Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINTRAVENOUSHigh Alert

Kimyrsa

ORITAVANCIN DIPHOSPHATE

Standard Dose
2 DOSAGE AND ADMINISTRATION There are two oritavancin products (KIMYRSA and ORBACTIV ® , another oritavancin product) that have differences in dose strength, duration of infusion and preparation instructions, including reconstitution and dilution instructions and compatible diluents ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer 1,200 mg of KIMYRSA as a single dose by intravenous infusion over 1 hour. ( 2.1 , 5.3 ) Carefully follow the recommended dosage and dose preparation instructions for KIMYRSA in the full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 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. 2.2 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) ] . 2.3 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 (SWFI) 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. 2.4 Compatibilities KIMYRSA solution for administration by 1-hour infusion is compatible with: 0.9% sodium chloride injection 5% dextrose in sterile water (D5W) 2.5 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.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms.
Summary

Indications and usage 1 INDICATIONS AND USAGE KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Acute Bacterial Skin and Skin Structure Infections KIMYRSA ® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus dysgalactiae , Streptococcus anginosus group (includes S. anginosus , S. intermedius , and S. constellatus ), and Enterococcus faecalis (vancomycin-susceptible isolates only). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Acute Bacterial Skin and Skin Structure Infections KIMYRSA ® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus dysgalactiae , Streptococcus anginosus group (includes S. anginosus , S. intermedius , and S. constellatus ), and Enterococcus faecalis (vancomycin-susceptible isolates only). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dosage and administration 2 DOSAGE AND ADMINISTRATION There are two oritavancin products (KIMYRSA and ORBACTIV ® , another oritavancin product) that have differences in dose strength, duration of infusion and preparation instructions, including reconstitution and dilution instructions and compatible diluents ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer 1,200 mg of KIMYRSA as a single dose by intravenous infusion over 1 hour. ( 2.1 , 5.3 ) Carefully follow the recommended dosage and dose preparation instructions for KIMYRSA in the full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 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. 2.2 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) ] . 2.3 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 (SWFI) 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. Withdra

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours.
  • • For patients who require aPTT monitoring within 120 hours of KIMYRSA dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.
  • • ( 5.1 , 7.2 ) Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including KIMYRSA.
  • • Discontinue infusion if signs of acute hypersensitivity occur.

Interaction Notes

  • • 7 DRUG INTERACTIONS 7.1 Effect of KIMYRSA on CYP Substrates A screening drug-drug interaction study indicated that oritavancin is a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or inducer (CYP3A4 and CYP2D6) of several CYP isoforms [see Clinical Pharmacology (12.3) ] .
  • • A drug-drug interaction study that assessed the interaction potential of a single 1,200 mg dose of oritavancin on the pharmacokinetics of S-warfarin (CYP2C9 probe substrate) showed no effect of oritavancin on S-warfarin C max or AUC.
  • • Avoid administering KIMYRSA concomitantly with drugs that are predominantly metabolized by one of the affected CYP450 enzymes, as co-administration may increase or decrease concentrations of those drugs.
  • • Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given KIMYRSA while on a potentially affected compound (e.g., patients should be monitored for bleeding if concomitantly receiving KIMYRSA and warfarin).