oritavancin

REMS

Acute bacterial skin and skin structure infections caused by or suspected to be caused by susceptible designated gram-positive bacteria.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity (cross-sensitivity with other glycopeptides may occur);
Heparin use for 120 hr (5 days) following administration of oritavancin (causes false ↑ aPTT);
Confirmed/suspected osteomyelitis (alternate treatment required).

Use Cautiously in:

Severe renal impairment;
Severe hepatic impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have ↑ sensitivity to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

CV: tachycardia

Derm: limb/SUBQ abscess formation

GI: ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE ASSOCIATED DIARRHEA (CDAD), nausea, vomiting.

Local: injection site reactions

Neuro: headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), infusion reactions (including infusion-related reaction resembling vancomycin flushing syndrome)

Interactions ⬆ ⬇

Drug-drug:

↑risk of bleeding with warfarin; avoid concurrent use, if possible.
Affects the activities of several CYP450 enzymes; careful monitoring of other drugs metabolized by the CYP450 system that have narrow therapeutic indices to assess for toxicity or ineffectiveness is recommended.

Availability ⬆ ⬇

Lyophilized powder for injection (Orbactiv): 400 mg/vial
Lyophilized powder for injection (Kimyrsa): 1200 mg/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 1200 mg as a single dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to bacterial cell wall, resulting in cell death.

Therapeutic effects:

Bactericidal action against susceptible bacteria with resolution of infection.

Spectrum:

Active against Staphylococcus aureus (including methicillin-susceptible and resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus (including S. anginosus, S. intermidius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains only).

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: lipoglycopeptides

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Penetrates skin/skin structures.

Metabolism/Excretion: Slowly excreted unchanged in urine (5% in 2 wk) and feces (1% in 2 wk).

Half-Life: 245 hr.

Time/Action Profile ⬆ ⬇

( plasma concentrations)

ROUTE		ONSET		PEAK		DURATION
IV		rapid		end of infusion		≥2 wk

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Instruct patient to notify health care provider if signs and symptoms of hypersensitivity reactions (rash, hives, dyspnea, facial swelling) occur.
Instruct patient to notify health care provider immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care provider.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

68225- Patheon Italia S.p.A
- 68225-051-
  - 68225-051-01- 7344 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CONTAINER (68225-051-01)

70842- Melinta Therapeutics, LLC
- 70842-140- Orbactiv
  - 70842-140-03- 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)

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Indications ⬇