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ORBACTIV
Bacterial infections
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Drug Name:

ORBACTIV Rx

Generic Name and Formulations:
Oritavancin 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.

Company:
The Medicines Company

Therapeutic Use:

Indications for ORBACTIV:

Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) microorganisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).

Adult:

Give by IV infusion over 3hrs. ≥18yrs: 1200mg as a single dose.

Children:

<18yrs: not established.

Contraindications:

Use of IV unfractionated heparin sodium for 120hrs (5 days) after oritavancin administration.

Warnings/Precautions:

History of glycopeptide allergy. Discontinue immediately if acute hypersensitivity reaction occurs. Consider slowing or interrupting infusion if infusion-related reactions occur. Risk of Clostridium difficile-associated diarrhea; evaluate and may need to discontinue if occurs. Monitor for signs/symptoms of osteomyelitis; use alternative therapy if suspected or diagnosed. Severe hepatic or renal impairment: not studied. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Increased risk of bleeding with concomitant warfarin; may prolong aPTT for up to 120hrs, PT/INR for up to 12hrs, and ACT for up to 24hrs; monitor for bleeding. Avoid concomitant drugs with a narrow therapeutic window that are metabolized by the affected CYP450 enzymes. May increase concentrations of CYP2C9/CYP2C19 substrates. May decrease concentrations of CYP3A4/CYP2D6 substrates. May interfere with coagulation tests; consider non-phospholipid dependent test (eg, Factor Xa assay) or alternative anticoagulant not requiring aPTT monitoring.

Pharmacological Class:

Lipoglycopeptide.

Adverse Reactions:

Headache, nausea, vomiting, limb and subcutaneous abscesses, diarrhea.

Generic Availability:

NO

How Supplied:

Single-use vial—3

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