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).

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.

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

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.

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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Assess for signs and symptoms of infection (fever, ↑ WBC) before and periodically during therapy. Screen for latent TB before beginning therapy (except in COVID-19); treat if screen is positive. Anakinra should not be instituted in patients with active infections and should be discontinued if a serious infection develops.
Observe for hypersensitivity reactions (anaphylaxis, urticaria, dyspnea, hypotension). Discontinue anakinra if severe reaction occurs. Medications (antihistamines, acetaminophen, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction.
Monitor for DRESS (skin rash, fever, swollen lymph nodes, facial swelling).
Rheumatoid Arthritis: Assess range of motion and degree of swelling and pain in affected joints before and periodically during therapy.
Neonatal-Onset Multisystem Inflammatory Disease: Assess symptoms of neonatal-onset multisystem inflammatory disease (fever, rash, joint pain, vomiting, headache) before and periodically during therapy.
Deficiency of Interleukin-1 Receptor Antagonist: Assess symptoms of deficiency of interleukin-1 receptor antagonist (respiratory distress, joint swelling, stomatitis, pustular psoriasis) before and periodically during therapy.
COVID-19: Monitor respiratory status (lung sounds, supplemental oxygen amount) during therapy.

Lab Test Considerations:

May ↓ neutrophil counts. Monitor CBC with differential before, then monthly for 3 mo, and then every 3 mo for a period of up to 1 yr.
Obtain baseline TB test.
Monitor serum creatinine.

Implementation ⬆ ⬇

SC: Provided in single-use prefilled syringes. If dose is separated into two injections, a new syringe is used for each dose. Solution may contain trace amounts of small translucent-to-white amorphous particles of protein in the solution. Do not use if solution is discolored or cloudy or contains particulate matter, if number of translucent-to-white amorphous particles is excessive, or if beyond expiration date. Store in refrigerator; do not freeze. Remove from refrigerator and allow to reach room temperature for 30 min before injection. Avoid injecting into areas that are red or swollen.

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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