Atelvia

— THERAPEUTIC CATEGORIES —
  • Bone disorders

Atelvia Generic Name & Formulations

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