Zoletrust 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
• Acts primarily on bone
• Inhibitor of osteoclast-mediated bone resorption
• High affinity for mineralized bone
• Rapidly distributed to bone when intravenously administered
• Main molecular target in osteoclast is the enzyme farnesyl pyrophosphate synthase
• Possesses anti-tumour activity, anti-angiogenic activity, and anti-pain activity
• Not metabolized and excreted unchanged via the kidney

Dosage

• Maximum recommended dose for hypercalcemia of malignancy is 4 mg
• Recommended dose in patients with multiple myeloma and metastatic bone lesions is 4 mg every 3-4 weeks

Administration

• Required amount of concentrate from one vial must be diluted with 100 ml of calcium-free infusion solution
• Duration of infusion must not be less than 15 minutes
• Infusion solution must be used as soon as possible after addition
• Must not be mixed with calcium or other divalent cation-containing infusion solutions

Interaction

• Administered concomitantly with commonly used anticancer agents, diuretics, antibiotics, and analgesics without interactions
• Caution advised when administered with aminoglycosides or loop diuretics
• Risk of renal dysfunction may be increased when used in combination with thalidomide

Contraindications

• Hypersensitivity to the active substance or to any bisphosphonates
• Severe renal impairment (Creatinine clearance <30 ml/min)
• 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 breast-feeding women
• Not recommended for use in children and adolescents below 18 years of age

Precautions & Warnings

• Patients must be appropriately hydrated prior to administration
• Adequate hydration can be achieved by the patient drinking two glasses of fluid before and after the infusion
• Serum levels of calcium, phosphate, magnesium, potassium, and creatinine should be carefully monitored
• Careful renal function monitoring should be considered
• Use cautiously in the elderly and in patients receiving diuretic therapy

Use in Special Populations

• Not recommended in patients with severe renal impairment (Creatinine clearance <30 ml/min)
• No dose adjustment is necessary in patients with creatinine clearance >60 ml/min

Overdose Effects

• May cause hypocalcemia, hypophosphatemia, and hypomagnesemia

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
• Keep out of the reach and sight of children

Related Brands

• Adronic 4 mg/5 ml (IV Infusion) - aristopharma-ltd