Version May 2024
Endocarditis, treatment, step-down therapy in patients who inject drugs (alternative agent) (off-label use):
Note: Not first-line treatment; based on expert opinion. Reserve use for patients who inject drugs who had clinical improvement with IV treatment for S. aureus infection but cannot complete IV standard of care therapy and are unable to absorb oral antibiotics (Ref).
IV: 1.2 g once weekly for a total duration, including initial IV therapy, of 6 weeks (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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.
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).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Peripheral edema (<2%), tachycardia (3%)
Dermatologic: Cellulitis (1%), erythema multiforme (<2%), pruritus (<2%), skin rash (<2%), urticaria (<2%)
Endocrine & metabolic: Hyperuricemia (<2%), hypoglycemia (<2%)
Gastrointestinal: Diarrhea (4%), nausea (10%), vomiting (5%)
Hematologic & oncologic: Anemia (<2%), eosinophilia (<2%), positive direct Coombs' test (≤10%), positive indirect Coombs' test (≤10%)
Hepatic: Increased serum alanine aminotransferase (3%), increased serum aspartate aminotransferase (2%), increased total serum bilirubin (<2%)
Hypersensitivity: Angioedema (<2%), hypersensitivity angiitis (<2%), hypersensitivity reaction (<2%; including severe hypersensitivity reactions)
Infection: Abscess (subcutaneous and limb; 4%)
Local: Erythema at injection site (<2%), induration at injection site (<2%), injection-site phlebitis (3%), injection-site pruritus (2%), injection-site reaction (2%), rash at injection site (<2%)
Nervous system: Dizziness (3%), headache (7%)
Neuromuscular & skeletal: Myalgia (<2%), osteomyelitis (<2%), tenosynovitis (<2%)
Respiratory: Bronchospasm (<2%), wheezing (<2%)
Frequency not defined:
Nervous system: Chills
Miscellaneous: Fever
Postmarketing:
Gastrointestinal: Clostridioides difficile-associated diarrhea
Hypersensitivity: Anaphylaxis
Miscellaneous: Infusion-related reaction
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).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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, rash, flushing of the upper body) 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 difficile (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Other warnings/precautions:
• Product interchangeability: Oritavancin is available as 2 different products (Kimyrsa or Orbactiv) supplied in different strengths and with different preparation and administration directions; use extra precaution to ensure directions are followed correctly for desired product.
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, as diphosphate:
Kimyrsa: 1200 mg (1 ea)
Solution Reconstituted, Intravenous, as diphosphate [preservative free]:
Orbactiv: 400 mg (1 ea)
No
Solution (reconstituted) (Kimyrsa Intravenous)
1200 mg (per each): $6,217.73
Solution (reconstituted) (Orbactiv Intravenous)
400 mg (per each): $1,392.97
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Note: Oritavancin is available as 2 different products (Kimyrsa or Orbactiv) supplied in different strengths and with different preparation and administration directions; use extra precaution to ensure directions are followed correctly for desired product.
IV: If infusion-related reaction (pruritus, urticaria, flushing, rash) occurs, consider slowing or interrupting infusion.
Kimyrsa: Infuse over 1 hour. 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 or NS.
Orbactiv: 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.
Skin and soft tissue infection: Treatment of adult patients with skin and soft tissue infections 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)
Endocarditis, treatment, step-down therapy in patients who inject drugs
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: 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. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: 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. Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: 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. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Oritavancin may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies.
It is not known if oritavancin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Baseline serum urea nitrogen, serum creatinine, and LFTs (AST, ALT, bilirubin). Monitor patients for any kind of infusion-related reactions (pruritus, urticaria, flushing, rash), hypersensitivity reactions (especially in patients with reported glycopeptide allergy) and signs and symptoms of osteomyelitis.
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
Protein binding: 85%
Metabolism: Not metabolized
Half-life elimination: ~245 hours
Excretion: Feces and urine as unchanged drug (less than 1% and 5% in feces and urine, respectively, over two weeks postadministration)
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