Remimazolam

Hepatic Impairment In patients with severe hepatic impairment, the dose of BYFAVO should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications [see Clinical Pharmacology ] .

Important Dosage and Administration Instructions BYFAVO can depress respiration. Continuously monitor patients for early signs of hypoventilation, airway obstruction, and apnea using capnography, pulse oximetry, and clinical assessment. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO.

Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Supplemental oxygen, resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of BYFAVO.

A benzodiazepine reversal agent should be immediately available. Continuously monitor vital signs during sedation and through the recovery period [see Warnings and Precautions ] . Peak sedation occurs approximately 3 to 3.5 minutes after an initial 5 mg intravenous injection of BYFAVO given over a 1-minute period [see Clinical Pharmacology ].

Titrate subsequent doses of BYFAVO on the basis of clinical judgment and assessment of the depth of sedation. If maintenance of procedural sedation is inadequate, consider alternative medications [see Clinical Studies ] .

Preparation Reconstitution of BYFAVO (remimazolam) for injection Strict aseptic technique must be maintained during handling of BYFAVO. This product does not contain preservative. Once removed from packaging, protect vials from light. Each single-patient-use vial contains 20 mg BYFAVO lyophilized powder for reconstitution.

The product must be prepared immediately before use. To reconstitute, add 8.2 mL sterile 0.9% Sodium Chloride Injection, USP, to the vial, directing the stream of solution toward the wall of the vial. Gently swirl the vial (do not shake) until the contents are fully dissolved. The reconstituted product will deliver a final concentration of 2.5 mg/mL solution of BYFAVO.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Upon reconstitution, the solution should be a clear, colorless to pale yellow solution. Discard if particulate matter or discoloration is observed. If not used immediately, reconstituted BYFAVO may be stored in the vial for up to 8 hours under controlled room temperature at 20°C to 25°C (68°F to 77°F).

After 8 hours, any unused portion must be discarded.

Administration with Other Fluids BYFAVO has been shown to be compatible with the following intravenous fluids: 0.9% Sodium Chloride Injection, USP 5% Dextrose Injection, USP 20% Dextrose Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP. BYFAVO has also been shown to be compatible with Ringer's Solution, a solution containing Sodium Chloride, Potassium Chloride and Calcium Chloride Dihydrate.

BYFAVO has been shown to be incompatible with the following intravenous fluids: Lactated Ringer's Solution, a solution containing Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride Dihydrate. Lactated Ringer's Solution is also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, and Hartmann's Solution.

Acetated Ringer's Solution, a solution containing Sodium Chloride, Sodium Acetate, Potassium Chloride, and Calcium Chloride Dihydrate. BYFAVO compatibility with other agents has not been adequately evaluated. Do not mix BYFAVO with other drugs or fluids prior to administration.