Oritavancin

Oritavancin is an antibacterial drug [see Microbiology (12.4) ] .

• ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

• Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. ( 4.1 , 5.1 ) Known hypersensitivity to oritavancin products.contraindicated

There are two oritavancin products (ORBACTIV and KIMYRSA™, another oritavancin product) that have differences in dose strength, duration of infusion and preparation instructions, including reconstitution and dilution instructions and compatible diluents ( 2.1 , 2.2 , 2.3 , 2.4 ) Administer 1,200 mg of ORBACTIV as a single dose by intravenous infusion over 3 hours. ( 2.1 , 5.3 ) Carefully follow the recommended dosage and dose preparation instructions for ORBACTIV in the full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage and Administration Overview There are two oritavancin products (ORBACTIV and KIMYRSA™, another oritavancin product) that: Are supplied in different dose strengths of oritavancin [see Dosage Forms and Strengths (3) ] . Have different recommended durations of infusion [see Dosage and Administration (2.2) ]. Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents [see Dosage and Administration (2.3 , 2.4) ] . Carefully follow the recommended dosage and dose preparation instructions for ORBACTIV in this prescribing information (PI) [see Dosage and Administration (2.1 , 2.2 , 2.3 , 2.4) ]. Refer to the KIMYRSA prescribing information for relevant information of the other oritavancin product. 2.2 Recommended Dosage The recommended dosage of ORBACTIV is 1,200 mg administered as a single dose by intravenous infusion over 3 hours in patients 18 years and older [see Warnings and Precautions (5.3) ] .

Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours. For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT. ( 5.1 , 7.2 ) Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV. Discontinue infusion if signs of acute hypersensitivity occur. Carefully monitor patients with known hypersensitivity to glycopeptides. ( 5.2 ) Infusion Related Reactions: Administer ORBACTIV over 3 hours to minimize infusion. Infusion related reactions have been reported with the glycopeptide class of antimicrobial agents, including oritavancin products (e.g. ORBACTIV). Stopping or slowing the infusion may result in cessation of these reactions. ( 5.3 ) Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.4 ) Concomitant warfarin use: ORBACTIV has been shown to artificially prolong PT/INR for up to 12 hours ( 5.1 ). Patients should be monitored for bleeding if concomitantly receiving ORBACTIV and warfarin. ( 5.5 ) Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

The following adverse reactions are also discussed in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Related Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Osteomyelitis [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥3%) in patients treated with ORBACTIV were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ORBACTIV cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ORBACTIV has been evaluated in two, double-blind, controlled ABSSSI clinical trials, which included 976 adult patients treated with a single 1,200 mg intravenous dose of ORBACTIV and 983 patients treated with intravenous vancomycin for 7 to 10 days. The median age of patients treated with ORBACTIV was 45.6 years, ranging between 18 and 89 years of age with 8.8% ≥65 years of age. Patients treated with ORBACTIV were predominantly male (65.4%), 64.4% were Caucasian, 5.8% were African American, and 28.1% were Asian. Safety was evaluated for up to 60 days after dosing.

8.1 Pregnancy Risk Summary There are no available data on ORBACTIV use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development or survival were observed in pregnant rats or rabbits treated at the highest doses throughout organogenesis with intravenous oritavancin, at doses equivalent to 25% of the single clinical dose of 1,200 mg (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oritavancin at the highest doses administered throughout organogenesis, 30 mg/kg/day (gestation days 6-17) and 15 mg/kg/day (gestation days 7-19), respectively. Those doses would be equivalent to a human dose of 300 mg, or 25% of the single clinical dose of 1,200 mg. Higher doses were not evaluated in nonclinical developmental and reproductive toxicology studies.

Metabolism

The population PK analysis was derived using data from the two Phase 3 ABSSSI clinical trials in 297 patients. The mean ( ± SD) pharmacokinetic parameters of oritavancin in patients following a single 1,200 mg dose are presented in Table 3.

In the ORBACTIV clinical program there was no incidence of accidental overdose of ORBACTIV. Based on an in vitro hemodialysis study, ORBACTIV is unlikely to be removed from blood by hemodialysis. In the event of overdose, supportive measures should be taken.

• Aug 6, 2014NDANDA206334Melinta Therap
• Mar 12, 2021NDANDA214155Melinta Therap

1. 1Off Label Use22119%
2. 2Pruritus19817%
3. 3Chills17315%
4. 4Multiple Use Of Single-use Product12811%
5. 5Infusion Related Reaction12410%
6. 6Back Pain12210%
7. 7Urticaria1169.8%
8. 8Dyspnoea1119.3%
9. 9Rash1089.1%
10. 10Nausea1028.6%
11. 11Chest Pain776.5%
12. 12Erythema756.3%
13. 13Flushing756.3%
14. 14Tremor705.9%
15. 15Vomiting635.3%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Oritavancin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Oritavancin for Treatment of Serious Cardiac Infections
  Not yet recruiting · Phase 2 · Interventional · 20 enrolled · Kirby Institute
  NCT07550595updated 2026-04-29
• Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections
  Completed · Phase 1 · Interventional · 41 enrolled · Melinta Therapeutics, LLC
  NCT02134301updated 2025-12-12
• Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
  Completed · Phase 2 · Interventional · 118 enrolled · Melinta Therapeutics, LLC
  NCT05599295updated 2025-11-25
• Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
  Active not recruiting · Observational · 230 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT06688084updated 2025-11-17
• Comparing Oral Versus Parenteral Antimicrobial Therapy
  Terminated · Phase 4 · Interventional · 94 enrolled · West Virginia University
  NCT05977868updated 2025-08-26
• Oritavancin for CIED Infections With MDR Gram-positive Cocci
  Not yet recruiting · Interventional · 100 enrolled · Medical University of Silesia
  NCT07013552updated 2025-06-10
• Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
  Terminated · Phase 4 · Interventional · 2 enrolled · University of Maryland, Baltimore
  NCT05521880updated 2025-05-29
• Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
  Completed · Phase 4 · Interventional · 22 enrolled · The Medicines Company
  NCT02925416updated 2024-02-01
• A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants
  Completed · Phase 1 · Interventional · 150 enrolled · Melinta Therapeutics, Inc.
  NCT01762839updated 2024-02-01
• A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
  Completed · Phase 4 · Interventional · 17 enrolled · The Medicines Company
  NCT02452918updated 2023-12-20

Frequently asked questions

How does Oritavancin work?

Oritavancin is an antibacterial drug [see Microbiology (12.4) ] .

What is Oritavancin used for?

According to FDA labeling, Oritavancin carries indications including: ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oritavancin?

Oritavancin is classified as Glycopeptide antibacterials, Lipoglycopeptide Antibacterial, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 2D6 Inducers, Cytochrome P450 3A4 Inducers, Protein Synthesis Inhibitors, Transpeptidase Inhibitors, Decreased Cell Membrane Integrity, Decreased Cell Wall Synthesis & Repair, Increased Cellular Death.

What are the brand names for Oritavancin?

Oritavancin is marketed under brand names including Kimyrsa, Orbactiv.

What are the contraindications for Oritavancin?

Oritavancin labeling lists contraindications including: Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. ( 4.1 , 5.1 ) Known hypersensitivity to oritavancin products.. Always consult the full prescribing information and a clinician.