DOSAGE AND ADMINISTRATION
Dose
The dose of BONIVA is either one 150 mg tablet taken once monthly on the same date each month or one 2.5 mg tablet taken once daily.
Dosing Instructions
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To maximize absorption and clinical benefit, BONIVA should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins (see DRUG INTERACTIONS [7.1]).
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To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, BONIVA tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking BONIVA (see WARNINGS AND PRECAUTIONS [5.1]).
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Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking BONIVA.
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Plain water is the only drink that should be taken with BONIVA. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
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Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
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The BONIVA 150 mg tablet should be taken on the same date each month (i.e., the patient’s BONIVA day).
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The patient must not take two 150 mg tablets within the same week.
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If the once-monthly dose is missed, and the patient’s next scheduled BONIVA day is more than 7 days away, the patient should be instructed to take one BONIVA 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking one BONIVA 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
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If the once-monthly dose is missed, and the patient’s next scheduled BONIVA day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled BONIVA day to take their tablet. The patient should then return to taking one BONIVA 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see DRUG INTERACTIONS [7.1]).
Use in Specific Populations
BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 mL/min).
No dose adjustment is necessary for patients with mild or moderate renal impairment.
No dose adjustment is necessary for the elderly, or for patients with hepatic impairment.
DOSAGE FORMS AND STRENGTHS
Tablets, 2.5 mg and 150 mg
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HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied
BONIVA 2.5 mg tablets: supplied as white, oblong, film-coated tablets, engraved with "IT" on one side and "L3" on the other side and packaged in bottles of 30 tablets (NDC 0004-0185-23).
BONIVA 150 mg tablets: supplied as white, oblong, film-coated tablets, engraved with "BNVA" on one side and "150" on the other side. Packaged in boxes of 3 blister packs containing 1 tablet each (NDC 0004-0186-82).
16.2Storage and Handling
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
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