Fosavance Special Precautions

alendronic acid + colecalciferol


Merck Sharp & Dohme


Full Prescribing Info
Special Precautions
Alendronate Sodium: ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE), like other bisphosphonate-containing products, may cause local irritation of the upper gastrointestinal mucosa.
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with alendronate. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) and/or who fail to swallow it with a full glass of water, and/or who continue to take ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE & ADMINISTRATION).
While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications.
Because of possible irritant effects of alendronate on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) is given to patients with active upper gastrointestinal problems, such as dysphagia, esophageal diseases (including known Barrett's esophagus), gastritis, duodenitis, or ulcers.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should be instructed to swallow each tablet of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) with a full glass of water and not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) and consult their physician.
Localized osteonecrosis of the jaw (ONJ), generally associated with tooth extraction and/or local infection (including osteomyelitis) with delayed healing, has been reported rarely with oral bisphosphonates (see Post-Marketing Experience under SIDE EFFECTS). Most reported cases of bisphosphonate-associated ONJ have been in cancer patients treated with intravenous bisphosphonates. Known risk factors for ONJ include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection) and smoking. Patients who develop ONJ should receive appropriate care by an oral surgeon and discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment. Dental surgery may exacerbate the condition.
For patients requiring invasive dental surgery (e.g., tooth extraction, dental implants), clinical judgment of the treating physician and/or oral surgeon should guide the management plan, including bisphosphonate treatment, of each patient based on individual benefit/risk assessment.
Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In postmarketing experience, these symptoms have rarely been severe and/or incapacitating (see Post-Marketing Experience under SIDE EFFECTS). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in a small number of long-term (usually longer than three years) bisphosphonate-treated patients. Some were stress fractures (some of which were reported as insufficiency fractures) occurring in the absence of apparent trauma. Some patients experienced prodromal pain in the affected area, often associated with imaging features of stress fracture, weeks to months before a complete fracture occurred. Approximately one third of these fractures were bilateral; therefore the contralateral femur should be examined in patients who have sustained a femoral shaft stress fracture. Stress fractures with similar clinical features also have occurred in patients not treated with bisphosphonates. Patients with suspected stress fractures should be evaluated, including evaluation for known causes and risk factors (e.g., vitamin D deficiency, malabsorption, glucocorticoid use, previous stress fracture, lower extremity arthritis or fracture, extreme or increased exercise, diabetes mellitus, chronic alcohol abuse), and receive appropriate orthopedic care. Interruption of bisphosphonate therapy in patients with stress fractures should be considered, pending evaluation of the patient, based on individual benefit/risk assessment.
Patients should be instructed that if they miss a dose of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE), they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) is not recommended for patients with creatinine clearance <35 mL/min (see DOSAGE & ADMINISTRATION).
Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered.
Hypocalcemia must be corrected before initiating therapy with ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) (see CONTRAINDICATIONS). Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE).
Due to the positive effects of alendronate in increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur.
Cholecalciferol: Vitamin D3 may increase the magnitude of hypercalcemia and/or hypercalciuria when administered to patients with diseases associated with unregulated overproduction of calcitriol (e.g., leukemia, lymphoma, sarcoidosis). Urine and serum calcium should be monitored in these patients. Patients with malabsorption may not adequately absorb vitamin D3.
Pediatric Use: ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) has not been studied in children and should not be given to them.
Use in Elderly: In clinical studies, there was no age-related difference in the efficacy or safety profiles of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE).
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