Approved & therapeutic
Calcitonin salmon
Miacalcin (brand discontinued; only generic calcitonin salmon is marketed in the US)
Calcitonin salmon is a synthetic 32-amino-acid analogue of the salmon hormone. The injection is FDA-approved for symptomatic Paget's disease of bone and for postmenopausal osteoporosis in women more than five years past menopause, in both cases only when alternative treatments are not suitable, and for hypercalcemia. A nasal spray is approved for postmenopausal osteoporosis alone, again only when alternatives are not suitable. Both labels state that fracture reduction efficacy has not been demonstrated. The drug has been displaced by more effective osteoporosis agents and carries an unresolved malignancy signal that the label says requires periodic re-evaluation of continued therapy.
- Status
- Calcitonin salmon is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- About 1 hour in humans: terminal half-life approximately 58 minutes after intramuscular and 59 to 64 minutes after subcutaneous administration (injection label, Clinical Pharmacology).
- How it's taken
- Subcutaneous or intramuscular injection (Paget's disease, hypercalcemia, postmenopausal osteoporosis); a nasal spray formulation is marketed for postmenopausal osteoporosis only and requires baseline and periodic nasal examination
- Mechanism
- Other
How Calcitonin salmon works
Calcitonin salmon binds calcitonin receptors on osteoclasts, inhibiting their activity and reducing bone resorption. It also increases renal excretion of calcium and phosphate, which contributes to the acute lowering of serum calcium. Salmon calcitonin is considerably more potent at the human receptor than the human sequence.
What research has looked at
- Both the injection and the nasal spray labels state, in Indications and Usage, that fracture reduction efficacy has not been demonstrated. This is the FDA position for every marketed formulation, not a distinction between them.
- The labeled efficacy evidence for the nasal spray is bone mineral density, not fractures: two 2-year randomized placebo-controlled trials in 266 postmenopausal women more than five years past menopause showed lumbar spine bone density gains of about 1.4 and 2.9 percent over placebo. No cortical bone effect was demonstrated at the forearm or hip, and the label states it has not been shown to increase bone mineral density in early postmenopausal women.
- Outside the label, the 5-year PROOF trial (1,255 participants) reported a roughly 33 percent reduction in new vertebral fractures for one intermediate nasal dose, with neither the lower nor the higher dose separating from placebo. The absent dose-response, high attrition, and lack of nonvertebral or hip fracture benefit are why FDA did not accept this as fracture efficacy; it does not appear anywhere in the current US label.
- It lowers serum calcium rapidly in hypercalcemia, though the effect commonly wanes within days as tachyphylaxis develops.
- In symptomatic Paget's disease of bone, it reduces serum alkaline phosphatase and urinary hydroxyproline and has been reported to improve bone pain in some patients. The injection is indicated here only when alternative treatments are not suitable.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Contraindicated in patients with hypersensitivity to calcitonin salmon or any excipient. Reported reactions include anaphylaxis with death, bronchospasm, and swelling of the tongue or throat.
- Serious hypersensitivity reactions have been reported, including bronchospasm, swelling of the tongue or throat, anaphylactic shock and death due to anaphylaxis. Appropriate medical support should be readily available; the label advises considering skin testing before treatment in patients with suspected sensitivity.
- Malignancy: a meta-analysis of 21 randomized controlled trials found a higher overall incidence of malignancies in calcitonin salmon-treated patients (254 of 6,151, 4.1 percent) than placebo (137 of 4,732, 2.9 percent); risk difference 1.0 percent (95 percent CI 0.3 to 1.6). The label notes this result was heavily influenced by a single large 5-year trial with an observed risk difference of 3.4 percent. An increased risk cannot be excluded and benefit should be weighed against it.
- Limitations of Use: because of the possible association between malignancy and calcitonin salmon use, the label directs that the need for continued therapy be re-evaluated on a periodic basis.
- Hypocalcemia associated with tetany and seizure activity has been reported. Hypocalcemia must be corrected before starting, vitamin D deficiency should be treated, and provisions for parenteral calcium should be available during initial doses.
- Nasal spray only: nasal adverse reactions including rhinitis and epistaxis occur and mucosal alterations may develop. The label requires nasal examination with visualization of the mucosa, turbinates, septum and mucosal blood vessels before starting treatment, periodically during therapy, and whenever nasal symptoms occur. Discontinue for severe ulceration.
- Antibody formation to calcitonin salmon occurs and may cause loss of response; consider it in a patient who initially responds and later stops responding.
- Urine sediment abnormalities (coarse granular casts, casts containing renal tubular epithelial cells) have been reported with the injection; the label suggests considering periodic urine sediment examination. Sediment normalized after stopping treatment.
- Injection: nausea with or without vomiting (about 10 percent) and injection site inflammation (about 10 percent) are the most common reactions; facial or hand flushing occurs in 2 to 5 percent.
