Dalbavancin Injection
Dalbavancin injection is a long-acting antibacterial used to treat acute bacterial skin and skin structure infections caused by certain Gram-positive bacteria, including MRSA.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 7 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Dalbavancin Injection: Patient Information Guide
A plain-language walkthrough of Dalbavancin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Dalbavancin injection is approved to treat serious bacterial skin infections in both adults and children.
- Acute bacterial skin and skin structure infections (ABSSSI): Dalvance is indicated for adults and pediatric patients from birth through age 17 with ABSSSI caused by susceptible Gram-positive bacteria.
- Covered bacteria include Staphylococcus aureus (both methicillin-susceptible and methicillin-resistant/MRSA strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, the Streptococcus anginosus group, and vancomycin-susceptible Enterococcus faecalis.
- Dalbavancin should only be used when a susceptible bacteria is proven or strongly suspected — using antibiotics unnecessarily promotes drug-resistant bacteria.
⚙️How it works▾
Dalbavancin belongs to a class of antibiotics called lipoglycopeptides. It kills bacteria by interfering with how they build and maintain their cell walls — a process that is essential to bacterial survival. Without an intact cell wall, bacteria cannot thrive or multiply. Its antibacterial effect is tightly linked to how long drug levels stay above the minimum needed to inhibit bacterial growth.
Importantly, dalbavancin does not interact with the liver's cytochrome P450 enzyme system, which means it has very low potential to interfere with other medications processed by that system. Studies confirm it does not cause meaningful changes in heart rhythm at doses used in treatment.
💊How it's taken▾
Dalvance is given by IV infusion only, administered over 30 minutes in a clinical or hospital setting. For most adult patients, a single dose is all that is needed. Patients with significantly reduced kidney function who are not on regular dialysis may receive an adjusted dose — patients on regular hemodialysis do not need a dose change. In children, the dose is based on the child's age and weight.
- Given as a single intravenous infusion over 30 minutes
- No dose adjustment needed based on age alone in older adults, or for those on regular hemodialysis
- Kidney function should be considered before dosing — lower doses may be needed for certain patients with reduced kidney function
- Use caution and consult your doctor if you have moderate or severe liver disease
🤒Side effects — in detail▾
The most common side effects seen in clinical trials include:
- Nausea
- Headache
- Diarrhea
- Vomiting
- Rash
- Itching (pruritus)
- Flushing or hives during the infusion
- Fever — most commonly reported in pediatric patients
Serious reactions to watch for include severe allergic reactions (anaphylaxis), significant liver enzyme elevations, and C. difficile-associated diarrhea — which can develop even weeks after treatment and should be reported to your doctor promptly.
⚠️Warnings & precautions▾
- Serious allergic reactions (anaphylaxis): Rare but potentially life-threatening. Tell your care team immediately if you develop hives, difficulty breathing, or swelling during or after the infusion. People with prior allergies to glycopeptide antibiotics need especially close monitoring.
- Infusion-related reactions: Giving the infusion too quickly can cause flushing of the upper body, hives, itching, rash, or back pain. These usually stop when the infusion is slowed or paused.
- Liver enzyme elevations: Some patients have developed elevated liver enzymes during treatment. These returned to normal in all patients who were followed up. Monitoring may be appropriate.
- C. difficile-associated diarrhea (CDAD): This intestinal infection has been reported with nearly all antibiotics, including dalbavancin. It can range from mild to life-threatening. Contact your doctor if you have new or worsening diarrhea during or after treatment — even weeks later.
- Antibiotic resistance: Using dalbavancin when it isn't truly needed increases the risk of creating drug-resistant bacteria.
🔀What it interacts with▾
Dalbavancin has a low risk of drug-drug interactions, but there are some important compatibility considerations:
- IV fluid compatibility: Dalbavancin must only be mixed with 5% Dextrose (D5W) — saline-based IV fluids cause precipitation and must never be used.
- Other IV medications: Do not mix dalbavancin with other drugs or electrolytes in the same IV line or bag. Flush the line with D5W before and after each infusion if the line is shared.
- CYP450 enzymes: Dalbavancin does not significantly interact with the liver enzymes responsible for processing most common drugs — making major drug interactions unlikely.
- Lab tests: Dalbavancin does not artificially affect common clotting tests (PT or aPTT) at therapeutic levels.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to dalbavancin or glycopeptides: Do not use dalbavancin if you have a known allergy to it. If you have had a prior reaction to a glycopeptide antibiotic (like vancomycin), tell your doctor — cross-sensitivity is possible.
- Kidney disease: Patients with significantly reduced kidney function who are not on regular dialysis may need a lower dose. No adjustment is needed for patients on regular hemodialysis.
- Liver disease: No dose change is needed for mild liver impairment, but caution is advised for moderate or severe liver disease — dosing guidance is limited in these patients.
- Pregnancy: There are no well-controlled studies in pregnant women. Animal studies showed some risk at high doses. Discuss the potential benefits and risks with your doctor.
