Is there any data for administration of dalbavancin over more than 30 minutes?

Is there any data for administration of dalbavancin over more than 30 minutes?

Comment by InpharmD Researcher

Available literature describing dalbavancin infusions administered over longer than 30 minutes is very limited. A small pilot study reported administration of dalbavancin 1,500 mg over 60 to 90 minutes for catheter-related bloodstream infections, with 100% clinical success and no reported adverse events. A 2019 case report also described a graded challenge in a patient with documented vancomycin anaphylaxis in which the final 1,500 mg dalbavancin dose was infused over 60 minutes. The DALVANCE prescribing information recommends administration over 30 minutes to reduce the risk of infusion-related reactions and states that the infusion may be slowed if a reaction occurs, but it does not specify how much the infusion rate may be reduced. Overall, evidence supporting infusion durations longer than 30 minutes is limited and low quality, and the safety and efficacy of this approach have not been established.AbbVie, the manufacturer of Dalvance, was contacted for additional information regarding administration over longer infusion durations; the manufacturer reported that no pertinent information was identified in its search of the published medical literature.

PubMed and Google Scholar were searched using combinations of the terms dalbavancin, Dalvance, infusion, infusion duration, prolonged infusion, extended infusion, continuous infusion, and administration. Tertiary sources and the prescribing information were also reviewed for data describing dalbavancin administration over periods longer than 30 minutes.

Background

AbbVie Medical Information reported that a search of the published medical literature identified no pertinent information regarding continuous infusion of Dalvance (dalbavancin). The U.S. prescribing information also contains no relevant information regarding continuous infusion. AbbVie notes that Dalvance is indicated for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive organisms and does not endorse use inconsistent with the approved labeling. [1]

Full manufacturer response available in the documents' below:

Continuous_Infusion.pdf

No_Information_(US_Label).pdf

Dalvance_Product_Document.pdf

Cover_Letter__CASE-2026-088388.pdf

Relevant Prescribing Information

WARNINGS AND PRECAUTIONS [2]

Infusion-Related Reactions
DALVANCE is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of DALVANCE can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Is there any data for administration of dalbavancin over more than 30 minutes?

Level of evidence

C - Multiple studies with limitations or conflicting results Read more→

Please see Tables 1-2 for your response.

Dalbavancin in catheter-related bloodstream infections: a pilot study
Design	Pilot feasibility study N= 16
Objective	To assess the efficacy and safety of a "single step" treatment strategy combining dalbavancin administration, catheter removal, and early discharge in adult patients with catheter-related bloodstream infections (CRBSI)
Study Groups	All patients (n= 16)
Inclusion Criteria	Age ≥18 years, microscopic presumptive Gram-positive CRBSI
Exclusion Criteria	Pregnancy and breastfeeding, informed consent not available, absence of clinical information, alternative focus of infection, hypersensitivity/allergy to glycopeptides
Methods	Patients were treated with a single IV infusion of 1500 mg dalbavancin in 500 mL 5% dextrose over 60-90 minutes. Catheters were removed after dalbavancin administration. Patients were discharged without further antibiotic treatment. Safety evaluation included vital signs monitoring, symptom recording, and laboratory assessments until discharge
Duration	January 1, 2020, to December 31, 2022
Outcome Measures	Primary: Clinical success at the end of treatment (EOT) Secondary: Drug-related adverse events, hospital readmission within 30 days for infection recurrence
Baseline Characteristics		All patients (n= 16)
	Men	9 (56.3%)
	Age, years (mean [range])	68 (39-94)
	BMI, kg/m² (mean [range])	24.6 (17.7-30.4)
	Charlson comorbidity index	7 (3-14)
	Comorbidities Malignancy Chronic kidney disease Vascular disease Diabetes Obesity Active IV drugs use	8 (50%) 5 (31.3%) 4 (25%) 2 (12.5%) 2 (12.5%) 1 (6.3%)
	Aetiology MSSA MRSA MSSE MRSE Staphylococcus capitis Enterococcus faecalis	5 (31.3%) 1 (6.3%) 3 (18.8%) 3 (18.8%) 3 (18.8%) 1 (6.3%)
	Empiric treatment Daptomycin Oxacillin Vancomycin Ceftaroline Ceftriaxone	4 (25%) 3 (18.8%) 1 (6.3%) 1 (6.3%) 1 (6.3%)
	Abbreviations: BMI, body mass index; IV, intravenous; MRSA, methicillin-resistant staphylococcus aureus; MRSE, methicillin-resistant staphylococcus epidermidis; MSSA, methicillin-sensitive staphylococcus aureus; MSSE, methicillin-sensitive staphylococcus epidermidis
Results		All patients (n= 16)
	Clinical success at 30-day follow-up	100%
	Adverse drug reaction	0%
	Infection recurrence at 30 days follow-up	0%
	Length of stay after dalbavancin administration, days (mean [range])	2 (0-6)
Adverse Events	No adverse drug-related reactions were reported during the study
Study Author Conclusions	Single-dose dalbavancin is highly effective, well-tolerated, and cost-saving for Gram-positive CRBSI. It resulted in a 30-day absence of bacteraemia recurrences without adverse drug-related events.
Critique	The study's small sample size and lack of a control group limit the ability to draw definitive conclusions. The single-center nature of the study may affect the generalizability of the results. Additionally, the prior use of empiric antibiotic therapy in two-thirds of patients could have influenced the outcomes observed with dalbavancin.

Table 1 References:
[3] Venturini S, Reffo I, Avolio M, et al. Dalbavancin in catheter-related bloodstream infections: a pilot study. Infez Med. 2023;31(2):250-256. Published 2023 Jun 1. doi:10.53854/liim-3102-14

Graded Dalbavancin Challenge in a Patient with Severe Vancomycin Hypersensitivity Reaction
Design	Case report
Case presentation	A 42-year-old woman with substance use disorder and a history of multiple antibiotic reactions, including documented vancomycin anaphylaxis, presented with left knee septic arthritis requiring surgical washout and debridement, with cultures growing MRSA and Streptococcus pyogenes. Initial treatment with daptomycin and ceftriaxone was planned for 4 weeks; however, after tampering with her IV catheter, leaving against medical advice, and subsequently demonstrating nonadherence to prescribed oral linezolid, long-term vascular access was considered unsafe. She was therefore transitioned to dalbavancin 1500 mg once weekly for 2 weeks using a 3-step graded challenge because of her prior vancomycin reaction. Dalbavancin was diluted in 5% dextrose and administered as 15 mg (1/100th of the therapeutic dose) over 30 minutes, followed by 150 mg (1/10th of the therapeutic dose) over 30 minutes and 1500 mg over 60 minutes; no antihistamine or corticosteroid premedication was given. She tolerated the graded challenge without immediate or delayed hypersensitivity reactions. One week later, she returned for her second 1500-mg dalbavancin dose and experienced no immediate adverse effects, although she became anxious and left after receiving approximately 1275 mg (425 mL of the planned 500-mL infusion).
Study Author Conclusions	The dalbavancin graded challenge was successful in a patient with severe vancomycin hypersensitivity, suggesting potential tolerance to dalbavancin. However, this should not be generalized to all patients with vancomycin hypersensitivity.

Table 2 References:
[4] Ishizuka KT, Tran TK, Ayars AG, Chau AS, Chan JD. Graded Dalbavancin Challenge in a Patient With Severe Vancomycin Hypersensitivity Reaction. Clinical Infectious Diseases. 2019;70(6):1230-1232. doi:10.1093/cid/ciz646