Dalbavancin Accord: Uses, Dosage & Side Effects

What Is Dalbavancin Accord and What Is It Used For?

Dalbavancin Accord is a semisynthetic lipoglycopeptide antibiotic used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. It works by binding to the D-alanyl-D-alanine terminus of the bacterial cell wall precursor, inhibiting cell wall synthesis and causing bacterial cell death. Its extended half-life allows for single-dose treatment of serious skin infections.

Dalbavancin Accord contains the active substance dalbavancin, a second-generation lipoglycopeptide antibiotic structurally related to teicoplanin. It was developed to address the growing clinical need for effective, convenient treatment options for serious Gram-positive skin infections, particularly those caused by drug-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA). Skin and soft tissue infections represent one of the most common reasons for hospital admission and antibiotic therapy worldwide, with MRSA accounting for a significant and growing proportion of cases in many countries.

Traditional intravenous antibiotic therapy for serious skin infections typically requires daily administration for 7 to 14 days, often necessitating prolonged hospitalization or the establishment of outpatient parenteral antibiotic therapy (OPAT) with central venous access. Dalbavancin's remarkably long terminal half-life of approximately 346 hours (14.4 days) fundamentally changes this treatment paradigm. A single 30-minute intravenous infusion of 1,500 mg, or two infusions of 1,000 mg and 500 mg given one week apart, provides sustained therapeutic drug concentrations throughout the entire treatment period without the need for daily dosing.

This unique pharmacokinetic profile offers several clinical advantages. Patients may be discharged earlier from hospital, reducing the risk of healthcare-associated complications such as catheter-related bloodstream infections and Clostridioides difficile infection. It also simplifies outpatient management and improves treatment adherence, as patients do not need to manage daily infusions or remember to take oral antibiotics multiple times per day. Clinical trials, including the pivotal DISCOVER 1 and DISCOVER 2 studies, demonstrated that dalbavancin was non-inferior to vancomycin followed by oral linezolid in achieving early clinical response in ABSSSI.

Approved Indications

Dalbavancin Accord is approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible Gram-positive microorganisms. ABSSSI encompasses three primary types of skin infection:

• Wound infections: Infections developing in surgical or traumatic wounds, characterized by purulent drainage, erythema extending at least 75 cm² from the wound edge, swelling, and/or induration
• Cellulitis and erysipelas: Diffuse skin infections presenting with spreading areas of redness, edema, and warmth, with a minimum lesion surface area of 75 cm². Cellulitis involves the deeper dermis and subcutaneous tissue, while erysipelas primarily affects the upper dermis and superficial lymphatics
• Major cutaneous abscesses: Collections of pus within the dermis or deeper skin layers, surrounded by erythema, edema, and/or induration extending at least 75 cm² from the abscess margin. Surgical drainage is typically performed alongside antibiotic therapy

Spectrum of Activity

Dalbavancin demonstrates potent in vitro and clinical activity against a broad range of Gram-positive bacteria commonly responsible for skin and soft tissue infections. Understanding the spectrum of activity is essential for appropriate prescribing and ensuring effective treatment outcomes:

• Staphylococcus aureus (including MRSA and MSSA): The most common pathogen in ABSSSI globally, responsible for approximately 40–60% of cases. Dalbavancin achieves MIC₉₀ values of 0.06 μg/mL, demonstrating excellent potency
• Streptococcus pyogenes (Group A streptococcus): A frequent cause of cellulitis and erysipelas. Dalbavancin is highly active with MIC₉₀ values ≤ 0.03 μg/mL
• Streptococcus agalactiae (Group B streptococcus): Occasionally implicated in skin infections, particularly in patients with diabetes or immunocompromised states
• Streptococcus anginosus group: Important cause of abscess formation. Dalbavancin provides reliable coverage
• Vancomycin-susceptible Enterococcus faecalis: Dalbavancin is active against vancomycin-susceptible strains only. It has no reliable activity against vancomycin-resistant enterococci (VRE)

What Should You Know Before Receiving Dalbavancin Accord?

