Idiopathic Arthritis and Clinical Response to IL-1 Blockade. J Exp Med. 2005; 201(9):1479-1486. [PubMed 15851489]
  82. Pecher AC, Igney-Oertel A, Kanz L, Henes J. Treatment of familial Mediterranean fever with anakinra in patients unresponsive to colchicine. Scand J Rheumatol. 2017:1-3. doi:10.1080/03009742.2016.1245780 [PubMed 28097903]
  83. Phadke O, Rouster-Stevens K, Giannopoulos H, Chandrakasan S, Prahalad S. Intravenous administration of anakinra in children with macrophage activation syndrome. Pediatr Rheumatol Online J. 2021;19(1):98. doi:10.1186/s12969-021-00585-3 [PubMed 34187503]
  84. Picco P, Brisca G, Traverso F, Loy A, Gattorno M, Martini A. Successful treatment of idiopathic recurrent pericarditis in children with interleukin-1beta receptor antagonist (anakinra): an unrecognized autoinflammatory disease? Arthritis Rheum. 2009;60(1):264-268. [PubMed 19116906]
  85. Quartier P, Allantaz, Cimaz R, et al. A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011;70(5):747-754. [PubMed 21173013]
  86. Reddy S, Jia S, Geoffrey R, et al. An autoinflammatory disease due to homozygous deletion of the IL1RN locus. N Engl J Med. 2009;360(23):2438-2444. [PubMed 19494219]
  87. Refer to manufacturer's labeling.
  88. Reiff A. The Use of Anakinra in Juvenile Arthritis. Curr Rheumatol Rep. 2005;7(6):434-440. [PubMed 16303102]
  89. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76(1):29-42. doi:10.1136/annrheumdis-2016-209707 [PubMed 27457514]
  90. Riera E, Olivé A, Narváez J, et al. Adult onset Still's disease: review of 41 cases. Clin Exp Rheumatol. 2011;29(2):331-336. [PubMed 21385548]
  91. Rigante D, Leone A, Marrocco R, et al. Long-Term Response After 6-Year Treatment With Anakinra and Onset of Focal Bone Erosion in Neonatal-Onset Multisystem Inflammatory Disease (NOMID/CINCA). Rheumatol Int. 2011;31(12):1661-1664. [PubMed 21240490]
  92. Rigante D, Ansuini V, Caldarelli M, et al. Hydrocephalus in CINCA Syndrome Treated With Anakinra. Childs Nerv Syst. 2006;22(4):334-337. [PubMed 16525848]
  93. Ringold S, Weiss PF, Beukelman T, et al; American College of Rheumatology. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013;65(10):2499-2512. [PubMed 24092554]
  94. Saad Shaukat MH, Fiegen N, Malik MN, Petrasko M. Relapse of colchicine-intolerant, corticosteroid-dependent recurrent idiopathic pericarditis after perigestational discontinuation of anakinra: uncertain safety of anakinra in pregnancy and the need for shared decision-making. BMJ Case Rep. 2023;16(9):e256180. doi:10.1136/bcr-2023-256180 [PubMed 37714558]
  95. Saag KG, Khanna PP, Keenan RT, et al. A randomized, phase II study evaluating the efficacy and safety of anakinra in the treatment of gout flares. Arthritis Rheumatol. 2021;73(8):1533-1542. doi:10.1002/art.41699 [PubMed 33605029]
  96. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784. [PubMed 18512708]
  97. Sag E, Akal F, Atalay E, et al. Anti-IL1 treatment in colchicine-resistant paediatric FMF patients: real life data from the HELIOS registry. Rheumatology (Oxford). 2020;59(11):3324-3329. [PubMed 32306038]
  98. Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2020;72(4):529‐556. doi:10.1002/art.41191 [PubMed 32090480]
  99. Sánchez-Manubens J, Gelman A, Franch N, et al. A child with resistant Kawasaki disease successfully treated with anakinra: a case report. BMC Pediatr. 2017;17(1):102. [PubMed 28390409]
  100. Shafferman A, Birmingham JD, Cron RQ. High dose Anakinra for treatment of severe neonatal Kawasaki disease: a case report. Pediatr Rheumatol Online J. 2014;12:26. [PubMed 25045337]
  101. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  102. Sibley CH, Plass N, Snow J, et al. Sustained Response and Prevention of Damage Progression in Patients With Neonatal-Onset Multisystem Inflammatory Disease Treated With Anakinra: A Cohort Study to Determine Three- and Five-Year Outcomes. Arthritis Rheum. 2012;64(7):2375-2386. [PubMed 22294344]
  103. Smith CJF, Chambers CD. Five successful pregnancies with antenatal anakinra exposure. Rheumatology (Oxford). 2018;57(7):1271-1275. doi:10.1093/rheumatology/key093 [PubMed 29660063]
  104. So A, De Smedt T, Revaz S, et al. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther. 2007;9(2):R28. doi:10.1186/ar2143 [PubMed 17352828]
  105. Ter Haar NM, van Dijkhuizen EHP, Swart JF, et al. Treatment to target using recombinant interleukin-1 receptor antagonist as first-line monotherapy in new-onset systemic juvenile idiopathic arthritis: results from a five-year follow-up study. Arthritis Rheumatol. 2019;71(7):1163-1173. [PubMed 30848528]
  106. Thomas M, Forien M, Palazzo E, Dieudé P, Ottaviani S. Efficacy and tolerance of anakinra in acute calcium pyrophosphate crystal arthritis: a retrospective study of 33 cases. Clin Rheumatol. 2019;38(2):425-430. doi:10.1007/s10067-018-4272-2 [PubMed 30145636]
  107. Tremoulet AH, Jain S, Kim S, et al. Rationale and study design for a phase I/IIa trial of anakinra in children with Kawasaki disease and early coronary artery abnormalities (the ANAKID trial). Contemp Clin Trials. 2016;48:70-75. [PubMed 27080929]
  108. US Department of Health and Human Services (HHS) Panel on COVID-19 Treatment Guidelines. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://covid19treatmentguidelines.nih.gov. Updated September 1, 2020. Accessed September 30, 2020.
  109. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization (EUA) for Kineret. https://www.fda.gov/media/163075/download. Accessed November 8, 2022.
  110. van der Hilst JCH, Moutschen M, Messiaen PE, Lauwerys BR, Vanderschueren S. Efficacy of anti-IL-1 treatment in familial Mediterranean fever: a systematic review of the literature. Biologics. 2016;10:75-80. doi:10.2147/BTT.S102954 [PubMed 27110096]
  111. Vercruysse F, Barnetche T, Lazaro E, et al. Adult-onset Still's disease biological treatment strategy may depend on the phenotypic dichotomy. Arthritis Res Ther. 2019;21(1):53. doi:10.1186/s13075-019-1838-6 [PubMed 30755262]
  112. Vitale A, Cavalli G, Ruscitti P, et al. Comparison of early vs. delayed anakinra treatment in patients with adult onset Still's disease and effect on clinical and laboratory outcomes. Front Med (Lausanne). 2020;7:42. doi:10.3389/fmed.2020.00042 [PubMed 32154255]
  113. Yang B, Baughman S, Sullivan JT. Pharmacokinetics of Anakinra in Subjects With Different Levels of Renal Function. Clin Pharmacol Ther. 2003;74(1):85-94. [PubMed 12844139]
  114. Youngstein T, Hoffmann P, Gül A, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors. Rheumatology (Oxford). 2017;56(12):2102-2108. doi:10.1093/rheumatology/kex305 [PubMed 28968868]
Topic 9246 Version 263.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