DALVANCE (dalbavancin hydrochloride)

General Pharmacokinetic Properties Dalbavancin pharmacokinetic parameters have been characterized in healthy subjects, patients, and specific populations. Pharmacokinetic parameters following administration of single intravenous 1,000 mg and 1,500 mg doses were as shown in Table 4 . The pharmacokinetics of dalbavancin can be described using a three-compartment model. Table 4. Dalbavancin Pharmacokinetic Parameters in Healthy Subjects Parameter Single 1 , 000 mg Dose Single 1 , 500 mg Dose C max ...

Clinical Studies of DALVANCE in Adult Patients with Acute Bacterial Skin and Skin Structure Infections DALVANCE Two-dose Regimen (1 , 000 mg Day 1; 500 mg Day 8) Adult patients with ABSSSI were enrolled in two Phase 3, randomized, double-blind, double-dummy clinical trials of similar design (Trial 1 and Trial 2). The Intent-to-Treat (ITT) population included 1,312 randomized patients. Patients were treated for two weeks with either a two-dose regimen of intravenous DALVANCE (1,000 mg followed one week later by 500 mg) or intravenous vancomycin (1,000 mg or 15 mg/kg every 12 hours, with the opt...

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 )] The most common adverse reactions occurring in >4% of adult patients treated with DALVANCE were nausea, headache, and diarrhea....

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. Known hypersensitivity to dalbavancin ( 4 )

Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, discontinue treatment with DALVANCE and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides. ( 5.1 ) Rapid intravenous infusion of DALVANCE can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessatio...

7 DRUG INTERACTIONS 7.1 Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. DALVANCE at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT). 7.2 Drug-Drug Interactions No clinical drug-drug interaction studies have been conducted with DALVANCE. There is minimal potential for drug-drug...