Alendronate sodium, cholecalciferol.
Each tablet of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) contains 91.37 mg of alendronate monosodium salt trihydrate which is the molar equivalent to 70.0 mg of ALENDRONATE SODIUM + CHOLECALCIFEROL free acid, and 70 mcg or 140 mcg of cholecalciferol equivalent to 2800 IU or 5600 IU vitamin D3, respectively.
ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) contains alendronate sodium and cholecalciferol (vitamin D3).
Alendronate Sodium: Alendronate sodium is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Cholecalciferol: Cholecalciferol (vitamin D3) is a secosterol that is the natural precursor of the calcium regulating hormone calcitriol (1,25-dihydroxyvitamin D3).
ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) is indicated for: Treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures) and to help ensure vitamin D adequacy.
Treatment of osteoporosis in men to prevent fractures and to help ensure vitamin D adequacy.
ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate (see INTERACTIONS).
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see PRECAUTIONS).
The recommended dosage is one 70 mg/2800 IU or one 70 mg/5600 IU tablet once weekly. For most osteoporotic patients the appropriate dose is 70 mg/5600 IU once weekly. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy reevaluated on a periodic basis (see Clinical Studies under SIDE EFFECTS).
Patients should receive supplemental calcium and/or vitamin D, if intake is inadequate (see PRECAUTIONS). Physicians should consider the vitamin D intake from vitamins and dietary supplements. ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) 70 mg/2800 IU and 70 mg/5600 IU are intended to provide seven days' worth of 400 and 800 IU daily vitamin D in a single, once-weekly dose, respectively.
No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Alendronate Sodium: No specific information is available on the treatment of overdosage with alendronate. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Cholecalciferol: Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day. In a clinical study of healthy adults, a 4000 IU daily dose of vitamin D3 for up to five months was not associated with hypercalciuria or hypercalcemia.
Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
Inability to stand or sit upright for at least 30 minutes.
Hypersensitivity to any component of this product.
Hypocalcemia (see 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).
Pregnancy: ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) has not been studied in pregnant women and should not be given to them.
Nursing Mothers: ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) has not been studied in breast-feeding women and should not be given to them.
Clinical Studies: ALENDRONATE SODIUM (FOSAMAX): In clinical studies ALENDRONATE SODIUM (FOSAMAX) was generally well tolerated. In studies of up to five years in duration, side effects, which usually were mild, generally did not require discontinuation of therapy.
Treatment of Osteoporosis: Postmenopausal women: In two three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational) of virtually identical design, the overall safety profiles of ALENDRONATE SODIUM (FOSAMAX) 10 mg/day and placebo were similar. The following upper gastrointestinal adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥1% of patients treated with ALENDRONATE SODIUM (FOSAMAX) 10 mg/day and at a greater incidence than in patients treated with placebo: abdominal pain [ALENDRONATE SODIUM (FOSAMAX), 6.6% vs. placebo, 4.8%], dyspepsia (3.6%, 3.5%), esophageal ulcer (1.5%, 0.0%), dysphagia (1.0%, 0.0%), and abdominal distention (1.0%, 0.8%).
Rarely, rash and erythema have occurred.
Additionally, the following adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥ 1% of patients treated with ALENDRONATE SODIUM (FOSAMAX) 10 mg/day and at a greater incidence than in patients treated with placebo: musculoskeletal (bone, muscle or joint) pain [ALENDRONATE SODIUM (FOSAMAX), 4.1% vs. placebo, 2.5%], constipation (3.1%, 1.8%), diarrhea (3.1%, 1.8%), flatulence (2.6%, 0.5%), and headache (2.6%, 1.5%).
In the two-year extension (treatment years 4 and 5) of the above studies, the overall safety profile of ALENDRONATE SODIUM (FOSAMAX) 10 mg/day was similar to that observed during the three-year placebo-controlled period. Additionally, the proportion of patients who discontinued ALENDRONATE SODIUM (FOSAMAX) 10 mg/day due to any clinical adverse experience was similar to that during the first three years of the study.
In a one-year, double-blind, multicenter study, the overall safety and tolerability profiles of ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg (n = 519) and ALENDRONATE SODIUM (FOSAMAX) 10 mg daily (n = 370) were similar. The following adverse experiences were reported by the investigators as possibly, probably, or definitely drug related in ≥ 1% of patients in either treatment group: abdominal pain [ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg, 3.7%; ALENDRONATE SODIUM (FOSAMAX) 10 mg daily, 3.0%], musculoskeletal (bone, muscle or joint) pain (2.9%, 3.2%), dyspepsia (2.7%, 2.2%), acid regurgitation (1.9%, 2.4%), nausea (1.9%, 2.4%), abdominal distension (1.0%, 1.4%), constipation (0.8%, 1.6%), flatulence (0.4%, 1.6%), muscle cramp (0.2%, 1.1%), gastritis (0.2%, 1.1%), and gastric ulcer (0.0%, 1.1%).