Before receiving dalbavancin, your healthcare provider will assess your kidney and liver function, allergy history (particularly to glycopeptide antibiotics such as vancomycin or teicoplanin), and current medications. Dalbavancin should be used with caution in patients with known hypersensitivity to glycopeptides, moderate to severe hepatic impairment, or severe renal impairment.

As with all antibiotic therapies, the decision to use dalbavancin should be guided by local antimicrobial resistance patterns, available culture and sensitivity data, and individual patient factors. Appropriate antibiotic stewardship is essential to preserve the effectiveness of this valuable agent. Dalbavancin should not be used for infections where narrower-spectrum antibiotics would be equally effective, and it should not be used for infections caused by organisms outside its spectrum of activity.

Contraindications

Dalbavancin Accord must not be used in the following circumstances:

• Hypersensitivity to dalbavancin: If you have a known allergy to dalbavancin or any of the excipients in the formulation (including mannitol, lactose monohydrate, hydrochloric acid, and sodium hydroxide), this medication must not be administered
• Known severe allergy to other glycopeptides: Patients with a documented history of severe hypersensitivity (anaphylaxis, severe skin reactions) to vancomycin, teicoplanin, or other glycopeptide antibiotics should not receive dalbavancin due to the risk of cross-reactivity. Mild infusion reactions to vancomycin (“red man syndrome”) do not necessarily contraindicate dalbavancin use, but increased caution and slower infusion rates are warranted

Warnings and Precautions

The following conditions and situations require careful assessment and ongoing monitoring when dalbavancin is being considered or administered. Discuss your complete medical history with your treating physician before receiving this medication:

• Infusion-related reactions: Like other glycopeptide antibiotics, rapid intravenous infusion of dalbavancin can trigger “red man syndrome,” characterized by flushing, erythema, urticaria, and pruritus of the upper body and face. This reaction is not a true allergy but is caused by histamine release from mast cells. To minimize this risk, dalbavancin must be infused over at least 30 minutes. If a reaction occurs, the infusion should be slowed or temporarily stopped until symptoms resolve
• Hypersensitivity and anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been reported with glycopeptide-class antibiotics. Facilities and medications for the treatment of anaphylaxis should be immediately available when dalbavancin is administered. If an anaphylactic reaction occurs during infusion, administration must be discontinued immediately and appropriate emergency treatment initiated
• Clostridioides difficile-associated diarrhea (CDAD): All antibiotics, including dalbavancin, can alter the normal intestinal flora and lead to overgrowth of C. difficile, producing toxins that cause diarrhea ranging from mild to life-threatening pseudomembranous colitis. CDAD must be considered in any patient who develops diarrhea during or after antibiotic treatment. If CDAD is suspected or confirmed, ongoing antibiotics not directed against C. difficile may need to be discontinued, and appropriate specific therapy (oral vancomycin or fidaxomicin) should be initiated
• Hepatic impairment: Dalbavancin is partly metabolized in the liver. No dose adjustment is needed for mild hepatic impairment (Child-Pugh Class A). However, caution is advised in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C), as limited data are available for these populations. Liver function should be monitored during treatment
• Renal impairment: In patients with severe renal impairment (creatinine clearance below 30 mL/min) who are not receiving regular hemodialysis, the recommended dose of dalbavancin should be reduced. Specifically, in the single-dose regimen, the dose is reduced from 1,500 mg to 1,125 mg; in the two-dose regimen, from 1,000 mg/500 mg to 750 mg/375 mg. No dose adjustment is needed in patients receiving regular hemodialysis, as dalbavancin is not significantly removed by hemodialysis
• Superinfection: As with all antibiotics, prolonged use or use in the absence of a proven bacterial infection may promote the growth of resistant organisms. If superinfection occurs during treatment, appropriate measures should be taken
• Coagulation monitoring: Dalbavancin may interfere with certain coagulation laboratory tests, particularly the activated partial thromboplastin time (aPTT). This is an in vitro laboratory artifact that does not affect the body’s actual clotting ability. However, healthcare providers should be aware of this potential interference when interpreting coagulation test results in patients recently treated with dalbavancin

