Xydalba
Xydalba Uses, Dosage, Side Effects, Food Interaction and all others data.
Xydalba is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin . Modifications from these older glycoprotein classes facilitated a similar mechanism of action for dalbavancin but with increased activity and once-weekly dosing . Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, S. dysgalactiae, the S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin susceptible strains) . Xydalba acts by interfering with bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of nascent cell wall peptidoglycan and preventing cross-linking .
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 . An exposure-response analysis of a single study in patients with complicated skin and skin structure infections supports the two-dose regimen for which dalbavancin injection is administered .
Subsequently, the recommended dosage regimen of dalbavancin in patients with normal renal function is 1500 mg, administered either as a single dose, or 1000 mg followed one week later by 500 mg [FDA Label, F2356. Xydalba should be administered over 30 minutes by intravenous infusion .
| Trade Name | Xydalba |
| Availability | Prescription only |
| Generic | Dalbavancin |
| Dalbavancin Other Names | Dalbavancin, Dalbavancina |
| Related Drugs | ciprofloxacin, azithromycin, ceftriaxone, Augmentin, amoxicillin / clavulanate, cefdinir |
| Type | infusion |
| Protein binding | Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin . The plasma protein binding of dalbavancin is 93% and is not altered as a function of drug concentration, renal insufficiency, or hepatic insufficiency . |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | Correvio UK Ltd |
| Available Country | United Kingdom |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Xydalba is an antibacterial used to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible strains of Gram-positive bacteria.
Xydalba for injection is indicated for the 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, Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains) .
Xydalba is not active against gram-negative bacteria; therefore, combination therapy may be clinically indicated if the ABSSSI is polymicrobial and includes a suspected or documented gram-negative pathogen .
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin and other antibacterial drugs, dalbavancin should be used only to treat 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 .
Xydalba is also used to associated treatment for these conditions: Bacterial Infections, Skin and Subcutaneous Tissue Bacterial Infections
How Xydalba works
Xydalba has a spectrum and mechanism of action similar to vancomycin, a naturally formed glycopeptide antimicrobial . The bactericidal action of dalbavancin results primarily from inhibition of cell-wall biosynthesis . Specifically, dalbavancin prevents incorporation of N-acetylmuramic acid (NAM)- and N-acetylglucosamine (NAG)-peptide subunits from being incorporated into the peptidoglycan matrix; which forms the major structural component of Gram-positive cell walls . The large hydrophilic molecule is able to form hydrogen bond interactions with the terminal D-alanyl-D-alanine moieties of the NAM/NAG-peptides, which is normally a five-point interaction . Binding of dalbavancin to the D-Ala-D-Ala prevents the incorporation of the NAM/NAG-peptide subunits into the peptidoglycan matrix . In addition, dalbavancin alters bacterial-cell-membrane permeability and RNA synthesis.
Toxicity
Treatment with antibacterial agents can alter the normal flora of the colon leading to growth of C. difficile and commonly occurs in the development of C. difficile-associated diarrhea . Other common side effects include nausea, vomiting, diarrhea, headache, rash, and pruritis . Side effects that occurred in less than 2% of patients during clinical trials include blood and lymphatic system disorders, gastrointestinal disorders, hepatotoxicity, anaphylactoid reactions, hepatic enzyme elevation, hypoglycaemia, dizziness, bronchospasm, urticaria, and vascular disorders . There have been no adequate or well-controlled studies to conclude that use of dalbavancin is safe during pregnancy or breastfeeding .
Food Interaction
No interactions found.Xydalba Disease Interaction
Volume of Distribution
Clearance and volume of distribution at steady state are comparable between healthy subjects and patients with infections . The volume of distribution at steady state was similar to the volume of extracellular fluid .
Elimination Route
In healthy subjects, dalbavancin AUC0-24h and Cmax both increased proportionally to dose following single intravenous (IV) dalbavancin doses ranging from 140 mg to 1500 mg, indicating linear pharmacokinetics .
No apparent accumulation of dalbavancin was observed following multiple IV infusions administered once weekly for up to eight weeks, with 1000 mg on Day 1 followed by up to seven weekly 500 mg doses, in healthy adults with normal renal function .
Half Life
Terminal half life is 346 hours .
Clearance
0.0513 L/h .
Elimination Route
Following administration of a single 1000 mg dose in healthy subjects, 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. Approximately 20% of the administered dose was excreted in feces through 70 days post-dose .
Innovators Monograph
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