Aclasta 5 mg/100 mg Solution for infusion

Indication

Treatment of osteoporosis in postmenopausal women and in men at high risk of fracture, Paget's disease of bone, and prevention of skeletal-related events in patients with bone metastases from solid tumors.

Dosage (summary)

5 mg administered as a single intravenous infusion over at least 15 minutes once a year for osteoporosis; for Paget's disease, a single dose of 5 mg may be sufficient.

Onset of Action / Duration

The onset of action for bone density increase may be observed within 3 months, with maximum effects typically seen after 1-2 years of treatment.

Special Populations

• Elderly patients
• Patients with renal impairment
• Patients with a history of hypocalcemia

Pregnancy & Breastfeeding

Use during pregnancy is not recommended. It is unknown if zoledronic acid is excreted in human milk; caution should be exercised when administering to nursing mothers.

Key Drug Interactions

• Other bisphosphonates
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Aminoglycosides
• Calcium supplements

Contraindications

• Hypersensitivity to zoledronic acid or any of its excipients
• Pregnancy
• Severe renal impairment (creatinine clearance < 35 mL/min)
• Hypocalcemia

Common side effects

• Flu-like symptoms
• Fever
• Headache
• Nausea
• Fatigue
• Hypocalcemia
• Renal impairment

Counselling Points

• Ensure adequate hydration before administration.
• Monitor renal function before each dose.
• Advise patients to report any signs of hypocalcemia (e.g., muscle spasms, tingling).
• Inform patients about potential flu-like symptoms post-infusion.