Adronic 4 mg/5 ml (IV Infusion)

Indications

• Hypercalcaemia of malignancy
• Bone metastases associated with solid tumors
• Osteolytic lesions associated with multiple myeloma
• Corticosteroid-induced osteoporosis
• Increase bone mass in men with osteoporosis
• Osteoporosis in postmenopausal women
• Paget's disease of bone
• Prophylaxis of postmenopausal osteoporosis

Pharmacology

• Belongs to the class of nitrogen-containing bisphosphonates
• Inhibitor of osteoclast-mediated bone resorption
• Rapidly distributed to bone
• Main molecular target is the enzyme farnesyl pyrophosphate synthase
• Anti-tumour activity
• Anti-angiogenic activity
• Anti-pain activity
• Cytostatic and pro-apoptotic activity on tumour cells
• No accumulation in plasma after multiple doses
• Not metabolized, excreted unchanged via the kidney

Dosage

• Maximum recommended dose for hypercalcemia of malignancy is 4 mg
• Retreatment may be considered if serum calcium does not return to normal
• Recommended dose for multiple myeloma and bone metastases is 4 mg every 3-4 weeks
• Patients should be administered an oral calcium supplement and Vitamin-D daily

Administration

• Must be further diluted with calcium-free infusion solution
• Duration of infusion must not be less than 15 minutes
• Infusion solution should be used as soon as possible
• Must not be mixed with calcium or other divalent cation-containing infusion solutions
• Refrigerated solution must be allowed to reach room temperature before administration

Interaction

• Administered concomitantly with commonly used anticancer agents, diuretics, antibiotics, and analgesics without interactions
• Caution with aminoglycosides, thalidomide, and loop diuretics
• Caution with other potentially nephrotoxic drugs

Contraindications

• Hypersensitivity to the active substance or any of the excipients or to any bisphosphonates
• Severe renal impairment
• Pregnancy and lactation

Side Effects

• Headache
• Nausea
• Anorexia
• Fatigue
• Osteonecrosis of jaw
• Anemia
• Bone pain
• Constipation
• Fever
• Vomiting
• Flu-like syndrome
• Hypocalcemia
• Myalgia
• Arthralgia
• Hypophosphataemia

Pregnancy & Lactation

• Contraindicated during pregnancy and in breastfeeding women
• Not recommended for use in children and adolescents below 18 years of age

Precautions & Warnings

• Patients must be appropriately hydrated prior to administration
• Serum levels of calcium, phosphate, magnesium, potassium, and creatinine should be carefully monitored
• Renal function monitoring should be considered

Use in Special Populations

• Not recommended in patients with severe renal impairment
• Dose adjustment based on creatinine clearance

Overdose Effects

• May cause hypocalcemia, hypophosphatemia, and hypomagnesemia
• Corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate

Therapeutic Class

• Bisphosphonate preparations

Reconstitution

• Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%

Storage Conditions

• Store below 30°C prior to opening
• Protect from moisture and light
• Must be kept out of the reach and sight of children

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