"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"...
Treatment Of Postmenopausal Osteoporosis
Fortical nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Fortical nasal spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Important Limitations Of Use
- Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see WARNINGS AND PRECAUTIONS].
- Calcitonin-salmon nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women.
DOSAGE AND ADMINISTRATION
Basic Dosing Information
The recommended dose of Fortical nasal spray is 1 spray (200 International Units) per day intranasally, alternating nostrils daily.
Priming (Activation) Of Pump
Unopened Fortical nasal spray should be stored in the refrigerator. Before using the first dose of Fortical nasal spray, the patient should wait until the bottle has reached room temperature. Remove the protective cap and clip from the bottle of Fortical nasal spray. To prime the pump before it is used for the first time, the bottle should be held upright and the two white side arms of the pump depressed 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 patient's head in the upright position, then the pump should be firmly depressed toward the bottle. The pump should not be primed before each daily use.
Recommendations For Calcium And Vitamin D Supplementation
Patients who use Fortical nasal spray should receive adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (at least 400 International Units per day).
Dosage Forms And Strengths
Fortical nasal spray consists of one glass bottle and one screw-on pump. The bottle contains 3.7 mL of calcitonin-salmon clear solution at a concentration of 2200 International Units per mL. A primed pump delivers 0.09 mL (200 International Units) calcitonin-salmon per actuation.
Fortical® (calcitonin-salmon [rDNA origin]) nasal spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle with screw-on pump that contains 2200 International Units of calcitonin-salmon per mL. Following priming, the pump will deliver 200 International Units of calcitonin-salmon per activation (0.09 mL per spray). Fortical® nasal spray is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump (NDC# 0245-0008-35).
Storage And Handling
Store unopened bottle in refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing. After opening, store bottle in use in an upright position at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). Discard the bottle after 30 doses have been used.
Distributed by : Upsher-Smith Laboratories, Inc., Maple Grove, MN USA 55369. www.upsher-smith.com. Revised 07/14
Last reviewed on RxList: 7/24/2014
This monograph has been modified to include the generic and brand name in many instances.
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