BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Treatment of Postmenopausal Osteoporosis

In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures (see CLINICAL STUDIES). Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2 standard deviations below the premenopausal mean [ie, T-score]).

Prevention of Postmenopausal Osteoporosis

BONIVA may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.

Factors such as family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced BMD (at least 1.0 SD below the premenopausal mean), thin body frame, Caucasian or Asian race, and smoking, are associated with an increased risk of developing osteoporosis and fractures. The presence of these risk factors may be important when considering the use of BONIVA for preventing osteoporosis.

The recommended dose of BONIVA for treatment of postmenopausal osteoporosis is one 2.5-mg tablet taken once daily or one 150-mg tablet taken once monthly on the same date each month (see INDICATIONS AND USAGE).

The recommended dose of BONIVA for the prevention of postmenopausal osteoporosis is one 2.5-mg tablet taken once daily. Alternatively, one 150-mg tablet taken once monthly on the same date each month may be considered (see INDICATIONS AND USAGE).

• 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 : INFORMATION FOR PATIENTS and DRUG INTERACTIONS).
• 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 PRECAUTIONS: General and INFORMATION FOR PATIENTS).
• Plain water is the only drink that should be taken with BONIVA. Please 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 150-mg tablet should be taken on the same date each month (ie, the patient's BONIVA day).
• 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.
• The patient must not take two 150-mg tablets within the same week. If the patient's next scheduled BONIVA day is only 1 to 7 days away, the patient must wait until their next 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.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see PRECAUTIONS: INFORMATION FOR PATIENTS).

Patients with Hepatic Impairment

No dose adjustment is necessary (see CLINICAL PHARMACOLOGY: Special Populations).

Patients with Renal Impairment

No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 mL/min.

BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance of < 30 mL/min) (see CLINICAL PHARMACOLOGY: Special Populations).

Geriatric Patients

No dosage adjustment is necessary in the elderly (see PRECAUTIONS: Geriatric Use).

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).

Storage

Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Distributed by: Pharmaceuticals, Roche Leboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199, Co-promoted by Roche Laboratories Inc. and GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: August 2006. FDA revision date: 2/13/2007

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