Xydalba

For the treatment of adults with methicillin resistant Staphylococcus aureus (MRSA) infection meeting all the following criteria;

1. Patient is 18 years of age or older; AND

2. Diagnosed with an acute bacterial skin and skin structure infection (ABSSSI) (e.g. cellulitis/erysipelas, major cutaneous abscess, wound infection) that is known (i.e. confirmed by culture and sensitivity test) or suspected to be caused by MRSA; AND

3. Treatment with standard orally administered antibiotics is inappropriate or inadequate; AND

4. Patient is deemed to be at high risk of nonadherence to a standard antibiotic treatment for MRSA ABSSSI or treatment with dalbavancin rather than a standard antibiotic treatment for MRSA ABSSSI will avoid the need for hospitalization OR will limit the need for prolonged hospitalization; AND

5. Patient’s ABSSSI is not caused by non-MRSA or methicillin-sensitive Staphylococcus aureus (MSSA); AND

6. Patient does not have ABSSSI associated with any of the following types of infections:
   • Known or suspected osteomyelitis or septic arthritis
   • Infections complicated by the presence of prosthetic materials that would not be removed such as permanent cardiac pacemaker battery packs, or those involving joint replacement prosthesis
   • Self-limited infections such as isolated folliculitis and isolated furuncles or other infections that have a high cure rate after surgical incision alone
   • Patients who have had more than 2 surgical interventions or are expected to need more than 2 surgical interventions (defined as surgery that cannot be performed at the bedside) for the ABSSSI
   • Skin and skin structure infection with arterial insufficiency, such as deep diabetic foot ulcers, decubitus ulcers, and ischemic ulcers
   • Necrotizing fasciitis, gas gangrene
   • Burns greater than 20% of total body surface

Approved dose: Up to 1500mg intravenously (IV), administered either as a single dose OR A two dose regimen of 1000mg IV followed one week later by 500mg IV.

Duration: One treatment course using a single dose or a two dose regimen.

Retreatment within 30 days from the initial dose may be considered on a case-by-case basis through the Exceptional Access Program (EAP).

Please submit the culture and sensitivity report and other relevant clinical details regarding the patient’s infection presentation including the dose, duration, and approximate date of treatment of all anti-infectives used to manage the infection.

Dalbavancin

• Brand(s): Xydalba
• Dosage Form/Strength: 500 mg vial for injection
• Effective date: May 31, 2024

Dalbavancin for the treatment of adults diagnosed with an acute bacterial skin and skin structure infection (ABSSSI) (e.g. cellulitis/erysipelas, major cutaneous abscess, wound infection) due to methicillin resistant staphylococcus aureus (MRSA) infection is funded as a Limited use benefit on the ODB formulary upon meeting specified funding criteria.

Retreatment within 30 days from the initial dose may be considered on a case-by-case basis through the Exceptional access program (EAP). Please submit the culture and sensitivity report and other relevant clinical details regarding the patient’s infection presentation including the dose, duration, and approximate date of treatment of all anti-infectives used to manage the infection.

Patients are not eligible if they have ABSSSI associated with any of the following types of infections:

• Known or suspected osteomyelitis or septic arthritis
• Infections complicated by the presence of prosthetic materials that would not be removed such as permanent cardiac pacemaker battery packs, or those involving joint replacement prosthesis
• Self-limited infections such as isolated folliculitis and isolated furuncles or other infections that have a high cure rate after surgical incision alone
• Patients who have had more than 2 surgical interventions or are expected to need more than 2 surgical interventions (defined as surgery that cannot be performed at the bedside) for the SSSI
• Skin and skin structure infection with arterial insufficiency, such as deep diabetic foot ulcers, decubitus ulcers, and ischemic ulcers
• Necrotizing fasciitis, gas gangrene
• Burns greater than 20% of total body surface

EAP funding criteria for Dalbavancin (Xydalba) if retreatment is required within 30 days of doses provided through the Limited use mechanism.

For the retreatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) meeting the following criteria:

1. Confirmed culture and sensitivity test showing that the patient continues to have one or more susceptible isolates of methicillin resistant staphylococcus aureus (MRSA) in spite of having had a treatment course of dalbavancin at least 2 weeks prior;
   AND
2. Patient is deemed to be at high risk of nonadherence to a standard antibiotic treatment for MRSA ABSSSI or treatment with standard antibiotic treatment for MRSA ABSSSI is not feasible.
   OR
   Treatment with dalbavancin rather than a standard antibiotic regimen for MRSA ABSSSI will avoid the need for hospitalization OR will limit the need for prolonged hospitalization;
   AND
3. Full or partial response and improvement is seen within the first 28 days from the initial dose;
   AND
4. Request is from an infectious disease specialist or has been requested in consultation with an infectious disease specialist (provide consult notes).

Requests that are not from an infectious disease specialist may be reviewed on a case-by-case basis.

Notes:

1. Submit the culture and sensitivity report and other relevant clinical details including the dose, duration, and approximate date of treatment of all anti-infectives used to manage the infection.

Approved additional dose for ABSSSI: Up to 1500 mg intravenously (IV), administered either as a single dose OR A two dose regimen of 1000 mg IV followed one week later by 500 mg IV.