oritavancin

(redirected from Orbactiv)

oritavancin

(oh-rit-a-van-sin),

Orbactiv

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: lipoglycopeptides
Pregnancy Category: C

Indications

Treatment of acute bacterial skin and skin structure infections caused by or suspected to be caused by susceptible designated Gram-positive bacteria.

Action

Binds to bacterial cell wall resulting in cell death.

Therapeutic effects

Bactericidal action against susceptible bacteria with resolution of infection.
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).

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Penetrates skin/skin structures.
Metabolism and Excretion: Slowly excreted unchanged in urine (5% in two weeks) and feces (1% in two weeks).
Half-life: 245 hr (terminal).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusionat least 2 wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity (cross-sensitivity with other glycopeptides may occur); Heparin use within 48 hr following administration of oritavancin (causes false ↑ aPTT); Concurrent warfarin (↑ risk of bleeding, use only if benefit outweighs bleeding risk); Confirmed/suspected osteomyelitis (alternate treatment required).
Use Cautiously in: Concurrent use of drugs with narrow therapeutic indices that are metabolized by the CYP450 enzyme system (effects may be altered); Severe hepatic/renal impairment; Geriatric: Elderly patients may be ↑ sensitive to drug effects; Obstetric: Use during pregnancy only if potential benefit justifies fetal risk; Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in patients <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Cardiovascular

  • tachycardia

Gastrointestinal

  • diarrhea including Clostridium difficile
  • ↑ liver enzymes
  • nausea
  • vomiting

Local

  • infusion site reactions

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • infusion reactions including “Red-Man Syndrome”
  • limb/subcutaneous abscess formation

Interactions

Drug-Drug interaction

↑ risk of bleeding with warfarin (avoid 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).

Route/Dosage

Intravenous (Adults >18 yr) 1200 mg single dose.

Availability

Lyophylized powder for intravenous administration (requires reconstitution) : 400 mg/vial

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
  • Obtain specimens for culture and sensitivity prior to therapy. First dose may be given before receiving results.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to 2 mo following cessation of therapy.
  • Monitor for infusion reactions (Red-man syndrome—flushing of upper body, urticaria, pruritus, rash). May resolve with stopping or slowing infusion.
  • Lab Test Considerations: Monitor hepatic function tests. May cause ↑ ALT, AST, and bilirubin.
    • May cause hyperuricemia and hypoglycemia.
    • Causes falsely ↑ aPTT for 48 hr after infusion. Avoid heparin administration during this time. Use a non-phospholipid dependent coagulation test such as Factor Xa assay if needed.
    • Artificially prolongs PT and INR for up to 24 hr. May increase risk of bleeding with warfarin.

Potential Nursing Diagnoses

Risk for infection (Indications)
Diarrhea (Adverse Reactions)

Implementation

  • Using three 400 mg vials, add 40 mL of Sterile Water for Injection to each vial for a 10 mg/mL solution/vial. Swirl gently to avoid foaming and ensure powder is completely reconstituted. Solution is clear and colorless to pale yellow; do not administer solutions that are discolored or contain particulate matter. Diluent: Withdraw and discard 120 mL from 1000 mL bag of D5W. Withdraw 40 mL from each vial and add to D5W bag. Do not use 0.9% NaCl; may cause precipitation.Concentration: 1.2 mg/mL. Use within 6 hr at room temperature or 12 hr if refrigerated, including 3 hr infusion.
  • Rate: Infuse over 3 hr.
  • Y-Site Incompatibility: Do not mix with other solutions or medications. Flush line before and after infusion.

Patient/Family Teaching

  • Instruct patient to notify health care professional if signs and symptoms of hypersensitivity reactions (rash, hives, dyspnea, facial swelling) occur.
  • Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Instruct the patient to notify health care professional if symptoms do not improve.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.
References in periodicals archive ?
The acquisition includes the purchase of global rights for Vabomere, Orbactiv and Minocin IV and the business unit supporting those products.
The deal calls for USD 270m in upfront consideration and guaranteed payments (USD 215m of guaranteed cash and USD 55m of Melinta common stock), tiered royalty payments of 5% to 25% on worldwide net sales of Vabomere, Orbactiv and Minocin IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.
The business includes three marketed products, recently approved and launched Vabomere (vaborbactam/meropenem), and established commercial products Orbactiv (oritavancin) and Minocin IV (minocycline).
In January 2015 the European Medicines Agency (EMA) also granted market authorization for Orbactiv and Sivextro.
These new antibiotics include Orbactiv (oritavancin), Sivextro (tedizolid phosphate) and Xydalba (dalbavancin), which have indicated to treat acute bacterial skin and skin structure infections (ABSSSIs).
Medical solution company The Medicines Company (NasdaqGS:MDCO) said on Friday that it has been recommended for marketing authorisation for KENGREXAL, ORBACTIV , and RAPLIXA by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
With a single-dose treatment regimen, Orbactiv may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections," said Dr.
The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.
Healthcare company The Medicines Company (NasdaqGS:MDCO) disclosed on Friday that it has scheduled a conference call for 16 September at 7:30 Eastern Time to discuss plans for launching ORBACTIV (oritavancin) for injection.
M2 PHARMA-August 7, 2014-The Medicines Company passes the US FDA approval for ORBACTIV for injection for treating acute bacterial skin and skin structure infections (ABSSSIs), with expected launch in 2H/2014
Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
M2 EQUITYBITES-August 7, 2014-The Medicines Company passes the US FDA approval for ORBACTIV for injection for treating acute bacterial skin and skin structure infections (ABSSSIs), with expected launch in 2H/2014