Product Details

Zoledronic Acid for Inj. Concentrate

Zoledronic Acid
4 mg/5 mL
Solution for Injection
5-mL Pack (Preservative-Free)

DIN/PIN/NPN

02422425

Manufacturer

Dr. Reddy's Laboratories Inc.

Formulary Listing Date

2014-09-25  

Unit Price

415.5600

Amount MOH Pays

415.5600

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

M05BA08

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02248296 Zometa Concentrate NA NA
02401606 Zoledronic Acid-Z 415.5600 415.5600
02472805 Zoledronic Acid for Injection 415.5600 415.5600
02444739 Zoledronic Acid for Injection 415.5600 415.5600
02434458 Zoledronic Acid for Injection 415.5600 415.5600
02407639 Zoledronic Acid for Injection 415.5600 415.5600
02422425 Zoledronic Acid for Inj. Concentrate 415.5600 415.5600
02413701 Zoledronic Acid for Inj. Concentrate 415.0000 415.0000
02415186 Taro-Zoledronic Acid Concentrate 415.5600 415.5600
02482525 Jamp-Zoledronic Acid 415.5600 415.5600
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology – Supportive Management

Zoledronic Acid

  • Brand(s): Zometa Concentrate
  • Dosage Form/Strength: 4 mg/ 5 mL Vial

Zoledronic acid as Zometa Concentrate will only be considered for the treatment of bony metastases in those with hormone refractory prostate cancer as well as other cancers through the Exceptional Access Program (EAP) in those receiving outpatient care who do not meet the criteria of Cancer Care Ontario (CCO).

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

Duration of Approval: 6 Months

For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease1, despite castrate serum testosterone levels (less than 50 ng/dL).

1Progressive bony disease should be demonstrated by:
• progressive changes in radionucleotide bone scan OR
• clinical signs of disease progression (e.g., via radionucleotide scanning, pathologic fracture or increasing bone pain).

Requests for patients who have undergone orchidectomy do not need to provide a serum testosterone level.

For the prevention of skeletal related events in patients who have not experienced previous skeletal related events2 and who have bony metastases secondary to:

  • solid tumours (e.g., renal, small cell lung, pancreatic cancers) who have good performance status3 OR

  • breast cancer or multiple myeloma who are intolerant to pamidronate.

2A skeletal related event is defined as pathologic fracture, spinal cord compression, radiation therapy to bone or surgery to bone.

3Good performance status is defined as patients that are ambulatory, capable of self-care and up and about more than 50 per cent of waking hours.

For the treatment of patients with symptoms due to bony metastases secondary to breast cancer or multiple myeloma who have failed or are intolerant to pamidronate.

  • Consideration for patients who are symptomatic due to bony metastases secondary to other types of solid tumours or cancers will be considered on a case-by-case basis. The physician is asked to include information describing the patient’s bone pain and use of other therapies including the use of bisphosphonates. The use of other non-pharmacologic treatment modalities such as surgery or radiation that have been tried should be provided in the request.

Duration of Approval: 6 Months

Renewals will be considered for patients who are responding to therapy and are still deemed to require treatment.

Duration of Approval: 6 Months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph