Alendronate Sodium (FOSAMAX)

1. Health Canada Product Monograph — Alendronate Sodium

• Used to treat osteoporosis in postmenopausal women, increasing bone mass and reducing the risk of hip and spine fractures.
• Used to treat osteoporosis in men, increasing bone mass and reducing fracture risk.
• Used to prevent osteoporosis in postmenopausal women who are at risk of developing the condition.
• Used to treat and prevent glucocorticoid-induced osteoporosis in men and women on long-term corticosteroid therapy who have low bone density.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• FOSAMAX should not be used by pregnant women; it has not been studied in this population, and osteoporosis therapy is not generally relevant to a population of childbearing age.

• FOSAMAX should not be used during breastfeeding, since it is unknown whether alendronate or its breakdown products pass into breast milk, and a risk to the nursing infant cannot be excluded.

• Clinical studies found no age-related difference in the effectiveness or safety of FOSAMAX, and no dosage adjustment is required based on age alone, though older adults should still carefully follow the administration instructions to reduce the risk of esophageal irritation.

• Not authorized for use in patients under 18 years of age, as no data are available to support pediatric use.

• For treatment of osteoporosis in postmenopausal women or men, the recommended dose is 70 mg once weekly (or 10 mg once daily using an alternate alendronate product).
• For prevention of osteoporosis in postmenopausal women, the recommended dose is 5 mg once daily.
• For treatment or prevention of glucocorticoid-induced osteoporosis, the recommended dose is 5 mg once daily, or 10 mg once daily in postmenopausal women not taking estrogen.
• The tablet must be swallowed first thing in the morning, at least 30 minutes before the day's first food, beverage, or other medication, with a full glass of plain water (200 to 250 mL); the patient must stay upright and not lie down for at least 30 minutes and until after eating.
• Tablets should not be chewed, sucked, or crushed, due to the risk of mouth or throat irritation.
• If a weekly dose is missed, it should be taken the next morning it is remembered, and the patient should then resume the original weekly schedule; two doses should never be taken on the same day.

• Abdominal pain may occur.
• Indigestion (dyspepsia) may occur.
• Constipation may occur.
• Diarrhea may occur.
• Gas (flatulence) may occur.
• Acid regurgitation may occur.
• Nausea may occur.
• Musculoskeletal pain (bone, muscle, or joint pain) may occur.
• Headache may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Esophageal problems such as esophagitis, esophageal ulcers, or esophageal erosion may occur, rarely progressing to stricture or perforation.
• Unusual thigh or groin pain may signal a rare atypical fracture of the thigh bone associated with long-term bisphosphonate use.
• Severe, sometimes disabling, bone, joint, or muscle pain has been reported.
• Osteonecrosis of the jaw, a serious condition involving bone breakdown in the jaw often following dental extractions, may occur, more commonly with poor oral hygiene or dental disease.
• Osteonecrosis of the external auditory canal has been reported.
• Low blood calcium (hypocalcemia) may occur or worsen, especially if not corrected before starting treatment.
• Severe allergic reactions, including hives and swelling (angioedema), may occur.
• Eye inflammation such as uveitis, scleritis, or episcleritis may occur.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely.
• Seek prompt medical attention for difficulty or pain swallowing, new chest pain, worsening heartburn, unusual thigh pain, or jaw pain or swelling, especially after dental work.

• Use with caution in patients with active upper gastrointestinal problems such as difficulty swallowing, esophageal disease (including known Barrett's esophagus), gastritis, duodenitis, or ulcers.
• Use with caution in patients at risk for osteonecrosis of the jaw, such as those with cancer, poor oral hygiene, dental disease, or those on chemotherapy, corticosteroids, or immunosuppressive drugs; a dental exam is advisable before starting therapy in these patients.
• Use with caution in patients planning dental extractions or implants while on long-term therapy.
• Correct hypocalcemia and other calcium or vitamin D disorders before starting treatment.
• Use with caution in patients who may not be able to follow the strict dosing instructions, such as remaining upright and waiting before food or other medications.

• Contraindicated in patients with known hypersensitivity to alendronate or to any ingredient in the formulation.
• Contraindicated in abnormalities of the esophagus that delay esophageal emptying, such as stricture or achalasia.
• Contraindicated in patients who cannot stand or sit upright for at least 30 minutes.
• Contraindicated in patients with hypocalcemia.
• Contraindicated in patients with severe renal insufficiency (creatinine clearance under 35 mL/min).

• Calcium supplements, antacids, and other multivalent cation-containing products interfere with alendronate absorption, so at least 30 minutes should separate them from a dose.
• Ranitidine has been shown to roughly double the bioavailability of oral alendronate; the clinical significance with other H2-blockers is unknown.
• Combined use with hormone replacement therapy (estrogen with or without progestin) produces greater increases in bone mass than either treatment alone, without added safety concerns identified in studies.
• Concurrent use of daily alendronate doses above 10 mg with acetylsalicylic acid (aspirin)-containing products has been linked to increased upper gastrointestinal irritation.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) can be used with alendronate, but caution is advised since NSAIDs themselves can irritate the stomach and intestines.

• Food and beverages other than plain water markedly reduce the absorption and effectiveness of alendronate, so it must be taken at least 30 minutes before the day's first food, beverage, or other medication.

• Taken first thing in the morning upon rising, at least 30 minutes before any food, drink, or other medication, with a full glass of plain water; the patient must remain upright afterward.

• Store at room temperature (15-30 degrees C), and keep out of reach and sight of children.

• Alendronate sodium (FOSAMAX) is a bisphosphonate used to treat or prevent osteoporosis and to protect bone density in people on long-term corticosteroids, reducing the risk of fractures.
• Take the tablet first thing in the morning on an empty stomach with a full glass of plain water, then stay upright and avoid food, drink, or other medications for at least 30 minutes.
• Common side effects include stomach pain, heartburn, indigestion, constipation, or diarrhea.
• Contact your doctor's office right away if you develop difficulty or pain swallowing, new or worsening chest pain or heartburn, unusual thigh or groin pain, or jaw pain or swelling after dental work, as these can signal serious complications.
• Never lie down right after your dose, and tell your dentist you are taking this medication before any dental procedures.
• Store at room temperature, out of reach of children, and let your doctor know if you are or may become pregnant or are breastfeeding, since this medication should not be used in those situations.