DALBAVANCIN HYDROCHLORIDE 500 mg/25mL Injection, Powder, For Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Lipoglycopeptide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Dalbavancin injection is used to treat skin infections caused by certain types of bacteria. Dalbavancin is in a class of medications called lipoglycopeptide antibiotics. It works by killing bacteria. Antibiotics such as dalbavancin will not kill viruses that can cause colds, flu, or other infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Yes, dalbavancin (Dalvance) is specifically approved for serious bacterial skin infections — what doctors call acute bacterial skin and skin structure infections, or ABSSSI. These...
- What kind of infection does this treat — is it just for skin infections?
- That's the unique thing about dalbavancin — it has an unusually long half-life of about 8.5 days, meaning it stays active in your body at effective levels for well over a week afte...
- Why do I only need one IV infusion? Antibiotics usually take days or weeks.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dalbavancin Hydrochloride — tap one for details:
Dalbavancin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
129 mg / 25 mL
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
129 mg / 25 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1,139.62 | $28,490.53 / 25 ml |
| Medicare Part B allowsASP · J0875 | $11.293 / J0875 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dalbavancin 500 mg/25mL 00480-3325-01 | Teva | 1 vial | — | AP | FDA listed | — |
| Dalvance 500 mg/25mL 57970-0100-01 | Allergan, | 1 vial | — | AP | FDA listed | — |
| Dalbavancin Hydrochloride 500 mg/25mLthis 65219-0120-12 | Fresenius | 1 vial | — | AP | FDA listed | — |
| Dalbavancin 500 mg/25mL 71288-0034-50 | Meitheal | 1 vial | — | AP | FDA listed | — |
| Dalbavancin 500 mg/25mL 71839-0144-01 | BE | 1 vial | — | AP | FDA listed | — |
| Dalbavancin 500 mg 81298-2390-01 | Long | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65219-0120-12 You're viewing this | 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL | 2025-11-10 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 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.
( 1.2 )
1.1Acute Bacterial Skin and Skin Structure Infections Dalbavancin for injection is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus ) and Enterococcus faecalis (vancomycin susceptible isolates).
1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial agents, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosage in Adult Patients ( 2.1 , 2.3 ) : Estimated Creatinine Clearance (CLcr) 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.
2.1Recommended Dosage 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 )] .
2.2Recommended Dosage Regimen in Pediatric Patients with CLcr 30 mL/min/1.73m 2 and Above 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. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years with CLcr less than 30 mL/min/1.73m 2 [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.3 )] .
Table 1. Dosage of Dalbavancin for Injection in Pediatric Patients with CLcr * 30 mL/min/1.73m 2 and above *Estimate CLcr or glomerular filtration rate (GFR) using an age-appropriate equation accepted for pediatric patients (birth to less than 18 years old) to define renal function impairment. Age Range Dosage (Single Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum 1,500 mg)
2.3Dosage Adjustments in Adult Patients with CLcr less than 30 mL/min In adult patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended dosage regimen of dalbavancin for injection is 1,125 mg, administered as a single dose regimen. No dosage adjustment is recommended for adult patients receiving regularly scheduled hemodialysis, and dalbavancin for injection can be administered without regard to the timing of hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .
2.4Preparation and Administration Dalbavancin for injection must be reconstituted with either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, and subsequently diluted only with 5% Dextrose Injection, USP, to a final concentration of 1 mg/mL to 5 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitution: dalbavancin for injection must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, for each 500 mg vial.
To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution.
Reconstituted vials may be stored either refrigerated at 2°C to 8°C (36°F to 46°F), or at controlled room temperature 20°C to 25°C (68°F to 77°F). Do not freeze. Dilution: Adult Patients: Aseptically transfer the required dose of reconstituted dalbavancin…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Dalbavancin for injection is supplied as a white/off-white to pale yellow lyophilized sterile powder for reconstitution in a single-dose clear glass vial containing dalbavancin hydrochloride equivalent to 500 mg of dalbavancin. For injection: 500 mg of lyophilized powder in a single-dose vial for reconstitution ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin. Known hypersensitivity to dalbavancin ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 )
5.1Hypersensitivity 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.
Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during treatment with dalbavancin for injection in patients with a history of glycopeptide allergy [see Patient Counseling Information ( 17 )] .
5.2Infusion-Related Reactions Dalbavancin for injection is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions 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.
5.3Hepatic Effects In Phase 2 and 3 clinical trials, more dalbavancin for injection than comparator-treated subjects with normal baseline transaminase levels had post-baseline alanine aminotransferase (ALT) elevation greater than 3 times the upper limit of normal (ULN). Overall, abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the dalbavancin for injection and comparator arms [see Adverse Reactions ( 6.1 )].
5.4Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including dalbavancin for injection, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.5Development of Drug-Resistant Bacteria Prescribing dalbavancin for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-r…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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.
The median age of patients treated with dalbavancin for injection was 48 years, ranging between 16 and 93 years. Patients treated with dalbavancin for injection were predominantly male (59.5%) and White (81.2%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation Serious adverse reactions occurred in 121/2,473 (4.9%) of patients treated with any regimen of dalbavancin for injection.
