Atelvia Generic Name & Formulations
Legal Class
Rx
General Description
Risedronate (as sodium) 35mg; delayed-release tabs.
Pharmacological Class
Bisphosphonate.
How Supplied
Tabs—4
Manufacturer
Generic Availability
YES
Atelvia Indications
Indications
Treatment of postmenopausal osteoporosis.
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3–5yrs.
Atelvia Dosage and Administration
Adult
Swallow whole; take in the AM with a full glass (4oz) plain (not mineral) water immediately after breakfast; take in upright position; do not lie down for at least 30min afterwards. 35mg once weekly.
Children
Not recommended.
Atelvia Contraindications
Contraindications
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30mins. Hypocalcemia.
Atelvia Boxed Warnings
Not Applicable
Atelvia Warnings/Precautions
Warnings/Precautions
Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <30mL/min): not recommended. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Ensure adequate Vit. D and calcium intake. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reevaluate periodically. Pregnancy: discontinue therapy if recognized. Nursing mothers.
Atelvia Pharmacokinetics
Elimination
Renal. Half-life: 561 hours.
Atelvia Interactions
Interactions
Concomitant H2-blockers, PPIs, or other risedronate-containing products (eg, Actonel): not recommended. Calcium or magnesium-based supplements, antacids, laxatives, or iron preparations reduce absorption (separate dosing). Caution with aspirin, NSAIDs, other GI irritants. May interfere with bone-imaging agents.
Atelvia Adverse Reactions
Adverse Reactions
Diarrhea, influenza, arthralgia, back pain, abdominal pain; atypical femur fractures, esophageal reactions, hypocalcemia; rare: jaw osteonecrosis, hypersensitivity (eg, angioedema, Stevens-Johnson), eye inflammation.
Atelvia Clinical Trials
See Literature
Atelvia Note
Not Applicable
Atelvia Patient Counseling
See Literature