Alendronate

DEA Class; Rx

Common Brand Names; Fosamax, Binosto, Fosamax Plus D

Postmenopausal women

• Indicated for treatment and prevention of osteoporosis in postmenopausal women

For osteoporosis prophylaxis.

Indicated for treatment of glucocorticoid-induced osteoporosis

Indicated for treatment of Paget disease of bone

Hypersensitivity

Hypocalcemia

Abnormalities of the esophagus delaying esophageal emptying such as stricture or achalasia

Inability to stand or sit upright for 30 minutes

Daily dosing

• Abdominal pain (2.1-6.6%)

• Musculoskeletal (bone, muscle or joint) pain (4.1%)

• Acid regurgitation (2-4.1%)

• Flatulence (2.6-4.1%)

• Nausea (0.6-3.6%)

• Dyspepsia (3.4-3.6%)

• Constipation (1.3-3.1%)

• Diarrhea (1.4-3.1%)

• Headache (0.6-2.6%)

• Esophageal ulcer (1.5%)

• Vomiting (1%)

• Dysphagia (1%)

• Abdominal distention (1%)

Weekly dosing

• Abdominal pain (1.7-3.7%)

• Musculoskeletal pain (2.9%)

• Dyspepsia (1.9-2.7%)

• Acid regurgitation (1.4-1.9%)

• Nausea (1.4-1.9%)

• Abdominal distention (1%)

• Constipation (0.8%)

• Flatulence (0.4%)

• Gastritis (0.2%)

• Muscle pain (0.2%)

May cause local irritation of upper GI mucosa

Take with plain water only, not coffee, juice, or mineral water; sit or stand upright for at least 30 minutes after administration

Hypocalcemia reported with use of bisphosphonates; correct hypocalcemia prior to therapy; ensure adequate calcium and vitamin D intake

Conjunctivitis, uveitis, episcleritis, and scleritis reported with alendronate use; perform ophthalmic evaluation in patients with signs of ocular inflammation

Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

Not recommended in severe renal impairment (CrCl <35 mL/min)

In Paget disease, drug is available only through Paget’s Patient Support Program with Pharma Care Specialty Pharmacy (800-238-7828 x58197) distribution system for 40-mg dosage regimen

Risk of severe bone, joint, or muscle pain; discontinue therapy in patients who experience severe symptoms of pain; avoid use in patients with history of these symptoms in association with bisphosphonate therapy

Possible increased risk of atypical subtrochanteric and diaphyseal femur fractures; may consider discontinuing therapy after 3-5 years in patients at low-risk for fracture; following discontinuation, re-evaluate fracture risk periodically; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

Use effervescent tablet with caution in sodium-restricted patients (tablet contains 603 mg sodium, equivalent to approximately 1532 of NaCl or salt)

Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized.

Not known whether drug present in human breast mild, affects milk production or has effects on infants