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Ibandronate

    DEA Class; Rx

    Common Brand Names; Boniva

    • Calcium Metabolism Modifiers; 
    • Bisphosphonate Derivatives

    Potent oral and parenteral third-generation bisphosphonate
    Primarily used for treatment and prevention of postmenopausal osteoporosis; increases bone mineral density and reduces vertebral fracture risk; consider if spine-specific osteoporosis therapy needed
    Used off-label for hypercalcemia of malignancy and for reduction of skeletal events in patients with breast cancer and bone metastases

    Indicated for treatment and prevention of osteoporosis in postmenopausal women; increases BMD and reduces vertebral fracture incidence

    For the treatment of Paget’s disease.

    Hypersensitivity; anaphylaxis reported, including fatalities

    Uncorrected hypocalcemia

    Inability to stand or sit upright for at least 60 min

    Esophagus abnormalities that delay emptying (eg, stricture, achalasia)

    • ADRs frequency similar to placebo
    • URI (34%)
    • Back pain (14%)
    • Dyspepsia (12%)
    • Bronchitis (10%)
    • Asthenia
    • Diarrhea
    • Dizziness
    • Myalgia
    • Pneumonia
    • Tooth disorder
    • UTI

    Potential for esophagitis, dysphagia & esophageal ulcers

    Severe esophageal risk greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water

    Do not continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation

    Food decreases bioavailability

    Ensure adequate intake of calcium, vitamin D; correct hypocalcemia before use

    Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

    Risk of severe bone, joint and/or muscle pain; consider discontinuing if symptoms develop

    Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

    Not recommended in severe renal impairment (CrCl <30 mL/min)

    Avoid concomitant multivalent cation-containing drugs or food

    Pregnancy: Ibandronate is not indicated for use in women of reproductive potential; there are no data with ibandronate use in pregnant women to inform any drug-associated risks

    Lactation: Ibandronate is not indicated for use in women of reproductive potential; there is no information on the presence of ibandronate in human milk

    Adults

    2.5 mg/day PO, 150 mg/month PO, or 3 mg IV every 3 months for osteoporosis-related indications; for selected off-label indications, doses as large as 50 mg/day PO or 6 mg IV infusion as a single dose have been used.

    Geriatric

    2.5 mg/day PO, 150 mg/month PO, or 3 mg IV every 3 months for osteoporosis-related indications; for selected off-label indications, doses as large as 50 mg/day PO or 6 mg IV infusion as a single dose have been used.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Ibandronate

    tablet

    • 150mg

    prefilled syringe

    • 1 mg/1 mL (3 mL)