"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Treatment And Prevention Of Postmenopausal Osteoporosis
Important Limitations Of Use
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.
DOSAGE AND ADMINISTRATION
The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.
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). 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). 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.
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).
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.
Dosage Forms And Strengths
BONIVA 150 mg tablets: white, oblong, engraved with “BNVA” on one side and “150” on the other side.
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).
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].
Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: October 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/8/2016
Additional Boniva Information
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