"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.
But the panel backed off giving any sp"...
Treatment and Prevention of Postmenopausal Osteoporosis
BONIVA (ibandronate sodium) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. BONIVA (ibandronate sodium) increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
Important Limitations of Use
The safety and effectiveness of BONIVA (ibandronate sodium) for the treatment of osteoporosis are based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
DOSAGE AND ADMINISTRATION
The dose of BONIVA (ibandronate sodium) is either one 150 mg tablet taken once monthly on the same date each month or one 2.5 mg tablet taken once daily.
- To maximize absorption and clinical benefit, BONIVA (ibandronate sodium) 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).
- To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, BONIVA (ibandronate sodium) 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).
- Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking BONIVA.
- 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.
- Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
- The BONIVA (ibandronate sodium) 150 mg tablet should be taken on the same date each month (i.e., the patient's BONIVA (ibandronate sodium) day).
- The patient must not take two 150 mg tablets within the same week.
- 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 (ibandronate sodium) 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking one BONIVA (ibandronate sodium) 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
- 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 (ibandronate sodium) day to take their tablet. The patient should then return to taking one BONIVA (ibandronate sodium) 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).
Use In Specific Populations
BONIVA (ibandronate sodium) 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
BONIVA (ibandronate sodium) 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 (ibandronate sodium) 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).
Storage and Handling
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Issued: January 2011. Distributed by: Genentech USA, Inc, 1 DNA Way, South San Francisco, CA 94080-4990
Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Boniva Information
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