Zoledronic Acid(zoh leh droh’ nik)
Reclast, Zometa
PREGNANCY CATEGORY D
Drug Classes
Bisphosphonate
Calcium regulator
Therapeutic Actions
A bisphosphonic acid that inhibits bone resorption, possibly by inhibiting osteoclast activity and promoting osteoclast cell apoptosis; this action leads to a decrease in the release of calcium from bone and a decrease in serum calcium.
Indications
IV treatment of the hypercalcemia of malignancy (Zometa)
Treatment of Paget disease of bone in men and women (Reclast)
Treatment of postmenopausal osteoporosis and osteoporosis in men (Reclast)
Prevention of new clinical fractures in patients with low-trauma hip fractures (Reclast)
Treatment of patients with multiple myelomas and patients with documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy (Zometa)
Treatment and prevention of glucocorticoid-induced osteoporosis (Reclast)
Prevention of osteoporosis in postmenopausal women (Reclast)
Unlabeled uses: Osteopenia in androgen-deprived prostate cancer patients or estrogen-deprived breast cancer patients; prevention of postrenal transplant bone loss
Contraindications and Cautions
Contraindicated with allergy to any components of the drug or to bisphosphonates; severe renal impairment, hypocalcemia, severe renal impairment.
Use cautiously with renal impairment (do not exceed single doses of 4 mg, and duration of infusion must not be less than 15 min), hepatic impairment, aspirin-sensitive asthmatic patients, pregnancy, or lactation.
Available Forms
Injection—4 mg/5 mL, 4 mg/100 mL (Zometa); 5 mg/100 mL (Reclast); 4 mg/5 mL, 4 mg/500 mL, 5 mg/100 mL (generic)
Dosages
Adults
Zometa: 4 mg IV as a single-dose infusion of not less than 15 min for hypercalcemia of malignancy with albumin-corrected serum calcium levels of 12 mg/dL or greater. Retreatment may be done with 4 mg IV if needed; a minimum of 7 days should elapse between doses with careful monitoring of serum creatinine levels. Patients with solid tumors should receive 4 mg IV every 3–4 wk to treat bone metastasis.
Reclast: 5 mg IV infused via vented infusion line over at least 15 min. Retreatment may be considered as needed once every 2 yr for osteoporosis.
Pediatric patients
Safety and efficacy not established.
Patients with renal impairment
Zometa: Mild to moderate renal impairment for patients with multiple myeloma and bone metastases from solid tumors (see chart for dosages).
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