Product Description.:
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Miacalcin? (calcitonin-salmon) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin.
Active Ingredient: calcitonin-salmon 2200 I.U. per mL (corresponding to 200 I.U. per 0.09 mL actuation).
Inactive Ingredients: sodium chloride, benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH) and purified water.
The activity of Miacalcin Nasal Spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute of Biologic Standards and Control, Holly Hill, London.
INDICATIONS
Postmenopausal Osteoporosis
Miacalcin? (calcitonin-salmon) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Miacalcin Nasal Spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 I.U. per day) intake to retard the progressive loss of bone mass. The evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials.
Two randomized, placebo controlled trials were conducted in 325 postmenopausal females (227 Miacalcin Nasal Spray treated and 98 placebo treated) with spinal, forearm or femoral bone mineral density (BMD) at least one standard deviation below normal for healthy premenopausal females. These studies conducted over two years demonstrated that 200 I.U. daily of Miacalcin Nasal Spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic females who were greater than 5 years postmenopause. Miacalcin Nasal Spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as six months after initiation of therapy with persistence of this level for up to 2 years of observation.
No effects of Miacalcin 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 one year of treatment changing to a trend at 2 years that was no longer statistically significant.
DOSAGE AND ADMINISTRATION
The recommended dose of Miacalcin? (calcitonin-salmon) Nasal Spray in postmenopausal osteoporotic females is one spray (200 I.U.) per day administered intranasally, alternating nostrils daily.
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 Miacalcin 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 Miacalcin Nasal Spray therapy in these patients.
Priming (Activation) of Pump
Before the first dose and administration, Miacalcin Nasal Spray should be at room temperature. To prime the pump, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle 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 dose.
Store and Dispense
Store unopened bottle in refrigerator between 2?C-8?C (36?F-46?F). Protect from freezing.
Store bottle in use at room temperature between 15?C-30?C (59?F-86?F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses.
SIDE EFFECTS
The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to Miacalcin? (calcitonin-salmon) Nasal Spray (N=341) and to placebo nasal spray (N=131) and reported in greater than 3% of Miacalcin Nasal Spray-treated patients are presented below in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).
