Important Safety Information Full Prescribing Information

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Outpatient Infusion

ORBACTIV provides effective ABSSSI treatment in a single three-hour
infusion. Consider ORBACTIV for patient care in any setting.

		Efficacy and Safety Summary of clinical trial data Clinical Profile Safety			Treatment for any site of care Options for inpatient and outpatient settings, supporting transition of care Settings of Care
		Treatment for any site of care Options for inpatient and outpatient settings, supporting transition of care Settings of Care
		Patient Profiles Common patients who may benefit from Oritavancin ORBACTIV Patients			Dosing & Administration Preparation, storage, dosing and administration Dosing Preparation Administration
		Dosing & Administration Preparation, storage, dosing and administration Dosing Preparation Administration
		Patient Support Reimbursement support, savings & patient education Support Resources Patient Enrollment Form Patient Education			Ordering Ordering Information Ordering
		Ordering Ordering Information Ordering
					Billing & Coding Billing and coding information ICD-10 Codes Billing & Coding
		Billing & Coding Reimbursement, billing scenarios, and J-code ICD-10 Codes Billing & Coding

DISCLAIMER

Content provided for informational purposes only. This information does not guarantee coverage or payment. Codes, coverage, and payment may vary from setting to setting, and from insurer to insurer. The provider submitting a claim is solely responsible for the accuracy of the codes submitted and for compliance with all coverage and reimbursement policies.

Decisions to prescribe ORBACTIV® are by providers working with their patients. The ORBACTIV® Support Program provides information about ORBACTIV® and about assistance that may be available to patients who meet certain criteria, including that they are not insured by a federal health care program. More information is available through the ORBACTIV® Support Program.

Melinta Therapeutics, LLC, does not guarantee, and assumes no responsibility for the quality, availability, or scope of the ORBACTIV® Support Program services. Melinta Therapeutics, LLC, reserves the right to rescind, revoke, or amend this offer at any time without notice. Void where prohibited by law.

INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

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 susceptible bacteria.

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 may remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

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

Warnings and Precautions

Coagulation test interference: Oritavancin 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. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of oritavancin dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.

Infusion Related Reactions: Administer ORBACTIV® over 3 hours to minimize infusion-related reactions. Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products (e.g. ORBACTIV®), including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.

Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. 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 or a prophylactic indication 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.

Please see Full Prescribing Information for ORBACTIV®.

INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

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 susceptible bacteria.