"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...
(dalbavancin) for Injection
DALVANCE (dalbavancin) for injection is a lipoglycopeptide synthesized from a fermentation product of Nonomuraea species.
Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologues share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the figure and table below).
Figure 1: Dalbavancin
Table 2: Substitution
Patterns for Dalbavancin API Homologs
|Dalbavancin||R1||R2||Molecular Formula||Molecular Weight*|
|A0||CH(CH3)2||H||C87H98N10O28Cl2 • l.6 HC1||1802.7|
|A1||CH2CH2CH3||H||C87H98N10O28O2 • 1.6 HCl||1802.7|
|B0||CH2CH(CH3)2||H||C88H100N10O28Cl2 • 1.6 HCl||1816.7|
|B1||CH2CH2CH2CH3||H||C88H100N10O28Cl2 · 1.6 HCl||1816.7|
|B2||CH2CH(CH3)2||CH3||C89H102N 1qO28Cl2 • 1.6 HCl||1830.7|
|*Anhydrous free base|
The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride.
DALVANCE is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of anhydrous dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [see DOSAGE AND ADMINISTRATION and HOW SUPPLIED/Storage and Handling].
Last reviewed on RxList: 6/9/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Dalvance Information
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