In the Phase 2/3 trials comparing dalbavancin for injection to comparator, serious adverse reactions occurred in 109/1,778 (6.1%) of patients in the dalbavancin for injection group and 80/1,224 (6.5%) of patients in the comparator group. In a Phase 3 trial comparing dalbavancin for injection single dose and another dalbavancin dosing regimen, serious adverse reactions occurred in 7/349 (2.0%) of patients in the dalbavancin for injection single dose group and 5/346 (1.4%) of patients in another dalbavancin dosing regimen group.
Dalbavancin for injection was discontinued due to an adverse reaction in 64/2,473 (2.6%) patients treated with any regimen of dalbavancin for injection. In the Phase 2/3 trials comparing dalbavancin for injection to comparator, dalbavancin for injection was discontinued due to an adverse reaction in 53/1,778 (3.0%) of patients in the dalbavancin for injection group and 35/1,224 (2.9%) of patients in the comparator group. In a Phase 3 trial comparing dalbavancin for injection single dose and another dalbavancin dosing regimen, dalbavancin for injection was discontinued due to an adverse reaction in 6/349 (1.7%) of patients in the dalbavancin for injection single dose group and 5/346 (1.4%) of patients in another dalbavancin dosing regimen group.
Most Common Adverse Reactions The most common adverse reactions in patients treated with dalbavancin for injection in Phase 2/3 trials were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). The median duration of adverse reactions was 3.0 days in patients treated with dalbavancin for injection. In the Phase 2/3 trials comparing dalbavancin for injection to comparator, the median duration of adverse reactions was 3.0 days for patients in the dalbavancin for injection group and 4.0 days in patients in the comparator group.
In a Phase 3 trial comparing dalbavancin for injection single dose and another dalbavancin dosing regimen, the median duration of adverse reactions was 3.0 days for patients in the dalbavancin for injection single dose and…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. Dalbavancin for injection at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).
7.2Drug-Drug Interactions No clinical drug-drug interaction studies have been conducted with dalbavancin for injection. There is minimal potential for drug-drug interactions between dalbavancin for injection and cytochrome P450 (CYP450) substrates, inhibitors, or inducers [see Clinical Pharmacology ( 12.3 )] .
🔄 Drug / Laboratory Test Interactions ▾
7.1Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. Dalbavancin for injection at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
8.2Lactation Risk Summary There are no data on the presence of dalbavancin or its metabolite in human milk, the effects on the breast-fed child, or the effects on milk production. Dalbavancin is excreted in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dalbavancin for injection and any potential adverse effects on the breast-fed child from dalbavancin for injection or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of dalbavancin for injection for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years. Use of dalbavancin for injection for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] . There is insufficient information to recommend dosage adjustment for pediatric patients with ABSSSI and CLcr less than 30 mL/min/1.73m 2 [see Dosage and Administration ( 2.2 )].
8.5Geriatric Use Of the 2,473 patients treated with dalbavancin for injection in Phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. The efficacy and tolerability of dalbavancin for injection were similar to comparator regardless of age. The pharmacokinetics of dalbavancin for injection was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.
Dalbavancin for injection is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
8.6Renal Impairment In patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen for dalbavancin for injection is 1,125 mg, administered as a single dose. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin for injection can b…
🤰 Pregnancy ▾
8.1Pregnancy 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). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dalbavancin for injection for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years. Use of dalbavancin for injection for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] . There is insufficient information to recommend dosage adjustment for pediatric patients with ABSSSI and CLcr less than 30 mL/min/1.73m 2 [see Dosage and Administration ( 2.2 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 2,473 patients treated with dalbavancin for injection in Phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. The efficacy and tolerability of dalbavancin for injection were similar to comparator regardless of age. The pharmacokinetics of dalbavancin for injection was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.
Dalbavancin for injection is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
🆘 Overdosage ▾
10 OVERDOSAGE 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 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dalbavancin is an antibacterial drug [see Microbiology ( 12.4 )] .
12.2Pharmacodynamics The antibacterial activity of dalbavancin appears to best correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) for Staphylococcus aureus based on animal models of infection [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 )] . Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 200 healthy subjects received dalbavancin 1,000 mg IV, dalbavancin 1,500 mg IV, oral moxifloxacin 400 mg, or placebo.
Neither dalbavancin 1,000 mg nor dalbavancin 1,500 mg had any clinically relevant adverse effect on cardiac repolarization.
12.3Pharmacokinetics 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 . The pharmacokinetics of dalbavancin can be described using a three-compartment model.
Table 4. Dalbavancin Pharmacokinetic Parameters in Healthy Subjects All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects.
