oritavancin (Rx)

Brand and Other Names:Orbactiv
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 400mg/50mL per vial

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

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Interactions

Interaction Checker

and oritavancin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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%)

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            Warnings

            Contraindications

            Hypersensitivity

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

            Cautions

            Hypersensitivity, including anaphylaxis, 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

            Infusion reactions characterized by chest pain, back pain, chills and tremor observed with use of drug, including after administration of more than one dose during a single course of therapy; stopping or slowing infusion may result in cessation of these reactions; safety and effectiveness of more than one dose during a single course of therapy have not been established

            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

            Drug interaction overview

            • Oritavancin is a nonspecific, weak CYP2C9 and CYP2C19 inhibitor; weak CYP3A4 and CYP2D6 inducer
            • Shown to artificially prolong PT/INR for up to 12 hr; coadministration with warfarin may result in higher exposure of warfarin and increase risk for bleeding; monitor frequently for signs of bleeding
            • Coadministration with oritavancin and drugs that are predominantly metabolized by one of the affected CYP450 enzymes may increase or decrease concentrations of those drugs; closely monitor signs of toxicity or lack of efficacy if given oritavancin while on a potentially affected compound
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            Pregnancy & Lactation

            Pregnancy

            There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Animal data

            • In animal reproduction studies, no effects on embryo-fetal development or survival were observed in pregnant rats or rabbits treated at highest doses throughout organogenesis with intravenous drug, at doses equivalent to 25% of single clinical dose of 1200 mg

            Lactation

            There are no data on the presence of oritavancin in human milk, the effects on the breastfed child, or the effects on milk production

            Drug in the breast milk of rats

            Therefore, it will be present in human milk

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breast-fed child from drug or from underlying maternal condition

            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.

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            Pharmacology

            Mechanism of Action

            Lipoglycopeptide antibiotic that exerts concentration-dependent bactericidal activity

            Elicits the following mechanisms of action

            • Inhibits the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors
            • Inhibits the transpeptidation (cross-linking) step of cell wall biosynthesis by binding to the peptide-bridging segments of the cell wall
            • 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

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            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

            • Reconstitute each vial with 40 mL of sterile water 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
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            Formulary

            FormularyPatient Discounts

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