Alendra Special Precautions

Warning on Esophageal and Gastrointestinal Adverse Events: Similar to other bisphosphonate-containing products, local irritation of the upper gastrointestinal mucosa may be expected.
Esophageal adverse events, such as esophagitis, erosions and ulcerations, occasionally with bleeding and rarely followed by esophageal stricture or perforation have been seen in patients receiving alendronate. Some cases were severe and required hospitalization. Patients should be instructed to discontinue alendronate and seek immediate medical attention if symptoms such as dysphagia, odynophagia (pain on swallowing), worsening heartburn, or retrosternal pain develop.
Strictly follow proper administration of the drug to minimize the risk of severe esophageal adverse experience (see Dosage & Administration). Patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of esophageal irritation have a higher risk of developing severe esophageal reactions (which may be severe and require hospitalization).
Alendronate has possible irritant effects on the upper gastrointestinal mucosa and has a potential for worsening underlying disease. It should therefore be given with caution in patients with active gastrointestinal problems such as dysphagia, esophageal diseases (including Barrett's esophagus), gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal diseases such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty.
In cases where a patient develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn), they should be instructed to stop taking alendronate immediately and consult their physician.
There have been rare post-marketing reports of gastric and duodenal ulcers, some severe and with complications.
General Precautions: Consider causes of osteoporosis other than estrogen deficiency, aging and glucocorticoid use.
Correct hypocalcemia and other disturbances of mineral metabolism such as vitamin D deficiency before initiating alendronate therapy.
Small, asymptomatic decreases in serum calcium and phosphate may occur, particularly in patients with Paget's disease or patients receiving glucocorticoids.
Osteonecrosis of the Jaw (ONJ): Reports of ONJ have been associated with the use of bisphosphonates including alendronate. ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection (including osteomyelitis) with delayed healing. Although most reports have been in cancer patients treated with intravenous bisphosphonates, some cases have been seen in patients with osteoporosis receiving oral bisphosphonates.
Known risk factors for ONJ include: invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (such as chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, immunosuppressive drugs), poor oral hygiene, co-morbid disorders (such as periodontal and/or other pre-existing dental disease, poorly fitting dentures anemia, coagulopathy, infection, diabetes mellitus), smoking, heavy alcohol use, potency of the bisphosphonate (highest incidence with zoledronic acid), route of administration, and cumulative dose. These patients should consider a dental examination with appropriate preventive dentistry prior to treatment with bisphosphonates. All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms (e.g, dental mobility, pain, swelling) during bisphosphonate treatment.
For patients requiring invasive dental procedures, the risk for ONJ may be reduced by stopping bisphosphonate treatment. The management plan for each patient should be based on the clinical judgment of the physician and on individual risk/benefit assessment.
Patients who develop ONJ while on bisphosphonate therapy should receive appropriate antibiotic therapy and be seen by an oral surgeon. In these patients, extensive dental surgery may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
Osteonecrosis of the External Auditory Canal: Osteonecrosis of the external auditory canal (cholesteatoma) has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. Consider the possibility of osteonecrosis of the external auditory canal in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.
Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint and/or muscle pain have been reported infrequently in patients taking bisphosphonates. This may occur from one day to several months after initiation of treatment. Recurrence of symptoms has been observed in some patients when rechallenged with the same medicine or another bisphosphonate. Alendronate therapy may be discontinued if severe symptoms develop.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures: In bisphosphonate-treated patients, atypical, low-energy or low trauma fractures of the femoral shaft have been reported with time to onset in the majority of reports ranging from 18 months to 10 years. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. These fractures also occur in osteoporotic patients who have not been treated with bisphosphonates and therefore the causality of these fractures has not been established.
Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients experience prodromal pain (presenting as dull, aching thigh pain) in the affected area weeks to months before presenting with a completed femoral fracture. Poor healing of these fractures was also reported. Patients with suspected stress fractures should be evaluated, including evaluation for causes and risk factors of stress fractures (e.g., vitamin D deficiency, malabsorption, glucocorticoid use, lower extremity arthritis or fracture, previous stress fracture, extreme or increased exercise, diabetes mellitus, chronic alcohol abuse), and receive appropriate orthopedic care.
Evaluate any patient with a history of bisphosphonate exposure who presents with thigh or groin pain to rule out an incomplete femur fracture. Examine patients with atypical fracture for signs and symptoms of fractures in the contralateral limb. Discontinuation of bisphosphonate therapy should be considered, pending a benefit/risk assessment, on an individual basis.
Endocrine and Metabolism: Mild and transient decreases in serum calcium and phosphate have been observed in patients receiving alendronate, especially in patients with Paget's disease.
Rarely, reports of severe symptomatic hypocalcemia have occurred in patients with predisposing factors such as hypoparathyroidism, vitamin D deficiency and calcium malabsorption. Symptoms of hypocalcemia (e.g., paresthesias or muscle spasms) should be immediately reported to the patient's attending physician. Monitor serum calcium during therapy.
Atrial Fibrillation: A possible increased risk of atrial fibrillation has been observed with the use of bisphosphonates.
Ophthalmic: Conjunctivitis, uveitis, episcleritis and scleritis have been reported with alendronate therapy. Patients should be referred to an ophthalmologist for evaluation in cases where patients experience ocular events other than uncomplicated conjunctivitis. If ocular inflammatory symptoms are observed, treatment may need to be discontinued.
Effects on Ability to Drive and Use Machine (if available): There are no studies performed on the ability of alendronate to affect the ability of a person to drive and/or use machinery. Certain adverse reactions (e.g., dizziness, vertigo, visual disturbances, and severe bone, muscle and joint pain) have been reported which may affect some patients' ability to drive or operate machinery.
Osteogenesis Imperfecta: The overall safety profile of alendronate for 2 years in patients with osteogenesis imperfecta was generally similar to adults. An increased incidence of vomiting, however, was observed in patients with osteogenesis imperfecta compared to those receiving placebo.
Renal Impairment: No dosage adjustment is recommended in patients with mild to moderate kidney impairment (creatinine clearance 35 to 60 mL/minute). Alendronate is contraindicated in patients with severe kidney impairment (creatinine clearance <35 mL/minute).
Use in Children: Alendronate is not indicated for use in pediatric patients.
Use in the Elderly: Dosage adjustment is not necessary in elderly patients. There are no age-related differences in alendronate's efficacy and safety profile. However, some older individuals have greater sensitivity to alendronate.