oritavancin (Rx)

Brand and Other Names:Orbactiv
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 400mg per 50 mL vial supplied in a package of 3 vials for a 1200mg dose
more...

Skin & Skin Structure Infections

Indicated for treatment of acute bacterial skin and skin structure infections

A single 1200-mg dose administered IV over 3 hr

Susceptible isolates of gram-positive microorganisms

  • Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant S aureus [MRSA] isolates)
  • Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
  • Enterococcus faecalis (vancomycin-susceptible isolates only)

Dosage Modifications

Renal impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe: Not evaluated
  • Not removed by hemodialysis

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe: Not evaluated

<18 years: Safety and efficacy not established

Next:

Interactions

Interaction Checker

and oritavancin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            1-10%

            Nausea (9.9%)

            Headache (7.1%)

            Vomiting (4.6%)

            Abscess, limb and subcutaneous (3.8%)

            Diarrhea (3.7%)

            Increased ALT (2.8%)

            Dizziness (2.7%)

            Infusion site phlebitis (2.5%)

            Tachycardia (2.5%)

            Infusion site reactions (1.9%)

            Increased AST (1.8%)

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            Use of intravenous unfractionated heparin sodium within 120 hr (5 days) of oritavancin administration

            Cautions

            Please refer to the patient counseling section of the prescribing information

            Shown to artificially prolong PT/INR for up to 12 hr (5.1); coadministration with warfarin may result in higher exposure of warfarin and increase risk for bleeding; monitor frequently for signs of bleeding

            shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hr and ACT for up to 24 hr; for patients who require aPTT monitoring within 120 hr of dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT

            Hypersensitivity reported, including possible cross-sensitivity to other glycopeptides (eg, dalbavancin, telavancin, vancomycin); discontinue infusion if signs of acute hypersensitivity occur; monitor closely patients with known hypersensitivity to glycopeptides

            Infusion-related reactions, that resemble “Red- man Syndrome”, including flushing of the upper body, urticaria, pruritus and/or rash reported; consider slowing infusion rate or interrupting infusion

            Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs and may range from mild diarrhea to fatal colitis; evaluate patients if diarrhea occurs

            In clinical trials, more cases of osteomyelitis were reported with oritavancin compared with vancomycin; if osteomyelitis suspected, institute appropriate alternate antibacterial therapy

            To reduce development of drug-resistant bacteria and maintain effectiveness, use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria

            Coagulation test interference

            • Artificially prolongs aPTT for up to 120 hr, and may prolong PT and INR for up to 12 hr and ACT for up to 24 hr
            • For patients who require aPTT monitoring within 120 hr of dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT
            • Effects on activated clotting time (ACT) are expected since the phospholipid reagents are also used in this coagulation test
            • Oritavancin has no effect on the coagulation system
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Lipoglycopeptide antibiotic that exerts concentration-dependent bactericidal activity

            Elicits 3 mechanisms of action:

            1. Inhibits the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors

            2. Inhibits the transpeptidation (cross-linking) step of cell wall biosynthesis by binding to the peptide-bridging segments of the cell wall

            3. Disrupts bacterial membrane integrity, leading to depolarization, permeabilization, and cell death

            Absorption

            Peak plasma concentration: 138 mcg/mL

            AUC, 0-24 hr: 1110 mcg•hr/mL

            AUC, 0-infinity: 2800 mcg•hr/mL

            Distribution

            Protein bound: 85%

            Vd: 87.6 L; extensively distributed into tissues

            Metabolism

            Not metabolized

            Weak inhibitor of CYP2C9 and CYP2C19

            Weak inducer of CYP3A4 and CYP2D6

            Elimination

            Half-life, alpha: 2.29 hr

            Half-life, beta: 13.4 hr

            Half-life, terminal: 245 hr

            Clearance: 0.445 L/hr

            Excretion: <1% feces; <5% urine; following 2 weeks of collection

            Previous
            Next:

            Administration

            IV Compatibilities

            Dextrose 5% in water

            IV Incompatibilities

            Saline solutions

            Drugs formulated at a basic or neutral pH

            IV Preparation

            For IV infusion, only after reconstitution and dilution

            Three 400-mg vials need to be reconstituted and diluted to prepare a single 1200-mg IV dose

            Reconstitution

            • Add 40 mL of sterile water for injection to reconstitute each vial to provide a 10-mg/mL solution per vial
            • Gently swirl vials to avoid foaming and ensure that all powder is completely reconstituted in solution
            • Inspect each vial visually for particulate matter after reconstitution
            • Solution should appear to be clear and colorless to pale yellow

            Dilution

            • Use only 5% dextrose in sterile water (D5W) for dilution; do NOT use 0.9% NaCl for dilution, as it is incompatible with oritavancin and may cause precipitation of the drug
            • Use aseptic technique to:
            • -Withdraw and discard 120 mL from a 1000-mL IV bag of D5W
            • -Withdraw 40 mL from each of the 3 reconstituted vials and add to D5W IV bag to bring the bag volume to 1000 mL
            • -This yields a final concentration of 1.2 mg/mL

            IV Administration

            Infuse IV over 3 hr

            Do not administer simultaneously with other IV drugs through a common IV port or Y-site

            If the same IV line is used for sequential infusion of additional medications, flush the line before and after infusing oritavancin with D5W

            Storage

            Unreconstituted vials: Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-to 86ºF)

            Diluted IV solution in D5W

            • Room temperature: Use within 6 hr
            • Refrigerated (2-8°C [36-46°F]): Use within 12 hr
            • The combined storage time (reconstituted solution in the vial and diluted solution in the bag) and 3-hr infusion time should not exceed 6 hr at room temperature or 12 hr if refrigerated
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.