dalbavancin

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dalbavancin

(dal-ba-van-sin ),

Dalvance

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: lipoglycopeptides
Pregnancy Category: C

Indications

Treatment of skin/skin structure infections due to susceptible 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 agalactiae, Streptococcus anginosus (including S. anginosus, S. intermidius and S. constellatus) and Streptococcus pyogenes.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Penetrates tissues and fluids.
Metabolism and Excretion: 33% eliminated unchanged in urine, 12% eliminated as inactive metabolite, 20% excreted in feces.
Half-life: 346 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVunknownend of infusion1 wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Renal impairment (dose adjustment required for CCr <30 mL/min; Moderate to severe hepatic impairment; Geriatric: Consider age-related decrease in renal function; Obstetric: Use during pregnancy only if potential benefit justifies potential risk to the fetus; Lactation: Use cautiously if breastfeeding; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • diarrhea including Clostridium difficile (life-threatening)
  • nausea
  • ↑ ALT

Dermatologic

  • pruritus
  • rash

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • infusion reactions including “Red-Man Syndrome”

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults) 1000 mg followed one wk later by 500 mg.

Renal Impairment

Intravenous (Adults) CCr <30 mL/min—750 mg followed one wk later by 375 mg.

Availability

Lyophylized powder for intravenous injection (requires reconstitution and further dilution): 500 mg single-use 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.

Potential Nursing Diagnoses

Risk for infection (Indications)
Diarrhea (Adverse Reactions)

Implementation

  • Intravenous Administration
  • Intermittent Infusion: Reconstitute with 25 mL of Sterile water in each 500 mg vial. Alternate gentle swirling and inverting to avoid foaming, until completely dissolved. Do not shake. Reconstituted vial contains a clear colorless to yellow solution. Do not administer solutions that are discolored or contain particulate matter. Transfer reconstituted solution into D5W. Concentration: 1 mg/mL to 5 mg/mL. Discard unused solution. May be refrigerated or kept at room temperature; do not freeze. Infuse within 48 hr of reconstitution. Do not administer solutions containing particulate matter.
  • Rate: Infuse over 30 min.
  • Y-Site Incompatibility: Do not infuse with other medications or electrolytes. Saline solutions may cause precipitation. Flush line before and after infusion with D5W.

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 use effective contraception during therapy and to notify health care professional if pregnancy is 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 ?
DALVANCE Phase 3 study shows safety and efficacy of single-dose regimen compared to two-dose regimen in adults with acute bacterial skin and skin structure infections (ABSSSI); Data submitted to FDA and EMA to support single-dose indication for ABSSSI.
Additionally, expected launch of various antibacterial agents that are currently in developmental stages, such as tedizolid (Cubist Pharmaceuticals), Dalvance (Durata Therapeutics), surotomycin (Cubist Pharmaceuticals), MK-3415A (Merck) during the forecast period is also expected to restore growth of this market.
Application Seeks to Expand Label to Include Single-Dose Administration of DALVANCE for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in Adults -
The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.
Some of the major candidates such as Dalvance (Durata Therapeutics), tedizolidand surotomycin(Cubist Pharmaceuticals), and others are currently in phase III clinical trials.
dalbavancin) in the treatment of acute bacterial skin and skin structure infections (ABSSSI), the pharmacodynamic activity of DALVANCE and factors influencing admission/re-admission of patients with ABSSSI; the antimicrobial activity of TEFLARO[sup.
On October 6, 2014, WilmerHale client Durata Therapeutics announced that it had entered into a definitive merger agreement with Actavis plc under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23 per share in cash, or approximately $675 million in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5 per share if certain regulatory or commercial milestones related to Durata's lead product DALVANCE are achieved.
The agency approved Dalvance (dalbavancin) in May 2014 and Sivextro (tedizolid) in June 2014.
Durata Therapeutics declared that it has rolled out DALVANCE (dalbavancin) for injection in the US for the treatment of acute bacterial skin and skin structure infections (ABSSSI) for adult patients.
Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
DALVANCE is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Actavis announced positive top-line results for a phase 3 study comparing a single 1500 mg dose of Dalvance (dalbavancin) with the same total dose given as two-doses one week apart, for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).