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Zoledronic Acid

    Brands

    DEA Class; Rx

    Common Brand Names; Reclast, Zometa

    • Calcium Metabolism Modifiers; 
    • Bisphosphonate Derivatives

    Potent third-generation intravenous bisphosphonate; carefully select product based on indication for use
    Used for hypercalcemia of malignancy and bone metastases (e.g., Zometa); given as a single dose for Paget’s disease (e.g., Reclast)
    Given once-yearly for osteoporosis and corticosteroid-induced osteoporosis and prevention in both men and women, and every 2 years for osteoporosis prophylaxis in postmenopausal women (e.g., Reclast)

    Indicated for the treatment of hypercalcemia of malignancy (i.e., albumin-corrected serum calcium 12 mg/dL or higher).
    Reduction in incidence of fractures (hip, vertebral, and nonvertebral osteoporosis-related fractures)
    For the treatment of patients with multiple myeloma or with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
    For the treatment of Paget’s disease.

    Pregnancy

    All indications: Hypersensitivity, including rare cases of urticaria, angioedema, and anaphylactic reaction or shock

    Nononcologic uses: Hypocalcemia, severe renal impairment (CrCl <35 mL/min or evidence of acute renal impairment)

    • Bone pain (55%)
    • Nausea (29-46%)
    • Fever (32-44%)
    • Fatigue (39%)
    • Anemia (22-33%)
    • Vomiting (14-32%)
    • Constipation (27-31%)
    • Dyspnea (22-27%)
    • Diarrhea (17-24%)
    • Anorexia (9-22%)
    • Arthralgia (5-21%)
    • Headache (5-19%)
    • Dizziness (18%)
    • Insomnia (15-16%)
    • Urinary tract infection (UTI; 12-14%)
    • Anxiety (11-14%)
    • Hypophosphatemia (5-14%)
    • Hypokalemia (12%)
    • Hypotension (11%)
    • Hypomagnesemia (11%)
    • Rash (11%)

    Assess renal function before and after treatment; if renal function is decreased after treatment, withhold additional treatment until it returns to within 10% of baseline

    Before each Reclast dose, calculate CrCl on basis of actual body weight, using Cockcroft-Gault formula

    Other risks for renal impairment include coadministration of zoledronic acid with nephrotoxic or diuretic medications, severe dehydration before or after zoledronic acid administration, and advanced age

    Previous renal insufficiency (serum creatinine >3 mg/dL [265 mmol/L]), hepatic insufficiency, musculoskeletal pain

    Infuse over ≥15 minutes; faster infusion increases renal toxicity

    May cause significant risk of hypocalcemia (seizures, tetany, and numbness); hypocalcemia must be corrected before initiation of therapy; adequately supplement patients with calcium and vitamin D; monitor serum calcium closely with concomitant administration of other drugs known to cause hypocalcemia to avoid severe or life-threatening hypocalcemia

    Use with caution in aspirin-sensitive asthma; may cause bronchoconstriction

    Increased risk of osteonecrosis of jaw (advise patients against dental work); reported predominantly in cancer patients treated with IV bisphosphonates, including zoledronic acid; many patients were also receiving chemotherapy and corticosteroids which may be risk factors; risk may increase with duration of exposure to bisphosphonates; perform preventive dental exams before initiating therapy; avoid invasive dental procedures; monitor diabetic patients carefully

    Cases of osteonecrosis (primarily involving the jaw but also of other anatomical sites including hip, femur and external auditory canal) reported predominantly in cancer patients

    Risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

    Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years

    If patients are receiving Zometa, they should not receive Reclast

    Severe bone, joint, and muscle pain may occur; withhold future doses of zoledronic acid if severe symptoms occur

    There are no available data in pregnant women to inform the drug-associated risk

    Not known whether drug is present in human milk, or whether it affects milk production, or breastfed child; drug binds to bone long term and may be released over weeks to years

    Adults

    4 mg/dose IV for hypercalcemia/oncology indications; 5 mg/dose IV for Paget’s disease/osteoporosis.

    Geriatric

    4 mg/dose IV for hypercalcemia/oncology indications; 5 mg/dose IV for Paget’s disease/osteoporosis.

    Adolescents

    Safety and efficacy have not been established; however, 5 mg IV once yearly or doses up to 0.1 mg/kg/cycle IV every 4 to 6 months have been used off-label for osteogenesis imperfecta.

    Children

    3 to 12 years: Safety and efficacy have not been established; however, 5 mg IV once yearly or doses up to 0.1 mg/kg/cycle IV every 4 to 6 months have been used off-label for osteogenesis imperfecta.
    2 years: Safety and efficacy have not been established; however, 5 mg IV once yearly or doses up to 0.05 mg/kg/cycle IV every 3 months or 0.1 mg/kg/cycle IV every 6 months have been used off-label for osteogenesis imperfecta.
    1 year: Safety and efficacy have not been established; however, doses up to 0.05 mg/kg/cycle IV every 3 months or 0.1 mg/kg/cycle IV every 6 months have been used off-label for osteogenesis imperfecta.

    Infants

    Safety and efficacy have not been established; however, doses up to 0.05 mg/kg/cycle IV every 3 months or 0.1 mg/kg/cycle IV every 6 months have been used off-label for osteogenesis imperfecta.

    Neonates

    Safety and efficacy have not been established.

    Zoledronic acid

    IV injectable solution

    • 4mg/5mL (5mL)
    • 5mg/100mL