Alendronate

Class
Antiresorptive agents
Subclass
Bisphosphonates
Substance name
Alendronate sodium, alendronic acid
Brand names
Binosto®, Fosamax®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment
Osteoporosis • Corticosteroid-induced
•
5 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Osteoporosis in males
•
70 mg PO weekly
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Alternative
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Paget's disease
•
40 mg PO daily for 6 months
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Postmenopausal osteoporosis
•
70 mg PO weekly
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Alternative
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Osteopenia in patients with cystic fibrosis • Off-label
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Alternative
•
70 mg PO weekly
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Osteoporosis in males with hypogonadism • Off-label
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Osteoporosis in patients with Crohn's disease • Off-label
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Osteoporosis in patients with GHD • Off-label
•
10 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Alternative
•
70 mg PO weekly
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Prevention
Osteoporosis in postmenopausal females
•
35 mg PO weekly
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Alternative
•
5 mg PO daily
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Periprosthetic bone loss, after knee replacement • Off-label
•
10 mg PO daily starting on postoperative day 2 and continued for 6 months
Taken upon waking, on an empty stomach, with a full glass of plain water, more than 30 minutes before any other food or beverage intake. Counsel patients to sit upright or stand upright for at least 30 minutes after taking the medication.
Other off-label uses
•
Treatment of fibrous dysplasia
•
Treatment of hypercalcemia of malignancy
Indications for use
Labeled indications
Adults
•
Treatment of Paget's disease
•
Treatment of osteoporosis (corticosteroid-induced)
•
Treatment of osteoporosis in males
•
Treatment of postmenopausal osteoporosis
•
Prevention of osteoporosis in postmenopausal females
Off-label indications
Adults
•
Treatment of fibrous dysplasia
•
Treatment of hypercalcemia of malignancy
•
Treatment of osteopenia in patients with cystic fibrosis
•
Treatment of osteoporosis in patients with Crohn's disease
•
Treatment of osteoporosis in patients with GHD
•
Treatment of osteoporosis in males with hypogonadism
•
Prevention of periprosthetic bone loss, after knee replacement
Safety risks
Contraindications
Hypersensitivity to alendronate or its components
Delayed esophageal emptying
•
Do not use alendronate in patients with conditions delaying esophageal emptying, such as stricture or achalasia, or in patients unable to sit upright for at least 30 minutes.
Hypocalcemia
•
Correct hypocalcemia before initiating alendronate. Correct other mineral metabolism disturbances, including vitamin D deficiency, if present. Monitor serum calcium and symptoms of hypocalcemia throughout treatment.
Patients at risk of aspiration
Warnings and precautions
Increased serum sodium
•
Use caution in patients requiring sodium restriction, including patients with a history of HF, hypertension, or other CVDs, as alendronate effervescent tablets contain 650 mg of sodium.
Medication-related osteonecrosis of the jaw
•
Use caution in patients with poor oral hygiene, periodontal and/or other dental diseases, ill-fitting dentures, undergoing invasive dental procedures, having comorbid disorders (such as cancer, anemia, coagulopathy, infection), or receiving chemotherapy, corticosteroids, or angiogenesis inhibitors. Perform a dental examination with appropriate preventive dentistry before initiating alendronate.
Musculoskeletal pain, atypical femoral fracture
•
Maintain a high level of suspicion, as alendronate has been associated with an increased risk for these adverse events. Evaluate patients with new thigh or groin pain to rule out an incomplete femoral fracture. Consider discontinuing treatment.
Upper gastrointestinal bleeding, esophagitis, esophageal perforation
•
Use caution in patients with active upper gastrointestinal diseases, including Barrett's esophagus, dysphagia, gastritis, duodenitis, or peptic ulcers. Advise patients to take alendronate with an adequate amount of water and not to lie down for at least 30 minutes.
Specific populations
Renal impairment
CrCl ≥ 35 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 35 mL/min
•
Do not use.
Renal replacement therapy
Continuous renal replacement
•
Do not use.
Intermittent hemodialysis
•
Do not use.
Peritoneal dialysis
•
Do not use.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Do not use. Evidence of fetal harm in animals. There are no studies of alendronate use during pregnancy, but bisphosphonate use during pregnancy carries a theoretical risk of skeletal harm to the fetus.
Breastfeeding
Use only if benefits outweigh potential risks.
•
Consider monitoring the infant's serum calcium during the first 2 months postpartum if the mother receives a bisphosphonate.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ serum calcium, fever
Common 1-10%
•
Abdominal distension, chronic constipation, ↓ serum phosphate, gastroesophageal reflux disease, heart failure, abdominal pain, diarrhea, dyspepsia, dyspepsia, dysphagia, bone pain, muscle pain, muscle cramps, dizziness, vomiting, flatulence, headache, nausea
Uncommon < 1%
•
Atrial fibrillation, medication-related osteonecrosis of the jaw
Unknown frequency
•
Esophageal erosion, esophagitis, esophageal stricture, pericarditis, lung cancer, vertigo, peripheral edema, ↓ blood lymphocyte count, flu-like symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, peptic ulcer disease, asthma exacerbation, episcleritis, scleritis, uveitis
Interactions
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