Atelvia 30.1 mg/1

risedronate sodium · TABLET, DELAYED RELEASE · Allergan, Inc.

No Recall History

Plain English

Atelvia is a tablet, delayed release containing risedronate sodium at 30.1 mg/1, taken oral. Manufactured by Allergan, Inc..

Key Facts

Brand Name: Atelvia
Generic Name: risedronate sodium
NDC Code (Product): 0430-0979
Manufacturer: Allergan, Inc.
Strength: 30.1 mg/1
Dosage Form: TABLET, DELAYED RELEASE
Route: ORAL
Marketing Status
Application #: NDA022560
Marketing Start: 12/01/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,439 reports

pain2,436 reports

off label use2,410 reports

arthralgia2,153 reports

drug hypersensitivity2,120 reports

vomiting2,089 reports

dyspnoea2,069 reports

pneumonia1,919 reports

fatigue1,883 reports

rheumatoid arthritis1,801 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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 su…

Contraindications

4 CONTRAINDICATIONS Atelvia is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration (2) , Warnings and Precautions (5.2) ] Hypocalcemia [ see Warnings and Precautions (5.3) ] Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [see Adverse Reactions (6.2) ] Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 , 5.2 ) Inability to stand or sit upright for at least 30 minutes ( 4 , 5.2 ) Hypocalcemia ( 4 , 5.3 ) Known hypersensitivity to any component of this product ( 4 , 6.2 )

Drug Interactions

7 DRUG INTERACTIONS Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium supplements, antacids, proton pump inhibitors (PPIs), H 2 blockers, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of Atelvia ( 7.1 , 7.2 ) 7.1 Calcium Supplements/Antacids When Atelvia was administered following breakfast, the co-administration of a tablet containing 600 mg of elemental calcium and 400 international units vitamin D reduced risedronate bioavailability by approximately 38% [ see Clinical Pharmacology (12.3) ] . Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of Atelvia and should not be taken together. 7.2 Histamine 2 (H 2 ) Blockers and Proton Pump Inhibitors (PPIs) Drugs that raise stomach pH (for example, PPIs or H 2 blockers) may cause faster drug release from enteric coated (delayed-release) drug products such as Atelvia. Co-administration of Atelvia with the PPI, esomeprazole, increased risedronate bioavailability. The maximum plasma concentration (C max ) and the area under…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] Mineral Metabolism [see Warnings and Precautions (5.3) ] Jaw Osteonecrosis [ see Warnings and Precautions (5.4) ] Musculoskeletal Pain [see Warnings and Precautions (5.5) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.6) ] Renal Impairment [see Warnings and Precautions (5.7) ] Laboratory Test Interactions [see Warnings and Precautions (5.8) ] Most common adverse reactions (greater than 5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain ( 6.1 ) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducte…

Frequently Asked Questions

What is Atelvia used for?

Atelvia contains risedronate sodium. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Atelvia a controlled substance?

Atelvia is not classified as a controlled substance by the DEA.

What is the generic name for Atelvia?

The generic name for Atelvia is risedronate sodium. There are 12 other brand versions of risedronate sodium.

What is the NDC code for Atelvia 30.1 mg/1?

The NDC (National Drug Code) for Atelvia 30.1 mg/1 is 0430-0979, listed by Allergan, Inc..

Product NDC

0430-0979

Package NDC

0430-0979-03

Other Risedronate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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