ORBACTIV® (Oritavancin)

ORBACTIV®

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Important Safety Information

ORBACTIV® (oritavancin) is a prescription infusion antibiotic used to treat adult patients with acute bacterial skin and skin structure infections (ABSSSIs). These are caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis.

Some drug interactions may increase the risk of serious side effects — especially if you’re taking heparin. Tell your doctor about your medical history, as well as about all medications you’re currently taking — regardless of whether they are prescription, over-the-counter, herbal supplements, or vitamins. ORBACTIV® may cause live vaccines to not work effectively. When discussing your medical history, mention if you’ve recently been vaccinated or have an appointment to get a live vaccine.

Undergoing treatment with ORBACTIV® for extended periods of time could cause the patient to develop oral thrush or another type of yeast infection. Let your doctor know if you see white patches in your mouth or unusual vaginal discharge. If you are pregnant or planning on becoming pregnant, discuss with your healthcare provider the associated risks and benefits. It is unknown if ORBACTIV® would be passed to a baby via breast milk.

What is the most important information I should know about ORBACTIV®?

It is crucial to only use ORBACTIV® for the treatment of such infections or for infections that are strongly suspected to be caused by susceptible bacteria. This will lower the risk of developing drug-resistant bacteria.

Some patients have reported hypersensitivity reactions — including anaphylaxis. Tell your doctor immediately if you experience itching, scratchy throat, hives, nasal congestion, breathing difficulties, and/or swelling of the face, throat, lips, and/or tongue.

ORBACTIV® may rarely cause a severe intestinal reaction known as clostridium difficile diarrhea. While it can occur during treatment, it’s also possible for a patient to experience it months after treatment has stopped. Tell your doctor immediately if you experience cramping, abdominal pain, persistent diarrhea, or blood or mucus in your stool. Avoid using anti-diarrhea medications to treat such symptoms, as they could make them worse.

ORBACTIV® may interfere with lab testing — especially with blood clotting tests — which may cause false results. Tell lab personnel that you are undergoing treatment with this medication, including dentists for a routine dental cleaning or any kind of oral surgery.

Side Effects of ORBACTIV®

As with any prescription medication, ORBACTIV® carries the risk of side effects. The most common ones include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Clostridium difficile
  • Subcutaneous abscesses
  • Back pain
  • Chills
  • Tremors

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

ORBACTIV® is used to treat adult patients with acute bacterial skin and skin structure infections (ABSSSIs). Infusions should be administered for more than three hours to minimize infusion-related reactions.

Please refer to the full prescribing information.