Dosing and uses of Boniva (ibandronate)
Adult dosage forms and strengths
tablet
- 150mg
prefilled syringe
- 1 mg/1 mL (3 mL)
Osteoporosis
Indicated for treatment and prevention of osteoporosis in postmenopausal women; increases BMD and reduces vertebral fracture incidence
150 mg PO every month Or
3 mg IV every 3 months administered over 15-30 seconds (Treatment only)
Administration
Take at least 60 minutes before first food, drink or other medications; take with full glass of water, in upright position & remain upright for 60 minutes to minimize esophageal adverse events
Take with plain water only; juice or coffee can significantly reduce bioavailability
Do NOT chew or suck tablet
Pediatric dosage forms and strengths
Not applicable
Boniva (ibandronate) adverse (side) effects
ADRs frequency similar to placebo
>10%
URI (34%)
Back pain (14%)
Dyspepsia (12%)
Bronchitis (10%)
1-10% (selected)
Asthenia
Diarrhea
Dizziness
Myalgia
Pneumonia
Tooth disorder
UTI
Postmarketing Reports
Hypersensitivity: Allergic reactions including anaphylactic reaction/shock; in some cases fatal, angioedema, bronchospasm, asthma exacerbations, Stevens-Johnson syndrome, erythema multiforme, rash, and dermatitis bullous
Metabolic: Hypocalcemia
Musculoskeletal: Joint, bone, or muscle pain, described as severe or incapacitating; osteonecrosis of the jaw, atypical femoral shaft fracture resulting from low-energy or low-trauma
Warnings
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)
Cautions
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
Esophageal cancer risk (July 21, 2011 FDA safety communication)
- Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
- Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with full glass of water)
- An ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
- The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
- There are insufficient data to recommend endoscopic screening of asymptomatic patients
- FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
- Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
Pregnancy and lactation
Pregnancy category: C
Lactation: unknown; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Boniva (ibandronate)
Half-Life for 150 mg tablet: 37-157 hours
Peak Plasma Time: 1 hr
Bioavailability: 0.6% compared with IV dosing
Protein Bound: 90-99%
Vd: 90 L
Metabolism: none
Clearance
Total body: 84-160 mL/min
Renal: 42-80 mL/min
Other Information
Excretion: Urine (50-60%), feces (unabsorbed drug)
Mechanism of action
Bisphosphonate which inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone density
Administration
IV Administration
Direct IV injection over 15-30 seconds
Administer over 1 hour for metastatic bond disease
Administer over 2 hours for hypercalcemia of malignancy
