oritavancin (Rx)

Brand and Other Names:Kimyrsa, Orbactiv
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 400mg/vial (Orbactiv)
  • 1200mg/vial (Kimyrsa)

Skin & Skin Structure Infections

Indicated for treatment of acute bacterial skin and skin structure infections

1200 mg IV as a single dose

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

Dosing Considerations

There are 2 oritavancin products (ie, Orbactiv, Kimyrsa) that have differences in dose strengths, duration of infusion, reconstitution and dilution instructions, and compatible diluents

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (1)

              • cholera vaccine

                oritavancin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

              Monitor Closely (15)

              • carbamazepine

                oritavancin will decrease the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • clonidine

                oritavancin will decrease the level or effect of clonidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • disopyramide

                oritavancin will decrease the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • ethosuximide

                oritavancin will decrease the level or effect of ethosuximide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • flecainide

                oritavancin will decrease the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2D6 inducer; caution if coadministered with CYP2D6 substrates that have a narrow therapeutic index

              • fosphenytoin

                oritavancin will increase the level or effect of fosphenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C9 inhibitor; caution if coadministered with CYP2C9 substrates that have a narrow therapeutic index

              • phenobarbital

                oritavancin will increase the level or effect of phenobarbital by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C9 inhibitor; caution if coadministered with CYP2C9 substrates that have a narrow therapeutic index

              • phenytoin

                oritavancin will increase the level or effect of phenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C9 inhibitor; caution if coadministered with CYP2C9 substrates that have a narrow therapeutic index

              • primidone

                oritavancin will increase the level or effect of primidone by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C9 inhibitor; caution if coadministered with CYP2C9 substrates that have a narrow therapeutic index

              • quinidine

                oritavancin will decrease the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • quinine

                oritavancin will decrease the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • sirolimus

                oritavancin will decrease the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • tacrolimus

                oritavancin will decrease the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

              • valproic acid

                oritavancin will increase the level or effect of valproic acid by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C19 inhibitor; caution if coadministered with CYP2C19 substrates that have a narrow therapeutic index

              • warfarin

                oritavancin will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2C9 inhibitor; caution if coadministered with CYP2C9 substrates that have a narrow therapeutic index

              Minor (1)

              • cyclosporine

                oritavancin will decrease the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Oritavancin is a weak CYP3A4 inducer; caution if coadministered with CYP3A4 substrates that have a narrow therapeutic index

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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%)

              Postmarketing reports

              Clostridioides-difficile-associated diarrhea

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              Warnings

              Contraindications

              Hypersensitivity to oritavancin products

              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

              Clostridioides-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

              Kimyrsa

              • Dextrose 5% in water
              • 0.9% NaCl

              Orbactiv

              • Dextrose 5% in water

              IV Incompatibilities

              Kimyrsa

              • Drugs formulated at a basic or neutral pH

              Orbactiv

              • Saline solutions
              • Drugs formulated at a basic or neutral pH

              IV Preparation

              For IV infusion, only after reconstitution and dilution

              NOTE: There are 2 oritavancin products that have differences in dose strengths, duration of infusion, reconstitution and dilution instructions, and compatible diluents; carefully follow reconstitution and dilution instructions with the appropriate compatible diluent for specified product

              Reconstitution

              • Kimyrsa
                • Reconstitute 1200-mg vial with 40 mL of sterile water for injection to yield a 30-mg/mL solution
                • Gently swirl vial to avoid foaming and ensure that all powder is completely reconstituted Inspect vial visually for particulate matter after reconstitution
                • Solution should appear to be clear, colorless to pink
              • Orbactiv
                • Three 400-mg vials need to be reconstituted and diluted to prepare a single 1200-mg IV dose
                • Reconstitute each 400-mg vial with 40 mL of sterile water for injection to yield 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

              • Kimyrsa
                • May use D5W or 0.9% NaCl to prepare final dilution
                • Withdraw and discard 40 mL from a 250-mL IV bag of D5W or 0.9% NaCl
                • Withdraw 40 mL (1200 mg) of the reconstituted vial and add to D5W or 0.9% NaCl IV bag to bring the gab volume to 250 mL
                • This yields a final concentration of 4.8 mg/mL
              • Orbactiv
                • 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
                • Withdraw and discard 120 mL from a 1000-mL IV bag of D5W
                • Withdraw 40 mL from each of the 3 reconstituted vials to total 1200 mg 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

              Kimyrsa: Infuse IV over 1 hr

              Orbactiv: 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 or 0.9% NaCl (Kimyrsa only)

              Storage

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

              Diluted IV solution

              • Room temperature: Use within 6 hr (Orbactiv) or 4 hr (Kimyrsa)
              • Refrigerated (2-8°C [36-46°F]): Use within 12 hr
              • Combined storage time (reconstituted solution in the vial and diluted solution in the bag) and infusion time should not exceed the maximum room temperature or refrigerated storage times
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Orbactiv intravenous
              -
              400 mg vial
              Orbactiv intravenous
              -
              400 mg vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              oritavancin intravenous

              ORITAVANCIN - INJECTION

              (or-IT-a-VAN-sin)

              COMMON BRAND NAME(S): Kimyrsa, Orbactiv

              USES: This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.

              HOW TO USE: This medication is given by a health care professional as a single dose. Depending on your product, this medication is injected slowly into a vein over 1 or 3 hours.Tell your doctor if your condition persists or worsens.

              SIDE EFFECTS: Nausea, vomiting, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Injection reaction symptoms such as flushing of the upper body, hives, itching, back/chest pain, chills, or shaking may also occur. Tell your doctor right away if you have any of these symptoms. Stopping or slowing down the injection may help.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: bone pain, fast heartbeat, unusual tiredness, swelling ankles/feet/hands.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using oritavancin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history. See also Drug Interactions section.Oritavancin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using oritavancin before having any immunizations/vaccinations.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.One product that may interact with this drug is: heparin.This medication may interfere with certain lab tests (including blood clotting tests such as PT/INR/aPTT), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug, and if you are using warfarin or are being treated for bleeding/clotting disorders.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Laboratory and/or medical tests (such as liver function test) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: Not applicable.

              STORAGE: Not applicable. This medication is given in a hospital and will not be stored at home.

              Information last revised October 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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