Kimyrsa

KIMYRSA- oritavancin diphosphate injection, powder, lyophilized, for solution
Melinta Therapeutics, LLC

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

There are two oritavancin products (KIMYRSA and ORBACTIV® , another oritavancin product) that:

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 (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.

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.

3 DOSAGE FORMS AND STRENGTHS

KIMYRSA is supplied as sterile, white to off-white or pink lyophilized powder containing 1,200 mg of oritavancin (as oritavancin diphosphate) in a single-dose clear glass vial, which must be reconstituted and further diluted prior to intravenous administration.

4 CONTRAINDICATIONS

4.1 Intravenous Unfractionated Heparin Sodium

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after KIMYRSA administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours (5 days) after KIMYRSA administration [see Warnings and Precautions (5.1) and Drug Interactions (7.2)].

4.2 Hypersensitivity

KIMYRSA is contraindicated in patients with known hypersensitivity to oritavancin products.

5 WARNINGS AND PRECAUTIONS

5.1 Coagulation Test Interference

Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, PT and INR for up to 12 hours, and activated clotting time (ACT) for up to 24 hours following administration of a single 1,200 mg dose by binding to and preventing action of the phospholipid reagents commonly used in laboratory coagulation tests. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours after oritavancin administration.

For patients who require aPTT monitoring within 120 hours of KIMYRSA dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered [see Contraindications (4.1) and Drug Interactions (7.2)].

Oritavancin has no effect on the coagulation system in vivo.

5.2 Hypersensitivity

Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including KIMYRSA. If an acute hypersensitivity reaction occurs during KIMYRSA infusion, discontinue KIMYRSA immediately and institute appropriate supportive care. Before using KIMYRSA, inquire carefully about previous hypersensitivity reactions to glycopeptides. Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during KIMYRSA infusion in patients with a history of glycopeptide allergy. In the Phase 3 ABSSSI clinical trials, the median onset of hypersensitivity reactions in oritavancin-treated patients was 1.2 days and the median duration of these reactions was 2.4 days [see Adverse Reactions (6.1)].

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