Generic Name: Etidronate Disodium
Class: Bone Resorption Inhibitors
VA Class: HS900
CAS Number: 7414-83-7
Synthetic bisphosphonate; bone resorption inhibitor.c
Uses for Didronel
Paget’s Disease of Bone
Efficacy not established in asymptomatic patients.125 May consider prophylactic treatment in patients with extensive involvement of the skull or spinal column and the possibility of irreversible neurologic damage or in those with extensive involvement threatening major joints or weight-bearing bones.125
Relapse generally tends to occur within about 3–24 months in patients most likely to relapse (e.g., higher pretreatment markers of bone turnover).c
Resistance is most likely to develop in patients receiving >1 course of therapy per year or those with higher pretreatment indices of bone turnover.107
Used in the prevention and treatment of heterotopic ossification (myositis ossificans, ectopic calcification, periarticular ossification, or paraosteoarthropathy) following total hip arthroplasty or resulting from spinal cord injury.125
Bisphosphonates, including etidronate, have been used effectively for the prevention and treatment of corticosteroid-induced osteoporosis†.131 132 133 134 135 136 137 139 141 142 143 144 145 146 The American College of Rheumatology (ACR) currently recommends use of one of several other bisphosphonates (i.e., alendronate, risedronate, or zoledronic acid) in conjunction with lifestyle modification and calcium and vitamin D supplementation for the prevention and treatment of corticosteroid-induced osteoporosis† in select postmenopausal women and men ≥50 years of age who are initiating or currently receiving corticosteroid therapy.166
Didronel Dosage and Administration
Paget’s Disease of Bone
Monitor patients for recurrence of disease every 3–6 months.125 Consider retreatment only after a drug-free interval of ≥90 days following the previous course of therapy if biochemical, symptomatic, or other evidence of recurrence is present.125
Initiate therapy as soon as it is feasible following spinal cord injury and preferably before any radiographic evidence of heterotopic ossification.125 Efficacy of retreatment has not been established in these patients nor in patients undergoing total hip arthroplasty.125
Avoid lying down following oral administration.125
Avoid food, especially calcium-rich food (e.g., milk or milk products), vitamins with mineral supplements, or antacids that contain metals such as calcium, iron, magnesium, or aluminum for 2 hours before and after administration.125 c (See Food under Pharmacokinetics.)
Available as etidronate disodium; dosage expressed in terms of the salt.125
Paget’s Disease of Bone
Onset of therapeutic response may be delayed,125 and therapeutic effects may persist for months following a course of therapy.125 (See Onset under Pharmacokinetics.) Avoid premature increases in dosage125 since increased dosage may cause mineralization defects.125 c
Dosages >20 mg/kg daily not recommended.125
Retreatment: Dosage usually the same as initial treatment.125 Consider increasing dosage within the recommended range if inadequate response with original dosage.125 (See General: Paget’s Disease of Bone under Dosage and Administration.)
Prevention and TreatmentOral
Spinal cord injury: Initially, 20 mg/kg daily for 2 weeks followed by 10 mg/kg daily for an additional 10 weeks (12 weeks total).125
Total hip arthroplasty: Initially, 20 mg/kg daily administered preoperatively for 1 month and postoperatively for an additional 3 months (4 months total).125
Prevention and TreatmentOral
400 mg daily for 2 weeks every 3 months has been used, usually in conjunction with calcium (e.g., 500 mg daily) and vitamin D supplementation during the remaining 10–11 weeks of each cycle or continuously.141 142 143 144 145 146 147
ACR recommends that bisphosphonate therapy be administered for as long as corticosteroid therapy continues.166
Paget’s Disease of Bone
Maximum 20 mg/kg daily.125
Treatment duration: ≤6 months; continuous therapy for >6 months may increase the risk of fracture and osteomalacia.125
Reduce dosage in patients with reduced glomerular filtration; monitor such patients closely.125
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.125
Cautions for Didronel
Esophageal abnormalities that delay esophageal emptying (e.g., stricture, achalasia).125
Known hypersensitivity to etidronate disodium.125
Upper GI Effects
Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation).125 (See Oral Administration under Dosage and Administration.) Monitor for any manifestations and discontinue if dysphagia, odynophagia, new or worsening heartburn, or retrosternal pain occurs.125
Risk of severe adverse esophageal effects greater in patients who do not drink 180–240 mL of water with etidronate, do not avoid lying down for ≥30 minutes following oral administration, and/or continue to take drug after developing symptoms suggesting esophageal irritation.125 Instruct patients carefully about proper administration and give copy of patient instructions provided by the manufacturer.125
Use with caution in patients with history of upper GI disease (e.g., Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers).125 Gastric and duodenal ulcers (some severe and with complications) reported during postmarketing experience.125
Maintain an adequate intake of calcium and vitamin D during therapy.125