Pregnancy and Breastfeeding

The safety of dalbavancin during pregnancy has not been established in well-controlled human clinical trials. Animal reproduction studies have shown some evidence of developmental toxicity at doses significantly exceeding human therapeutic exposure. Dalbavancin should be used during pregnancy only if the potential benefit to the mother clearly justifies the potential risk to the fetus. Women of childbearing potential should discuss contraception and pregnancy planning with their healthcare provider before receiving dalbavancin.

It is not known whether dalbavancin is excreted in human breast milk. Given the drug’s long half-life (approximately 14 days), the potential for prolonged infant exposure through breastfeeding must be carefully considered. A risk-benefit assessment should be made, taking into account the importance of treatment for the mother and the potential effects on the breastfed infant, including disruption of the infant’s intestinal flora. If breastfeeding is continued during or after dalbavancin administration, the infant should be monitored for gastrointestinal disturbances such as diarrhea or oral thrush.

Driving and Operating Machinery

Dalbavancin is administered in a hospital or clinical setting and has no known direct effects on the ability to drive or operate machinery. However, as with any medication, if you experience dizziness, headache, or other side effects that could impair your alertness, you should avoid driving or operating heavy machinery until these symptoms resolve.

How Does Dalbavancin Accord Interact with Other Drugs?

Dalbavancin has a relatively low potential for drug-drug interactions compared to many other antibiotics. It is not significantly metabolized by cytochrome P450 enzymes and does not inhibit or induce major CYP isoforms at therapeutic concentrations. However, caution is advised when co-administering with drugs that have narrow therapeutic windows or known nephrotoxic potential.

In vitro studies have demonstrated that dalbavancin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 at clinically relevant concentrations, and it does not induce CYP1A2, CYP2C9, or CYP3A4. This favorable metabolic profile means that clinically significant pharmacokinetic drug interactions are unlikely. Nevertheless, as with all medications, it is important to inform your healthcare provider about all prescription drugs, over-the-counter medications, vitamins, and herbal supplements you are currently taking.

The most relevant interaction considerations with dalbavancin relate to additive pharmacodynamic effects rather than pharmacokinetic interactions. When combining dalbavancin with other medications that carry nephrotoxic risk, such as aminoglycoside antibiotics, amphotericin B, or intravenous contrast agents, enhanced monitoring of renal function is prudent. Similarly, when dalbavancin is used alongside other medications known to cause ototoxicity, audiometric monitoring should be considered.

Clinically Relevant Interactions

While significant pharmacokinetic interactions are uncommon, the following drug combinations warrant awareness and potential monitoring:

Laboratory Test Interference

Healthcare providers should be aware that dalbavancin can interfere with certain laboratory coagulation assays. Specifically, dalbavancin has been shown to artifactually prolong the activated partial thromboplastin time (aPTT) in in vitro testing. This effect is concentration-dependent and may persist for several days after the last infusion due to the drug’s long half-life. This is purely a laboratory artifact and does not represent an actual effect on the patient’s coagulation system. Alternative coagulation tests, such as the prothrombin time (PT/INR) or anti-factor Xa assays, are not affected and should be used when monitoring anticoagulation in patients who have recently received dalbavancin.

What Is the Correct Dosage of Dalbavancin Accord?

The recommended dose of Dalbavancin Accord for adults is a single intravenous infusion of 1,500 mg, or alternatively 1,000 mg followed by 500 mg one week later. The infusion must be administered over 30 minutes. Dose reduction is required in patients with severe renal impairment (CrCl < 30 mL/min) not on hemodialysis.

