Version May 2024
The FDA has issued an emergency use authorization (EUA) for the unapproved product Regiocit, a replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit. Regiocit is authorized for emergency use as a replacement solution in adults treated with continuous renal replacement therapy and for whom RCA of the extracorporeal circuit is appropriate during the COVID-19 pandemic. As part of the EUA, fact sheets pertaining to emergency use of Regiocit are required to be available for health care providers and patients/caregivers, and certain requirements for Regiocit administration under the EUA must be met as outlined in the FDA emergency use authorization letter. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with Regiocit use by either submitting a MedWatch form or FDA Form 3500 (health professional) by fax (1-800-FDA-0178).
Fact sheet for health care providers: https://www.fda.gov/media/141170/download
Fact sheet for patients and parents/caregivers: https://www.fda.gov/media/141172/download
Further information, including the EUA and Regiocit package insert, may be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
Replacement solution for regional citrate anticoagulation of continuous renal replacement circuit: Rate of solution administered depends upon the targeted citrate dose and the prescribed blood flow rate. Prefilter infusion rate is indexed to the blood flow rate to achieve a target blood citrate concentration of 3 to 4 mmol/L. Flow rate for anticoagulation of the extracorporeal circuit should be titrated to achieve a post-filter ionized calcium concentration of 0.25 to 0.35 mmol/L.
No dosage adjustment necessary.
Mild to moderate impairment: Dosage reduction may be needed; monitor closely for citrate accumulation.
Severe impairment: Contraindicated in patients with severe failure; avoid use in patients with reduced liver and muscle perfusion (eg, patients with lactic acidosis or septic shock).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions are reported for the individual agents rather than for the combination product. See sodium chloride monograph.
Frequency not defined:
Cardiovascular: Hypotension
Endocrine & metabolic: Fluid volume disorder, hypocalcemia (including severe hypocalcemia), hypoglycemia, hypokalemia, hypomagnesemia, hypophosphatemia, metabolic acidosis, metabolic alkalosis
Hypersensitivity to sodium chloride, sodium citrate, or any component of the formulation; severe liver failure; shock with muscle hypoperfusion.
Concerns related to adverse effects:
• Fluid and electrolyte imbalances: Electrolyte, acid-base, and volume abnormalities may occur, including hypocalcemia, hypomagnesemia, and hypovolemia; correct as necessary.
Disease-related concerns:
• Cerebral: Use with caution in patients with cerebral edema, increased intracranial pressure, or traumatic brain injury; solution is hypo-osmolar/hypotonic relative to standard CRRT replacement fluids.
• Hepatic impairment: Use with caution in patients with liver failure, including patients with acute liver failure, cirrhosis, or shock; citrate is partially metabolized by the liver and may accumulate with hepatic impairment, leading to toxicity. Considered contraindicated in patients with acute liver failure and blood transaminase values >1,000 units/L (Davenport 2018).
• Shock states: Use with caution in patients with shock and hypoperfusion to muscles. Citrate is partially metabolized by muscles and may accumulate with hypoperfusion, leading to toxicity. Considered contraindicated in patients with cardiogenic shock and blood lactate concentrations >8 mmol/L (Davenport 2018).
Dosage form specific issues:
• Citrate: Contains citrate; may affect acid-base and electrolyte balance.
Other warnings/precautions:
• Appropriate use: Administer only under the direction of a health care provider experienced in the use of CRRT. Use only with extracorporeal dialysis equipment appropriate for CRRT.
Not FDA-approved in the United States; however, product is available via an Emergency Use Authorization during the COVID-19 pandemic.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, In Vitro:
Regiocit: Chloride 86 mEq/L, citrate 54 mEq/L, sodium 140 mEq/L (5000 mL)
No
Solution (Regiocit Extracorporeal)
0.529% (per mL): $0.02
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Extracorporeal:
Regiocit: 0.529% (5000 mL)
Extracorporeal: Extracorporeal administration only; not for direct IV administration. May warm using dry heat only to 37°C prior to administration; do not heat in microwave or water. Administer using an integrated preblood pump with proper extracorporeal renal replacement equipment in predilution mode only. Use with a dialysis/replacement solution at an appropriate bicarbonate concentration; infusion rate must account for rate at which buffer administration occurs from other sources (dialysate, replacement fluid). Administer a separate infusion of calcium at the same time; IV magnesium supplementation may also be needed.
Osmolarity: 244 mOsm/L.
Note: Not FDA-approved in the United States; however, product is available via an Emergency Use Authorization during the COVID-19 pandemic.
Replacement solution for regional citrate anticoagulation of continuous renal replacement circuit : Replacement solution for regional citrate anticoagulation of the extracorporeal circuit in adults treated with CRRT, particularly when systemic anticoagulation with heparin is contraindicated (eg, in patients with increased bleeding risks).
Electrolytes (including magnesium, phosphate, potassium, and sodium); post-filter blood ionized calcium concentrations, systemic blood ionized calcium concentrations, total blood calcium concentrations, and serum total-to-ionized calcium ratio; hematocrit; acid-base balance; blood glucose; hemodynamic status; fluid balance.
Citrate provides regional anticoagulation of blood by binding to calcium, rendering calcium unavailable to the clotting cascade, in the CRRT extracorporeal circuit. Sodium and chloride are normal electrolytes in the human body and are considered to be pharmacologically inactive.
Metabolism: Citrate: Primarily hepatic (rapid).
Excretion: Citrate: Urine.
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