Reclast (zoledronic acid)

• Reclast is used for treatment of osteoporosis in men and postmenopausal women as well as Paget's disease.
• It also is used to prevent osteoporosis in postmenopausal women and treatment of steroid-induced osteoporosis.

Treatment of Osteoporosis in Postmenopausal Women

Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures.

Prevention of Osteoporosis in Postmenopausal Women

Reclast is indicated for prevention of osteoporosis in postmenopausal women.

Glucocorticoid-Induced Osteoporosis

Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months.

Paget's Disease of Bone

Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.

What brand names are available for zoledronic acid?

Reclast

Is zoledronic acid available as a generic drug?

No

Do I need a prescription for zoledronic acid?

Yes

The most common adverse reactions of Reclast include:

• Fever
• Bone pain
• Muscle pain
• Headache
• Nausea
• Fatigue
• Constipation
• Anemia
• Pain in hands
• Pain in the feet

Other side effects include:

• Headache
• Joint pain
• Dizziness
• Insomnia
• Urinary tract infection
• Anxiety
• Low levels of phosphate
• Low levels of potassium
• Low blood pressure
• Low magnesium blood levels

Possible serious side effects include:

• Severe bone, joint, and muscle pain may occur.
• Low calcium levels may occur if calcium and vitamin D intake is not adequate.
• Reduced kidney function after administration of Reclast has occurred.
• Patients may experience jaw problems (osteonecrosis of the jaw) associated with delayed healing and infection after tooth extraction.
• Bone, joint, and muscle pain also occur and low-trauma femoral fractures have been reported.

Other important but rare side effects include cases of severe allergic reactions involving:

• Shock
• Swelling of tongue
• Throat
• Closure of airways

Reclast is given intravenously over no less than 15 minutes. Administration of acetaminophen or ibuprofen may reduce infusion related reactions.

• For treatment of postmenopausal osteoporosis, a single 5 mg infusion once a year is recommended.
• For prevention of postmenopausal osteoporosis the recommended dose is 5 mg every two years.
• Paget's disease of bone is treated with a single 5 mg infusion. Patients with Paget's disease should also receive 1500 mg of elemental calcium and 800 IU vitamin D daily, especially during the two weeks after the injection of Reclast.
• For prevention or treatment of steroid-induced osteoporosis, the recommended dose is 5 mg once yearly.

• Combining Reclast with aminoglycoside antibiotics such as gentamycin or loop diuretics such as furosemide (Lasix) or bumetanide (Bumex) may lead to reduced calcium in blood.
• Reclast should be used with caution in patients who are taking drugs that affect kidney function because Reclast has been associated with reduced kidney function.
• Since Reclast contains the same active ingredient as zoledronic acid (Zometa), patients treated with Zometa should not receive Reclast.

• Reclast should not be administered to pregnant women. Women of childbearing age should be advised to use a reliable method of birth control.
• It is not known whether Reclast is excreted in human milk. Since many drugs are excreted in human milk, and Reclast binds to bone long-term, Reclast should not be administered to nursing women.

What preparations of zoledronic acid are available?

Solution: 5 mg/100 ml

How should I keep zoledronic acid stored?

• Unopened bottles should be kept at room temperature 15 C-30 C (59 F-86 F).
• Opened bottles of solution are stable for 24 hours at 2 C-8 C (36 F-46 F).