Dalbavancin

Dalbavancin is an antibacterial drug [see Microbiology ( 12.4 )] .

• INDICATION AND USAGE Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

• Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin.contraindicated

Dosage in Adult Patients ( 2.1 , 2.3 ): Estimated Creatinine Clearance ( C L cr) Single Dose Regimen 30 mL/min and above or on regular hemodialysis 1,500 mg Less than 30 mL/min and not on regular hemodialysis 1,125 mg Administer by intravenous infusion over 30 minutes ( 2.1 , 2.4 ) See Full Prescribing Information for instructions on reconstitution of lyophilized powder and preparation of injection ( 2.4 ) Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m 2 and above ( 2.2 ) Age Range Dosage (Single Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum of 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum of 1,500 mg) Dosage adjustment in pediatric patients with CLcr less than 30 mL/min has not been studied. 2.1 Recommended Dos ag e Regimen in Adult Patients with CLcr 30 mL/min and Above The recommended dosage regimen of dalbavancin for injection in adult patients with CLcr 30 mL/min and above is 1,500 mg, administered as a single dose regimen. Administer dalbavancin for injection over 30 minutes by intravenous infusion. For adult patients with CLcr less than 30 mL/min, dosage adjustment is required [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 ) ] . 2.2 Recommended Dosage Regimen in Pediatric Patients with CLcr 30 mL/min/ 1.73m 2 and Abov e The recommended dosage regimen of dalbavancin for injection in pediatric patients with CLcr 30 mL/min/1.73m 2 and above is a single dose regimen based on the age and weight of the pediatric patient (Table 1). Administer dalbavancin for injection over 30 minutes by intravenous infusion.

Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides. ( 5.1 ) Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions. ( 5.2 ) Alanine Aminotransferase (ALT) elevations with dalbavancin for injection treatment were reported in clinical trials. ( 5.3 , 6.1 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including dalbavancin for injection. Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction to dalbavancin for injection occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Before using dalbavancin for injection, inquire carefully about previous hypersensitivity reactions to other glycopeptides.

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1­888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of dalbavancin for injection cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adult Patients Adverse reactions were evaluated for 2,473 patients treated with dalbavancin for injection: 1,778 patients were treated with dalbavancin for injection in seven Phase 2/3 trials comparing dalbavancin for injection to comparator antibacterial drugs and 695 patients were treated with dalbavancin for injection in one Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen.

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with dalbavancin for injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes. No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [ see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).

Metabolism

General Pharmacokinetic Properties Dalbavancin pharmacokinetic parameters have been characterized in healthy subjects, patients, and specific populations. Pharmacokinetic parameters following administration of single intravenous 1,000 mg and 1,500 mg doses were as shown in Table 4.

Specific information is not available on the treatment of overdose with dalbavancin for injection, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered cumulative doses of up to 4,500 mg over a period of up to 8 weeks (not an approved dosing regimen), with no signs of toxicity or laboratory results of clinical concern. Treatment of overdose with dalbavancin for injection should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed [see Clinical Pharmacology ( 12.3 )].

• May 23, 2014NDANDA021883Abbvie
• Oct 23, 2025ANDAANDA219465Teva Pharms Inc
• Nov 10, 2025ANDAANDA217591Fresenius Kabi Usa
• Nov 26, 2025ANDAANDA218929Kindos
• Feb 26, 2026ANDAANDA218602Long Grove Pharms

1. 1Off Label Use16214%
2. 2Rash1008.7%
3. 3Pruritus635.5%
4. 4Back Pain595.1%
5. 5Dyspnoea585.1%
6. 6Vomiting585.1%
7. 7Drug Ineffective564.9%
8. 8Nausea524.5%
9. 9Erythema504.4%
10. 10Hypersensitivity474.1%
11. 11Urticaria403.5%
12. 12Acute Kidney Injury383.3%
13. 13Pyrexia383.3%
14. 14Diarrhoea332.9%
15. 15Infusion Related Reaction322.8%

The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Dalbavancin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
  Recruiting · Phase 1 · Interventional · 29 enrolled · St. Jude Children's Research Hospital
  NCT06810583updated 2026-02-03
• Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
  Active not recruiting · Observational · 230 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT06688084updated 2025-11-17
• Comparing Oral Versus Parenteral Antimicrobial Therapy
  Terminated · Phase 4 · Interventional · 94 enrolled · West Virginia University
  NCT05977868updated 2025-08-26
• Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
  Recruiting · Phase 4 · Interventional · 284 enrolled · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  NCT06423898updated 2025-07-25
• Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
  Recruiting · Phase 3 · Interventional · 406 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT05117398updated 2025-04-06
• Efficacy and Safety of Dalbavancin As Suppressive Therapy
  Recruiting · Observational · 33 enrolled · Hospices Civils de Lyon
  NCT06899906updated 2025-03-28
• DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
  Completed · Phase 2 · Interventional · 200 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT04775953updated 2024-12-10
• Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
  Completed · Phase 3 · Interventional · 199 enrolled · AbbVie
  NCT02814916updated 2024-09-19
• Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
  Recruiting · Phase 4 · Interventional · 100 enrolled · University of Colorado, Denver
  NCT06266494updated 2024-05-13
• Evaluation of Intravenous Dalbavancin for Peritonitis
  Terminated · Observational · 2 enrolled · University of Colorado, Denver
  NCT04624451updated 2024-05-09

Frequently asked questions

How does Dalbavancin work?

Dalbavancin is an antibacterial drug [see Microbiology ( 12.4 )] .

What is Dalbavancin used for?

According to FDA labeling, Dalbavancin carries indications including: INDICATION AND USAGE Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dalbavancin?

Dalbavancin is classified as Glycopeptide antibacterials, Lipoglycopeptide Antibacterial, Protein Synthesis Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Dalbavancin?

Dalbavancin is marketed under brand names including Dalvance.

What are the contraindications for Dalbavancin?

Dalbavancin labeling lists contraindications including: Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin.. Always consult the full prescribing information and a clinician.