A brand-new lipoglycopeptide of the second generation, dalbavancin (also known as Dalvance), is in the same class as vancomycin. It is prescribed to treat infections of the skin and soft tissues. The medication can be given as two injections spaced a week apart or as a single injection with an extended half-life.

Dalbavancin (Dalvance) Uses:

• Acute bacterial skin and skin structure infections:

  • It is recommended for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) brought on by the following gram-positive pathogens.:
    • Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains),
    • Streptococcus pyogenes,
    • Streptococcus agalactiae,
    • S. dysgalactiae,
    • Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and
    • Enterococcus faecalis (vancomycin-susceptible strains)

Dalbavancin (Dalvance) Dose in Adults

Dalbavancin (Dalvance) Dose in the treatment of acute bacterial skin and skin structure infections: IV:

• Single-dose regimen:

  • 1,500 mg as a single dose slow intravenous infusion.

• Two-dose regimen:

  • 500 mg was administered one week following the final dose of 1,000 mg as a single slow IV infusion.

Use in Children:

Not indicated

Dalbavancin (Dalvance) Pregnancy Risk Category: C

• Animal reproduction studies have shown that adverse fetal events can be observed.
• When assessing potential exposure to the fetus, it is important to keep in mind the long half-life dalbavancin.

Dalbavancin use during breastfeeding:

• It is unknown if the drug will be excreted into breast milk.
• It is recommended that you use it with caution if you are lactating.

Dalbavancin (Dalvance) Dose in Kidney Disease:

• CrCl ≥30 mL/minute:

  • Adjustment in the dose is not necessary.

• CrCl <30 mL/minute (not on regularly scheduled dialysis):

  • Single-dose regimen:
    • As a single dose, 1,125 milligrammes
  • Two-dose regimen:
    • Initially, a single dose of 750 mg is given, and then, one week after the initial dose, a single dose of 375 mg.

• ESRD patients receiving intermittent hemodialysis (IHD) (regularly scheduled):

  • Adjustment in the dose is not necessary.
  • The drug may be administered without regard to the timings of hemodialysis.

Dalbavancin (Dalvance) Dose in Liver disease:

• Mild impairment (Child-Pugh class A):

  • Adjustment in the dose is not necessary.

• Moderate or severe impairment (Child-Pugh class B or C):

  • In the manufacturer's labeling adjustment in the dose has not been provided as the drug has not been studied.
  • It should be used with caution.

Side Effects of Dalbavancin (Dalvance):

• Cardiovascular:

  • Flushing
  • Phlebitis

• Central Nervous System:

  • Headache
  • Dizziness

• Dermatologic:

  • Skin Rash
  • Pruritus
  • Urticaria

• Endocrine & Metabolic:

  • Hypoglycemia
  • Increased Gamma-Glutamyl Transferase
  • Increased Lactate Dehydrogenase

• Gastrointestinal:

  • Nausea
  • Diarrhea
  • Vomiting
  • Abdominal Pain
  • Clostridioides Difficile Colitis
  • Gastrointestinal Hemorrhage
  • Hematochezia
  • Melena
  • Oral Candidiasis

• Hematologic & Oncologic:

  • Acute Posthemorrhagic Anemia
  • Anemia
  • Eosinophilia
  • Hematoma
  • Increased INR
  • Leukopenia
  • Neutropenia
  • Petechia
  • Thrombocythemia
  • Thrombocytopenia
  • Wound Hemorrhage

• Hepatic:

  • Hepatotoxicity

• Hepatic:

  • Increased Serum Alkaline Phosphatase
  • Increased Serum Transaminases

• Hypersensitivity:

  • Anaphylactoid Reaction

• Infection:

  • Vulvovaginal Infection

• Respiratory:

  • Bronchospasm

• Miscellaneous:

  • Infusion Related Reaction

Contraindications to Dalbavancin (Dalvance):

• Allergic reactions to dalbavancin or any component of the formulation

Warnings and Precautions

• Hepatic effects

  • The treatment may cause hepatic impairment.
  • Patients may have ALT or AST levels that are more than three times the upper limit of normal.
  • Treatment discontinuation can reverse liver dysfunction.

• Hypersensitivity reactions

  • The treatment can cause severe allergic reactions, including skin reactions.
  • If an allergic reaction is observed, the treatment can be stopped.
  • Cross-reactions can occur in patients who have experienced allergic reactions to other glycopeptides.
  • Before initiating treatment, patients must be tested for allergies to glycopeptides.

• Infusion reactions

  • Rapid infusion of the drug can cause reactions similar to "Red-Man Syndrome".
  • Patients might experience urticaria, flushing, rash and pruritus.
  • These reactions can be exacerbated if the infusion rate is decreased or stopped.

• Superinfection

  • The treatment may cause superinfections.
  • Superinfections can include fungal and bacterial infections, including Clostridium difficile-associated diarrhea (CDAD), pseudomembranous collitis, and Clostridium difficile (formerly Clostridium).
  • CDAD can be observed up to 2 months after the last antibiotic dose.

• Hepatic impairment

  • Patients with severe to moderate hepatic impairment (Child Puugh class B orC) should be cautious about using the drug.

Dalbavancin: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• BUN, serum creatinine, and liver function tests (AST, ALT, bilirubin) at baseline.
• Throughout the course of the therapy, patients should be watched for superinfections and any adverse responses to the infusion.

How to administer Dalbavancin (Dalvance)?

IV:

• It is administered as an intravenous infusion over at least 30 minutes.
• In case, other intravenous medications are administered via the same IV line, the line should be flushed with 5% DW before and after the drug is administered.

Mechanism of action of Dalbavancin (Dalvance):

• It is a lipoglycopeptide that binds to the stem pentapeptide's D-alanyl-D-alanine terminus to prevent the development of cell walls.
• In vitro, it is bactericidal to Staphylococcus aureus and Streptococcus piyogenes.

Protein binding:

• 93% (primarily to albumin)

Metabolism:

• Minor metabolite (hydroxy-dalbavancin)

Half-life elimination:

• 346 hours

Excretion:

• Urine (33% as unchanged drug, 12% as hydroxy metabolite);
• feces (20%)

International Brand Names of Dalbavancin:

• Dalvance
• Xydalba

Dalbavancin Brand Names in Pakistan:

It is not available in Pakistan.