dalbavancin (Rx)

Brand and Other Names:Dalvance
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 500mg/vial (20mg/mL after reconstitution)
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Skin & Skin Structure Infections

Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive bacteria

1-dose regimen of 1500 mg IV, or

2-dose regimen of 1000 mg IV followed 1 week later by 500 mg IV

Infuse IV over 30 minutes

Susceptible isolates of Gram-positive microorganisms

  • Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant Staphylococcus aureus [MRSA])
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus anginosus group (including S anginosus, S intermedius, S constellatus)

Dosage Modifications

Renal impairment

  • CrCl <30 mL/min
    • 1-dose regimen: Decrease dose to 1125 mg IV
    • 2-dose regimen: Decrease dose to 750 mg IV followed 1 week later by 375 mg IV
    • If receiving regularly scheduled hemodialysis: No dosage adjustment required

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment required
  • Moderate or severe (Child-Pugh B and C): Cautions, no data are available

Safety and efficacy not established

Osteomyelitis (Orphan)

Orphan designation for treatment of acute osteomyelitis in children aged ≤16 yr

Sponsor

  • Durata Therapeutics International B.V.; Spaces Zuidas II, Kantoor 4.03; 1083HN, Amsterdam; Netherlands
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Adverse Effects

2-10%

Nausea (5.5%)

Headache (4.7%)

Diarrhea (4.4%)

Vomiting (2.8%)

Rash (2.7%)

Pruritus (2.1%)

<2%

Blood and lymphatic system disorders: Anemia, hemorrhagic anemia, leukopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis

Gastrointestinal disorders: Gastrointestinal hemorrhage, melena, hematochezia, abdominal pain

General disorders and administration site conditions: Infusion-related reactions

Hepatobiliary disorders: Hepatotoxicity

Immune system disorders: Anaphylactoid reaction

Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection

Investigations: Hepatic transaminases increased, blood alkaline phosphatase increased, INR ratio increased

Metabolism and nutrition disorders: Hypoglycemia

Nervous system disorders: Dizziness

Respiratory, thoracic and mediastinal disorders: Bronchospasm

Skin and subcutaneous tissue disorders: Urticaria

Vascular disorders: Flushing, phlebitis, wound hemorrhage, spontaneous hematoma

Elevated ALT, >3x ULN (0.8%)

Postmarketing Reports

Back pain

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Warnings

Contraindications

Hypersensitivity

Cautions

Serious hypersensitivity (anaphylactic) and skin reactions reported with glycopeptide antibacterial agents, including dalbavancin

Rapid IV infusion of glycopeptide antibacterial agents can cause reactions, including upper body flushing, urticaria, pruritus, and rash

ALT elevations >3x ULN reported

Clostridium difficile-associated diarrhea (CDAD) reported with nearly all systemic antibacterial agents, including dalbavancin; evaluate if diarrhea occurs

Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria

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Pregnancy & Lactation

Pregnancy Category: C

No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively)

Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis)

Lactation: Unknown if distributed in human breast milk

Excreted in milk of lactating rats

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Lipoglycopeptide antibiotic; interferes with cell wall synthesis by binding to D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking

Bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations observed in humans at recommended doses

Absorption

Single 1000 mg dose

  • Peak plasma concentration: 4287 mg/L
  • AUC 0-24: 3185 mg•hr/L
  • AUC 0-Day7: 11,160 mg•hr/L
  • AUC 0-inf: 23,443 mg•hr/L

Single 1500 mg dose

  • Peak plasma concentration: 423 mg/L
  • AUC 0-24: 4837 mg•hr/L

Distribution

Protein bound, reversible: 93%, primarily albumin

Metabolism

Not a substrate, inhibitor, or inducer of CYP450 isoenzymes

Minor metabolite (hydroxy-dalbavancin) observed in urine

Elimination

Half-life: 346 hr (single 1000 mg dose)

Clearance: 0.513 L/hr (single 1000 mg dose)

Excretion: 33% unchanged in urine; 12% metabolite in urine; 20% in feces

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Administration

IV Compatabilities

Dextrose 5%

IV Incompatabilities

Saline-based solutions (precipitation occurs)

Compatibility of reconstituted dalbavancin with IV medications, additives, or substances other than 5% dextrose has not been established

IV Preparation

Reconstitution

  • Reconstitute under aseptic conditions, using 25 mL of sterile water for injection for each 500-mg vial
  • To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved
  • Do NOT shake
  • Reconstituted vial contains 20 mg/mL
  • Reconstituted solution should appear clear and colorless to yellow

Dilution

  • Aseptically transfer the required dose of reconstituted solution from the vial(s) to IV bag or bottle containing D5W
  • Final concentration of diluted solution must be between 1 mg/mL and 5 mg/mL
  • Discard any unused portion of the reconstituted vials

IV Administration

Visually inspect for particulate matter before infusion

If common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each dose

Infuse IV over 30 minutes

Infusion-related reactions associated with rapid IV infusion

Storage

Reconstituted vials or diluted solution

  • Store either refrigerated at 2-8°C (36-46 °F), or at controlled room temperature 20-25°C (68-77°F)
  • Do not freeze
  • Total time from reconstitution to dilution to administration should not exceed 48 hr
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.