- Breastfeeding: It is unknown whether dalbavancin passes into human breast milk. Discuss with your doctor before breastfeeding while receiving this drug.
- Children: Dalbavancin is approved from birth through age 17; dosing is adjusted based on age and weight. There is not enough information to guide dosing in children with severely reduced kidney function.
- Older adults: Effectiveness and tolerability are similar to younger adults, but because older adults are more likely to have reduced kidney function, kidney function should be checked when selecting the dose.
🚑If you take too much▾
No dose-limiting toxicity has been observed in clinical studies, even at high cumulative doses given over several weeks. If an overdose is suspected, treatment consists of observation and supportive care. Hemodialysis removes very little of the drug and is not expected to be an effective way to clear it from the body.
📡Pharmacodynamics — effects in the body▾
Dalbavancin's antibacterial effect is most closely tied to how much drug exposure accumulates relative to the minimum concentration needed to inhibit bacterial growth (a measure called AUC/MIC ratio). Studies in animal infection models and clinical pharmacology analysis both support this relationship. At doses used clinically, dalbavancin does not cause meaningful changes in heart rhythm — specifically, it does not affect the QT interval (the electrical recovery phase of the heartbeat) in a clinically relevant way.
🔬Pharmacokinetics — how your body processes it▾
After a single IV infusion, dalbavancin reaches high peak blood levels quickly and then distributes widely through the body, including into skin tissue — where it maintains effective concentrations for up to 7 days after a dose. It is about 93% bound to blood proteins (primarily albumin), and this binding is not meaningfully changed by kidney or liver impairment. The drug has an unusually long effective half-life of approximately 8.5 days, which is why a single infusion is often sufficient for treatment.
Dalbavancin is not broken down by the liver's main enzyme system (CYP450). About one-third of the drug is cleared unchanged through the urine, and about 20% is excreted in feces. Patients with severely reduced kidney function (who are not on dialysis) clear the drug more slowly, which is why the dose is adjusted in that group. Less than 6% of a dose is removed by hemodialysis, so timing of dialysis does not need to be coordinated with dosing.
📦How to store it▾
stored at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) . of the reconstituted and diluted solutions of Dalbavancin for Injection are described elsewhere in the prescribing information .
📄 Written from Dalbavancin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Dalbavancin Injection
27 supplements and herbal products have documented interactions with Dalbavancin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 26
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Dalbavancin Injection has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Dalbavancin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What kind of infection does this treat — is it just for skin infections? ▾
Why do I only need one IV infusion? Antibiotics usually take days or weeks. ▾
What side effects should I actually watch out for after my infusion? ▾
I take several other medications. Will dalbavancin interact with them? ▾
I have kidney disease — is this medication safe for me? ▾
Can this be given to my child? ▾
Is Dalbavancin Injection available over the counter? ▾
When was Dalbavancin Injection first available? ▾
Who makes Dalbavancin Injection? ▾
💬 Answers drafted from Dalbavancin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Dalbavancin Injection comes
Dalbavancin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Dalvance is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults and children from birth through age 17
- Dalvance is active against susceptible Gram-positive bacteria including MRSA, several Streptococcus species, and vancomycin-susceptible Enterococcus faecalis
- Dalvance is given as an intravenous (IV) infusion over exactly 30 minutes in a clinical setting
- Dalvance must only be diluted with 5% Dextrose Injection (D5W) — saline-based solutions can cause the drug to precipitate and must not be used
- If a shared IV line is used for other drugs, flush the line with 5% Dextrose before and after each Dalvance infusion
- Do not mix Dalvance with other medications or electrolytes in the same IV bag or line
📊 Dalbavancin Injection across the U.S. market
How Dalbavancin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Dalbavancin Injection is used
A general measure of how commonly Dalbavancin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dalbavancin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dalbavancin Injection prescribed? Of the 1,596 medications we measure, Dalbavancin Injection ranks #1,033 by Medicaid prescriptions — more than 35% of them.
Utilization by Dalbavancin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dalbavancin 500 MG Injection
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1539243
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dalbavancin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 6 listed Dalbavancin Injection NDCs with Medicaid activity.
🔍 Compare Dalbavancin Injection products
A representative set of FDA-listed product records for Dalbavancin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 500 mg/25 mL | Intravenous | Allergan, Inc. × 2 listings | NDA | View NDC → |
| 500 mg/25 mL | Intravenous | BE Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg/25 mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 500 mg | Intravenous | Long Grove Pharmaceuticals, LLC | ANDA | View NDC → |
| 500 mg/25 mL | Intravenous | Meitheal Pharmaceuticals Inc | ANDA | View NDC → |
| 500 mg/25 mL | Intravenous | Somerset Therapeutics, LLC | ANDA | View NDC → |
| 500 mg/25 mL | Intravenous | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Dalbavancin Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dalbavancin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dalbavancin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Dalbavancin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1539239 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1806675In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 1539243
Look up RxCUI 1539239 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Dalbavancin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Dalbavancin Injection belongs to the Lipoglycopeptide Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Allergan, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.