dalbavancin hydrochloride: clinical use

Prescribing considerations

• Confirm that the infection fits the licensed indication and is likely to involve susceptible Gram-positive organisms.
• Obtain appropriate microbiology samples and follow antimicrobial-stewardship guidance.
• Provide separate active treatment if a mixed infection involving Gram-negative organisms is suspected.
• Assess renal function before prescribing; exposure increases in severe renal impairment, while evidence in affected paediatric patients is insufficient.
• Use caution in moderate or severe hepatic impairment because clinical data are limited.
• Evidence is limited in severely immunocompromised patients and outside studied skin-infection presentations.
• Agree non-licensed use with an infection or microbiology specialist.

Contraindications and cautions

• Hypersensitivity to dalbavancin or any formulation excipient.

Monitoring

• Observe during infusion for hypersensitivity and infusion-related reactions.
• Monitor clinical response and investigate deterioration or possible superinfection.
• Arrange blood monitoring according to the specialist or OPAT plan; renal function, liver enzymes and blood counts may be relevant.
• Assess significant diarrhoea for Clostridioides difficile infection and avoid medicines that suppress intestinal motility when this is suspected.
• Ask about hearing changes, particularly when other potentially ototoxic medicines are used.

Clinical pharmacology

Dalbavancin is a bactericidal lipoglycopeptide with a very long terminal half-life and high, reversible albumin binding. It inhibits Gram-positive bacterial cell-wall synthesis by binding the terminal D-alanyl-D-alanine target and preventing peptidoglycan cross-linking. Elimination involves renal and non-renal pathways, with little CYP-mediated metabolism.

Formulation and product differences

• The product is a single-use powder for concentrate requiring reconstitution with sterile water and further dilution with glucose solution before intravenous administration.
• Sodium chloride solutions can cause precipitation and must not be used for reconstitution or dilution.
• If a shared intravenous line is used, flush it with glucose solution before and after administration.
• The formulation contains mannitol and lactose monohydrate and is essentially sodium-free.

Solution for infusion

Route: Intravenous

Strengths: 500 mg