BONIVA Film-coated tablet Ref.[50365] Active ingredients: Ibandronic acid

2.1 Dosage Information

The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.

2.2 Important Administration Instructions

Instruct Patients to do the following:

• Take BONIVA 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 to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1]). Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.
• Swallow BONIVA tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking BONIVA (see WARNINGS AND PRECAUTIONS [5.1]). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.
• Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking BONIVA.

2.3 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of BONIVA administration because co-administration of BONIVA and calcium may interfere with the absorption of ibandronate sodium (see DRUG INTERACTIONS [7.1]).

2.4 Administration Instructions for Missed Once-Monthly Doses

If the once-monthly dose is missed, instruct patients to do the following:

• If the next scheduled BONIVA day is more than 7 days away, take one BONIVA 150 mg tablet in the morning following the date that it is remembered.
• If the next scheduled BONIVA day is only 1 to 7 days away, wait until the subsequent month’s scheduled BONIVA day to take their tablet.

For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one BONIVA 150 mg tablet every month on their previous chosen day.

No specific information is available on the treatment of overdosage of BONIVA. However, based on knowledge of this class of compounds, oral overdosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, dyspepsia, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind BONIVA. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.

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