Dalbavancin (Dalvance) is a novel second-generation lipoglycopeptide that belongs to the same class as vancomycin. It is indicated for the treatment of skin and soft-tissue infections. The drug has a long half-life and can be administered as a single injection or two injections administered a week apart.

Dalbavancin (Dalvance) Uses:

• Acute bacterial skin and skin structure infections:

  • It is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible organisms of the following gram-positive microorganisms:
    • 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:

  • 1,000 mg as a single dose slow IV infusion initially, followed by 500 mg one weel after the last dose.

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:
    • 1,125 mg as a single dose
  • Two-dose regimen:
    • Initially, 750 mg as a single dose is administered that is followed by 375 mg as a single dose after one week of the first dose.

• 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 might have elevated ALT or AST levels that exceed three times the normal upper limit.
  • 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.
• Patients should be monitored for superinfections during the treatment and any infusion-related reactions.

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 which interferes with cell wall production by binding to D-alanyl–D-alanine terminus in the stem pentapeptide.
• It is bactericidal against Staphylococcus aureus in vitro and streptococcus piyogenes in vitro.

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.