Drometa 4 mg/5 ml (IV Infusion)

Indications

• Hypercalcaemia of malignancy
• Bone metastases associated with solid tumours
• 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

Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone.

Dosage

• Hypercalcemia of malignancy: The maximum recommended dose of Zoledronic Acid in hypercalcemia of malignancy (serum calcium 12 mg/dl or 3.0 mmol/l) is 4 mg.
• Multiple myeloma and bone metastases of solid tumors: The recommended dose of Zoledronic Acid in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused every 3-4 weeks.

Administration

Prior to administration, the required amount of concentrate from one vial must be further diluted with 100 ml of calcium-free infusion solution. The duration of infusion must not be less than 15 minutes.

Interaction

• Drometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without interactions.
• Caution is advised when Drometa are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods.

Contraindications

The drug is contraindicated if patients have hypersensitivity to the active substance or to 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

Zoledronic acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.

Precautions & Warnings

Patients must be appropriately hydrated prior to administration of Drometa. Serum levels of calcium, phosphate, magnesium and potassium, as well as serum creatinine should be carefully monitored after initiating Drometa therapy.

Use in Special Populations

• Patients with renal impairment: No dose adjustment is necessary in patients with creatinine clearance >60 ml/min. Based on creatinine clearance the following dose should be used in patient with impaired renal function.

Overdose Effects

Over dosage may cause hypocalcemia, hypophosphatemia, and hypomagnesemia. In such case, reduction in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate and magnesium sulfate respectively.

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. Drometa must be kept out of the reach and sight of children.

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