Men: In two, placebo-controlled, double-blind, multicenter studies in men (a two-year study of ALENDRONATE SODIUM (FOSAMAX) 10 mg/day [n=146] and a one-year study of ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg [n=109]), the safety profile of ALENDRONATE SODIUM (FOSAMAX) was generally similar to that seen in postmenopausal women.
Other studies in men and women: In a ten-week endoscopy study in men and women (n=277; mean age: 55) no difference was seen in upper gastrointestinal tract lesions between ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg and placebo.
In an additional one-year study in men and women (n=335; mean age: 50) the overall safety and tolerability profiles of ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg were similar to that of placebo and no difference was seen between men and women.
In two one-year studies in men and women (n=477) receiving glucocorticoids, melena was reported in two patients treated with ALENDRONATE SODIUM (FOSAMAX) 10 mg/day.
Concomitant Use with Estrogen/Hormone Replacement Therapy: In two studies (of one and two years' duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with ALENDRONATE SODIUM (FOSAMAX) 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.
ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE): In a 15-week, double-blind, multinational study in osteoporotic postmenopausal women (n=682) and men (n=35), the safety profile of once weekly ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) (alendronate 70mg/vitamin D3 2800 IU) was similar to that of ALENDRONATE SODIUM (FOSAMAX) once weekly 70 mg. In the 24-week double-blind extension study in women (n=619) and men (n=33), the safety profile of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) (70 mg/2800 IU) administered with an additional 2800 IU vitamin D3 for a total of 5600 IU was similar to that of ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) (70 mg/2800 IU).
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing use with alendronate: Body as a Whole: hypersensitivity reactions including urticaria and rarely angioedema. As with other bisphosphonates, transient symptoms as in an acute-phase response (myalgia, malaise, asthenia and rarely, fever) have been reported with alendronate, typically in association with initiation of treatment. Rarely, symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Rarely, peripheral edema.
Gastrointestinal: nausea, vomiting, esophagitis, esophageal erosions, esophageal ulcers, rarely esophageal stricture or perforation, and oropharyngeal ulceration; rarely, gastric or duodenal ulcers, some severe and with complications (see DOSAGE & ADMINISTRATION and PRECAUTIONS). Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), with delayed healing has been reported rarely (see PRECAUTIONS).
Musculoskeletal: bone, joint, and/or muscle pain, rarely severe and/or incapacitating (see PRECAUTIONS); joint swelling; low-energy femoral shaft fracture (see PRECAUTIONS).
Nervous System: dizziness, vertigo, dysgeusia.
Skin: rash (occasionally with photosensitivity), pruritus, alopecia, rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses: rarely uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis) has been reported rarely.
Laboratory Test Findings: In double-blind, multicenter, controlled studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking ALENDRONATE SODIUM (FOSAMAX) versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dL (2.0 mM) and serum phosphate to ≤ 2.0 mg P/dL (0.65 mM) were similar in both treatment groups.
Alendronate Sodium: If taken at the same time it is likely that calcium supplements, antacids, and other oral medications will interfere with absorption of alendronate. Therefore, patients must wait at least one-half hour after taking ALENDRONATE SODIUM + CHOLECALCIFEROL (FOSAVANCE) before taking any other oral medication.
No other drug interactions of clinical significance are anticipated.
Concomitant use of HRT (estrogen ± progestin) and ALENDRONATE SODIUM (FOSAMAX) was assessed in two clinical studies of one or two years' duration in postmenopausal osteoporotic women. Combined use of ALENDRONATE SODIUM (FOSAMAX) and HRT resulted in greater increases in bone mass, together with greater decreases in bone turnover, than seen with either treatment alone. In these studies, the safety and tolerability profile of the combination was consistent with those of the individual treatments (see Clinical Studies, Concomitant use with estrogen/hormone replacement therapy under SIDE EFFECTS).
Specific interaction studies were not performed. ALENDRONATE SODIUM (FOSAMAX) was used in osteoporosis studies in men and postmenopausal women with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions.
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Cholecalciferol: Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D.
Store at temperatures not exceeding 30°C. Protect from moisture and light. Store tablets in the original blister package until use.
M05BB03 - alendronic acid and colecalciferol ; Belongs to the class bisphosphonates, combinations. Used in the treatment of bone diseases.
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2's (P1,080/pack)
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