Dalbavancin Accord is supplied as a lyophilized (freeze-dried) powder that must be reconstituted with sterile water for injection and then further diluted in 5% glucose solution before intravenous administration. The preparation and administration of dalbavancin should be performed by qualified healthcare professionals in a hospital or clinical setting equipped to manage potential infusion-related reactions.

Adults

Two dosing regimens are approved for the treatment of ABSSSI in adults, both demonstrating equivalent clinical efficacy in phase III clinical trials:

Renal Impairment

No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min) or for patients receiving regular hemodialysis (dalbavancin is not significantly removed by hemodialysis). However, for patients with severe renal impairment (creatinine clearance below 30 mL/min) who are not on hemodialysis, dose reduction is recommended:

Children and Adolescents

The safety and efficacy of dalbavancin in pediatric patients (under 18 years of age) have not been established. Dalbavancin Accord is not currently approved for use in children or adolescents. Clinical trials investigating appropriate dosing in pediatric populations are ongoing, and regulatory approvals for pediatric indications may be forthcoming as data become available. Until such data are published and regulatory approval is granted, dalbavancin should not be used in patients under 18 years of age.

Elderly

No dose adjustment is required based on age alone. Clinical trials included patients aged 65 years and older, and no clinically meaningful differences in safety or efficacy were observed between elderly and younger patients. However, elderly patients are more likely to have reduced renal function, and dose adjustment based on creatinine clearance should be applied as described above. Additionally, elderly patients may have a higher baseline risk of adverse events, and careful monitoring is recommended.

Missed Dose

In the two-dose regimen, the second dose of 500 mg should be given on Day 8. If the second infusion is delayed, it should be administered as soon as possible. The efficacy of dalbavancin is maintained even if the second dose is given up to several days late, due to the drug’s long half-life. However, delays exceeding 7 days beyond the scheduled Day 8 administration should be discussed with the treating physician to determine whether additional clinical assessment or alternative therapy is needed.

Overdose

There is limited clinical experience with dalbavancin overdose. In clinical trials, single doses up to 1,500 mg have been well tolerated. In the event of overdose, general supportive measures should be employed, with monitoring of renal function, liver function, and clinical status. Dalbavancin is not significantly removed by hemodialysis due to its high protein binding (~93%), so dialysis would not be expected to accelerate elimination. There is no specific antidote for dalbavancin overdose.

What Are the Side Effects of Dalbavancin Accord?

Dalbavancin is generally well tolerated. The most common side effects include nausea, headache, and diarrhea. Serious but rare adverse events include anaphylaxis, Clostridioides difficile-associated diarrhea, and severe infusion-related reactions. Most side effects are mild to moderate in severity and resolve without specific treatment.

In clinical trials involving more than 2,000 adult patients treated with dalbavancin for ABSSSI, the overall safety profile was favorable and comparable to standard-of-care antibiotic regimens. The adverse events reported are categorized below by frequency, according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and the standard frequency convention used in Summary of Product Characteristics across the European Union.

It is important to remember that this list does not include all possible side effects. Individual patients may experience adverse reactions not listed here. If you notice any unusual symptoms during or after receiving dalbavancin, inform your healthcare provider promptly. Given the long half-life of dalbavancin, side effects may occur or persist for several days or even weeks after the infusion, so continued vigilance is warranted.

Reporting Side Effects

Reporting side effects helps regulatory authorities continuously monitor the safety of medicines. If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to your national pharmacovigilance authority. In the European Union, reports can be submitted through the EudraVigilance system. In the United States, adverse events can be reported to the FDA MedWatch program. By reporting side effects, you contribute to ensuring the ongoing safety of this medication for all patients.

How Should You Store Dalbavancin Accord?

Store the unopened vials below 25°C in the original packaging to protect from light. The reconstituted solution can be stored for up to 48 hours at 2–8°C. Once diluted for infusion, the solution should be used within 48 hours if stored at room temperature (20–25°C) or under refrigeration (2–8°C).

