Dalvance Dosage

2.1 Recommended Dosage Regimen in Adult Patients with CLcr 30 mL/min and Above

​The recommended dosage regimen of DALVANCE in adult patients with CLcr 30 mL/min and above is 1500 mg, administered either as a single dose regimen, or as a two-dose regimen of DALVANCE 1000 mg followed one week later by 500 mg. Administer DALVANCE over 30 minutes by intravenous infusion. For adult patients with CLcr less than 30 mL/min, dosage adjustment is required [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

2.2 Recommended Dosage Regimen in Pediatric Patients with CLcr 30 mL/min/1.73m2 and Above

​The recommended dosage regimen of DALVANCE in pediatric patients with CLcr 30 mL/min/1.73m2 and above is a single dose regimen based on the age and weight of the pediatric patient (Table 1). Administer DALVANCE over 30 minutes by intravenous infusion.

​There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years with CLcr less than 30 mL/min/1.73m2 [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

*Estimate CLcr or glomerular filtration rate (GFR) using an age-appropriate equation accepted for pediatric

patients (birth to less than 18 years old) to define renal function impairment.

2.3 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 DALVANCE is 1125 mg, administered either as a single dose regimen, or as a two-dose regimen of DALVANCE 750 mg followed one week later by 375 mg.

​No dosage adjustment is recommended for adult patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

​

2.4 Preparation and Administration

DALVANCE (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: DALVANCE 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 DALVANCE 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 DALVANCE will vary according to the age and weight of the child up to a maximum of 1500 mg [see Dosage and Administration (2.2)]. Aseptically transfer the required dose of reconstituted DALVANCE 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, DALVANCE 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 DALVANCE should be inspected visually for particulate matter prior to infusion. If particulate matter is identified, do not use.

Administration: After reconstitution and dilution, administer DALVANCE via intravenous infusion, using a total infusion time of 30 minutes.

Do not co-infuse DALVANCE with other medications or electrolytes. Saline-based infusion solutions may cause precipitation and should not be used. The compatibility of reconstituted DALVANCE 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 DALVANCE, the line should be flushed before and after each DALVANCE infusion with 5% Dextrose Injection, USP.