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 (Calcitonin) (salmon) nasal spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin (Calcitonin) (salmon) nasal spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 IU 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 Calcitonin (salmon) 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 IU daily of Miacalcin (Calcitonin) (salmon) nasal spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic females who were greater than 5 years postmenopause. Miacalcin (Calcitonin) (salmon) nasal spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as six months after initiation of therapy with persistance of this level for up to 2 years of observation. No effects of Miacalcin (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 one year of treatment changing to a trend at 2 years that was no longer statistically significant.

Follow the directions for using Miacalcin provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about Miacalcin side effects. BEFORE THE FIRST DOSE, the pump must be activated. Hold the bottle upright and depress the 2 white side arms toward the bottle until a faint spray is seen. This needs to be done the first time only. After the first faint spray is seen, the bottle is activated and ready for use. TO USE THIS MEDICINE: Use medicine in only 1 nostril each day. Alternate nostrils every day. Per the manufacturer, place the nozzle into the nostril with your head upright and depress the pump toward the bottle. It is not necessary to inhale while spraying this medicine. Per the manufacturer, place the nozzle into the nostril with your head bent slightly forward and depress the pump toward the bottle. After taking a dose, sniff vigorously several times to prevent the medicine from running out of the nose. STORE THE UNOPENED BOTTLE in the refrigerator. After opening, the bottle may be kept at room temperature until gone (up to 30 days). Store the bottle in an upright position. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Miacalcin side effects, that may go away during treatment, include dry nose, stuffy nose, or runny nose. If Miacalcin side effects continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience Miacalcin side effects like sores in nose, nosebleeds, or rash. If you notice other Miacalcin side effects not listed above, contact your doctor, nurse, or pharmacist.

The recommended dose of Miacalcin (Calcitonin) (salmon) nasal spray in postmenopausal osteoporotic females is 200 IU per day administered intranasally, alternating nostrils daily. Miacalcin (Calcitonin) 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 (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 Miacalcin (Calcitonin) (salmon) nasal spray therapy in these patients. Activation of Pump: Before the first dose, it is necessary to activate the pump. The bottle should be held upright and the two white side arms depressed toward the bottle six times until a faint spray is emitted. The pump is activated once this first faint spray has been emitted. At this point, the nozzle should be placed firmly into the nostril with the head in the upright position, and the pump depressed toward the bottle. It is not necessary to reactivate the pump before each daily dose.