Classes
DEA Class; Rx
Common Brand Names; Boniva
- Calcium Metabolism Modifiers;
- Bisphosphonate Derivatives
Description
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
Indications
Indicated for treatment and prevention of osteoporosis in postmenopausal women; increases BMD and reduces vertebral fracture incidence
Contraindications
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)
Adverse Effects
- ADRs frequency similar to placebo
- URI (34%)
- Back pain (14%)
- Dyspepsia (12%)
- Bronchitis (10%)
- Asthenia
- Diarrhea
- Dizziness
- Myalgia
- Pneumonia
- Tooth disorder
- UTI
Warnings
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 and Lactation
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
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Ibandronate
tablet
- 150mg
prefilled syringe
- 1 mg/1 mL (3 mL)