Xoleron 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

• Belongs to nitrogen-containing bisphosphonates
• Inhibitor of osteoclast-mediated bone resorption
• High affinity for mineralized bone
• Rapidly distributed to bone
• Inhibitory activity against bone resorption
• Anti-tumour activity
• Anti-angiogenic activity
• Anti-pain activity
• Cytostatic and pro-apoptotic activity on tumour cells
• Synergistic cytostatic effect with other anti-cancer drugs
• Not metabolized and excreted unchanged via the kidney

Dosage

• Maximum recommended dose for hypercalcemia of malignancy is 4 mg
• 4 mg dose must be given as a single-dose intravenous infusion
• Recommended dose in multiple myeloma and metastatic bone lesions from solid tumors is 4 mg every 3-4 weeks
• Patients should also be administered an oral calcium supplement and Vitamin-D daily

Administration

• Required amount of concentrate must be diluted with 100 ml of calcium-free infusion solution
• Duration of infusion must not be less than 15 minutes
• Infusion solution should 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
• Risk of renal dysfunction may be increased when used in combination with thalidomide
• Concomitant use of loop diuretics increases the risk of hypocalcemia
• Caution indicated when used with other potentially nephrotoxic drugs

Contraindications

• Hypersensitivity to the active substance or 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 drinking two glasses of fluid before and after the infusion
• Serum levels of calcium, phosphate, magnesium and potassium, as well as serum creatinine should be carefully monitored
• Short-term supplemental therapy may be necessary if hypocalcemia, hypophosphatemia, or hypomagnesemia occurs
• Careful renal function monitoring should be considered

Special populations

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

Overdose effects

• May cause hypocalcemia, hypophosphatemia, and hypomagnesemia
• Reduction in serum levels should be corrected by intravenous administration of appropriate substances

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

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