Dalbavancin Hydrochloride (2 brand names, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- DALBAVANCIN HYDROCHLORIDE
- DALVANCE
Contraindications
Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin.
Adverse Reactions
The following clinically significant adverse reactions are also discussed elsewhere in the labeling: •Hypersensitivity Reactions [see Warnings and Precautions (5.1)] •Infusion Related Reactions [see Warnings and Precautions (5.2)] •Hepatic Effects [see Warnings and Precautions (5.3)] • Clostridioides difficile-associated Diarrhea [see Warnings and Precautions (5.4)]
Mechanism of Action
Dalbavancin is an antibacterial drug [see Microbiology (12.4)].
Overdosage
Specific information is not available on the treatment of overdose with dalbavancin for injection, as dose- limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered cumulative doses of up to 4,500 mg over a period of up to 8 weeks (not an approved dosing regimen), with no signs of toxicity or laboratory results of clinical concern. Treatment of overdose with dalbavancin for injection should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed [see Clinical Pharmacology (12.3)].