Product Details
Aclasta
Zoledronic Acid5 mg/100 mL
Solution for Injection
100-mL Pack (Preservative-Free)
DIN/PIN/NPN
02269198
Manufacturer
Sandoz Canada Inc.
Formulary Listing Date
2006-10-23
Unit Price
833.7300
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. |