Dosing & Uses
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 500mg/vial (20mg/mL after reconstitution)
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria
1-dose regimen of 1500 mg IV, or
2-dose regimen of 1000 mg IV followed 1 week later by 500 mg IV
Infuse IV over 30 minutes
Susceptible isolates of Gram-positive microorganisms
- Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant S aureus [MRSA])
- Streptococcus pyogenes
- Streptococcus agalactiae
- Streptococcus dysgalactiae
- Streptococcus anginosus group (including S anginosus, S intermedius, S constellatus)
- Enterococcus faecalis (vancomycin-susceptible isolates)
Dosage Modifications
Renal impairment
-
CrCl <30 mL/min
- 1-dose regimen: Decrease dose to 1125 mg IV
- 2-dose regimen: Decrease dose to 750 mg IV followed 1 week later by 375 mg IV
- If receiving regularly scheduled hemodialysis: No dosage adjustment required
Hepatic impairment
- Mild (Child-Pugh A): No dosage adjustment required
- Moderate or severe (Child-Pugh B and C): Exercise caution; no data are available
Dosage Forms & Strengths
lyophilized powder for reconstitution
- 500mg/vial (20mg/mL after reconstitution)
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria in pediatric patients from birth
Birth to <6 years: 22.5 mg/kg IV as a single dose
6 to <18 years: 18 mg/kg IV as a single dose
Not to exceed 1500 mg/dose
Infuse IV over 30 minutes
Susceptible isolates of Gram-positive microorganisms
- Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant S aureus [MRSA])
- Streptococcus pyogenes
- Streptococcus agalactiae
- Streptococcus dysgalactiae
- Streptococcus anginosus group (including S anginosus, S intermedius, S constellatus)
- Enterococcus faecalis (vancomycin-susceptible isolates)
Osteomyelitis (Orphan)
Orphan designation for treatment of acute osteomyelitis in children aged ≤16 yr
Sponsor
- Durata Therapeutics International B.V.; Spaces Zuidas II, Kantoor 4.03; 1083HN, Amsterdam; Netherlands
Adverse Effects
1-10%
Adults
- Nausea (5.5%)
- Headache (4.7%)
- Diarrhea (4.4%)
- Vomiting (2.8%)
- Rash (2.7%)
- Pruritus (2.1%)
<2% (adults)
- Blood and lymphatic system disorders: Anemia, hemorrhagic anemia, leukopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis
- Gastrointestinal disorders: Gastrointestinal hemorrhage, melena, hematochezia, abdominal pain
- General disorders and administration site conditions: Infusion-related reactions
- Hepatobiliary disorders: Hepatotoxicity
- Immune system disorders: Anaphylactoid reaction
- Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection
- Investigations: Hepatic transaminases increased, blood alkaline phosphatase increased, INR ratio increased, blood lactate dehydrogenase increased, gamma-glutamyl transferase increased
- Metabolism and nutrition disorders: Hypoglycemia
- Nervous system disorders: Dizziness
- Respiratory, thoracic and mediastinal disorders: Bronchospasm
- Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria
- Vascular disorders: Flushing, phlebitis, wound hemorrhage, spontaneous hematoma
Pediatrics
- Pyrexia (1.2%)
<1%
Adults
- Elevated ALT, >3x ULN (0.8%)
Pediatrics
- Gastrointestinal disorders: Diarrhea
- Nervous system disorders: Dizziness
- Skin and subcutaneous tissue disorders: Pruritus
Postmarketing Reports
Back pain as an infusion-related reaction
Warnings
Contraindications
Hypersensitivity
Cautions
Administer via intravenous infusion, using a total infusion time of 30 minutes to minimize risk of infusion-related reaction; rapid IV infusion of glycopeptide antibacterial agents can cause reactions, including upper body flushing, urticaria, pruritus, back pain, and rash; stopping or slowing infusion may result in cessation of these reactions
ALT elevations >3x ULN reported
Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection, or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria
Clostridioides difficile-associated diarrhea (CDAD)
- CDAD reported with severity ranging from mild diarrhea to fatal colitis; treatment with antibacterial agents can alter normal flora of the colon, and may permit overgrowth of C. difficile
- C. difficile produces toxins A and B which contribute to 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 necessary because CDAD has been reported to occur more than 2 months after 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
Hypersensitivity reactions
- Serious hypersensitivity (anaphylactic) and skin reactions reported with glycopeptide antibacterial agents, including dalbavancin
- If an allergic reaction occurs, discontinue treatment and institute appropriate therapy for the allergic reaction; before using product, inquire carefully about previous hypersensitivity reactions to other glycopeptides
- Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during treatment in patients with a history of glycopeptide allergy
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies with 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
Lactation
There are no data on presence of dalbavancin or its metabolite in human milk, effects on breastfed child, or 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 therapy and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Lipoglycopeptide antibiotic; interferes with cell wall synthesis by binding to D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking
Bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations observed in humans at recommended doses
Absorption
Single 1000 mg dose
- Peak plasma concentration: 4287 mg/L
- AUC 0-24: 3185 mg•hr/L
- AUC 0-Day7: 11,160 mg•hr/L
- AUC 0-inf: 23,443 mg•hr/L
Single 1500 mg dose
- Peak plasma concentration: 423 mg/L
- AUC 0-24: 4837 mg•hr/L
Distribution
Protein bound, reversible: 93%, primarily albumin
Metabolism
Not a substrate, inhibitor, or inducer of CYP450 isoenzymes
Minor metabolite (hydroxy-dalbavancin) observed in urine
Elimination
Half-life: 346 hr (single 1000 mg dose)
Clearance: 0.513 L/hr (single 1000 mg dose)
Excretion: 33% unchanged in urine; 12% metabolite in urine; 20% in feces
Administration
IV Compatabilities
Dextrose 5%
IV Incompatabilities
Saline-based solutions (precipitation occurs)
Compatibility of reconstituted dalbavancin with IV medications, additives, or substances other than 5% dextrose has not been established
IV Preparation
Reconstitution
- Reconstitute under aseptic conditions, using 25 mL of sterile water for injection 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
- Reconstituted vial contains 20 mg/mL
- Reconstituted solution should appear clear and colorless to yellow
Dilution
- Aseptically transfer required dose of reconstituted solution from vial(s) to IV bag or bottle containing D5W
- Final concentration of diluted solution must be between 1-5 mg/mL
- Discard any unused portion of reconstituted vials
IV Administration
Visually inspect for particulate matter before infusion
If common IV line is being used to administer other drugs in addition to dalbavancin, flush line before and after each dose
Infuse IV over 30 minutes
Infusion-related reactions associated with rapid IV infusion
Storage
Unopened vials: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Reconstituted vials or diluted solution
- May refrigerate at 2-8°C (36-46°F) or store at controlled room temperature 20-25°C (68-77°F)
- Do not freeze
- Total time from reconstitution to dilution to administration should not exceed 48 hr
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Dalvance intravenous - | 500 mg vial | ![]() |
Copyright © 2010 First DataBank, Inc.
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