"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"...
Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies].
Important Limitations Of Use
The optimal duration of use has not been determined. The safety and effectiveness of Atelvia for the treatment of osteoporosis are based on clinical data of one year 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
Treatment Of Postmenopausal Osteoporosis
[see INDICATIONS AND USAGE]
The recommended regimen is:
- one 35 mg delayed-release tablet orally, taken once-a-week
Important Administration Instructions
Instruct patients to do the following:
- Take Atelvia in the morning immediately following breakfast. Atelvia should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting.
- Swallow Atelvia whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication [see WARNINGS AND PRECAUTIONS].
- Do not chew, cut, or crush Atelvia tablets.
Recommendations For Calcium And Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see WARNINGS AND PRECAUTIONS] and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of Atelvia.
Administration Instructions For Missed Doses
If the once-weekly dose is missed, instruct patients to take one tablet on the morning after they remember and return to taking one tablet once-a-week, as originally scheduled on their chosen day. Patients should not take two tablets on the same day.
Dosage Forms And Strengths
Delayed-release tablets: 35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.
Storage And Handling
Atelvia® (risedronate sodium) delayed-release tablets are:
35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.
NDC 0430-0979-03 Dosepak of 4 tablets
Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
Manufactured by: Norwich Pharmaceuticals, Inc. North Norwich, NY 13814. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866. 1-800-521-8813. Revised: March 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2015
Additional Atelvia Information
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