This site is intended for U.S. health care professionals only.

ORBACTIV® (oritavancin): The first Single dose regimen for treating ABSSSI

A single 1200 mg infusion helps ensure adherence to a full course of therapy.

No dosing adjustment is required for1:

  • Mild-to-moderate renal impairment*
  • Mild-to-moderate hepatic impairment
  • Weight
  • Age (≥18 years of age)
  • Gender
  • Race

No therapeutic drug monitoring required.1

Allows treatment in more than one setting.2

Orbactiv® (oritavancin) dosing regimen chart
Tap to zoom

* Mild renal impairment creatine clearance (CrCl) 50-79 mL/min, moderate renal impairment CrCl 30-49 mL/min.

† Moderate hepatic impairment (Child-Pugh Class B).

REFERENCES:

  1. ORBACTIV® (oritavancin) Prescribing Information, Parsippany, NJ: The Medicines Company; 2016.
  2. Data on file.

Pharmacokinetic profile supports a Single dose IV regimen for ABSSSI1

Population mean plasma concentration-time profile after single 1200 mg dose of ORBACTIV® administered intravenously over 3 hours - semi-log scale

mean plasma-concentration-time profile for Orbactiv® (oritavancin)
Tap to zoom


Population PK analysis based on data from 297 SOLO I and SOLO II patients.

REFERENCES:

  1. ORBACTIV® (oritavancin) Prescribing Information, Parsippany, NJ: The Medicines Company; 2016.

Important Safety Information

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

ORBACTIV® is contraindicated in patients with known hypersensitivity to ORBACTIV®.

Warnings and Precautions

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, ACT for up to 24 hours, and D-dimer for up to 72 hours.

Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.

Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops.

Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

See Full Prescribing Information

www.orbactiv.com

This site is intended for U.S. Healthcare Professionals. If you are a U.S. Healthcare Professional, click OK to continue.

Ok
Cancel