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 ABSSI or treatment with 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.