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XYDALBA is a brand name for Dalbavancin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XYDALBA (dalbavancin for injection) is indicated for: • treatment of adults and pediatric patients aged 3 months and older with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The safety and efficacy of XYDALBA when administered for more than 1500 mg have not been established. • In ABSSSI, the types of infections treated were cellulitis/erysipelas, major cutaneous abscesses, and wound infections.
Other types of skin infections have not been studied. • 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.
• See Recommended Dose and Dosage Adjustment for Renal Impairment. • See Recommended Dose and Dosage Adjustment for Hepatic Impairment. 2 Recommended Dose and Dosage Adjustment Recommended Dose Adults The recommended dosage regimen for XYDALBA in adult patients with ABSSSI is 1500 mg, administered either as a single dose or 1000 mg followed one week later by 500 mg.
XYDALBA should be administered over 30 minutes by intravenous infusion. Pediatrics (≥ 6 years of age to < 18 years of age) The recommended dosage regimen for XYDALBA in children (≥ 6 years of age) and adolescent patients with ABSSSI is a single dose of 18 mg / kg of body weight (maximum of 1500 mg).
XYDALBA should be administered over 30 minutes by intravenous infusion. 5 mg / kg of body weight (maximum of 1500 mg). XYDALBA should be administered over 30 minutes by intravenous infusion. Pediatrics (< 3 months of age) Health Canada has not authorized an indication for pediatric use in patients less than 3 months of age.
Dosage Adjustment Renal Impairment in Adults Dose adjustments are not required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 to 79 mL/min). Dose adjustments are not required for patients receiving regularly scheduled hemodialysis (3 times/week), and XYDALBA may be administered without regard to the timing of hemodialysis.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). Table 1 – Dosage of XYDALBA in Patients with Renal Impairment Estimated CrCl1 XYDALBA Single Dose Regimen2 XYDALBA Two-Dose Regimen2 > 30 mL/min or on regular hemodialysis 1500 mg 1000 mg followed one week later by 500 mg < 30 mL/min and not on regular hemodialysis 1000 mg 750 mg followed one week later by 375 mg 1 As calculated using the Cockcroft-Gault formula.
). Hepatic/Biliary/Pancreatic No dose adjustment of XYDALBA is recommended for adult patients with mild hepatic impairment (Child-Pugh Class A). 2 Recommended Dose and Dosage Adjustment). In Phase 2 and 3 clinical trials in adults, more XYDALBA 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 XYDALBA and comparator arms (see 8 ADVERSE REACTIONS). 2 Recommended Dose and Dosage Adjustment). XYDALBA (dalbavancin) Product Monograph Page 11 of 46 Immune Hypersensitivity Reactions Serious hypersensitivity (anaphylactic/anaphylactoid) and skin reactions have been reported in patients treated with XYDALBA.
If an allergic reaction occurs, treatment with XYDALBA should be discontinued and appropriate therapy for the allergic reaction should be instituted. Before using XYDALBA, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy (see 8 ADVERSE REACTIONS).
Renal Information on the efficacy and safety of XYDALBA in patients with creatinine clearance < 30 mL/min is limited. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
Reproductive Health:
Female and Male Potential Fertility Studies in animals have shown reduced fertility (see 16 NON-CLINICAL TOXICOLOGY). The potential risk for humans is unknown. Sensitivity/Resistance Development of Drug Resistant Bacteria Prescribing XYDALBA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). Table 1 – Dosage of XYDALBA in Patients with Renal Impairment Estimated CrCl1 XYDALBA Single Dose Regimen2 XYDALBA Two-Dose Regimen2 > 30 mL/min or on regular hemodialysis 1500 mg 1000 mg followed one week later by 500 mg < 30 mL/min and not on regular hemodialysis 1000 mg 750 mg followed one week later by 375 mg 1 As calculated using the Cockcroft-Gault formula.
2 Administer by intravenous infusion over 30 minutes. Renal Impairment in Pediatrics Dose adjustments are not required for pediatric patients with mild or moderate renal impairment (creatinine clearance 30 to 79 mL/min). 73m2 as no observed pharmacokinetic data is available.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). XYDALBA (dalbavancin) Product Monograph Page 7 of 46 Hepatic Impairment in Adults No dose adjustment of XYDALBA is recommended for patients with mild hepatic impairment (Child-Pugh Class A).
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). 3 Administration Intravenous Use After reconstitution and dilution, XYDALBA is to be administered via intravenous infusion, using a total infusion time of 30 minutes.
Do not co-infuse XYDALBA with other medications or electrolytes. Sodium chloride containing solutions may cause precipitation and should not be used. The compatibility of reconstituted XYDALBA with intravenous medications, additives, or substances other than 5% Dextrose Injection, has not been established.
If a common intravenous line is being used to administer other drugs in addition to XYDALBA, the line should be flushed before and after each XYDALBA infusion with 5% Dextrose Injection. 4 Reconstitution XYDALBA (dalbavancin for injection) must be reconstituted with either Sterile Water for Injection, or 5% Dextrose Injection, and subsequently diluted only with 5% Dextrose Injection, to a final concentration of 1 mg/mL to 5 mg/mL.
