Why Skin Infections Matter

More Than a Surface Problem

Acute bacterial skin and skin structure infections include cellulitis (spreading infection of the deeper skin layers), abscesses, and infected wounds. They are among the most common reasons people seek care for bacterial infection. Some are mild and treated at home, but others spread quickly and need prompt antibiotic therapy.

The Role of Staphylococcus Aureus

Staphylococcus aureus is a frequent cause of these infections, including MRSA. MRSA resists methicillin and related antibiotics, so clinicians need other options. For decades, IV vancomycin has been the mainstay for serious MRSA infections, but it requires frequent dosing and drug-level monitoring.

Why Convenience Matters

Frequent IV visits or hospital stays add cost, inconvenience, and risk. A drug that can be completed with one or two infusions can allow treatment in a clinic and reduce the number of trips for the patient.

Key Takeaways

• Dalvance (dalbavancin) received FDA approval on May 23, 2014, for adults with ABSSSI caused by susceptible gram-positive bacteria, including MRSA.
• It is a long-acting lipoglycopeptide given by IV infusion. It was the first drug approved with the Qualified Infectious Disease Product designation.
• The original regimen is 1,000 mg on day 1 followed by 500 mg one week later. A single 1,500 mg dose was approved in January 2016 as an alternative.
• In the DISCOVER 1 and DISCOVER 2 trials, the two-dose regimen was noninferior to vancomycin for ABSSSI.
• The FDA approved Dalvance for pediatric patients with ABSSSI in July 2021.
• Warnings include infusion reactions, hypersensitivity reactions, and C. difficile infection. Dose adjustment is needed for reduced kidney function.

What Is Dalvance

Brand and Generic Names

Dalvance is the brand name for dalbavancin. The drug was developed by Durata Therapeutics and later became part of the Allergan and AbbVie portfolios. It is supplied as a powder that is reconstituted and infused intravenously.

Drug Class

Dalbavancin is a lipoglycopeptide, related to vancomycin. Like vancomycin, it interferes with bacterial cell wall synthesis and is active against gram-positive bacteria. Its chemical structure, however, gives it a much longer half-life.

Dosage Form

Dalvance is not a tablet. It is given by IV infusion in a clinic, infusion center, or hospital, where staff monitor the infusion and watch for reactions.

FDA Approval: May 23, 2014

The Decision

The FDA approved Dalvance on May 23, 2014, for adults with ABSSSI caused by susceptible gram-positive organisms, including Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group organisms.

Advisory Committee

The FDA's Anti-Infective Drugs Advisory Committee voted unanimously in favor of approval in the spring of 2014, before the final decision.

Qualified Infectious Disease Product Designation

Dalvance was the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. This designation provides regulatory incentives to encourage development of antibiotics for serious infections.

How Dalbavancin Works

Cell Wall Targeting

Dalbavancin binds to the terminal D-alanyl-D-alanine residues of the bacterial cell wall precursors. This prevents the cross-linking needed to build a strong cell wall, leading to bacterial death.

Spectrum

The drug is active against many gram-positive bacteria, including MRSA and streptococci. It does not treat gram-negative infections, which need different antibiotics.

Why Structure Matters

Dalbavancin's lipophilic side chain helps it bind to plasma proteins and persist in tissues. This is the basis for its long half-life and single or two-dose regimens.

Why the Long-Acting Design Matters

Fewer Visits

Because dalbavancin remains in the body for days, a complete course can be given in one or two infusions. This avoids daily IV infusions or a central line for home therapy.

Outpatient Potential

Patients who would otherwise need a hospital stay for IV therapy may be treated in an outpatient clinic, subject to clinical judgment and infusion capacity.

Trade-Offs

A long-acting drug cannot be stopped quickly if a reaction occurs, because levels persist. This is one reason monitoring during and after infusion is important.

Approved Uses and Labeling Limits

Who Is Eligible

The approved population is adults with ABSSSI caused by susceptible organisms. The FDA later extended use to pediatric patients.

Labeling Limits

The label is limited to skin and skin structure infections. It is not approved for bacteremia, endocarditis, osteomyelitis, or pneumonia. Use outside the labeled indications is a clinical decision for the treating team.

Stewardship Statement

Like other antibiotics, dalbavancin should be used only when infections are proven or strongly suspected to be caused by susceptible bacteria.

The DISCOVER Trials

Design

The pivotal DISCOVER 1 and DISCOVER 2 trials were randomized, double-blind, multicenter studies of adults with ABSSSI. They compared dalbavancin with vancomycin, with an option to switch to oral linezolid after three days. The trials were designed with identical methods, which strengthens confidence in the combined results.

Population

Together, the two trials enrolled more than 1,300 patients. Eligible patients had cellulitis, major abscess, or wound infection, with defined lesion sizes, and were assessed at multiple visits.

Comparator

Vancomycin was the comparator, reflecting its role as the standard IV therapy for serious gram-positive skin infections, including MRSA.

