ANAKINRA INJ,SOLN

Clinical Criteria Summary

Hospitalized patients with severe COVID-19
Positive SARS-CoV-2 direct viral test
Requirement for supplemental oxygen (low or high-flow)
At risk for progressing to severe respiratory failure
Likely to have elevated plasma soluble urokinase plasminogen activator receptor (suPAR)

Adults: 100 mg subcutaneously daily for up to 10 days
Renal insufficiency (severe or end-stage renal disease): 100 mg every other day for a total of 5 doses over 10 days
Supplied as prefilled syringe (100 mg/0.67 mL) intended for single use; discard any unused portion after dosing
Do not administer if solution is discolored, cloudy, or contains particulate matter

At least 3 of the following criteria: Age ≥ 75 years, severe pneumonia by WHO criteria, SOFA score ≥ 3, neutrophil to lymphocyte ratio ≥ 7, hemoglobin ≥ 10.5 g/dL, medical history of ischemic stroke, blood urea ≥ 50 mg/dL and/or history of renal disease
Predictors of favorable response (at least 2 of the following): CRP > 50 mg/L, neutrophil to lymphocyte ratio > 5.5, ferritin > 700 ng/mL, AST > 44 U/L

Known hypersensitivity to E.coli derived proteins, anakinra, or any components of the product

Serious infections: Monitor for signs and symptoms of new infections during and after treatment; limited data available for patients with concomitant active serious infections
TNF blocking agents: Not recommended for concurrent use due to increased risk of serious infections
Hypersensitivity reactions (including anaphylaxis and angioedema): Discontinue anakinra and initiate appropriate therapy if severe reaction occurs
Immunosuppression: Impact on development of malignancies is unknown
Immunizations: Avoid use of live vaccines; no data available for other inactivated vaccines or effects of live vaccination on secondary transmission

Assess neutrophil counts prior to initiation; monitor for neutropenia per current clinical practices (patients with ANC < 1500 cells/mm3 were excluded from trials)
Monitor closely for unusual clinical or laboratory events, record per local policy, and report to VA ADERS

Pregnancy: Insufficient data to identify drug-associated risk of maternal or fetal adverse events; animal studies showed no evidence of fetal harm at doses up to 25 times the maximum recommended human dose
Lactation: No data on presence in human or animal milk; risk to infant during lactation is unclear
Geriatric: Higher incidence of infections in elderly population; use caution

Patient must meet all criteria outlined in the FDA Emergency Use Authorization
Healthcare providers must communicate information from the "Fact Sheet for Patients, Parents and Caregivers" prior to administration (unless delay endangers life)
Patient or surrogate decision maker has the option to accept or refuse therapy
All medication errors and adverse drug events must be documented per local policy and reported to VA ADERS within 7 calendar days

Hospitalized adults requiring supplemental oxygen (low or high-flow) for COVID-19
Patients at risk of progressing to severe respiratory failure

Laboratory confirmed COVID-19 diagnosis
Requiring supplemental oxygen (low- or high-flow oxygen)
At risk for progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR)

Known hypersensitivity to ANA, E.coli derived proteins, or any component of the product
Concurrent use of TNF blocking agents

Likely to have suPAR levels ≥ 6 ng/mL at baseline if meeting at least 3 of the following criteria: age ≥ 75 years, severe pneumonia by WHO criteria, current/previous smoker, SOFA score ≥ 3, neutrophil-to-lymphocyte ratio (NLR) ≥ 7, hemoglobin ≤ 10.5 g/dL, history of ischemic stroke, blood urea ≥ 50 mg/dL, and/or history of renal disease

100mg as a subcutaneous injection daily for 10 days
Consider reducing the dose to 100mg every other day in patients with severe renal insufficiency or end-stage renal disease (CrCl < 30 mL/min)

Counseling provided and documented per EUA, including: communication consistent with the “Fact Sheet for Patients and Parents/Caregivers,” documentation of fact sheet provision, informing patient it is an unapproved drug authorized under EUA, discussing alternatives/risks/benefits, and right to refuse/accept
Exception: If providing fact sheet information delays administration to endanger life, provide to caregiver as soon as feasible after administration (document in record)
Patient advised to notify provider if any adverse drug event (ADE) occurs
All ADEs and medication errors (with interventions) must be recorded per local policy AND placed in VA ADERS within 7 calendar days of notification, with MedWatch reporting selection
Appropriate storage maintained until administration consistent with authorization terms