- Nasal spray: the most commonly reported nasal adverse reactions were rhinitis (12 percent), epistaxis (4 percent) and sinusitis (2 percent). Note that in the label's controlled-trial table epistaxis was 4 percent on drug versus 5 percent on placebo, and non-rhinitis nasal symptoms 11 percent versus 16 percent on placebo, so not all reported nasal events exceed placebo.
- Both indications are gated on alternative treatments not being suitable. The Miacalcin brand is discontinued in the US for both the injection and the nasal spray; only generic products remain marketed.
Sources
- PubMed research on Calcitonin salmon · NIH · National Library of Medicine
- DrugBank record for Calcitonin salmon · DrugBank
- Active clinical trials for Calcitonin salmon · U.S. National Library of Medicine
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Calcitonin salmon FAQ
What is Calcitonin salmon?
Calcitonin salmon is a synthetic 32-amino-acid analogue of the salmon hormone. The injection is FDA-approved for symptomatic Paget's disease of bone and for postmenopausal osteoporosis in women more than five years past menopause, in both cases only when alternative treatments are not suitable, and for hypercalcemia. A nasal spray is approved for postmenopausal osteoporosis alone, again only when alternatives are not suitable. Both labels state that fracture reduction efficacy has not been demonstrated. The drug has been displaced by more effective osteoporosis agents and carries an unresolved malignancy signal that the label says requires periodic re-evaluation of continued therapy.
How does Calcitonin salmon work?
Calcitonin salmon binds calcitonin receptors on osteoclasts, inhibiting their activity and reducing bone resorption. It also increases renal excretion of calcium and phosphate, which contributes to the acute lowering of serum calcium. Salmon calcitonin is considerably more potent at the human receptor than the human sequence.
Is Calcitonin salmon FDA approved?
Yes. Calcitonin salmon is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Calcitonin salmon?
Reported half-life: About 1 hour in humans: terminal half-life approximately 58 minutes after intramuscular and 59 to 64 minutes after subcutaneous administration (injection label, Clinical Pharmacology).
How is Calcitonin salmon taken?
Subcutaneous or intramuscular injection (Paget's disease, hypercalcemia, postmenopausal osteoporosis); a nasal spray formulation is marketed for postmenopausal osteoporosis only and requires baseline and periodic nasal examination.
What side effects have been reported with Calcitonin salmon?
Reported in the sources: Contraindicated in patients with hypersensitivity to calcitonin salmon or any excipient. Reported reactions include anaphylaxis with death, bronchospasm, and swelling of the tongue or throat; Serious hypersensitivity reactions have been reported, including bronchospasm, swelling of the tongue or throat, anaphylactic shock and death due to anaphylaxis. Appropriate medical support should be readily available; the label advises considering skin testing before treatment in patients with suspected sensitivity; Malignancy: a meta-analysis of 21 randomized controlled trials found a higher overall incidence of malignancies in calcitonin salmon-treated patients (254 of 6,151, 4.1 percent) than placebo (137 of 4,732, 2.9 percent); risk difference 1.0 percent (95 percent CI 0.3 to 1.6). The label notes this result was heavily influenced by a single large 5-year trial with an observed risk difference of 3.4 percent. An increased risk cannot be excluded and benefit should be weighed against it; Limitations of Use: because of the possible association between malignancy and calcitonin salmon use, the label directs that the need for continued therapy be re-evaluated on a periodic basis; Hypocalcemia associated with tetany and seizure activity has been reported. Hypocalcemia must be corrected before starting, vitamin D deficiency should be treated, and provisions for parenteral calcium should be available during initial doses; Nasal spray only: nasal adverse reactions including rhinitis and epistaxis occur and mucosal alterations may develop. The label requires nasal examination with visualization of the mucosa, turbinates, septum and mucosal blood vessels before starting treatment, periodically during therapy, and whenever nasal symptoms occur. Discontinue for severe ulceration; Antibody formation to calcitonin salmon occurs and may cause loss of response; consider it in a patient who initially responds and later stops responding; Urine sediment abnormalities (coarse granular casts, casts containing renal tubular epithelial cells) have been reported with the injection; the label suggests considering periodic urine sediment examination. Sediment normalized after stopping treatment; Injection: nausea with or without vomiting (about 10 percent) and injection site inflammation (about 10 percent) are the most common reactions; facial or hand flushing occurs in 2 to 5 percent; Nasal spray: the most commonly reported nasal adverse reactions were rhinitis (12 percent), epistaxis (4 percent) and sinusitis (2 percent). Note that in the label's controlled-trial table epistaxis was 4 percent on drug versus 5 percent on placebo, and non-rhinitis nasal symptoms 11 percent versus 16 percent on placebo, so not all reported nasal events exceed placebo; Both indications are gated on alternative treatments not being suitable. The Miacalcin brand is discontinued in the US for both the injection and the nasal spray; only generic products remain marketed.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.