dalbavancin

Therapeutic Classification: anti-infectives

Pharmacologic Classification: lipoglycopeptides

Indications ⬆ ⬇

REMS

Acute bacterial 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.

Spectrum:

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

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Penetrates tissues and fluids.

Metabolism/Excretion: 33% eliminated unchanged in urine, 12% eliminated as inactive metabolite, 20% excreted in feces.

Half-Life: 346 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	1 wk

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Renal impairment (dose adjustment required for adults with CCr <30 mL/min and not receiving hemodialysis);
Moderate to severe hepatic impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Geri: Consider age-related in renal function in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: pruritus, rash

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

Neuro: headache

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

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults ): 1500 mg as a single dose or 1000 mg followed 1 wk later by 500 mg.
IV (Children 6–<18 yr): CCr ≥30 mL/min/1.73 m²: 18 mg/kg (max dose = 1500 mg) as a single dose.
IV (Children Birth–<6 yr): CCr ≥30 mL/min/1.73 m²: 22.5 mg/kg (max dose = 1500 mg) as a single dose.

Renal Impairment

IV (Adults ): CCr <30 mL/min (with no hemodialysis): 1125 mg as a single dose or 750 mg followed 1 wk later by 375 mg.

Availability ⬆ ⬇

Lyophilized powder for injection: 500 mg/vial

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 CDAD. May begin up to 2 mo following cessation of therapy.
Monitor for infusion reactions (infusion-related reaction resembling vancomycin flushing syndrome—flushing of upper body, urticaria, pruritus, rash, back pain). May resolve with stopping or slowing infusion.

Lab Test Considerations:

Monitor hepatic function tests. May cause ↑ ALT, AST, and bilirubin.

Implementation ⬆ ⬇

IV Administration:

Intermittent Infusion: Reconstitution: Reconstitute with 25 mL of sterile water or D5W 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 ⬆ ⬇

Explain purpose of dalbavancin to patient.
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.
Rep: Advise females of reproductive potential 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.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

57970- Durata Therapeutics Inc.
- 57970-100- DALVANCE
  - 57970-100-01- 1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL

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Pronunciation ⬇

Classifications ⬆ ⬇