Drug Detail:Kimyrsa (Oritavancin [ or-it-a-van-sin ])
Generic Name: ORITAVANCIN DIPHOSPHATE 1200mg in 40mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: Glycopeptide antibiotics
Dosage and Administration Overview
There are two oritavancin products (KIMYRSA and ORBACTIV®, another oritavancin product) that:
- Are supplied in different dose strengths of oritavancin [see Dosage Forms and Strengths (3)].
- Have different recommended durations of infusion [see Dosage and Administration (2.2)].
- Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents [see Dosage and Administration (2.3, 2.4)].
Carefully follow the recommended dosage and dose preparation instructions for KIMYRSA in this prescribing information (PI) [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)]. Refer to the ORBACTIV prescribing information for relevant information of the other oritavancin product.
Recommended Dosage
The recommended dosage of KIMYRSA is 1,200 mg administered as a single dose by intravenous infusion over 1 hour in patients 18 years and older [see Warnings and Precautions (5.3)].
Preparation of KIMYRSA for Intravenous Infusion
There are two oritavancin products (KIMYRSA and ORBACTIV, another oritavancin product) that have differences in dose strengths, duration of infusion, reconstitution and dilution instructions, and compatible diluents. Carefully follow the reconstitution, and dilution instructions with the appropriate compatible diluent for KIMYRSA specified in this prescribing information. Refer to the ORBACTIV prescribing information for relevant information of the other oritavancin product.
KIMYRSA is intended for intravenous infusion, only after reconstitution and dilution.
One KIMYRSA 1,200 mg single-dose vial needs to be reconstituted and diluted to prepare a single 1,200 mg intravenous dose.
Reconstitution: Aseptic technique should be used to reconstitute one KIMYRSA 1,200 mg vial.
- Add 40 mL of sterile water for injection (WFI) to reconstitute the vial to provide a 30 mg/mL solution.
- Gently swirl the contents to avoid foaming and ensure that all KIMYRSA powder is completely dissolved to form a reconstituted solution.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted vial should appear to be a clear, colorless to pink solution, free of visible particles.
Dilution: Use 0.9% sodium chloride injection or 5% dextrose in sterile water (D5W) for dilution to prepare the final intravenous solution for infusion. Since no preservative or bacteriostatic agent is present in KIMYRSA, aseptic technique must be used in preparing the final intravenous solution as follows:
- Withdraw and discard 40 mL from a 250 mL intravenous bag of 0.9% sodium chloride injection or D5W.
- Withdraw 40 mL of the reconstituted vial of KIMYRSA and add to the intravenous bag of 0.9% sodium chloride injection or D5W to bring the bag volume to 250 mL. This yields a concentration of 4.8 mg/mL.
Discard any unused portion of the reconstituted solution remaining in the vial.
Storage and Use of Intravenous Solution: Diluted intravenous solution in an infusion bag should be used within 4 hours when stored at room temperature, or used within 12 hours when refrigerated at 2 to 8°C (36 to 46°F). The combined storage time (reconstituted solution in the vial and diluted solution in the bag) and 1 hour infusion time should not exceed 4 hours at room temperature or 12 hours if refrigerated.
Compatibilities
KIMYRSA solution for administration by 1-hour infusion is compatible with:
- 0.9% sodium chloride injection
- 5% dextrose in sterile water (D5W)
Incompatibilities
Drugs formulated at a basic or neutral pH may be incompatible with KIMYRSA. KIMYRSA should not be administered simultaneously with commonly used intravenous drugs through a common intravenous port. If the same intravenous line is used for sequential infusion of additional medications, the line should be flushed before and after infusion of KIMYRSA with 0.9% sodium chloride injection or D5W.
