dalbavancin

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 ?
The Company's portfolio of approved and marketed brands includes: Xydalba (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera/Mabelio (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome.
One-shot intravenous dalbavancin infusion combined with negative pressure drainage (VAC) of Crohn's anal fistulas may be an alternative to traditional methods (1,2).
Dalbavancin was approved by the FDA in 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria.
Alternative drugs for bloodstream infections caused by MRSA have been released, including telavancin, dalbavancin, oritavancin, and daptomycin; however, these options are not affordable in some developing countries [11].
(NASDAQ: CRME) (TSX: COM) has initiated the commercial launch of Xydalba (dalbavancin hydrochloride) in Sweden, Finland and the Republic of Ireland, the company said.
The most well-known international brands are Trittico (trazodone, antidepressant), Tantum (benzydamine, antiinflammatory), Aulin (nimesulide, analgesic - anti-inflammatory), Vellofent (fentanyl, analgesic) and Xydalba (dalbavancin, antibiotic).
M2 EQUITYBITES-December 9, 2016-Cardiome unveils Xydalba (dalbavancin) in the UK ABSSSI market
In the last few years, newer antibiotics such as linezolid, daptomycin, tigecycline, dalbavancin, telavancin, oritavancin, ceftobiprole, ceftaroline, and iclaprim have been added to the arsenal of anti-MRSA drugs with many of them already in clinical use and some on the horizon.
Last year, FDA approved three new drugs: tedizolid phosphate (SIVEXTRO[R]), oritavancin (ORBACTIV[TM]), and dalbavancin
The seven new anti-infectives and their indications are dalbavancin (Dalvance) for treatment of skin infections caused by gram-positive organisms; efinaconazole (Jublia) for treatment of fungal infections of the toenails; miltefosine (Impavido) for treatment of visceral, cutaneous, and mucosal infections by various Leishmania species; oritavancin (Orbactiv) for skin infections caused by gram-positive bacteria; peramivir (Rapivab) for acute uncomplicated influenza; tavaborole (Kerydin) for treatment of fungal infections of the toenails; and tedizolid (Sivextro) for treatment of bacterial skin infections.
The seven new anti-infectives and their indications are dalbavancin (Dalvance) for treatment of skin infections caused by gram-positive organisms; efinaconazole (Jublia), for treatment of fungal infections of the toenails; miltefosine (Impavido) for treatment of visceral, cutaneous, and mucosal infections by various Leishmania species; oritavancin (Orbactiv) for skin infections caused by gram-positive bacteria; peramivir (Rapivab), for acute uncomplicated influenza; tavaborole (Kerydin) for treatment of fungal infections of the toenails; and tedizolid (Sivextro) for treatment of bacterial skin infections.
They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.