Therapy has been withheld in some patients with enterocolitis since diarrhea may occur, especially with high dosages.125
Impairs mineralization of new osteoid, principally in pagetic lesions and to a lesser extent in normal bone at dosages of 10–20 mg/kg daily.125 c Also may delay mineralization of ectopic bone.c Mineralization occurs normally following completion of therapy.125
Long bones affected mainly by lytic pagetic lesions, particularly in patients whose disease is unresponsive to therapy, may be especially prone to fractures.125 Monitor patients with predominantly lytic lesions closely, both radiographically and biochemically, to permit timely discontinuance of therapy in those whose disease is unresponsive.125 If fractures occur, may be advisable to delay or withhold therapy until callus is evident.125
Osteonecrosis and osteomyelitis of the jaw reported, principally in cancer patients receiving bisphosphonates, usually when given IV.125 147 148 149 150 151 Associated mostly with dental procedures (e.g., tooth extraction), but some cases occurred in patients with postmenopausal osteoporosis† receiving oral therapy.125 Known risk factors include cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, preexisting dental disease, anemia, coagulopathy, and infection.125
In patients requiring dental procedures, no data are available to suggest whether discontinuance of therapy prior to procedure reduces the risk of osteonecrosis of the jaw.125 170 Base management of patients requiring dental treatment on an individual assessment of risks and benefits.125 170
Severe and occasionally incapacitating bone, joint, and/or muscle pain reported infrequently with bisphosphonate therapy.125 128 148 153 154 Time to onset varied from 1 day to years (mean onset about 3 months) after treatment initiation.125 128 148 153 154 Such pain generally improves following discontinuance, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.125 128 148 153 154
Although data are conflicting, possible increased risk of atrial fibrillation with use of bisphosphonates.155 FDA analysis of data from long-term (6 months to 3 years) controlled trials identified a higher rate of atrial fibrillation in patients receiving bisphosphonates (alendronate, ibandronate, risedronate, or zoledronic acid) versus placebo; however, only a few events reported in each study.155 FDA is continuing to monitor this safety concern.155
Potential Risk of Esophageal Cancer
Some evidence (from postmarketing experience and observational studies) suggests a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer.156 160 161 However, because of conflicting data,161 162 163 additional study needed to confirm such findings.160
FDA states that benefits of oral bisphosphonates continue to outweigh their potential risks in patients with osteoporosis; it is important to consider that esophageal cancer is rare, especially in women.160 161
Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.156
Safety and efficacy in children not established.125 Has been used in children for the prevention of heterotopic ossification or soft tissue calcification at weight-adjusted dosages recommended for adults.125
Rachitic syndrome reported infrequently in children receiving dosages of ≥10 mg/kg daily for approximately 1 year or longer.125 Epiphyseal radiographic changes associated with retarded mineralization of new osteoid and cartilage and associated occasional symptoms were reversible following discontinuance of the drug.125
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.125 (See Geriatric Patients under Dosage and Administration.)
Possible age-related impaired renal function and risk of toxic reactions; use with care.125 (See Renal Impairment under Cautions and under Dosage and Administration.)
Common Adverse Effects
Paget’s disease of bone: Bone pain, diarrhea, nausea.125
Heterotopic ossification: Diarrhea, nausea.125
Interactions for Didronel
Increases in PT, mostly without clinically important sequelae125
Monitor PT when etidronate added to therapy125
Approximately 3% of a dose is absorbed.125
Paget’s disease of bone: May persist for ≥1 year following discontinuance of therapy.125 In patients whose disease is most likely to relapse, relapse generally tends to occur within about 3–24 months.c
Heterotropic ossification: Persists for ≥9 months following drug discontinuance.125
Food decreases extent of absorption.c
Drug does not cross blood-brain barrier in animals.125
Not known whether etidronate is distributed into milk.125
No evidence of metabolism.125
25°C (may be exposed to 15–30°C).125
Paget’s disease of bone: Reduces the number of osteoclasts and osteoblasts.125
No immunosuppressive activity in animal studies.104
Advice to Patients
Importance of proper administration (e.g., avoiding food, vitamins with mineral supplements, or antacids that contain metals for 2 hours before and after administration).125
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.125
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.125
Importance of informing patients of other important precautionary information.125 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Didronel 400MG Tablets (WARNER CHILCOTT PHARMA): 30/$246.50 or 90/$699.59
AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 21, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
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