Generic Name and Formulations:
Zoledronic acid 5mg/100mL bottle; soln for IV infusion.
Novartis Pharmaceuticals Corp
Indications for RECLAST:
Treatment: postmenopausal osteoporosis; to reduce the incidence of new clinical fractures in patients at high risk of fractures (those with recent low–trauma hip fracture). Prevention of osteoporosis in postmenopausal women. To increase bone mass in men with osteoporosis. Paget's disease of bone (men and women). Treatment and prevention: glucocorticoid-induced osteoporosis in men and women expected to be on glucocorticoids for at least 12 months (see full labeling).
Give by IV infusion over at least 15 minutes. CrCl ≥35mL/min: Osteoporosis treatment: 5mg once a year. Osteoporosis prevention: 5mg once every 2 years. Glucocorticoid-induced: 5mg once a year. For all: supplement with calcium and Vit. D, when needed. Paget's disease: a single dose of 5mg; supplement with calcium 1500mg daily in divided doses and Vit. D 800 IU daily esp. during 2 wks post-treatment.
Hypocalcemia. CrCl <35mL/min and evidence of acute renal impairment.
Increased risk of renal impairment: pre-existing renal compromise, advanced age, concomitant nephrotoxic drugs or diuretics, or severe dehydration. Chronic renal impairment. Monitor creatinine clearance before each dose and in at-risk patients. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Do baseline oral exam and preventive dentistry if risks for jaw osteonecrosis exist (eg, cancer, chemotherapy, angiogenesis inhibitors, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy). Ensure adequate hydration, Vit.D and calcium intake. History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Aspirin-sensitive asthma. Avoid dental surgery (do preventative dental work before therapy). Reevaluate periodically. Elderly. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.
Avoid concomitant other forms of zoledronic acid (eg, Zometa). Additive hypocalcemic effect with aminoglycosides, loop diuretics. Caution with other nephrotoxic drugs (eg, NSAIDS).
Pyrexia, musculoskeletal pain (may be severe), headache, arthralgia, pain in extremity, nausea, vomiting, diarrhea, flu-like illness, eye inflammation, hypertension, hypocalcemia; acute renal failure, atypical femur fractures; rare: osteonecrosis of the jaw.