Dalbavancin guidelines for Adult Patients

Publication: 31/03/2020  
Next review: 09/08/2024  
Clinical Guideline
CURRENT 
ID: 6343 
Approved By:  
Copyright© Leeds Teaching Hospitals NHS Trust 2021  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Dalbavancin Antimicrobial Prescribing Guidelines for Adult patients

RESTRICTIONS TO PRESCRIBING
Dalbavancin is classed as a protected antimicrobial and is fully restricted therefore needs approval and an antimicrobial code from an infection specialist
For all use it must be approved by an Infectious Specialist prior to prescribing.

This guideline is not for use in paediatrics. Dalbavancin is NOT licensed in patients under the age of 18 years due to lack of evidence.
Please refer to the British National Formulary (BNF) or the Summary of Product Characteristics (SPC) for information on:

  • Pharmacokinetics
  • Interactions
  • Side effects
  • Allergy information
  • Use in Breastfeeding and pregnancy

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DRUG INFORMATION

Class of antimicrobial: bactericidal lipoglycopeptide

Antimicrobial spectrum: bactericidal activity against gram-positive bacteria, it doesn’t have any gram-negative activity. Dalbavancin should be co-administered with appropriate antibacterial agents or other agents should be considered in cases of mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected.

Allergy advice: use with caution in patients with other glycopeptide sensitivity. Hypersensitivity reactions and anaphylaxis have been reported with dalbavancin. If such a reaction occurs, dalbavancin administration should be stopped immediately and appropriate emergency measures taken.

Caution should be taken if a patient has had a reaction to a glycopeptide including vancomycin and teicoplanin previously.

Dalbavancin can cause infusion-related reactions and, if infused more rapidly than over 30 minutes, can cause ‘Red Man Syndrome’ reactions. Symptoms include flushing of the upper body, urticaria, pruritus and/or rash. If this occurs the infusion should be stopped.

Elimination half-life: 372 hours (1)

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ADMINISTRATION

Dalbavancin should be administered via as an intravenous infusion.

Reconstitution

Slowly add 25mLs of water for injection to the 500mg dalbavancin vial. Do not shake the vial. To avoid foaming, alternate between gently swirling and inversion of the vial. Reconstitution may take up to five minutes.

Further Dilution

For 1000mg dose: dilute two 500mg vials in 250mLs of glucose 5%

For 1500mg dose: dilute three 500mg vials in 500mLs of glucose 5%

Duration of Administration

Administer as an intravenous infusion over 30 minutes.

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INDICATIONS AND DOSING

Dalbavancin is licensed for acute bacterial skin and soft tissue infections; however there is evidence to suggest it can be used for other infections caused by Gram positive bacteria. Any use outside of skin and soft tissue infections is considered off-label use and this should be discussed with the patient prior to being prescribed it.
Criteria for use of dalbavancin:

  • Likely Gram-positive bacterial infection, excluding vancomycin resistant organisms.
  • Patient aged ≥18 years 
  • No barriers to discharge other than intravenous antimicrobial therapy and able to be discharged within the next 24 hours.

No dosing adjustment is required in obesity.

Usual Dosage in adults

Indication

Dosing

Day 1

Day 8

Skin and soft tissue infections

1500mg as a single dose  

Not required

Deep seated Gram positive infections including bone and joint infections
Note this dose is unlicensed.

1500mg as a single dose  

1500mg as a single dose

Infective endocarditis (used on advice of infective endocarditis team only) 
Note this dose is unlicensed.

1000mg as a single dose  

500mg as a single dose  

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RENAL IMPAIRMENT DOSING

Creatinine clearance (CrCl) using the Cockcroft and Gault calculation should be calculated; eGFR should not be used. Calculators can be found here:
https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation

Ideal body weight (IBW) should be used to calculate CrCl if a patient is overweight. If a patient’s actual body weight is more than 25% greater than there IBW, adjusted body weight should be used to calculate CrCl.

No adjustments are required for patients with mild or moderate renal impairment (CrCl ≥30 - 79 mL/min)

No adjustments are required for patients having haemodialysis, including HDF/Hi-Flux dialysis used for patients in Leeds.

For patients with a CrCl of <30 mL/min and for those who are having peritoneal dialysis:

Indication

Dosing

Day 1

Day 8

Skin and soft tissue infections

1000mg as a single dose  

Not required

Deep seated Gram positive infections including bone and joint infections.
Note this dose is unlicensed.

1000mg as a single dose  

1000mg as a single dose  

Infective endocarditis (used on advice of infective endocarditis team only) 
Note this dose is unlicensed.

750mg as a single dose  

375mg as a single dose  

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FUNDING IMPLICATIONS

Dalbavancin is red drug and will need to be issued by the hospital

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DISCHARGE INFORMATION

The Outpatient Parenteral Antimicrobial Therapy (OPAT) service can support with discharging patients requiring dalbavancin; if a second dose is required (deep seated infections only) please refer to the OPAT/CIVAS team. All doses should be supplied on discharge. The OPAT drug monographs includes all of the information required for administration, reconstitution and supply at discharge.

Provenance

Record: 6343
Objective:
Clinical condition:
Target patient group:
Target professional group(s): Secondary Care Doctors
Pharmacists
Adapted from:

Evidence base

  • Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on 1st June 2021]
  • Advanz (2021) Xydalba 500mg powder for concentrate for solution for infusion Targocid SmPC. Available at: https://www.medicines.org.uk/emc/product/2270/smpc#gref (Accessed: 1st June 2021)

 

  1. Rappo U et al. 2018. Dalbavancin for the Treatment of Osteomyelitis in Adult Patients: A Randomized Clinical Trial of Efficacy and Safety. Open Forum Infectious Diseases. 10.6.(1)
  2. Bork, J.T., et al. 2019. Dalbavancin Use in Vulnerable Patients Receiving Outpatient Parenteral Antibiotic Therapy for Invasive Gram Positive Infections. Infectious Diseases and Therapy. 8. p171-184
  3. Morata L. et al. 2019. Safety and Efficacy of Prolonged Use of Dalbavancin in Bone and Joint Infections. Antimicrobial Agents and Chemotherapy. 25. 63. 5
  4. Fantoni M. et al. 2019. Systemic antibiotic treatment of chronic osteomyelitis in adults. European Review for Medical and Pharmacological Sciences. 23. 2. p258-270
  5. Cada, D. J et al. 2014. Dalbavancin. Hospital Pharmacy. 49.9.p851-861
  6. Buckwater M et al. 2005. Population pharmacokinetic analysis of dalbavancin, a novel lipoglycopeptide. Journal of Clinical Pharmacology. 45. 11. P1279-87
  7. Tobudic, S. et al. 2018. Dalbavancin as Primary and Sequential Treatment for Gram-Positive Infective Endocarditis: 2-Year Experience at the General Hospital of Vienna. Clinical Infectious Diseases. 67.5.p795-798
  8. Wunsch S. et al. 2019. Multicenter clinical experience of real life dalbavancin use in Gram-positive infections. International Journal of Infectious Diseases. 81. p210-214

 

Document history

LHP version 2.0

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