Dalbavancine

Generic name
Dalbavancine
Brand name
ATC Code
J01XA04
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Dalbavancine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Simulated mean (SD) of the pharmacokinetic parameters using a population based PK-Analysis (SmPC Xydalba)

Age Preterm Neonate (GA 26 -  < 37 weeks) Term Neonate
(Birth -1 month)		 Young infant
(1 month - < 3 months)		 Infant
(3 months - < 2 years)		 Toddler (2 years - < 6 years)             Child (6 years - < 12 years) adolescent (12 years - < 18 Jahre)
Dose 22,5 mg/kg 22,5 mg/kg 22,5 mg/kg 22,5 mg/kg 22,5 mg/kg             18 mg/kg 18 mg/kg
Cmax (mg/L)
 231 (89) 306 (130) 306 (130) 307 (130) 304 (130)             259 (110) 251 (110)
 AUC0-120 uur (mg*h/l) 6620 (2000) 9000 (2900) 9080 (3000) 9490 (3100) 10.200 (3200) 8870 (2900) 9060 (3100)

The antibacterial activity of dalbavancin correlates most strongly with the ratio of area under the unbound plasma concentration-time curve to the minimum inhibitory concentration (fAUC/MIC).

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Infections of the skin and skin structures
  • Intravenous
    • 3 months up to 6 years
      [1]
      • 22.5 mg/kg/day, once only. Max: 1.500 mg/day.
    • 6 years up to 18 years
      • 18 mg/kg/day, once only. Max: 1.500 mg/day.
    • 1 month up to 6 years
      • 22.5 mg/kg/day, once only. Max: 1.500 mg/day.
    • Term neonate
      • 22.5 mg/kg/day, once only. Max: 1.500 mg/day.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The safety profile in children is similar to that in adults.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER ANTIBACTERIALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Glycopeptide antibacterials
J01XA02
J01XA01
Polymyxins
J01XB01
Steroid antibacterials
J01XC01
Nitrofuran derivatives
J01XE01
Other antibacterials
J01XX09
J01XX08
J01XX01

References

  1. AbbVie Deutschland GmbH & Co. KG, SmPC Xydalba (EU/1/14/986/001) Rev15. 14-12-2022, www.ema.europa.eu
  2. AbbVie Deutschland GmbH & Co. KG, SmPC Xydalba (EU/1/14/986/001) Rev 20. 23-05-2025, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose