APMA News - September/October 2024 - 80

IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions
Hypersensitivity Reactions
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide
antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to
glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with
DALVANCE should be discontinued.
Infusion-related Reactions
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body,
urticaria, pruritus, rash, and/or back pain.
Hepatic Effects
ALT elevations with DALVANCE treatment were reported in clinical trials.
Clostridioides difficile-associated Diarrhea
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic
antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs.
Development of Drug-resistant Bacteria
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection or a
prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in adult patients treated with DALVANCE in Phase 2/3 trials were
nausea (5.5%), headache (4.7%), and diarrhea (4.4%). The most common adverse reaction that occurred
in more than 1% of pediatric patients was pyrexia (1.2%).
Use in Specific Populations
* There are no adequate and well-controlled studies with DALVANCE use in pregnant or nursing women.
The developmental and health benefits of breastfeeding should be considered along with the mother's
clinical need for DALVANCE and any adverse effects on the breast-fed child from DALVANCE or from
the underlying maternal condition.
* In patients with renal impairment whose known creatinine clearance (CLcr) is less than
30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended
regimen of DALVANCE is 1125 mg, administered as a single dose, or 750 mg followed one
week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly
scheduled hemodialysis, and DALVANCE can be administered without regard to the timing
of hemodialysis. There is insufficient information to recommend dosage adjustment for
pediatric patients younger than 18 years of age with CLcr less than 30 mL/min/1.73m2
.
* Caution should be exercised when prescribing DALVANCE to patients with moderate or
severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine
the appropriate dosing in these patients.
Please see Brief Summary of full Prescribing Information on adjacent page or visit
https://www.rxabbvie.com/pdf/dalvance_pi.pdf
References: 1. DALVANCE®
(dalbavancin) [prescribing information]. Madison, NJ: Allergan USA, Inc.; 2021. 2. Data on file. AbbVie, Inc.
© 2024 AbbVie. All rights reserved. US-DAV-240028 05/24
DALVANCE®
and its design are trademarks of Allergan Pharmaceuticals International
Limited, an AbbVie company. Dalvance Connects® is a registered service mark of
Allergan Pharmaceuticals International Limited, an AbbVie company.

https://www.rxabbvie.com/pdf/dalvance_pi.pdf

APMA News - September/October 2024

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