Oritavancin

DEA Class; Rx

Common Brand Names; Kimyrsa, Orbactiv

Indicated for treatment of acute bacterial skin and skin structure infections

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)

Hypersensitivity to oritavancin products

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

• 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%)
• Clostridioides-difficile-associated diarrhea

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

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

Oritavancin

injection, lyophilized powder for reconstitution

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