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Oritavancin

Pronunciation

(or it a VAN sin)

Index Terms

  • LY333328
  • Oritavancin Diphosphate

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)

Brand Names: U.S.

  • Orbactiv

Pharmacologic Category

  • Glycopeptide

Pharmacology

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.

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)

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

ESRD requiring hemodialysis: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); not removed by hemodialysis.

Dosing: Hepatic Impairment

Mild to moderate hepatic impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe hepatic impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

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.

Compatibility

Stable in D5W.

Incompatible: NS or any saline-based solution; drugs formulated at a basic or neutral pH may also be incompatible. If a common IV line or port is being used to administer other drugs in addition to oritavancin, the line should be flushed before and after each infusion with D5W.

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

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. 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 (<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: Clostridium difficile-associated diarrhea, hypersensitivity reaction

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Serious hypersensitivity reactions 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. 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 C. difficile-associated diarrhea (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 Risk Factor

C

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, injection site irritation, diarrhea, vomiting, or nausea. Have patient report immediately to prescriber flushing or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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