3 Based upon population pharmacokinetic analyses of data from patients, the effective half-life is approximately 8.5 days (204 hours). 4 Data from 49 healthy subjects. Abbreviation: ND – not determined Parameter Single 1,000 mg Dose Single 1,500 mg Dose C max (mg/L) 287 (13.9) 1 423 (13.2) 4 AUC 0-24 (mg•h/L) 3,185 (12.8) 1 4,837 (13.7) 4 AUC 0-Day7 (mg•h/L) 11,160 (41.1) 2 ND AUC 0-inf (mg•h/L) 23,443 (40.9) 2 ND Terminal t ½ (h) 346 (16.5) 2,3 ND CL (L/h) 0.0513 (46.8) 2 ND In healthy subjects, dalbavancin AUC 0-24h and C max both increased proportionally to dose following single IV dalbavancin doses ranging from 140 mg to 1,500 mg, indicating linear pharmacokinetics.
No apparent accumulation of dalbavancin was observed following multiple IV infusions administered once weekly for up to eight weeks, with 1,000 mg on Day 1 followed by up to seven weekly 500 mg doses, in healthy adults with normal renal function. Distribution Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin. The plasma protein binding of dalbavancin is approximately 93% and is not altered as a function of drug concentration, renal impairment, or hepatic impairment.
The mean concentrations of dalbavancin achieved in skin blister fluid remain above 30 mg/L up to 7 days (approximately 146 hours) post dose, following 1,000 mg IV dalbavancin. The mean ratio of the AUC 0-144 hrs in skin blister fluid/AUC 0-144 hrs in plasma is 0.60 (range 0.44 to 0.64). Metabolism In vitro studies using human microsomal enzymes and hepatocytes indicate that dalbavancin is not a substrate, inhibitor, or inducer of CYP450 isoenzymes.
A minor metabolite of dalbavancin (hydroxy-dalbavancin) has been observed in the urine of healthy subjects. Quantifiable concentrations of the hydroxy-dalbavancin metabolite have not been observed in human plasma (lower limit of quantitation = 0.4 μg/mL) [see Drug Interactions ( 7.2 )] . Excretion Following administration of a single 1,000 mg dose in healthy subjects, 20% of the dose was excreted in feces through 70 days post dose.
An average of 33% of the administered dalbavancin dose was excreted in urine as unchanged dalbavancin and approximately 12% of the administered dose was excreted in urine as the metabolite hydroxy-dalbavancin through 42 days post dose. Specific Populations Renal Impairment The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function. Following a single dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CL T ) was reduced 11%, 3…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dalbavancin is an antibacterial drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dalbavancin for injection is supplied as a white/off-white to pale yellow sterile lyophilized powder in a single-dose glass vial containing dalbavancin hydrochloride equivalent to 500 mg dalbavancin: Product Code Unit of Sale Strength 221012 NDC 65219-120-12 Individually packaged 500 mg per single-dose vial Dalbavancin for injection should be stored at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Storage of the reconstituted and diluted solutions of dalbavancin for injection are described elsewhere in the prescribing information [see Dosage and Administration ( 2.4 )].
The container closure is not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION 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 (A 0 , A 1 , B 0 , B 1 , and B 2 ); the component B 0 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 (R 1 ) structure and/or the presence of an additional methyl group (R 2 ) on the terminal amino group (shown in the Figure 1 and Table 3 below).
Figure 1. Dalbavancin Structural Formula Table 3. Substitution Patterns for Dalbavancin API Homologs * Anhydrous free base Dalbavancin R 1 R 2 Molecular Formula Molecular Weight * A 0 CH(CH 3 ) 2 H C 87 H 98 N 10 O 28 Cl 2 ·
1.6HCl 1,802.7 A 1 CH 2 CH 2 CH 3 H C 87 H 98 N 10 O 28 Cl 2 ·
1.6HCl 1,802.7 B 0 CH 2 CH(CH 3 ) 2 H C 88 H 100 N 10 O 28 Cl 2 ·
1.6HCl 1,816.7 B 1 CH 2 CH 2 CH 2 CH 3 H C 88 H 100 N 10 O 28 Cl 2 ·
1.6HCl 1,816.7 B 2 CH 2 CH(CH 3 ) 2 CH 3 C 89 H 102 N 10 O 28 Cl 2 ·
1.6HCl 1,830.7 The B 0 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. Dalbavancin for injection 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 ( 2.4 ), How Supplied/Storage and Handling ( 16 )] . Figure 1.
Dalbavancin Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur with dalbavancin for injection, and that serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to dalbavancin for injection, or other glycopeptides [see Warnings and Precautions ( 5.1 )] . Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including dalbavancin for injection, and usually resolves when the drug is discontinued.
Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider [see Warnings and Precautions ( 5.4 )] . Development of Drug-Resistant Bacteria Patients should be counseled that antibacterial drugs including dalbavancin for injection should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When dalbavancin for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may ( 1 ) decrease the effectiveness of the immediate treatment, and ( 2 ) increase the likelihood that bacteria will develop resistance and will not be treatable by dalbavancin for injection or other antibacterial drugs in the future [see Warnings and Precautions ( 5.5 )] .
Manufactured by: Lake Zurich, Illinois 60047 www.fresenius-kabi.com/us 451844A Fresenius Kabi Logo