Dalbavancin

What is Dalbavancin?

• Dalbavancin (DALVANCE) is a lipoglycopeptide antibacterial used for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms.

What are the uses of this medicine?

• This medicine is used for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible isolates).

How does this medicine work?

• Dalbavancin, a semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking.

Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to dalbavancin.

What drug interactions can this medicine cause?

• No clinical drug-drug interaction studies have been conducted with DALVANCE.
• There is minimal potential for drug-drug interactions between DALVANCE and cytochrome P450 (CYP450) substrates, inhibitors, or inducers.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage: Recommended Dosage Regimen in Adult Patients with CLcr 30 mL/min and Above

• The recommended dosage regimen of DALVANCE in adult patients with CLcr 30 mL/min and above is 1500 mg, administered either as a single dose regimen, or as a two-dose regimen of DALVANCE 1000 mg followed one week later by 500 mg.

Recommended Dosage Regimen in Pediatric Patients with CLcr 30 mL/min/1.73m2 and Above

• The recommended dosage regimen of DALVANCE in pediatric patients with CLcr 30 mL/min/1.73m2 and above is a single dose regimen based on the age and weight of the pediatric patient as shown below:

Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m2 and above
Age Range	Dosage (Single Dose Regimen)
Birth to less than 6 years	22.5 mg/kg (maximum of 1500 mg)
6 to less than 18 years	18 mg/kg (maximum of 1500 mg)

Dosage Adjustments in Adult Patients with CLcr less than 30 mL/min

• In adult patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended dosage regimen of DALVANCE is 1125 mg, administered either as a single dose regimen, or as a two-dose regimen of DALVANCE 750 mg followed one week later by 375 mg.
• No dosage adjustment is recommended for adult patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Administration

• After reconstitution and dilution, administer DALVANCE via intravenous infusion, using a total infusion time of 30 minutes.
• Do not co-infuse DALVANCE with other medications or electrolytes.
• Saline-based infusion solutions may cause precipitation and should not be used.
• The compatibility of reconstituted DALVANCE with intravenous medications, additives, or substances other than 5% Dextrose Injection, USP has not been established.
• If a common intravenous line is being used to administer other drugs in addition to DALVANCE, the line should be flushed before and after each DALVANCE infusion with 5% Dextrose Injection, USP.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 500 mg of lyophilized powder in a vial for reconstitution

This medicine is available in fallowing brand namesː

• DALVANCE

What side effects can this medication cause?

The most common side effects of this medicine include: In adults:

• nausea
• headache
• diarrhea

In pediatric patients

• pyrexia

What special precautions should I follow?

• Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, discontinue treatment with DALVANCE and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides.
• Rapid intravenous infusion of DALVANCE can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.
• Alanine Aminotransferase (ALT) elevations with DALVANCE treatment were reported in clinical trials.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.

What to do in case of emergency/overdose?

Management of overdosage:

• Treatment of overdose with DALVANCE should consist of observation and general supportive measures.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with DALVANCE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of DALVANCE for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years.
• There is insufficient information to recommend dosage adjustment for pediatric patients with ABSSSI and CLcr less than 30 mL/min/1.73m2.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DALBAVANCIN HYDROCHLORIDE

Inactive ingredients:

• LACTOSE MONOHYDRATE
• MANNITOL

Who manufactures and distributes this medicine?

• Packager: Allergan, Inc.

What should I know about storage and disposal of this medication?

• DALVANCE (dalbavancin) for injection should be stored at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF).

• Dailymed label info on Dalbavancin
• FDA Dalbavancin

Dalbavancin Resources
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