Atelvia

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Atelvia is a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis ( 1.1 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.2 ) 1.1 Postmenopausal Osteoporosis 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 (14.1) ] . 1.2 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 2 DOSAGE AND ADMINISTRATION One 35 mg delayed-release tablet once-a-week ( 2.1 ) Instruct patients to: Take Atelvia in the morning immediately following breakfast with at least 4 ounces of plain water ( 2.2 ) Avoid lying down for 30 minutes after taking Atelvia ( 2.2 ) Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.3 ) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1) ] The recommended regimen is: one 35 mg delayed-release tablet orally, taken once-a-week 2. 2 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 (5.2) ] . Do not chew, cut, or crush Atelvia tablets. 2.3 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 (5.3) ] 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. 2.4 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with Atelvia ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the J aw has been reported ( 5.4 ) Severe B one, J oint, M uscle P ain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Fractures Including F em oral F ractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered ( 5.6 ) 5.1 Drug Products with the Same Active Ingredient Atelvia contains the same active ingredient found in Actonel ® . A patient being treated with Actonel should not receive Atelvia. 5. 2 Upper Gastrointestinal Adverse Reactions Atelvia, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Atelvia is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [ see Contraindications (4) , Adverse Reactions (6.1) , Information for Patients (17) ] . Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be aler