Zoledronic Acid

Generic Name: zoledronic acid

Over-the-Counter (OTC)

Brand Names:

Zoledronic Acid

Zoledronic acid injection is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis, and treatment of Paget's disease of bone in men and women. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. It is administered as an intravenous infusion.

Overview

Zoledronic acid injection is a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis, and treatment of Paget's disease of bone in men and women. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. It is administered as an intravenous infusion.

Uses

Zoledronic acid injection is indicated for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis, and treatment of Paget's disease of bone in men and women. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Dosage

5 mg given intravenously over no less than 15 minutes. Treatment of postmenopausal osteoporosis, treatment to increase bone mass in men, and treatment/prevention of glucocorticoid-induced osteoporosis: 5 mg once a year. Prevention of postmenopausal osteoporosis: 5 mg once every 2 years. Treatment of Paget's disease: single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily.

Side Effects

Most common adverse reactions (greater than 10%): pyrexia, myalgia, headache, arthralgia, pain in extremity. Other important reactions: flu-like illness, nausea, vomiting, diarrhea, eye inflammation. Acute phase reaction symptoms typically occur within first 3 days and usually resolve within 3 days but may take 7-14 days. Renal impairment including acute renal failure has been reported. Hypocalcemia, osteonecrosis of jaw, atypical fractures, and severe musculoskeletal pain reported.

Interactions

Aminoglycosides may lower serum calcium for prolonged periods. Loop diuretics may increase risk of hypocalcemia. Nephrotoxic drugs should be used with caution. Drugs primarily excreted by kidney may have increased exposure with renal impairment; monitor serum creatinine in at-risk patients.

Warnings

Patients receiving Zometa should not receive zoledronic acid injection. Hypocalcemia may worsen during treatment; adequate calcium and vitamin D supplementation required. Renal impairment: single dose should not exceed 5 mg; infusion duration no less than 15 minutes. Monitor creatinine clearance before each dose. Osteonecrosis of the jaw has been reported; routine oral examination required prior to treatment. Atypical fractures including femoral fractures reported. Severe bone, joint, and muscle pain may occur. Contraindicated in patients with hypocalcemia, creatinine clearance less than 35 mL/min, or known hypersensitivity.

Pregnancy

Discontinue zoledronic acid injection when pregnancy is recognized. Animal studies showed increases in fetal skeletal, visceral, and external malformations starting at 2 times the recommended dose. Bisphosphonates incorporated into bone matrix over years; potential risk of fetal harm if woman becomes pregnant after completing bisphosphonate therapy. Female fertility may be impaired based on animal studies.

Storage

If refrigerated, allow solution to reach room temperature before administration. After opening, solution stable for 24 hours at 2 to 8 degrees C (36 to 46 degrees F). Supplied as 5 mg in a 100 mL ready-to-infuse solution.

Frequently Asked Questions

What is Zoledronic Acid used for?

Zoledronic acid injection is indicated for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis, and treatment of Paget's disease of bone in men and women. Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

What are the side effects of Zoledronic Acid?

Most common adverse reactions (greater than 10%): pyrexia, myalgia, headache, arthralgia, pain in extremity. Other important reactions: flu-like illness, nausea, vomiting, diarrhea, eye inflammation. Acute phase reaction symptoms typically occur within first 3 days and usually resolve within 3 days but may take 7-14 days. Renal impairment including acute renal failure has been reported. Hypocalcemia, osteonecrosis of jaw, atypical fractures, and severe musculoskeletal pain reported.

Can I take Zoledronic Acid during pregnancy?

Discontinue zoledronic acid injection when pregnancy is recognized. Animal studies showed increases in fetal skeletal, visceral, and external malformations starting at 2 times the recommended dose. Bisphosphonates incorporated into bone matrix over years; potential risk of fetal harm if woman becomes pregnant after completing bisphosphonate therapy. Female fertility may be impaired based on animal studies.

What are the important warnings for Zoledronic Acid?

Patients receiving Zometa should not receive zoledronic acid injection. Hypocalcemia may worsen during treatment; adequate calcium and vitamin D supplementation required. Renal impairment: single dose should not exceed 5 mg; infusion duration no less than 15 minutes. Monitor creatinine clearance before each dose. Osteonecrosis of the jaw has been reported; routine oral examination required prior to treatment. Atypical fractures including femoral fractures reported. Severe bone, joint, and muscle pain may occur. Contraindicated in patients with hypocalcemia, creatinine clearance less than 35 mL/min, or known hypersensitivity.

Related Medications

Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.