Dalbavancin
Dosing in kidney impairment
Dosage Adjustments in Adult Patients with CLcr less than 30 mL/min In adult patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended dosage regimen of dalbavancin for injection is 1,125 mg, administered as a single dose regimen. No dosage adjustment is recommended for adult patients receiving regularly scheduled hemodialysis, and dalbavancin for injection can be administered without regard to the timing of hemodialysis [see Use in Specific Populations and Clinical Pharmacology].
| Dosage in Adult Patients (2.1, 2.3): | |
| Estimated Creatinine Clearance (CLcr) | Single Dose Regimen |
| 30 mL/min and above or on regular hemodialysis | 1,500 mg |
| Less than 30 mL/min and not on regular hemodialysis | 1,125 mg |
| Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m2 and above (2.2) | |
| Age Range | Dosage (Single Dose Regimen) |
| Birth to less than 6 years | 22.5 mg/kg (maximum of 1,500 mg) |
| 6 to less than 18 years | 18 mg/kg (maximum of 1,500 mg) |
Dosing in liver impairment
Hepatic Impairment No dosage adjustment of dalbavancin for injection is recommended for patients with mild hepatic impairment (Child-Pugh Class A). Caution should be exercised when prescribing dalbavancin for injection to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients [see Clinical Pharmacology].
Preparation and administration
Preparation and Administration Dalbavancin for injection must be reconstituted with either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, and subsequently diluted only with 5% Dextrose Injection, USP, to a final concentration of 1 mg/mL to 5 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstitution: Dalbavancin for injection must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, for each 500 mg vial. To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved.
Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution. Reconstituted vials may be stored either refrigerated at 2°C to 8°C (36°F to 46°F), or at controlled room temperature 20°C to 25°C (68°F to 77°F). Do not freeze. Dilution: Adult Patients: Aseptically transfer the required dose of reconstituted dalbavancin for injection solution from the vial(s) to an intravenous bag or bottle containing 5% Dextrose Injection, USP.
The diluted solution must have a final dalbavancin concentration of 1 mg/mL to 5 mg/mL. Discard any unused portion of the reconstituted solution. Pediatric Patients: For pediatric patients, the dose of dalbavancin for injection will vary according to the age and weight of the child up to a maximum of 1,500 mg [see Dosage and Administration].
Aseptically transfer the required dose of reconstituted dalbavancin for injection solution, based on the child's weight, from the vial(s) to an intravenous bag or bottle containing 5% Dextrose Injection, USP. The diluted solution must have a final dalbavancin concentration of 1 mg/mL to 5 mg/mL. Discard any unused portion of the reconstituted solution.
Once diluted into an intravenous bag or bottle as described above, dalbavancin for injection may be stored either refrigerated at 2°C to 8°C (36°F to 46°F) or at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Do not freeze. The total time from reconstitution to dilution to administration should not exceed 48 hours.
Like all parenteral drug products, diluted dalbavancin for injection should be inspected visually for particulate matter prior to infusion. If particulate matter is identified, do not use. Administration: After reconstitution and dilution, administer dalbavancin for injection via intravenous infusion, using a total infusion time of 30 minutes.
Do not co-infuse dalbavancin for injection with other medications or electrolytes. Saline-based infusion solutions may cause precipitation and should not be used. The compatibility of reconstituted dalbavancin for injection with intravenous medications, additives, or substances other than 5% Dextrose Injection, USP has not been established.
If a common intravenous line is being used to administer other drugs in addition to dalbavancin for injection, the line should be flushed before and after each dalbavancin for injection infusion with 5% Dextrose Injection, USP.