XYDALBA (dalbavancin for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin and telavancin.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Administer by intravenous infusion over 30 minutes. Renal Impairment in Pediatrics Dose adjustments are not required for pediatric patients with mild or moderate renal impairment (creatinine clearance 30 to 79 mL/min). 73m2 as no observed pharmacokinetic data is available.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). XYDALBA (dalbavancin) Product Monograph Page 7 of 46 Hepatic Impairment in Adults No dose adjustment of XYDALBA is recommended for patients with mild hepatic impairment (Child-Pugh Class A).
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). 3 Administration Intravenous Use After reconstitution and dilution, XYDALBA is to be administered via intravenous infusion, using a total infusion time of 30 minutes.
Do not co-infuse XYDALBA with other medications or electrolytes. Sodium chloride containing solutions may cause precipitation and should not be used. The compatibility of reconstituted XYDALBA with intravenous medications, additives, or substances other than 5% Dextrose Injection, has not been established.
If a common intravenous line is being used to administer other drugs in addition to XYDALBA, the line should be flushed before and after each XYDALBA infusion with 5% Dextrose Injection. 4 Reconstitution XYDALBA (dalbavancin for injection) must be reconstituted with either Sterile Water for Injection, or 5% Dextrose Injection, and subsequently diluted only with 5% Dextrose Injection, to a final concentration of 1 mg/mL to 5 mg/mL.
Reconstitution:
XYDALBA must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, or 5% Dextrose Injection, for each 500 mg vial (Table 2). 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. XYDALBA (dalbavancin) Product Monograph Page 8 of 46 Table 2 – Reconstitution Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Nominal Concentration per mL 48 mL 25 mL 25 mL 20 […]
Potential for Microbial Overgrowth The use of any antibiotics, including XYDALBA, may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken. 1 Pregnant Women There are no data from the use of XYDALBA in pregnant women.
Studies in animals have shown reproductive toxicity (see below and 16 NON-CLINICAL TOXICOLOGY). XYDALBA should not be used during pregnancy unless the benefit to the mother clearly outweighs the risk to the fetus. No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin.
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 below and 16 NON-CLINICAL TOXICOLOGY).
7 times the human dose on an exposure basis, respectively). 5 times the human dose on an exposure basis). 5 times the human dose on an exposure basis) (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding It is not known whether XYDALBA or its metabolites are excreted in human milk.
However, dalbavancin is excreted in the milk of lactating rats and may be excreted in human breast milk. Therefore, caution should be exercised when XYDALBA is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XYDALBA and any potential adverse effects on the breastfed child from XYDALBA or from the underlying maternal condition.
3 Pediatrics Pediatrics (< 3 months of age): Based on data submitted and reviewed by Health Canada, the safety and efficacy of XYDALBA in pediatric patients less than 3 months of age has not been established; therefore, Health Canada has not authorized an indication for pediatric use in patients less than 3 months of age.
3%) were 65 years of age or older. The efficacy and tolerability of XYDALBA were similar to comparator regardless of age. The pharmacokinetics of XYDALBA was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.
XYDALBA 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 […]
Reconstitution:
XYDALBA must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, or 5% Dextrose Injection, for each 500 mg vial (Table 2). 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. XYDALBA (dalbavancin) Product Monograph Page 8 of 46 Table 2 – Reconstitution Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Nominal Concentration per mL 48 mL 25 mL 25 mL 20 mg/mL dalbavancin Reconstituted vials may be stored either refrigerated at 2 to 8°C, or at controlled room temperature of 20 to 25°C.
Do not freeze.
Dilution:
Aseptically transfer the required dose of reconstituted dalbavancin solution from the vial(s) to an intravenous bag or bottle containing 5% Dextrose Injection. 2 Recommended Dose and Dosage Adjustment). The diluted solution must have a final dalbavancin concentration of 1 mg/mL to 5 mg/mL.
Discard any unused portion of the reconstituted solution. Once diluted into an intravenous bag or bottle as described above, XYDALBA may be stored either refrigerated at 2 to 8°C or at a controlled room temperature of 20 to 25°C. Do not freeze.
The total time from reconstitution to dilution to administration should not exceed 48 hours. Like all parenteral drug products, diluted XYDALBA should be inspected visually for particulate matter prior to infusion. If particulate matter is identified, do not use.
5 OVERDOSAGE Specific information is not available on the treatment of overdose with XYDALBA, 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 4500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
Treatment of overdose with XYDALBA should consist of observation and general supportive measures. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). For management of a suspected drug overdose, contact your regional poison control centre.
XYDALBA (dalbavancin) Product Monograph Page 9 of 46 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3 – Dosage Forms, Strengths, Composition and Packaging XYDALBA is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off- white to pale yellow powder containing dalbavancin hydrochloride (equivalent to 500 mg of dalbavancin as the free base).
One box contains one single-use 48 mL type I glass vial with an elastomeric […]