Usual Adult Dose for Rheumatoid Arthritis

100 mg subcutaneously once a day

Comments:

• This drug can be used alone or in combination with disease modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) blocking agents.
• Higher doses did not result in a higher response.
• The dose should be administered at about the same time each day.

Use: To reduce signs and symptoms and slow the progression of structural damage in moderately to severely active rheumatoid arthritis in patients who have failed 1 or more DMARDs

Usual Adult Dose for Cryopyrin-Associated Periodic Syndrome

Starting dose: 1 to 2 mg/kg subcutaneously per day
Dose adjustments: Doses should be adjusted in 0.5 to 1 mg/kg increments.
Maximum dose: 8 mg/kg/day

Comments:

• The dose can be individually adjusted to the maximum daily dose to control active inflammation.
• Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Use: For the treatment of neonatal-onset multisystem inflammatory disease (NOMID)

Usual Adult Dose for Interleukin-1 Receptor Antagonist Deficiency

Starting dose: 1 to 2 mg/kg subcutaneously per day
Dose adjustments: Doses should be adjusted in 0.5 to 1 mg/kg increments.
Maximum dose: 8 mg/kg/day

Comments:

• The dose can be individually adjusted to the maximum daily dose to control active inflammation.

Use: For the treatment of deficiency of interleukin-1 receptor antagonist (DIRA)

Usual Adult Dose for COVID-19

For investigational use only

100 mg subcutaneously once a day for 10 days

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this drug for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR); this drug is not approved by the US FDA for this use.
• The Fact Sheet for Health Care Providers should be consulted regarding available alternatives.
• ClinicalTrials.gov should be consulted for information on clinical trials of this drug and other therapies for the treatment of COVID-19.
• In the trial used to support the safety and efficacy of this drug in COVID-19, key exclusion criteria were: partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ratio less than 150 mmHg (millimeters of mercury), requirement for noninvasive ventilation (NIV), requirement for mechanical ventilation (MV), requirement for extracorporeal membrane oxygenation (ECMO), and less than 1500 neutrophils/mm3. All enrolled patients were required to have a plasma suPAR level at least 6 ng/mL.
• The suPAR assay is not commercially available in the US; to identify a comparable population as studied in the trial, an alternative patient identification method was developed to select patients most likely to have suPAR at least 6 ng/mL based on commonly measured patient characteristics.
• Patients with at least 3 of the following 8 criteria are considered likely to have suPAR at least 6 ng/mL at baseline: (1) age at least 75 years; (2) severe pneumonia by WHO criteria; (3) current/previous smoking status; (4) Sequential Organ Failure Assessment (SOFA) score at least 3; (5) neutrophil-to-lymphocyte ratio at least 7; (6) hemoglobin up to 10.5 g/dL; (7) medical history of ischemic stroke; (8) blood urea at least 50 mg/dL and/or medical history of renal disease.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the treatment of COVID-19 in hospitalized patients with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma suPAR

Usual Pediatric Dose for Cryopyrin-Associated Periodic Syndrome

Starting dose: 1 to 2 mg/kg subcutaneously per day
Dose adjustments: Doses should be adjusted in 0.5 to 1 mg/kg increments.
Maximum dose: 8 mg/kg/day

Comments:

• The dose can be individually adjusted to the maximum daily dose to control active inflammation.
• Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Use: For the treatment of NOMID

Usual Pediatric Dose for Interleukin-1 Receptor Antagonist Deficiency

Starting dose: 1 to 2 mg/kg subcutaneously per day
Dose adjustments: Doses should be adjusted in 0.5 to 1 mg/kg increments.
Maximum dose: 8 mg/kg/day

Comments:

• The dose can be individually adjusted to the maximum daily dose to control active inflammation.

Use: For the treatment of DIRA

Renal Dose Adjustments

Severe renal dysfunction or ESRD: Administration of the prescribed dose every other day should be considered.

EUA RECOMMENDATIONS FOR TREATMENT OF COVID-19 IN ADULTS:

• Severe renal dysfunction or ESRD: 100 mg subcutaneously every other day should be considered (total of 5 doses over 10 days)

Comments:

• Severe renal dysfunction/ESRD is defined as CrCl less than 30 mL/min, as estimated from serum creatinine levels.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to Escherichia coli-derived proteins, the active component, or any of the ingredients

Safety and efficacy in the treatment of juvenile rheumatoid arthritis (JRA) have not been established in patients younger than 18 years; this drug is not recommended for pediatric use in JRA. This drug is not authorized/approved for emergency use in the treatment of COVID-19 in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Severe renal dysfunction or ESRD: A dose schedule change should be considered.

Comments:

• Less than 2.5% of the administered dose was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
• This drug has not been studied in COVID-19 patients with ESRD requiring hemofiltration or peritoneal hemodialysis.

Other Comments

Administration advice:

• Administer at about the same time every day.
• Each syringe is intended for a single use; use a new syringe for each dose. Discard any unused portion after each dose.
• Do not allow patients or caregivers to administer this drug until the patient/caregiver has shown a thorough understanding of procedures and an ability to inject the product correctly.

Storage requirements:

• Store in the refrigerator at 2C to 8C (36F to 46F); do not freeze or shake.
• Protect from light.

Monitoring:

• Hematologic: Neutrophil counts (before starting therapy, monthly for 3 months, and thereafter quarterly for up to 1 year)
• If used for treatment of COVID-19: Neutrophil counts (before starting therapy); for neutropenia (according to clinical practices)
• Hypersensitivity: Allergic reactions in DIRA patients (especially in the first several weeks after starting therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• If used for treatment of COVID-19: Read the Fact Sheet for Patients and Caregivers.
• Important: Contact physician if any symptoms of infection develop.
• Remove the prefilled syringe from refrigeration and leave at room temperature for 30 minutes before injecting.
• Avoid injecting into an area that is already swollen or red.
• Notify the prescribing physician of any persistent reaction.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?