Limited Use Note(s)

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ZOLEDRONIC ACID5mg/100mL Inj Sol-100mL Pk (Preservative-Free)
Reason For Use CodeClinical Criteria
319For the treatment of Paget's disease.
LU Authorization Period: Indefinite.
436For 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.
LU Authorization Period: Indefinite.
523For 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% based 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.
LU Authorization Period: Indefinite.
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.