Lipoglycopeptide Antibacterial

Skin Diseases, Infectious

Staphylococcal Infections

Streptococcal Infections

<section class="Section" data-sectioncode="34089-3"><a name="section-10"></a><h1>11        DESCRIPTION</h1>DALVANCE (dalbavancin) for injection is a lipoglycopeptide antibacterial 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 homologs 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 1 and Table 3 below).<img alt="Figure 1. Dalbavancin Structural Formula" src="dalvance-01.jpg"/>Figure 1. Dalbavancin Structural Formula<table><caption>Table 3. Substitution Patterns for Dalbavancin API Homologs</caption><col width="82"/><col width="110"/><col width="66"/><col width="192"/><col width="132"/><tbody class="Headless"><tr class="First"><td class="Lrule Rrule Toprule">Dalbavancin</td><td class="Lrule Rrule Toprule">R1</td><td class="Lrule Rrule Toprule">R2</td><td class="Lrule Rrule Toprule">Molecular Formula</td><td class="Lrule Rrule Toprule">Molecular Weight*</td></tr><tr><td class="Lrule Rrule Toprule">A0</td><td class="Lrule Rrule Toprule">CH(CH3)2</td><td class="Lrule Rrule Toprule">H</td><td class="Lrule Rrule Toprule">C87H98N10O28Cl2 · 1.6 HCl</td><td class="Lrule Rrule Toprule">1802.7</td></tr><tr><td class="Lrule Rrule Toprule">A1</td><td class="Lrule Rrule Toprule">CH2CH2CH3</td><td class="Lrule Rrule Toprule">H</td><td class="Lrule Rrule Toprule">C87H98N10O28Cl2 · 1.6 HCl</td><td class="Lrule Rrule Toprule">1802.7</td></tr><tr><td class="Lrule Rrule Toprule">B0</td><td class="Lrule Rrule Toprule">CH2CH(CH3)2</td><td class="Lrule Rrule Toprule">H</td><td class="Lrule Rrule Toprule">C88H100N10O28Cl2 · 1.6 HCl</td><td class="Lrule Rrule Toprule">1816.7</td></tr><tr><td class="Lrule Rrule Toprule">B1</td><td class="Lrule Rrule Toprule">CH2CH2CH2CH3</td><td class="Lrule Rrule Toprule">H</td><td class="Lrule Rrule Toprule">C88H100N10O28Cl2 · 1.6 HCl</td><td class="Lrule Rrule Toprule">1816.7</td></tr><tr class="Last"><td class="Lrule Rrule Toprule">B2</td><td class="Lrule Rrule Toprule">CH2CH(CH3)2</td><td class="Lrule Rrule Toprule">CH3</td><td class="Lrule Rrule Toprule">C89H102N10O28Cl2 · 1.6 HCl</td><td class="Lrule Rrule Toprule">1830.7</td></tr></tbody></table>*Anhydrous free baseThe 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 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 (<a href="#_2_4_Preparation_and">2.4</a>), How Supplied/Storage and Handling (<a href="#_16_HOW_SUPPLIED_STORAGE">16</a>)]. </section>

DALVANCE

dalbavancin

dalbavancin 500 MG Injection

Dalvance

dalbavancin 500 MG Injection [Dalvance]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event

Prescribing Information

Submit MSL Request 

Pharmacy List 

How To Order Dalvance

Billing & Coding Guide

Coverage Authorization Request 

Coverage Authorization Appeal 

Letter of Medical Necessity 

Dalvance Connect Enrollment Form

Enroll in Patient Savings Program

Instructions For Use: Acute Bacterial Skin and Skin Structure Infections