Generic Name
Risedronate
Brand Names
Atelvia, Actonel
FDA approval date: May 17, 2002
Classification: Bisphosphonate
Form: Tablet
What is Atelvia (Risedronate)?
Risedronate sodium is a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis.
Approved To Treat
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Brand Information
Atelvia (risedronate sodium)
1DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 35 mg, yellow, oval-shaped, and engraved with EC 35 on one side.
2CONTRAINDICATIONS
Atelvia is contraindicated in patients with the following conditions:
• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [
• Inability to stand or sit upright for at least 30 minutes [
• Hypocalcemia [
• Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis , have been reported [
3DRUG INTERACTIONS
Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450).
3.1Calcium 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% [
3.2Histamine 2 (HBlockers and Proton Pump Inhibitors (PPIs)
Drugs that raise stomach pH (for example, PPIs or H
Concomitant administration of Atelvia and H
3.3Hormone Therapy
Concomitant use of Atelvia with estrogens and estrogen agonist/antagonists has not been studied.
3.4Aspirin/Nonsteroidal Anti-Inflammatory Drugs
In the Phase 3 study comparing Atelvia 35 mg once-a-week immediately following breakfast and risedronate sodium 5 mg daily, 18% of NSAID users (any use) in both groups developed upper gastrointestinal adverse reactions. Among non-users, 13% of patients taking Atelvia 35 mg once-a-week immediately following breakfast developed upper gastrointestinal adverse reactions, compared to 12% taking risedronate sodium 5 mg daily.
4OVERDOSAGE
Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. While milk or antacids containing calcium may be given to bind risedronate sodium immediate- release and reduce absorption of the drug, the impact of this intervention for Atelvia delayed-release tablets has not been evaluated.
In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.
Lethality after single oral doses of risedronate was seen in female rats at 903 mg/kg and male rats at 1703 mg/kg. The minimum lethal dose in mice and rabbits was 4000 mg/kg and 1000 mg/kg, respectively. These values represent 320 to 620 times the human Paget’s disease dose of 30 mg/day based on surface area (mg/m
5DESCRIPTION
Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA).
Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelvia tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C
![The chemical structure for Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelvia tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt.](https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=atelvia-01.jpg&setid=c8b9ab88-1a26-46c3-80ec-4eaa45202021)
Molecular Weight:
Anhydrous: 305.10
Hemi-pentahydrate: 350.13
Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.
Inactive Ingredients
Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.
6HOW SUPPLIED/STORAGE AND HANDLING
Atelvia
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].
7PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (
Instruct patients to read the Medication Guide before starting therapy with Atelvia and to re-read it each time the prescription is renewed.
Instruct patients that Atelvia and Actonel contain the same active ingredient and if they are taking Actonel, they should not take Atelvia [
Instruct patients to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions.
Instruct patients to take Atelvia in the morning, while in an upright position (sitting or standing) with at least 4 ounces of plain water immediately following breakfast. Atelvia should not be taken before breakfast.
Instruct patients to swallow Atelvia tablets whole. Patients should not chew, cut, or crush the tablet because of a potential for oropharyngeal irritation, and because the tablet coating is an important part of the delayed-release formulation. Patients should not lie down for 30 minutes after taking the medication.
Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn) they should consult their physician before continuing Atelvia [
If a dose of Atelvia 35 mg once-a-week is missed, instruct the patient 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 2 tablets on the same day.
Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [
Instruct patients to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day because they interfere with the absorption of Atelvia.
Remind patients to give all of their healthcare providers an accurate medication history. Instruct patients to tell all of their healthcare providers that they are taking Atelvia. Patients should be instructed that any time they have a medical problem they think may be from Atelvia they should talk to their doctor.
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Content Updated: August 2020
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