Product Details

Daptomycin for Injection

Daptomycin
500 mg/Vial
Powder for Solution for Injection
Vial Pack

DIN/PIN/NPN

02490838

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2020-11-30

Unit Price

162.3500

Amount MOH Pays

162.3500

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

08:12:28 Other Antibiotics

Therapeutic Note

NO

ATC Code

J01XX09

Interchangeable Products

DIN/ PIN/ NPN	Brand name	Unit Price	Amount MOH pays
02490838	Daptomycin for Injection	162.3500	162.3500
02490463	Daptomycin for Injection	162.3500	162.3500
02299909	Cubicin	NA	NA
02511738	Daptomycin for Injection	162.3500	162.3500

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Anti-Infectives	Daptomycin Brand(s): Cubicin RF and generic daptomycin (Refer to the formulary for funded list) Dosage Form/Strength: 500 mg/10 mL powder for injection Note that initial requests for Daptomycin may be accessed through the EAP’s Telephone Request Service for some of the below indications (see latter part of this document under TRS). For the treatment of patients experiencing the following types of infections due to methicillin-resistant Staphylococcus aureus (MRSA) bacteria: Staphylococcus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE); AND/OR Osteomyelitis; AND/OR Device-related osteoarticular or prosthetic joint infections; AND/OR Diabetic foot infections. Additionally, the patient must have failed to adequately respond to, be intolerant¹ to, or have a contraindication to vancomycin. ¹Intolerance due to Red Man Syndrome. If the physician asserts that the patient is intolerant to vancomycin due to red man’s syndrome, additional clinical details of the patient’s intolerance, including rate of infusion and the use of antihistamines and other histamine blockers prior to therapy with vancomycin. Duration of Approval: Up to 8 weeks Renewals will be considered on a case-by-case basis. (Physicians must submit adequate clinical information to justify the need for ongoing therapy with daptomycin.) Duration of Approval: Case-by-case Exclusion Criteria: Daptomycin is not funded for patients with MRSA-related pneumonia; Daptomycin is not funded for patients with skin/skin structure infections other than diabetic foot infections caused by MRSA. For the treatment of invasive infections¹ caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: VRE infection is confirmed by blood or tissue culture and sensitivity report Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance² to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication² to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). ¹Not approved for colonization (e.g., nares, skin, stool) ²Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin. EAP Drug Request Form: Standard Form for EAP Drug Requests
Anti-Infectives – Telephone Request Service (TRS) Drugs	Daptomycin Brand(s): Cubicin RF, daptomycin generics (refer to formulary for funded drugs) Dosage Form/Strength: 500 mg/10mL powder for injection For the treatment of patients with one or more of the following condition(s): Osteomyelitis caused by methicillin-resistant Staphylococcus aureus (MRSA) Device-related osteoarticular or prosthetic joint infections caused by methicillin resistant Staphylococcus aureus (MRSA); Diabetic foot infections caused by methicillin-resistant Staphylococcus aureus (MRSA); AND/OR Staphylococcus aureus bloodstream (SAB) infection including right-sided Staphylococcus aureus infective endocarditis (SARIE) infection caused by methicillin-resistant Staphylococcus aureus (MRSA) Additionally, the patient must have failed to adequately respond to, be intolerant* to, or have a contraindication to vancomycin. Requests involving red-man-syndrome with vancomycin must provide details of the intolerance including the rate of infusion and the use of antihistamines and other histamine blockers prior to therapy. Standard Approval Duration: Up to maximum of 56 days Exclusion Criteria: Daptomycin is not funded for patients with: MRSA-related pneumonia; skin/skin structure infections other than diabetic foot infections caused by MRSA. For the treatment of invasive infections¹* caused by vancomycin-resistant enterococcus (VRE) in patients who meet the following criteria: VRE infection is confirmed by blood or tissue culture and sensitivity report Patient is unable to use linezolid as a result of at least ONE of the following reasons: i) has developed resistance to linezolid as confirmed by the microbiology sensitivity report ii) has experienced intolerance² to linezolid (for example: severe gastric symptoms, myelosuppression, peripheral neuropathy requiring medical intervention, lactic acidosis) iii) has a contraindication² to linezolid OR Prescribed by an infectious disease expert for a patient who is able to use linezolid but where the bacteriostatic effect of linezolid may not be deemed to be clinically optimal due to other patient factors or comorbidities (e.g., immunocompromised, neutropenic). ¹Not approved for colonization (e.g., nares, skin, stool) ²Intolerances and contraindications to linezolid must be fully described in the EAP application. Recommended dose: 8 to 12 mg/kg daily for VRE with adjustments based on renal function Duration of approval: Note that the below are examples of durations for reimbursement of some common VRE infections. This is not an all-inclusive list. Urinary tract infections: up to 10 days Bacteremia: up to 14 days Endocarditis: up to 6 weeks Osteomyelitis: up to 8 weeks Requests for longer durations of funding will be considered case-by-case through external review and must be accompanied by a recent microbiology sensitivity report to confirm sensitivity to daptomycin.

Product Monograph