Phase 1: COVID-19 Emergency Use Authorization (EUA) Products
Oxiris Set
The Oxiris Set device is authorized under EUA200164 (Emergency Use Authorization) to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) infection admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification, including use in continuous renal replacement therapy. This device has neither been cleared or approved for the indication to treat patients with COVID-19 infection. The device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Oxiris Set under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The Oxiris filterset performs multiple blood purification therapies simultaneously, including CRRT and the removal of cytokines and inflammatory mediators from the blood.
Prismaflex HF20 Set
The Prismaflex HF20 Set has been authorized by the FDA to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the Coronavirus Disease 2019 (COVID-19) pandemic. The Prismaflex HF20 Set has neither been cleared or approved to provide CRRT in an acute care environment. The Prismaflex HF20 Set has been authorized by FDA under EUA201769. The Prismaflex HF20 Set is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Prismaflex HF20 Set under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Also usable across all CRRT modalities, HF20 filtersets are appropriate for low-weight patients and patients with low blood volume.
Regiocit (sodium chloride and sodium citrate)
Regiocit has been authorized by FDA for emergency use. Regiocit is not FDA-approved. Regiocit is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Regiocit under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Regiocit: a replacement solution that contains citrate for Regional Citrate Anticoagulation (RCA) of the extracorporeal circuit. Regiocit has been authorized for emergency use as a replacement solution in adult patients treated with Continuous Renal Replacement Therapy (CRRT), and for whom RCA is appropriate, during the COVID-19 pandemic. Regiocit is intended for use in a critical care setting. Regiocit is intended to be used in continuous venovenous hemofiltration (CVVH) and continuous venovenous hemodiafiltration (CVVHDF) modalities. Use of Regiocit is limited to healthcare providers and/or institutions that Vantive has qualified to administer Regiocit for these emergency uses.
Hemofiltration solution for regional citrate anticoagulation in CRRT.
Regiocit resources:
Important Safety Information
INDICATIONS
Regiocit (sodium chloride and sodium citrate) solution is indicated for use as replacement solution for regional citrate anticoagulation (RCA ) of the extracorporeal circuit in adults treated with continuous renal replacement therapy (CRRT ), particularly when systemic anticoagulation with heparin is contraindicated, e.g., in patients with increased bleeding risks.
IMPORTANT RISK INFORMATION
- Regiocit solution is contraindicated in patients with severe liver failure, shock with muscle hypoperfusion and those who are hypersensitive to this drug, any ingredients (including non-medicinal ingredients ), formulation or component of the container.
- There have been reports of system failure due to apparent operator error during administration of CRRT with Regiocit solution, leading to serious adverse events, including life-threatening hypocalcemia. Plasma electrolyte and acid-base parameters should be closely monitored during CRRT. Special attention is required in patients with liver failure, including hepatic cirrhosis or acute hepatic failure, or in shock, as patients may be exposed to citrate accumulation. Systemic metabolism of citrate to bicarbonate may be impaired in patients with hepatic impairment and can result in metabolic acidosis and ionized hypocalcemia.
- Medicinal products containing calcium used for maintenance of calcium homeostasis in CRRT patients can increase the risk of hypercalcemia and can result in a reduced anticoagulation effect.
- Use of the Regiocit solution may result in hypomagnesemia due to CRRT effluent losses, hypoglycemia, or hypokalemia.
- Additional sodium bicarbonate (or buffer source) contained in the CRRT fluids or in other fluids administered during therapy may increase the risk of metabolic alkalosis. Metabolic acidosis may occur if metabolic clearance of citrate by the liver or skeletal muscle is impaired.
- Regiocit solution should be used with caution in patients with traumatic brain injury, cerebral edema, or increased intracranial pressure.
- Plasma electrolyte and acid–base parameters should be closely monitored during CRRT. Closely monitor sodium, magnesium, potassium, phosphate, calcium, blood glucose levels, hematocrit, hemodynamic status and fluid balance, pH, bicarbonate, total-to-ionized calcium ratio, and systemic ionized calcium. Infusion of electrolytes may be needed to supplement any loss.
- Adverse Reactions – Hypotension, hypocalcemia, other electrolyte imbalances (hypomagnesemia, hypokalemia, hypophosphatemia ), acid base balance disorders (including metabolic alkalosis, metabolic acidosis ), hypoglycemia, fluid imbalance.
Click here for full Prescribing Information for Regiocit Renal Replacement Solution.
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The Oxiris set is a disposable, extracorporeal circuit for use with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
The Oxiris set is indicated for use in critically ill patients with a body weight equal or greater than 30 kg (66lb) for hemoperfusion and / or renal replacement modalities such as:
Slow Continuous UltraFiltration (SCUF)
Continuous Veno-Venous Hemofiltration (CVVH)
Continuous Veno-Venous HemoDialysis (CVVHD)
Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
When used for hemoperfusion only, the SCUF mode shall be used with no fluid removal prescription, as the indication is to reduce elevated levels of inflammatory mediators, such as cytokines, and to reduce endotoxins.
If patients suffer from acute kidney injury and / or volume overload, the Oxiris set is indicated for continuous renal replacement therapies (CRRT), to perform fluid management and removal of uremic toxins. The removal of inflammatory mediators and endotoxins is performed simultaneously when indicated for CRRT.
Rx Only. For safe and proper use of the products mentioned herein, please refer to the appropriate Operator’s Manual or Instructions for Use.
Vantive and Oxiris, Prismaflex, PrisMax and Regiocit are trademarks of Vantive Health LLC or its affiliates.