anakinra

REMS

Moderately to severely active rheumatoid arthritis in patients who have failed other disease-modifying antirheumatic drugs (DMARDs) (may be used in combination with other DMARDs other than tumor necrosis factor [TNF] blocking agents).
Neonatal-onset multisystem inflammatory disease.
Deficiency of interleukin-1 receptor antagonist.
Coronavirus disease 2019 (COVID-19) in hospitalized patients with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and are likely to have elevated levels of soluble urokinase plasminogen activator receptor (an emergency use authorization [EUA] has been issued for this use of anakinra; this drug is not FDA-approved for this use).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infections;
Hypersensitivity;
Hypersensitivity to other Escherichia coli–derived products;
OB: Pregnancy.

Use Cautiously in:

Other chronic debilitating illness;
Underlying immunosuppression;
Renal impairment;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children with COVID-19 or juvenile rheumatoid arthritis;
Geri: Older adults may be more sensitive to toxicity due to age-related ↓ in renal function; ↑ incidence of infection.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)

F and E: hyperkalemia, hypernatremia

GI: ↑liver enzymes, constipation, diarrhea, nausea

GU: acute kidney injury

Hemat: neutropenia

Local: injection site reactions

Neuro: anxiety, headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA) ( RISK IN PATIENTS WITH DEFICIENCY OF INTERLEUKIN-1 RECEPTOR ANTAGONIST), ↑ risk in patients with deficiency of interleukin-1 receptor antagonist), INFECTIONS

Interactions ⬆ ⬇

Drug-drug:

↑risk of serious infection with tumor necrosis factor blocking agents, such as etanercept.
May ↓ antibody response to and ↑ risk of adverse reactions from vaccines; avoid concurrent administration of live vaccines.

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 100 mg/0.67 mL

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis

SC (Adults ): 100 mg once daily.

Neonatal-Onset Multisystem Inflammatory Disease

SC (Adults and Children ): 1–2 mg/kg/day given in 1–2 divided doses; may ↑ by 0.5–1 mg/kg/day, as needed (maximum = 8 mg/kg/day).

Deficiency of Interleukin-1 Receptor Antagonist

SC (Children ): 1–2 mg/kg/day; may ↑ by 0.5–1 mg/kg/day, as needed (maximum = 8 mg/kg/day).

COVID-19

SC (Adults ): 100 mg once daily for 10 days.

Renal Impairment

SC (Adults ): CCr <30 mL/min: 100 mg every other day for a total of five doses over 10 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Blocks the destructive effects of interleukin-1 on cartilage and bone resorption by inhibiting its binding at specific tissue receptor sites.

Therapeutic effects:

Slowed progression of rheumatoid arthritis.
Reduction in neonatal-onset multisystem inflammatory disease symptoms.
Achievement of inflammatory remission in deficiency of interleukin-1 receptor antagonist.
Improved survival associated with COVID-19.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics (DMARD)

Pharmacologic Classification: interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (95%) following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 4–6 hr.

Time/Action Profile ⬆ ⬇

(clinical response)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 12 wk	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient in correct technique for injection and care and disposal of equipment.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional if signs and symptoms of infection (fever, sore throat, cough, headache, nausea, vomiting, abdominal pain) occur.
Inform patient of the signs and symptoms of hypersensitivity reactions (including anaphylaxis) and injection site reactions (pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, hemorrhage). Advise patient to seek immediate medical attention if needed.
Advise patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery to hold dose for 1 day before surgery to ↓ infection risk.
Advise patient not to receive live vaccines during therapy without consulting health care professional.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Home Care Issues: Instruct patient or caregiver on preparation and correct technique for administration of injection and care and disposal of equipment. Caution patients and caregivers not to reuse needles, syringes, or drug product.

section name header

Indications ⬇