Product Details

Xgeva

Denosumab
120 mg/1.7 mL
Solution for Subcutaneous Injection
Single-Use 120-mg Vial (Preservative-Free)

DIN/PIN/NPN

02368153

Manufacturer

Amgen Canada Inc.

Formulary Listing Date

2023-05-31  

Unit Price

681.1600

Amount MOH Pays

681.1600

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

M05BX04

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology – Supportive Management

Denosumab

  • Brand(s): Xgeva
  • Dosage Form/Strength: 120 mg per vial for subcutaneous injection

For the treatment of bony metastases in patients with hormone refractory prostate cancer.

Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic.

Hormone refractory prostate cancer is determined using the following criteria:

  • Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2.

1Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain.

2Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission.

Approved Dosing: 120 mg subcutaneously every four (4) weeks

Duration of Approval: 1 Year

Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment.

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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