BONIVA- ibandronate sodium tablet, film coated
BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
The optimal duration of use has not been determined. The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.
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 BONVIA administration because co-administration of BONIVA and calcium may interfere with the absorption of ibandronate sodium (see DRUG INTERACTIONS [7.1]).
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.
BONIVA 150 mg tablets: white, oblong, engraved with "BNVA" on one side and "150″ on the other side.
The safety of BONIVA 150 mg once monthly in the treatment of postmenopausal osteoporosis was assessed in a two year trial which enrolled 1583 patients aged 54 – 81 years, with 395 patients exposed to BONIVA 2.5 mg daily and 396 exposed to BONIVA 150 mg monthly. Patients with active or significant pre-existing gastrointestinal disease were excluded from this trial. Patients with dyspepsia or concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in this study. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.
BONIVA 150 mg tablets: supplied as white, oblong, film-coated tablets, engraved with "BNVA" on one side and "150″ on the other side. Packaged as a three-month supply in:
A box of 3 blister packs containing 1 tablet each (NDC 0004-0186-82) or a box with 1 blister pack containing 3 tablets (NDC 0004-0186-83).
16.2 Storage and Handling
tore at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
17.1 Information for Patients
Instruct patients to read the Medication Guide carefully before taking BONIVA and to re-read it each time the prescription is renewed because it contains important information the patient should know about BONIVA. The Medication Guide also includes the dosing instructions in order 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 and before taking any oral medication or supplementation including calcium, antacids or vitamins (see DRUG INTERACTIONS [7.1]).
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.
Patients should not eat, drink anything except for water, or take other medications for 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 150 mg tablet should be taken on the same date each month (i.e., the patient's BONIVA 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 150 mg tablet in the morning following the date that it is remembered (see DOSAGE AND ADMINISTRATION [2.3]). 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.
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.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Intake of supplemental calcium and vitamin D should be delayed for at least 60 minutes following oral administration of BONIVA in order to maximize absorption of BONIVA.
Physicians should be alert to signs or symptoms signaling a possible esophageal reaction during therapy, and patients should be instructed to discontinue BONIVA and seek medical attention if they develop symptoms of esophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
What is BONIVA?
BONIVA is a prescription medicine used to treat or prevent osteoporosis in women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).
It is not known how long BONIVA works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.
It is not known if BONIVA is safe and effective in children.
Who should not take BONIVA?
Do not take BONIVA if you:
Have certain problems with your esophagus, the tube that connects your mouth with your stomach
Cannot stand or sit upright for at least 60 minutes
Have low levels of calcium in your blood
Are allergic to BONIVA or any of its ingredients. A list of ingredients is at the end of this leaflet
What should I tell my doctor before taking BONIVA?
Before you start BONIVA, be sure to talk to your doctor if you:
Have problems with swallowing
Have stomach or digestive problems
Have low blood calcium
Plan to have dental surgery or teeth removed
Have kidney problems
Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
Are pregnant, or plan to become pregnant. It is not known if BONIVA can harm your unborn baby.
Are breast-feeding or plan to breast-feed. It is not known if BONIVA passes into your milk and may harm your baby.
Tell your doctor and dentist about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how BONIVA works.
Especially tell your doctor if you take:
Nonsteroidal Anti-Inflammatory (NSAID) medicines
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.
How should I take BONIVA?
Take BONIVA exactly as your doctor tells you.
Take 1 BONIVA 150 mg tablet 1 time every month on the same day each month.
BONIVA works only if taken on an empty stomach.
Take 1 BONIVA tablet, after you get up for the day and before taking your first food, drink, or other medicine.
Take BONIVA while you are sitting or standing.
Do not chew or suck on a tablet of BONIVA.
Swallow BONIVA tablet with a full glass (6-8 oz) of plain water only.
Do not take BONIVA with mineral water, coffee, tea, soda, or juice.
After swallowing BONIVA tablet, wait at least 60 minutes:
Before you lie down. You may sit, stand or walk, and do normal activities like reading.
Before you take your first food or drink except for plain water.
Before you take other medicines, including antacids, calcium, and other supplements and vitamins.
Do not lie down for at least 60 minutes after you take BONIVA and do not eat your first food of the day for at least 60 minutes after you take BONIVA.
If you miss a dose of BONIVA, do not take it later in the day. Call your doctor for instructions.
If you take too much BONIVA, call your doctor. Do not try to vomit. Do not lie down.
What are the possible side effects of BONIVA?
BONIVA may cause serious side effects.
See "What is the most important information I should know about BONIVA?"
The most common side effects of BONIVA are:
Stomach area (abdominal) pain
Pain in your arms and legs