Trial Results Explained

Noninferiority

The two-dose dalbavancin regimen was noninferior to vancomycin for early clinical response, meaning it was not meaningfully worse within a set margin. This is the main basis for approval.

What Noninferiority Does Not Show

Noninferiority does not show that dalbavancin is more effective. It shows it works about as well as an established option, with a different dosing schedule.

Reading the Numbers

Skin infection trials often measure lesion size changes at specific times. Clinicians interpret these alongside symptoms, the patient's overall condition, and the course of infection.

The 2016 Single-Dose Option

What Changed

In January 2016, the FDA approved an updated label that includes a single 1,500 mg IV dose given over 30 minutes. This option was supported by a phase 3b trial that compared a single 1,500 mg dose with the two-dose regimen.

Trial Findings

The single-dose regimen was noninferior to the two-dose regimen on lesion area reduction at 48 to 72 hours. Reported figures were 81.4 percent versus 84.2 percent, with a confidence interval that crossed the prespecified margin only within the noninferiority range.

Why It Matters

A single infusion can simplify care, especially for patients who have difficulty returning for a second dose. Clinicians choose between the regimens based on the infection, the patient's situation, and clinic logistics.

The 2021 Pediatric Approval

What Changed

In July 2021, the FDA approved Dalvance for pediatric patients with ABSSSI. The approval follows the labeling and dosing in the current prescribing information.

Why Dosing Is Individualized

Children's dosing is weight- and age-based and set by pediatric specialists. Parents should not calculate doses from adult regimens.

Questions for Parents

Ask the pediatric team about the dosing schedule, infusion monitoring, and what symptoms should prompt an urgent call.

Dosing and Administration

Two-Dose Regimen

The original regimen is 1,000 mg IV on day 1 followed by 500 mg IV one week later. Each dose is infused over about 30 minutes.

Single-Dose Regimen

The single-dose option is 1,500 mg IV over 30 minutes. The choice between regimens depends on the infection and clinical judgment.

Preparation

Pharmacists reconstitute and dilute the drug according to the label. Infusion rate matters because fast infusion increases the risk of reactions.

Missed Doses

For the two-dose regimen, the second dose timing is set by the care team. Patients should not make up missed doses on their own.

Kidney Function and Dosing

Labeled Adjustment

For patients with creatinine clearance below 30 mL/min who are not on regular hemodialysis, the label describes a reduced two-dose regimen. Exact figures should be confirmed in the current prescribing information.

Monitoring

Clinicians assess kidney function before treatment, particularly in older adults and people with diabetes or prior kidney disease.

Dialysis

Patients on hemodialysis need individualized planning with nephrology and pharmacy teams.

Which Bacteria It Targets

Labeled Organisms

The label covers susceptible strains of Staphylococcus aureus (including MRSA), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group organisms. Confirm the complete list in the current prescribing information.

Not for Gram-Negative Infections

Dalbavancin does not treat gram-negative organisms such as E. coli or Pseudomonas. Those infections require different antibiotics.

Culture Matters

Wound or abscess cultures identify the organism and its susceptibility, guiding whether dalbavancin is appropriate.

Common Side Effects

Gastrointestinal Effects

Nausea, diarrhea, and vomiting can occur. Most are mild. Persistent or bloody diarrhea needs prompt evaluation because C. difficile infection can occur with nearly all antibiotics.

Headache and Lab Changes

Headache and changes in some laboratory tests, such as liver enzymes or blood counts, have been reported. Your team may check labs during treatment.

Infusion-Site Reactions

Pain, redness, or swelling at the IV site can happen. Report these to your nurse.

Infusion Reactions and Red Man Syndrome

What It Is

Red man syndrome, also called infusion-related reaction, causes flushing, itching, or rash of the upper body during or shortly after infusion. It is related to how quickly the drug is given, and it is not a true allergy in most cases.

Prevention

Slower infusion reduces the risk. Staff monitor patients during infusion and may pause or slow the infusion if symptoms appear.

What to Report

Tell staff immediately about flushing, itching, dizziness, chest tightness, or trouble breathing. Serious reactions need emergency care.

Serious Risks and Warnings

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis, can occur. Hives, facial swelling, trouble breathing, or fainting require emergency care. Tell your team about any previous drug allergies.

C. difficile Infection

C. difficile can cause severe diarrhea and colitis. Report new or worsening diarrhea promptly, even weeks after treatment.

Other Warnings

The label includes guidance on use during pregnancy, kidney function, and monitoring. Read the current prescribing information for full details.

Who Should Not Receive Dalvance

Known Allergy

People with a known allergy to dalbavancin or to other glycopeptide antibiotics should not receive Dalvance without specialist review.

Kidney Disease

Patients with significant kidney impairment need dose planning and monitoring, as described above.

Other Considerations

Your clinician will consider the infection, prior reactions, and alternatives before choosing Dalvance.

