"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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Miacalcin®(calcitonin-salmon) Injection, Synthetic is indicated for the treatment of symptomatic Paget's disease of bone, for the treatment of hypercalcemia, and for the treatment of postmenopausal osteoporosis.
At the present time, effectiveness has been demonstrated principally in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion.
In these patients, the biochemical abnormalities were substantially improved (more than 30% reduction) in about 2/3 of patients studied, and bone pain was improved in a similar fraction. A small number of documented instances of reversal of neurologic deficits have occurred, including improvement in the basilar compression syndrome, and improvement of spinal cord and spinal nerve lesions. At present, there is too little experience to predict the likelihood of improvement of any given neurologic lesion. Hearing loss, the most common neurologic lesion of Paget's disease, is improved infrequently (4 of 29 patients studied audiometrically).
Patients with increased cardiac output due to extensive Paget's disease have had measured decreases in cardiac output while receiving calcitonin. The number of treated patients in this category is still too small to predict how likely such a result will be.
The large majority of patients with localized, especially monostotic disease do not develop symptoms and most patients with mild symptoms can be managed with analgesics. There is no evidence that the prophylactic use of calcitonin is beneficial in asymptomatic patients, although treatment may be considered in exceptional circumstances in which there is extensive involvement of the skull or spinal cord with the possibility of irreversible neurologic damage. In these instances, treatment would be based on the demonstrated effect of calcitonin on Pagetic bone, rather than on clinical studies in the patient population in question.
Miacalcin Injection is indicated for early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
Miacalcin Injection 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 Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin Injection is recommended in conjunction with adequate calcium and vitamin D intake to prevent the progressive loss of bone mass. No evidence currently exists to indicate whether or not Miacalcin Injection decreases the risk of vertebral crush fractures or spinal deformity. A recent controlled study, which was discontinued prior to completion because of questions regarding its design and implementation, failed to demonstrate any benefit of salmon calcitonin on fracture rate. No adequate controlled trials have examined the effect of salmon calcitonin injection on vertebral bone mineral density beyond 1 year of treatment. Two placebo-controlled studies with salmon calcitonin have shown an increase in total body calcium at 1 year, followed by a trend to decreasing total body calcium (still above baseline) at 2 years. The minimum effective dose of Miacalcin Injection for prevention of vertebral bone mineral density loss has not been established. It has been suggested that those postmenopausal patients having increased rates of bone turnover may be more likely to respond to anti-resorptive agents such as Miacalcin Injection.
DOSAGE AND ADMINISTRATION
The recommended starting dose of Miacalcin® (calcitonin-salmon) Injection, Synthetic in Paget's disease is 100 I.U. (0.5 mL) per day administered subcutaneously (preferred for outpatient self-administration) or intramuscularly. Drug effect should be monitored by periodic measurement of serum alkaline phosphatase and 24-hour urinary hydroxyproline (if available) and evaluations of symptoms. A decrease toward normal of the biochemical abnormalities is usually seen, if it is going to occur, within the first few months. Bone pain may also decrease during that time. Improvement of neurologic lesions, when it occurs, requires a longer period of treatment, often more than one year.
In many patients, doses of 50 I.U. (0.25 mL) per day or every other day are sufficient to maintain biochemical and clinical improvement. At the present time, however, there are insufficient data to determine whether this reduced dose will have the same effect as the higher dose on forming more normal bone structure. It appears preferable, therefore, to maintain the higher dose in any patient with serious deformity or neurological involvement.
In any patient with a good response initially who later relapses, either clinically or biochemically, the possibility of antibody formation should be explored. The patient may be tested for antibodies by an appropriate specialized test or evaluated for the possibility of antibody formation by critical clinical evaluation.
Patient compliance should also be assessed in the event of relapse.
In patients who relapse, whether because of antibodies or for unexplained reasons, a dosage increase beyond 100 I.U. per day does not usually appear to elicit an improved response.
The recommended starting dose of Miacalcin Injection in hypercalcemia is 4 I.U./kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 I.U./kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 I.U./kg every 6 hours.
The minimum effective dose of Miacalcin Injection for the prevention of vertebral bone mineral density loss has not been established. Data from a single one-year placebo-controlled study with salmon calcitonin injection suggested that 100 I.U. (subcutaneously or intramuscularly) every other day might be effective in preserving vertebral bone mineral density. Baseline and interval monitoring of biochemical markers of bone resorption/turnover (e.g., fasting AM, second-voided urine hydroxyproline to creatinine ratio) and of bone mineral density may be useful in achieving the minimum effective dose. Patients should also receive supplemental calcium such as calcium carbonate 1.5 g daily and an adequate vitamin D intake (400 units daily). An adequate diet is also essential.
If the volume of Miacalcin Injection to be injected exceeds 2 mL, intramuscular injection is preferable and multiple sites of injection should be used.
Miacalcin vials should be inspected visually. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.
Miacalcin® (calcitonin-salmon) Injection, Synthetic is available as a sterile solution in individual 2 mL vials containing 200 I.U. per mL ......................................NDC 0078-0149-23
Store in refrigerator between 2°C-8°C (36°F-46°F).
Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936.
Last reviewed on RxList: 5/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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