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Oritavancin

Generic name: oritavancin systemic

Brand names: Orbactiv, Kimyrsa

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Orbactiv: 400 mg (1 ea, 3 ea)

Solution Reconstituted, Intravenous [preservative free]:

Orbactiv: 400 mg (1 ea)

Pharmacology

Mechanism of Action

Oritavancin is a lipoglycopeptide with concentration-dependent bactericidal activity. It inhibits cell wall biosynthesis by inhibiting the polymerization step by binding to stem peptides of peptidoglycan precursors, by inhibiting crosslinking by binding to bridging segments, and by disrupting bacterial membrane integrity, leading to cell death.

Pharmacokinetics/Pharmacodynamics

Distribution

Vd: ~87.6 L

Metabolism

Not metabolized

Excretion

Feces and urine as unchanged drug (less than 1% and 5% in feces and urine, respectively, over two weeks postadministration)

Half-Life Elimination

~245 hours

Protein Binding

~85%

Use: Labeled Indications

Acute bacterial skin and skin structure infections: 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 (including S. anginosus, S. intermedius, S. constellatus); and Enterococcus faecalis (vancomycin-susceptible isolates only)

Contraindications

Hypersensitivity to oritavancin or any component of the formulation; use of intravenous unfractionated heparin for 120 hours (5 days) after oritavancin administration (oritavancin falsely elevates aPTT for up to 120 hours (5 days) after administration)

Dosage and Administration

Dosing: Adult

Acute bacterial skin and skin structure infections: IV: 1,200 mg as a single dose

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Reconstitute each 400 mg vial with 40 mL of SWFI. Swirl gently to avoid foaming. The reconstituted vial contains 10 mg/mL oritavancin as a clear, colorless to pale yellow solution. Withdraw and discard 120 mL of fluid from a D5W 1000 mL bag; withdraw 40 mL from each of 3 reconstituted vials and add to D5W to bring the total bag volume to 1000 mL. (final solution concentration 1.2 mg/mL).

Administration

IV: Infuse over 3 hours. If a common IV line is being used to administer other drugs in addition to oritavancin, the line should be flushed before and after each infusion with D5W. If infusion-related reaction (pruritus, urticaria, flushing) occurs, consider slowing or interrupting infusion.

Storage

Store intact vials at 20ºC to 25ºC (68ºF to 77ºF); excursions are permitted between 15ºC and 30ºC (59ºF and 86ºF). Reconstituted vials and solution diluted in D5W may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for 12 hours or at room temperature 20°C to 25°C (68°F to 77°F) for 6 hours. The total time from reconstitution and dilution to completed administration should be ≤6 hours at room temperature or ≤12 hours if refrigerated.

Drug Interactions

Anticoagulants: Oritavancin may diminish the therapeutic effect of Anticoagulants. Specifically, oritavancin may artificially increase the results of laboratory tests commonly used to monitor anticoagulant effectiveness, which could lead to incorrect decisions to decrease anticoagulant doses. Exceptions: Antithrombin; Bemiparin; Dalteparin; Enoxaparin; Fondaparinux; Nadroparin; Protein C Concentrate (Human); Tinzaparin. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Heparin: Oritavancin may diminish the therapeutic effect of Heparin. Specifically, oritavancin may artificially increase the results of laboratory tests commonly used to monitor IV heparin effectiveness, which could lead to incorrect decisions to decrease heparin doses. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Oritavancin may increase the serum concentration of Vitamin K Antagonists. Monitor therapy

Test Interactions

Artificially prolongs coagulation tests (binds to and prevents action of phospholipid reagents), including activated clotting time (ACT; ≤24 hours), aPTT (≤120 hours), prothrombin time (≤12 hours) and international normalized ratio (≤12 hours), silica clot time (SCT; ≤18 hours), dilute Russell's viper venom time (DRVVT; ≤72 hours), and D-dimer (≤72 hours). For patients requiring aPTT monitoring within 120 hours of a dose, consider a nonphospholipid dependent coagulation test (eg, Factor Xa [chromogenic] assay) or an alternative anticoagulant not requiring aPTT monitoring.

Adverse Reactions

1% to 10%:

Cardiovascular: Tachycardia (3%), hypersensitivity angiitis (<2%; leucocytoclastic vasculitis), peripheral edema (<2%)

Central nervous system: Headache (7%), dizziness (3%)

Dermatologic: Erythema multiforme (<2%), pruritus (<2%), skin rash (<2%), urticaria (<2%)

Endocrine & metabolic: Hyperuricemia (<2%), hypoglycemia (<2%)

Gastrointestinal: Nausea (10%), vomiting (5%), diarrhea (4%)

Hematologic & oncologic: Anemia (<2%), eosinophilia (<2%)

Hepatic: Increased serum ALT (3%), increased serum AST (2%), increased total serum bilirubin (<2%)

Hypersensitivity: Angioedema (<2%), hypersensitivity reaction (<2%)

Infection: Abscess (subcutaneous and limb; 4%)

Local: Injection site phlebitis (3%), injection site reaction (2%), erythema at injection site (<2%), extravasation (<2%), induration at injection site (<2%)

Neuromuscular & skeletal: Myalgia (<2%), osteomyelitis (<2%), tenosynovitis (<2%)

Respiratory: Bronchospasm (<2%), wheezing (<2%)

<1%, postmarketing, and/or case reports: Clostridioides (formerly Clostridium) difficile-associated diarrhea

Warnings/Precautions

Concerns related to adverse effects:

  • Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported (median onset in studies ~1.2 days). If an acute reaction occurs, discontinue infusion immediately and institute appropriate supportive care (median resolution ~2.4 days). Inquire about previous hypersensitivity reactions to glycopeptides; carefully monitor patients with a history of glycopeptide allergy.
  • Infusion reactions: Infusion related reactions (pruritus, urticaria, flushing) have been reported; reactions characterized by chest pain, back pain, chills, and tremor also have occurred. If reactions occur, consider slowing or interrupting infusion.
  • Osteomyelitis: In clinical trials, more cases of osteomyelitis were noted in patients treated with oritavancin. Monitor for signs and symptoms of osteomyelitis and institute appropriate alternate antibacterial therapy if warranted.
  • Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides (formerly Clostridium) difficile (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Concurrent drug therapy issues:

  • Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Monitoring Parameters

Baseline serum urea nitrogen, serum creatinine, and liver function tests (AST, ALT, bilirubin). Monitor patients for any kind of infusion-related reactions (pruritus, urticaria, flushing), hypersensitivity reactions (especially in patients with reported glycopeptide allergy) and signs and symptoms of osteomyelitis.

Pregnancy

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

What is this drug used for?

  • It is used to treat skin infections.

Frequently reported side effects of this drug

  • Headache
  • Injection site irritation
  • Diarrhea
  • Vomiting
  • Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

  • Skin rash during infusion
  • Flushing
  • Bone pain
  • Clostridium difficile (C. diff)-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
  • Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated January 29, 2020.