What is the indication and usage of Reclast (zoledronic acid)?

Indications and Usage of Reclast (Zoledronic Acid)

Zoledronic acid (Reclast) is indicated for the treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases from solid tumors (with prostate cancer having progressed after at least one hormonal therapy), as well as for osteoporosis treatment administered as a once-yearly infusion. 1

FDA-Approved Indications

• Hypercalcemia of malignancy: Defined as albumin-corrected calcium ≥12 mg/dL [3.0 mmol/L] 1
• Multiple myeloma: In conjunction with standard antineoplastic therapy 1
• Bone metastases from solid tumors: In conjunction with standard antineoplastic therapy, with prostate cancer having progressed after at least one hormonal therapy 1
• Osteoporosis: Administered as a 5 mg intravenous infusion once yearly 2, 3

Dosing and Administration

For Cancer-Related Indications:

• Dose: 4 mg as a single-use intravenous infusion 1
• Administration time: Over no less than 15 minutes 1
• Frequency:
  • For hypercalcemia of malignancy: Single dose with retreatment after a minimum of 7 days 1
  • For multiple myeloma and bone metastases: Every 3-4 weeks 1

For Osteoporosis:

• Dose: 5 mg via intravenous infusion 4, 3
• Frequency: Once yearly 4, 2
• Preparation: Requires adequate hydration before administration 4

Clinical Efficacy

In Cancer Patients:

• Zoledronic acid significantly reduces the incidence of skeletal-related events (SREs) in patients with bone metastases from various solid tumors 5
• In patients with NSCLC and bone metastases, zoledronic acid significantly reduced the incidence of SREs compared to placebo (p=0.039) 5
• For prostate cancer patients with bone metastases, zoledronic acid improved the SRE-free interval (HR 0.78; 95% CI 0.65-0.95; p=0.01) 5

In Osteoporosis:

• Increases bone mineral density in the lumbar spine and femoral neck by 6.7% and 5.1% respectively 3
• Reduces the incidence of new vertebral and hip fractures by 70% and 41% respectively in postmenopausal women 3

Monitoring Requirements

• Renal function: Monitor serum creatinine before each dose 6, 1
• Electrolytes: Regular monitoring of serum calcium, phosphate, magnesium, and hematocrit/hemoglobin 6
• Dental health: Preventive dental exams should be performed before starting therapy 4, 1

Important Precautions

• Renal toxicity: Risk may be greater in patients with renal impairment; do not use doses greater than 4 mg in these patients 1
• Osteonecrosis of jaw (ONJ): Preventive dental exams recommended before starting treatment 4, 1
• Hypocalcemia: Correct before initiating zoledronic acid; supplement patients with calcium (500 mg) and vitamin D (400 IU) daily 4, 1
• Pregnancy: Can cause fetal harm; advise females of reproductive potential of potential risk 1

Common Adverse Effects

• Post-dose fever, flu-like symptoms, myalgia, arthralgia, and headache (usually occur in first 3 days after infusion and are self-limited) 4, 3
• Nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea (occurring in >25% of patients) 1

Contraindications

• Hypersensitivity to zoledronic acid or its components 1
• Hypocalcemia 4
• Creatinine clearance <30-35 mL/min 4
• Pregnancy and lactation 4

Zoledronic acid has established itself as an effective treatment for both cancer-related bone complications and osteoporosis, with a convenient administration schedule that may improve compliance compared to other bisphosphonates 7, 8.