Zoltero 5 mg/100 ml (IV Infusion)

Indications

• Treatment and prevention of postmenopausal osteoporosis
• Treatment to increase bone mass in men with osteoporosis
• Treatment and prevention of glucocorticoid-induced osteoporosis
• Treatment of Paget’s disease of bone in men and women

Pharmacology

• Acts primarily on bone
• Inhibitor of osteoclast-mediated bone resorption
• High affinity for mineralized bone
• Rapidly partitions to bone
• Localizes preferentially at sites of high bone turnover
• Molecular target is the enzyme farnesyl pyrophosphate synthase
• Relatively long duration of action

Dosage

• Recommended 5 mg infusion once a year for treatment of osteoporosis in postmenopausal women
• Recommended 5 mg infusion once every 2 years for prevention of osteoporosis in postmenopausal women
• Recommended 5 mg infusion once a year for osteoporosis in men
• Recommended 5 mg infusion once a year for treatment and prevention of glucocorticoid-induced osteoporosis
• Recommended dose of 5 mg infusion for Paget’s Disease of Bone
• Re-treatment may be considered in certain cases
• Calcium and Vitamin D Supplementation instructions

Administration

• Must be administered as an intravenous infusion over no less than 15 minutes
• Patients must be appropriately hydrated prior to administration
• Inspect visually for particulate matter and discoloration
• Followed by a 10 mL normal saline flush
• Method of administration details provided
• Stability after opening

Interaction

• Aminoglycosides may lower serum calcium
• Loop diuretics may increase risk of hypocalcemia
• Nephrotoxic drugs should be used with caution
• Exposure may be increased with renal impairment

Contraindications

• Hypocalcemia
• Creatinine clearance less than 35 mL/min
• Evidence of acute renal impairment
• Hypersensitivity to any component

Side Effects

• Pyrexia
• Myalgia
• Headache
• Arthralgia
• Pain in extremity
• Flu-like illness
• Nausea
• Vomiting
• Diarrhea
• Eye inflammation

Pregnancy & Lactation

• Can cause fetal harm
• Not to be given to nursing women

Precautions & Warnings

• Hypocalcemia may worsen during treatment
• Renal Impairment precautions
• Osteonecrosis of the Jaw (ONJ) has been reported
• Atypical Femur Fractures reported
• Severe Bone, Joint, and Muscle Pain may occur

Use in Special Populations

• Not indicated for use in pediatric patients
• Special care to monitor renal function in geriatric use
• No dosage adjustment in patients with creatinine clearance of greater than or equal to 35 mL/min
• No clinical data available for use in patients with hepatic impairment

Overdose Effects

• Careful monitoring of patients
• May cause clinically significant renal impairment
• Hypocalcemia
• Hypophosphatemia
• Hypomagnesemia
• Corrective measures for reductions in serum levels of calcium, phosphorus, and magnesium
• Single doses should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes

Therapeutic Class

• Bisphosphonate preparations

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

• Aclasta 5 mg/100 ml (IV Infusion) - sandoz-a-novartis-division
• Zolenic 5 mg/100 ml (IV Infusion) - incepta-pharmaceuticals-ltd
• Zoledron 5 mg/100 ml (IV Infusion) - opsonin-pharma-ltd