"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
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FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. Use of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (400 International Units per day) intake to retard the progressive loss of bone mass. The evidence of efficacy for calcitonin-salmon is based on increases in spinal bone mineral density (BMD) observed in clinical trials.
Two randomized, placebo-controlled trials were conducted in 325 postmenopausal women (227 treated with calcitonin-salmon nasal spray and 98 treated with placebo) with spinal, forearm or femoral BMD at least one standard deviation below the normal value for healthy premenopausal women. These studies conducted over two years demonstrated that 200 International Units daily of calcitonin-salmon nasal spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic women who were greater than 5 years postmenopause. Calcitonin-salmon nasal spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as 6 months after initiation of therapy with persistence of this level for up to 2 years of observation.
No effects of calcitonin-salmon nasal spray on cortical bone of the forearm or hip were demonstrated. However, in one study, BMD of the hip showed a statistically significant increase compared with placebo in a region composed of predominantly trabecular bone after 1 year of treatment changing to a trend at 2 years that was no longer statistically significant.
DOSAGE AND ADMINISTRATION
The recommended dose of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray in postmenopausal osteoporotic patients is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily. Each bottle, filled with 3.7 mL of solution, contains enough medication for 30 doses. Drug effect may be monitored by periodic measurements of lumbar vertebral bone mass to document stabilization of bone loss or increases in bone density. Effects of calcitonin-salmon nasal spray on biochemical markers of bone turnover have not been consistently demonstrated in studies in postmenopausal osteoporosis. Therefore, these parameters should not be solely utilized to determine clinical response to calcitonin-salmon nasal spray therapy in these patients.
Priming (Activation) of Pump
Before the first dose and administration, allow the bottle to reach room temperature. Remove the protective cap and clip from the bottle of FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray. To prime the pump, hold the bottle upright and depress the two white side arms of the pump toward the bottle at least 5 times until a full spray is produced. The pump is primed once the first full spray is emitted. To administer, the nozzle should be carefully placed into the nostril with the head in the upright position and the pump firmly depressed toward the bottle. The pump should NOT be primed before each daily use.
FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL). A screw-on pump is provided. Following priming, the pump will deliver solution containing 200 International Units of calcitonin-salmon per activation. FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray contains 2200 International Units /mL calcitonin-salmon and is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump (NDC# 0245-0008-35).
Store and Dispense
Store unopened bottle in refrigerator between 36°F to 46°F (2°C to 8°C). Protect from freezing. After opening, store bottle in use in an upright position at 68°F to 77°F (20°C to 25°C). Excursions permitted to 15°C to 30°C (59°F to 86°F). Throw away the empty bottle of Fortical® Nasal Spray after you have used 30 doses.
Distributed by: Upsher-Smith Laboratories, Inc. Minneapolis, MN USA 55447-4709. Revised 0411
Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.
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