Dalbavancin Accord is supplied as a sterile lyophilized powder in single-use glass vials containing 500 mg of dalbavancin. The powder must be reconstituted and diluted before intravenous administration. Proper storage at each stage is essential to maintain the drug’s stability, sterility, and therapeutic efficacy:

• Unopened vials: Store below 25°C. Do not freeze. Keep the vials in the original carton to protect from light. Do not use the product after the expiry date printed on the vial label and outer carton
• After reconstitution: The reconstituted vial solution (containing 20 mg/mL of dalbavancin) may be stored in the vial at room temperature or under refrigeration (2–8°C) for up to 48 hours. Do not freeze the reconstituted solution
• After dilution: Once diluted in 5% glucose infusion solution to the final concentration for intravenous administration, the diluted solution should be used within 48 hours if stored at room temperature (20–25°C) or under refrigeration (2–8°C). The total combined storage time of the reconstituted solution in the vial and the diluted solution for infusion should not exceed 48 hours
• Do not use if the reconstituted or diluted solution is discolored, contains particulate matter, or appears cloudy. The reconstituted solution should be a clear to slightly yellow solution free of visible particles

As with all medications, keep dalbavancin out of the sight and reach of children. Hospital pharmacies and clinical facilities are responsible for ensuring appropriate storage conditions are maintained throughout the supply chain. Do not dispose of unused medication via household waste or wastewater. Ask your pharmacist about proper disposal procedures for unused or expired medicines to protect the environment.

What Does Dalbavancin Accord Contain?

Each vial of Dalbavancin Accord contains 500 mg of dalbavancin (as dalbavancin hydrochloride). The excipients include mannitol, lactose monohydrate, hydrochloric acid, and sodium hydroxide (for pH adjustment). The reconstituted solution is diluted in 5% glucose before intravenous infusion.

Active Substance

The active pharmaceutical ingredient is dalbavancin, present as dalbavancin hydrochloride. Each vial contains 500 mg of dalbavancin. Dalbavancin is a semisynthetic lipoglycopeptide antibiotic derived from the natural product A-40926, which is produced by the actinomycete Nonomuraea species. Its molecular formula is C₈₈H₁₀₀Cl₂N₁₀O₂₈, and it has a molecular weight of approximately 1816.7 g/mol. The molecule features the characteristic heptapeptide backbone and sugar moieties of the glycopeptide antibiotic class, with a lipophilic side chain that distinguishes it from older glycopeptides and confers its enhanced potency and prolonged half-life.

Excipients

The inactive ingredients in Dalbavancin Accord serve specific pharmaceutical functions:

• Mannitol (E421): Used as a lyoprotectant and bulking agent to maintain the stability of the freeze-dried powder and facilitate reconstitution
• Lactose monohydrate: Used as a stabilizer. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not use this medicine without consulting their healthcare provider
• Hydrochloric acid and sodium hydroxide: Used for pH adjustment to ensure the reconstituted solution falls within the appropriate pH range for intravenous administration (typically pH 3.5–4.5)

Each vial contains approximately 4.3 mmol (100 mg) of sodium when reconstituted. This should be taken into consideration for patients on a controlled sodium diet. For patients requiring sodium restriction, this information should be communicated to the prescribing physician so that it can be accounted for in the patient’s total daily sodium intake.

Reconstitution and Dilution

The powder is first reconstituted with 25 mL of sterile water for injection to produce a solution containing 20 mg/mL of dalbavancin. The vial should be swirled gently to dissolve the powder — do not shake vigorously, as this may cause foaming. The appropriate volume of reconstituted solution is then further diluted in 5% glucose infusion solution to a total volume of 250 mL for intravenous infusion. Dalbavancin must not be diluted with saline-based solutions (such as 0.9% sodium chloride) as these may cause precipitation.

Frequently Asked Questions