(dal ba VAN sin)
- BI 397
- Dalbavancin HCl
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Dalvance: 500 mg (1 ea)
Brand Names: U.S.
Dalbavancin is a lipoglycopeptide which binds to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, preventing cross-linking and interfering with cell wall synthesis. It is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes
Vd: 7 to 13 L (Leighton, 2004)
Minor metabolite (hydroxy-dalbavancin)
Urine (33% as unchanged drug, 12% as hydroxy metabolite); feces (20%)
93% (primarily to albumin)
Special Populations: Renal Function Impairment
Mean plasma clearance reduced 11%, 35%, and 47% in subjects with mild (CrCl 50 to 79 mL/minute), moderate (CrCl 30 to 49 mL/minute), and severe (CrCl <30 mL/minute) renal impairment, respectively.
Special Populations: Hepatic Function Impairment
Mean AUC0-336 hrs decreased 28% and 31% in Child-Pugh class B and C patients, respectively.
Use: Labeled Indications
Acute bacterial skin and skin structure infections: Treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, S. dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains)
Hypersensitivity to dalbavancin or any component of the formulation
Acute bacterial skin and skin structure infections: IV:
Single-dose regimen: 1,500 mg as a single dose
Two-dose regimen: 1,000 mg as a single dose initially, followed by 500 mg as a single dose 1 week later
Refer to adult dosing.
Dosing: Renal Impairment
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute (not on regularly scheduled dialysis):
Single-dose regimen: 1,125 mg as a single dose
Two-dose regimen: 750 mg as a single dose initially, followed by 375 mg as a single dose 1 week later.
ESRD patients receiving intermittent hemodialysis (IHD) (regularly scheduled): No dosage adjustment necessary; administer without regard to timing of hemodialysis.
Dosing: Hepatic Impairment
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate or severe impairment (Child-Pugh class B or C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
Reconstitute with 25 mL of either SWFI or D5W for each 500 mg vial. To avoid foaming, alternate between gentle swirling and inversion of the vial until contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution. Dilute for infusion in D5W (final solution concentration 1 to 5 mg/mL).
IV: Infuse over 30 minutes. If a common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each infusion with D5W.
Store intact vials at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Reconstituted vials and diluted solution in D5W may be stored refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature 20°C to 25°C (68°F to 77°F). Do not freeze. The total time from reconstitution to dilution to administration should be ≤48 hours.
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
1% to 10%:
Cardiovascular: Flushing (<2%), phlebitis (<2%)
Central nervous system: Headache (5%), dizziness (<2%)
Dermatologic: Skin rash (3%), pruritus (2%), urticaria (<2%)
Endocrine & Metabolic: Hypoglycemia (<2%)
Gastrointestinal: Nausea (6%), diarrhea (4%), vomiting (3%), abdominal pain (<2%), gastrointestinal hemorrhage (<2%), hematochezia (<2%), melena (<2%), oral candidiasis (<2%), pseudomembranous colitis (<2%)
Hematologic & oncologic: Acute posthemorrhagic anemia (<2%), anemia (<2%), eosinophilia (<2%), hematoma (spontaneous; <2%), increased INR (<2%), leukopenia (<2%), neutropenia (<2%), petechia (<2%), thrombocythemia (<2%), thrombocytopenia (<2%), wound hemorrhage (<2%)
Hepatic: Hepatotoxicity (<2%)
Hepatic: Increased serum alkaline phosphatase (<2%), increased serum transaminases (<2%)
Hypersensitivity: Anaphylactoid reaction (<2%)
Infection: Vulvovaginal infection (mycotic; <2%)
Respiratory: Bronchospasm (<2%)
Miscellaneous: Infusion related reaction (<2%)
<1% (Limited to important or life-threatening): Hypersensitivity reaction, increased serum ALT (>3 x ULN)
Concerns related to adverse effects:
• Hepatic effects: Patients with normal baseline transaminase levels may have ALT elevation >3 times the upper limit of normal (ULN) during therapy; in clinical studies, abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the dalbavancin and comparator arms. ALT elevations were reversible after discontinuation.
• Hypersensitivity reactions: Serious hypersensitivity (anaphylactic) and skin reactions have been reported with dalbavancin. Discontinue treatment if an allergic reaction occurs. Dalbavancin cross-sensitivity to other glycopeptides may occur; exercise caution in patients with a history of glycopeptide allergy; carefully screen for previous hypersensitivity reactions to glycopeptides prior to administration.
• Infusion reactions: Rapid intravenous infusions of dalbavancin (<30 minutes) may cause reactions that resemble “Red-Man Syndrome,” (eg, flushing of the upper body, urticaria, pruritus, rash). Stopping or slowing the infusion may result in cessation of these reactions.
• Superinfection: Use may result in fungal or bacterial superinfection, including Clostridium difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment (Child-Pugh class B or C).
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Baseline BUN, serum creatinine, and liver function tests (AST, ALT, bilirubin). Monitor patients for any infusion-related reactions and for superinfection during therapy.
Adverse events have been observed in animal reproduction studies. The long half-life of dalbavancin should be considered when evaluating potential exposure to the fetus.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea, headache, or nausea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), flushing, infusion reaction, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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- Drug class: glycopeptide antibiotics
Other brands: Dalvance