Product Details

Zoledronic Acid Injection

Zoledronic Acid
5 mg/100 mL
Solution for Injection
100-mL Pack (Preservative-Free)

DIN/PIN/NPN

02422433

Manufacturer

Dr. Reddy's Laboratories Inc.

Formulary Listing Date

2014-09-25  

Unit Price

356.0100

Amount MOH Pays

356.0100

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

M05BA08

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02422433 Zoledronic Acid Injection 356.0100 356.0100
02415100 Taro-Zoledronic Acid 356.0100 356.0100
02269198 Aclasta 833.7300 356.0100
 

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
Note: In all cases, patients receiving Aclasta should not be receiving concomitant bisphosphonate therapy. The recommended dose of Aclasta (zoledronic acid) is a single IV injection of 5mg, once yearly.
319 Indefinite

For the treatment of Paget's disease.

436 Indefinite

For the treatment of osteoporosis in postmenopausal females who meet the following criteria:

- High risk* for fracture; and

- For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g., esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.

*High fracture risk is defined as either:

- a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR

- a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR

- where a patient's 10-year fracture risk based on the CAROC or FRAX tool, is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture

Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.

523 Indefinite

For the treatment of osteoporosis in males who meet the following criteria:

- High risk* for fracture; and

- For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.

*High fracture risk is defined as either:

- a moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR

- a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR

- where the patient's 10-year fracture risk is below 10?sed on the CAROC or FRAX tool, a high fracture risk based on evaluation of clinical risk factors for fracture

Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.

 

EAP Criteria

NO

Product Monograph

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