General

Pronunciation
a-LEN-drone-ate

Trade Name(s)

• Fosamax

Pregnancy Category
Category C

Ther. class.
bone resorption inhibitors

Pharm. class.
biphosphonates

Indications

• Treatment and prevention of postmenopausal osteoporosis

• Treatment of osteoporosis in men

• Treatment of Paget's 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

Action

Inhibits resorption of bone by inhibiting osteoclast activity

Therapeutic Effect(s):

• Reversal of the progression of osteoporosis with decreased fractures

• Decreased progression of Paget's disease

Pharmacokinetics

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

Distribution: Transiently distributes to soft tissue, then distributes to bone

Metabolism and Excretion: Excreted in urine

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

TIME/ACTION PROFILE (inhibition of bone resorption)

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

†After discontinuation of alendronate

Contraindication/Precautions

Contraindicated in:

• Renal insufficiency (CCr <35 ml/min)

• OB: Lactation: Safety not established

Use Cautiously in:

• Patients with active GI pathology (dysphagia, esophageal disease, gastritis, duodenitis, ulcers)

• Pre-existing hypocalcemia or vitamin D deficiency

• Concurrent dental surgery (may risk of jaw osteonecrosis)

Adverse Reactions/Side Effects

CNS: headache.

EENT: blurred vision, conjunctivitis, eye pain/inflammation.

CV: atrial fibrillation.

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

Derm: erythema, photosensitivity, rash.

MS: musculoskeletal pain, osteonecrosis (primarily of jaw).

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Calcium supplements, antacids, and other oral medications the absorption of alendronate

• Doses >10 mg/day risk of adverse GI events when used with NSAIDs

• IV ranitidine blood levels

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

Route/Dosage

• PO (Adults):
Treatment of osteoporosis —10 mg once daily or 70 mg once weekly.
Prevention of osteoporosis—5 mg once daily or 35 mg once weekly.
Paget's disease—40 mg once daily for 6 mo. Re-treatment may be considered for patients who relapse.
Treatment of corticosteroid-induced osteoporosis in men and premenopausal women—5 mg once daily.
Treatment of corticosteroid-induced osteoporosis in postmenopausal women not receiving estrogen—10 mg once daily.

Availability

• Tablets: 5 mg, 10 mg, 35 mg, 40 mg, 70 mg

» Cost: 5 mg $248.19/90, 10 mg $240.97/90, 35 mg $235.97/12, 40 mg $177.89/30, 70 mg $239.96/12.

• Oral solution (raspberry flavor): 70 mg/75 ml

» Cost: $27.99/75 ml.

• In combination with: Cholecalciferol (Fosamax plus D) See combination drugs

Assessment

Osteoporosis

• Assess patients for low bone mass before and periodically during therapy

Paget's Disease

• Assess for symptoms of Paget's disease (bone pain, headache, decreased visual and auditory acuity, increased skull size)

Lab Test Considerations

• Osteoporosis: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating alendronate therapy. May cause mild, transient elevations of calcium and phosphate

» Paget's Disease: Monitor alkaline phosphatase before and periodically during therapy. Alendronate is indicated for patients with alkaline phosphatase twice the upper limit of normal

Potential Nursing Diagnoses

• Risk for injury (Indications)

Implementation

• Do not confuse Fosamax (alendronate) with Flomax (tamsulosin)

• PO: Administer first thing in the morning with 6–8 oz plain water 30 min before other medications, beverages, or food

Patient/Family Teaching

Instruct patient on the importance of taking exactly as directed, first thing in the morning, 30 min before other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Alendronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease 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 week on the chosen day. Do not take 2 tablets on the same day. Do not discontinue without consulting health care professional

» Caution patient to remain upright for 30 min following dose to facilitate passage to stomach and minimize 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

» 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 increase the risk of osteoporosis (stop smoking, reduce alcohol consumption)

» 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

» Advise female patient to notify health care professional if pregnancy is planned or suspected or if she is breastfeeding

Evaluation/Desired Outcomes

• Prevention of or decrease in the progression of osteoporosis in postmenopausal women

• Treatment of osteoporosis in men

• Decrease in the progression of Paget's disease

• Treatment of corticosteroid-induced osteoporosis

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