Description
Benzol (Zoledronic acid for injection) is a single use vial containing lyophilized drug concentrate.
Benzol Lyophilized Injection
Generic Name– Zoledronic acid
Drug Class – Bisphosphonates
Zoledronic acid is a parenteral bisphosphonates, used for treatment of skeletal-related events in patients with bone metastases associated with multiple myeloma or solid tumors. It is the first and only bisphosphonate to demonstrate efficacy in patients with a broad range of tumor types and in multiple myeloma. It acts by inhibiting osteoclast activity and reducing bone resorption and turnover.
Dosage and Administration
- Recommended dose in multiple myeloma and bone metastasis from solid tumors: 4 mg as a single-use intravenous infusion over no less than 15 minutes every 3-4 weeks for patients with creatinine clearance of greater than 60 mL/min
- Recommended dose in hypercalcemia of malignancy: 4 mg as a single-use intravenous infusion over no less than 15 minutes and 4 mg as retreatment after a minimum of 7 days
Dosage Form and Strength
- Supplied as a single-use vial of concentrate for intravenous infusion
- Available as 4mg for injection
Indications & Usage
Zoledronic acid is indicated for treatment of:
- Bone metastases from solid tumors, in conjunction with standard antineoplastic therapy
- Hypercalcemia of malignancy
- Multiple myeloma
Limitations of use:
- Zoledronic acid efficacy and safety has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia
Clinical Efficacy
- Effective and well tolerable in management of advanced cancer patients with bone metastases
- Shows sustained efficacy for up to 15 months in patients with bone metastases secondary to other solid tumors (e.g. lung, prostate)
- Significantly reduces the overall risk of developing skeletal complications, including hypercalcaemia of malignancy as compared to pamidronic acid
- Shows significant reduction in pain and skeletal related events with a marginal survival benefit in patients with multiple myleoma
Safety Information
Adverse reactions
- The most common adverse events associated with use of zoledronic acid are nausea, vomiting, constipation, fever, fatigue, anemia, bone pain, anorexia, decreased weight, myalgia, arthralgia, back pain, malignant neoplasm aggravated, headache, dizziness, insomnia, paresthesia, dyspnea, cough, and abdominal pain
Contraindications
- It is contraindicated in patients with a known hypersensitivity to zoledronic acid
Special Precautions
- Patients with hypercalcemia of malignancy should be adequately rehydrated prior to administration of zoledronic acid and their electrolytes level should be monitored during treatment
- Treatment with zoledronic acid is not recommended in patients with severe renal impairment and reduced dose should be used in renal impairment patients
- Serum creatinine levels should be monitored closely prior administration of each dose of zoledronic acid
- Oral calcium and Vitamin D supplements should be administered daily to reduce hypocalcaemia before starting zoledronic acid
- Preventive dental examination should be performed before starting zoledronic acid and invasive dental procedures should be avoided
- Discontinue use of zoledronic acid, if severe incapacitating bone, joint, and/or muscle pain occur
- Women of childbearing potential should avoid becoming pregnant as zoledronic acid can cause fetal harm
- Use of zoledronic acid is not recommended in aspirin-sensitive patients as it may cause bronchoconstriction in these patients
- Patients with thigh or groin pain should be monitored for the risk of femoral fractures and drug should be discontinued if atypical femur fracture is suspected
