alendronate

a-LEN-drone-ate

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: biphosphonates

REMS

Treatment and prevention of postmenopausal osteoporosis.
Treatment of osteoporosis in men.
Treatment of Paget disease of the bone.
Treatment of corticosteroid-induced osteoporosis in patients (men and women) who are receiving ≥7.5 mg of prednisone/day (or equivalent) with evidence of decreased bone mineral density.

Inhibits resorption of bone by inhibiting osteoclast activity.

Therapeutic effects:

Reversal of the progression of osteoporosis with decreased fractures.
Decreased progression of Paget disease.

Absorption: Poorly absorbed (0.6–0.8%) after oral administration.

Distribution: Transiently distributes to soft tissue; then distributes to bone.

Metabolism/Excretion: Excreted in urine.

Half-Life: 10 yr (reflects release of drug from skeleton).

(inhibition of bone resorption)

ROUTE	ONSET	PEAK	DURATION
PO	1 mo	3–6 mo	3 wk–7 mo‡

‡After discontinuation of alendronate.

Contraindicated in:

Abnormalities of the esophagus that delay esophageal emptying (e.g., strictures, achalasia);
Inability to stand/sit upright for at least 30 min;
Renal impairment (CCr <35 mL/min);
OB: Pregnancy.

Use Cautiously in:

History of upper GI disorders;
Pre-existing hypocalcemia or vitamin D deficiency;
Invasive dental procedures; cancer; receiving chemotherapy, corticosteroids, or angiogenesis inhibitors; poor oral hygiene; periodontal disease; dental disease; anemia; coagulopathy; infection; or poorly fitting dentures (may ↑ risk of jaw osteonecrosis);
HF or hypertension (effervescent tablet only);
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

CV: atrial fibrillation

Derm: erythema, photosensitivity, rash

EENT: blurred vision, conjunctivitis, eye pain/inflammation

GI: abdominal distention, abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, dysphagia, esophageal cancer, esophageal ulcer, esophagitis, flatulence, gastritis, nausea, taste perversion, vomiting

MS: musculoskeletal pain, femur fractures, osteonecrosis (primarily of jaw)

Neuro: headache

Resp: asthma exacerbation

Drug-drug:

Calcium supplements, antacids, and levothyroxine may ↓ absorption.
Doses >10 mg/day ↑ risk of adverse GI events when used with NSAIDs.

Drug-Food:

Food significantly ↓ absorption. Caffeine (coffee, tea, cola), mineral water, and orange juice also ↓ absorption.

Treatment of Osteoporosis

PO (Adults ): 10 mg once daily or 70 mg once weekly.

Prevention of Osteoporosis

PO (Adults ): 5 mg once daily or 35 mg once weekly.

Paget Disease

PO (Adults ): 40 mg once daily for 6 mo. Retreatment may be considered for patients who relapse.

Treatment of Corticosteroid-Induced Osteoporosis in Men and Women

PO (Adults ): Men and premenopausal women: 5 mg once daily. Postmenopausal women not receiving estrogen: 10 mg once daily.

(Generic available)

Tablets: 5 mg; 10 mg; 35 mg; 40 mg; 70 mg
Effervescent tablets strawberry flavor (contains 603 mg of sodium/tablet) (Binosto): 70 mg
Oral solution raspberry flavor: 70 mg/75 mL
In combination with: cholecalciferol (Fosamax plus D). See Appendix [not included in this PDA edition].

Osteoporosis: Assess for low bone mass before and periodically during therapy.
Paget Disease: Assess for symptoms of Paget disease (bone pain, headache, ↓ visual and auditory acuity, ↑ skull size).
Assess for upper GI adverse effects (dysphagia, odynophagia, upper abdominal pain, retrosternal pain, new or worsening heartburn). If these GI adverse effects occur, discontinue alendronate and evaluate for gastric or duodenal ulcers.
Monitor for fractures; temporary discontinuation may be necessary especially with atypical femur fractures.
Assess for signs and symptoms of osteonecrosis of the jaw (halitosis, jaw pain, jaw swelling, exposed bone, loose teeth, dental pain); discontinuation may be necessary.
Assess pain levels; if severe musculoskeletal pain develops, notify provider for evaluation; discontinuation may be necessary.

Lab Test Considerations:

Osteoporosis: Assess serum calcium, phosphate, and vitamin D levels before and periodically during therapy. Correct hypocalcemia and vitamin D deficiency before initiating alendronate therapy. May cause mild, transient ↑ of calcium and phosphate.
- Paget Disease: Monitor alkaline phosphatase before and periodically during therapy. Alendronate is indicated for patients with alkaline phosphatase twice the upper limit of normal.

PO: Administer 1st thing in the morning with 6–8 ounces of plain water 30 min before other medications, beverages, or food. Oral solution should be followed by ≥2 ounces of water. DNC: Swallow tablets whole; do not crush, break, or chew.
- For effervescent tablets, dissolve one tablet in half a glass (4 ounces) of plain room temperature water (not mineral water or flavored water). Wait ≥5 min after the effervescence stops, stir the solution for approximately 10 sec, and drink contents.

Explain the purpose and side effects of alendronate to patient. Instruct on the importance of taking exactly as directed, 1st thing in the morning, 30 min before other medications, beverages, or food. Waiting >30 min will improve absorption. Take alendronate with 6–8 ounces of plain water (mineral water, orange juice, coffee, and other beverages ↓ absorption). If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a weekly dose is missed, take the morning after remembered and resume the following wk on the chosen day. Do not take two tablets on the same day. Do not discontinue without consulting health care professional. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
- Caution patient to remain upright for 30 min following dose to facilitate passage to stomach and ↓ risk of esophageal irritation. Advise patient to discontinue alendronate and notify health care provider if pain or difficulty swallowing, retrosternal pain, or new/worsening heartburn occur.
- Caution patient not to swallow, chew, or allow undissolved effervescent tablet to dissolve in their mouth; may cause oropharyngeal irritation.
- Counsel patient on sodium-restricted diet that the effervescent tablet contains 603 mg sodium.
- Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D.
- Encourage patient to participate in regular exercise and to modify behaviors that ↑ the risk of osteoporosis (stop smoking, ↓ alcohol consumption).
- Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to inform health care professional of alendronate therapy prior to dental surgery.
- Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
- Advise patient to notify health care professional if blurred vision, eye pain, or inflammation occur.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding during therapy. If pregnancy is detected, discontinue alendronate as soon as possible.

Prevention of or decrease in the progression of osteoporosis in postmenopausal women. Reassess need for medication periodically. Consider discontinuation of alendronate after 3–5 yr in patients with low risk of fractures. If discontinued, reassess fracture risk periodically.
Treatment of osteoporosis in men.
Decrease in the progression of Paget disease.
Treatment of corticosteroid-induced osteoporosis.

Binosto, Fosamax

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Contraind./Precautions ⬆ ⬇

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US Brand Names ⬆ ⬇

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