CALCITONIN-SALMON (calcitonin salmon) · Fresenius Kabi
Calcitonin-salmon is indicated for the treatment of symptomatic Paget’s disease of bone (moderate to severe) in patients who have not responded to or are unsuitable for alternative therapies. It is also used in the early treatment of hypercalcemic emergencies when a rapid decrease in serum calcium is required. Additionally, it is indicated for post-menopausal osteoporosis in women more than five years post-menopause for whom alternative treatments are not suitable; however, efficacy in fracture reduction has not been demonstrated. Due to a possible association with malignancy, the clinical necessity of continued treatment should be re-evaluated periodically.
How CALCITONIN-SALMON Works
Calcitonin-salmon is a calcitonin receptor agonist that acts primarily on bone, with additional recognized effects on the kidneys and gastrointestinal tract. By binding to specific receptors on osteoclasts and osteoblasts, it mimics the actions of mammalian calcitonin but exhibits greater potency per milligram and a longer duration of action. These actions inhibit bone resorption and increase renal calcium excretion to lower serum calcium levels.
Details
- Status
- Prescription
- First Approved
- 2008-11-17
- Routes
- INJECTION, NASAL
- Dosage Forms
- INJECTABLE, SPRAY, METERED
Companies
CALCITONIN-SALMON Approval History
What CALCITONIN-SALMON Treats
3 indicationsCALCITONIN-SALMON is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Symptomatic Paget’s disease of bone
- Hypercalcemia
- Post-menopausal osteoporosis
CALCITONIN-SALMON Competitive Set
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Indication competitors
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CALCITONIN-SALMON FDA Label Details
Indications & Usage
Calcitonin salmon injection, synthetic is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable Treatment of hypercalcemia Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated 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 1.1 Treatment of Paget’s Disease of Bone Calcitonin salmon injection i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.