Drug Interactions

Medication Review

Give your care team a full list of medications, including prescriptions, over-the-counter products, and supplements. Pharmacists check for interactions before starting any new antibiotic.

Nephrotoxic Drugs

Medicines that affect the kidneys deserve attention because kidney function influences dosing decisions.

How Dalvance Compares With Other Options

Vancomycin

Vancomycin is the standard IV therapy for serious MRSA infections and was the comparator in DISCOVER. It requires frequent dosing and drug-level monitoring, which is a key difference from dalbavancin.

Oritavancin

Oritavancin is another long-acting lipoglycopeptide approved for ABSSSI, with a single-dose regimen. Choice between them depends on the infection, cost, and local practice.

Linezolid and Daptomycin

Linezolid has oral and IV forms for skin infections, and daptomycin is used for bacteremia. Neither has the same long-acting profile as dalbavancin.

Outpatient Treatment and Convenience

Benefits

Fewer visits, less reliance on a central line, and the potential to avoid hospital admission are key benefits when clinically appropriate.

Limits

Clinics must be equipped to monitor infusions and manage reactions. Patients who do not improve need prompt reassessment, because a long-acting drug does not allow rapid adjustment.

Follow-Up

Ask your team when to return for evaluation and what symptoms should prompt an earlier visit.

Antibiotic Stewardship

Use Only When Indicated

Dalbavancin should be reserved for infections that need it. Many minor skin infections are managed with simple wound care and oral antibiotics.

Culture and Susceptibility

When cultures are available, they guide whether dalbavancin is appropriate and whether the regimen should be adjusted.

Protecting the Drug

Overuse of any antibiotic increases resistance pressure. Responsible use helps keep dalbavancin and related drugs effective.

Availability and Cost

Availability

Dalvance is available through hospitals, clinics, and specialty pharmacies. Availability depends on the facility, so your care team can confirm stock.

Cost

Dalvance is a branded specialty antibiotic. Its cost can be significant, but it may be offset by fewer visits or shorter hospital stays. Ask your insurer or hospital financial counselor for current figures.

Coverage

Coverage for FDA-approved indications is generally more straightforward. Prior authorization may be required.

Pregnancy and Breastfeeding

Pregnancy

Pregnant patients with skin infections need careful evaluation. Decisions about dalbavancin should involve the obstetric and infectious disease teams, weighing benefits against the limited data available.

Breastfeeding

Discuss breastfeeding with your care team before treatment so they can consider the infant's needs.

Questions to Ask Your Care Team

• Is my infection caused by an organism susceptible to dalbavancin?
• Should I receive the one-dose or two-dose regimen, and why?
• How will the infusion be monitored for reactions?
• What signs should make me call right away, including diarrhea?
• When should I return for follow-up?

Frequently Asked Questions

Q: What is Dalvance used for?

A: Dalvance is approved for adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including MRSA. It is also approved for pediatric patients.

Q: When was it approved?

A: The FDA approved it on May 23, 2014.

Q: Is it a single dose or two doses?

A: Both options are labeled. The original regimen is two doses one week apart. A single 1,500 mg dose was approved in 2016.

Q: Is Dalvance the same as vancomycin?

A: They are related but different. Dalvance is long-acting and given less often, while vancomycin requires frequent dosing and drug-level monitoring.

Q: What is red man syndrome?

A: It is a flushing or rash reaction during fast infusion. It is usually managed by slowing the infusion, and it is different from a true allergy in most cases.

Q: Does Dalvance treat pneumonia or bloodstream infections?

A: No. The labeled indication is skin and skin structure infections. Other infections require different evaluation and treatment.

Q: Can children take Dalvance?

A: Yes, since 2021 for pediatric ABSSSI, with weight-based dosing set by the pediatric team.

Medical Disclaimer

This article is for general education only and does not provide medical advice, diagnosis, or treatment. Skin infections can spread and require evaluation by a qualified clinician. Do not start, stop, or change any antibiotic without guidance from your care team. For dosing, warnings, and interactions, consult the current U.S. prescribing information on DailyMed. If you have spreading redness, fever, chills, rapid heartbeat, or trouble breathing, seek emergency care immediately.

Sources and Further Reading

• U.S. FDA announcement on approval of dalbavancin (Dalvance), May 23, 2014
• Drugs.com Dalvance FDA approval history, including the January 2016 dosing update and July 2021 pediatric approval
• Allergan press release on FDA approval of the updated label for single-dose Dalvance, January 2016
• DISCOVER 1 and DISCOVER 2 phase 3 trial summaries (Boucher et al.)
• Single Dose vs. Two Dose Regimen of Dalbavancin trial record (NCT02127970)
• Dalvance U.S. Prescribing Information, including dosing, warnings, and renal adjustments

This article reflects information available as of October 2026. Confirm current prescribing details with your healthcare provider and the latest FDA labeling. For more on antibiotic options, visit MyOnlineMedShop blog or contact us.