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FOSAMAX is a brand name for Alendronate (also known as Alendronic Acid), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FOSAMAX® (alendronate sodium) is indicated for: • The treatment of osteoporosis in postmenopausal women. o For the treatment of osteoporosis in postmenopausal women, FOSAMAX® increases bone mass and prevents fractures, including those of the hip and spine (vertebral compression fractures). • The treatment of…
Verbatim from this product's HC label. Tap a section to expand.
).
Pediatrics Pediatrics (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. FOSAMAX® (alendronate sodium) Page 5 of 49 Geriatrics Geriatrics (≥65 years of age): In clinical studies, there was no age-related difference in the efficacy or safety profiles of FOSAMAX® (see 14 CLINICAL TRIALS) 2 CONTRAINDICATIONS FOSAMAX® is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see
Adverse Reaction Overview The most common drug related adverse reactions include gastrointestinal disorders (abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer, dysphagia, acid regurgitation, melena, nausea and abdominal distention), musculoskeletal (bone, muscle or joint) pain and headache.
It is important to follow the recommended dosing instructions. 4 Administration. Osteonecrosis of the Jaw and atypical bone fractures have been observed under post marketing setting. See 7 Warnings and precautions, Musculoskeletal. Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Treatment of Osteoporosis Postmenopausal Women:
In two, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational) of virtually identical design, with a total of 994 postmenopausal women, the overall safety profiles of FOSAMAX® 10 mg/day and placebo were similar.
0% of 397 patients treated with placebo. Adverse experiences considered by the investigators as possibly, probably, or definitely drug- related in ≥ 1% of patients treated with either FOSAMAX® 10 mg/day or placebo are presented in the following table.
0 * Considered possibly, probably, or definitely drug-related as assessed by the investigators. One patient treated with FOSAMAX® (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant acetylsalicylic acid (ASA) developed an anastomotic ulcer with mild hemorrhage, which was considered drug-related.
08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 4 Pediatrics..................................................................................................................
4 Geriatrics .................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................
5 4 DOSAGE AND ADMINISTRATION................................................................................ 5 Dosing Considerations ............................................................................................. 5 Recommended Dose and Dosage Adjustment ........................................................
6 Administration ......................................................................................................... 6 Missed Dose .............................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS .................................................................................
FOSAMAX® is contraindicated in patients with • hypersensitivities to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. • the inability to stand or sit upright for at least 30 minutes. • hypocalcemia (see 7 WARNINGS AND PRECAUTIONS). 58 mL/s (<35 mL/min) (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ASA and FOSAMAX® were discontinued and the patient recovered. In the two-year extension (treatment years 4 and 5) of the above studies, the overall safety profile of FOSAMAX® 10 mg/day was similar to that observed during the three-year placebo- controlled period.
Additionally, the proportion of patients who discontinued FOSAMAX® 10 mg/day due to any clinical adverse experience was similar to that during the first three years of the study. 1% of 3223 patients treated with placebo. 7%. The overall adverse experience profile was similar to that seen in other studies with FOSAMAX® 5 or 10 mg/day.
In a one-year, double-blind multicenter study, the overall safety and tolerability profiles of FOSAMAX® 70 mg once weekly and FOSAMAX® 10 mg daily were similar. 1 * Considered possibly, probably, or definitely drug-related as assessed by the investigators.
Men:
In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of FOSAMAX® 10 mg/day [n=146] and a one-year study of FOSAMAX® 70 mg once weekly [n=109]), the safety profile of FOSAMAX® was generally similar to that seen in postmenopausal FOSAMAX® (alendronate sodium) Page 15 of 49 women.
7% for FOSAMAX®® mg/day vs. 4% for FOSAMAX® 70 mg once weekly vs. 6% for placebo.
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 FOSAMAX® 70 mg once weekly and placebo. In an additional one-year study in men and women (n=335; mean age: 50) the overall safety and tolerability profiles of FOSAMAX® 70 mg once weekly were similar to that of placebo and no difference was seen between men and women.
Prevention of Osteoporosis in Postmenopausal Women:
The safety of FOSAMAX® 5 mg/day in postmenopausal women 40-60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive FOSAMAX® for either two or three years.
In these studies, the overall safety profiles of FOSAMAX® 5 mg/day and placebo were similar. Discontinuation of therapy due to any clinical […]
8 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
11 8 ADVERSE REACTIONS............................................................................................... 12 Adverse Reaction Overview ................................................................................... 12 Clinical Trial Adverse Reactions .............................................................................
12 FOSAMAX® (alendronate sodium) Page 3 of 49 Less Common Clinical Trial Adverse Reactions ...................................................... 16 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
16 Post-Market Adverse Reactions............................................................................. 17 9 DRUG INTERACTIONS .............................................................................................. 18 Drug Interactions Overview ...................................................................................
18 Drug-Behavioural Interactions ............................................................................... 18 Drug-Drug Interactions .......................................................................................... 18 Drug-Food Interactions ..........................................................................................
19 Drug-Herb Interactions .......................................................................................... 19 Drug-Laboratory Test Interactions......................................................................... 20 10 CLINICAL PHARMACOLOGY ......................................................................................
20 Mechanism of Action ....................................................................................... 20 Pharmacodynamics .......................................................................................... 20 Pharmacokinetics .............................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 24 PART II: SCIENTIFIC INFORMATION ..................................................................................... 25 13 PHARMACEUTICAL INFORMATION ..........................................................................
25 14 CLINICAL TRIALS ...................................................................................................... 26 Clinical Trials by Indication ..............................................................................
26 15 MICROBIOLOGY ...................................................................................................... 39 16 NON-CLINICAL TOXICOLOGY ....................................................................................
40 PATIENT MEDICATION INFORMATION ................................................................................ 42 FOSAMAX® (alendronate sodium) Page 4 of 49 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS FOSAMAX® (alendronate sodium) is indicated for: • The treatment of osteoporosis in postmenopausal women.
o For the treatment of osteoporosis in postmenopausal women, FOSAMAX® increases bone mass and prevents fractures, including those of the hip and spine (vertebral compression fractures). • The treatment of osteoporosis in men. o For the treatment of osteoporosis in men, FOSAMAX® increases bone mass and reduces the […]