Calcitonin Salmon

DEA Class; Rx

Common Brand Names; Miacalcin

  • Calcium Metabolism Modifiers

Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calcium
Synthetic salmon calcitonin is more potent and longer-acting than human calcitonin
Due to lower efficacy vs. other agents, not routinely used in Paget’s disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies

For the treatment of hypercalcemia.
For the treatment of moderate to severe symptomatic Paget’s disease.
For the treatment of osteoporosis in postmenopausal women who are more than 5 years past menopause.
For the acute management of bone pain due to an acute osteoporotic vertebral fracture.
Indicated for the treatment of postmenopausal osteoporosis in women greater than 5 yr postmenopause
 

Hypersensitivity to calcitonin-salmon

  • Rhinitis (12%)
  • Arthralgia (4%)
  • Back pain (5%)
  • Expistaxis (4%)
  • Injection site reactions (10%)
  • Nausea (10%)
  • Headache (3%)
  • Flushing of face or hands (2-5%)
  • Abdominal pain
  • Possible allergic reactions
  • Appetite decreased
  • Edema of feet
  • Eye pain
  • Feverish sensation
  • Nausea
  • Nocturia
  • Possible local irritative effects in the respiratory tract
  • Salty taste
  • Tremors

Serious hypersensitivity reactions, including fatal anaphylaxis, reported; consider skin testing prior to treatment

Hypocalcemia must be corrected before initiating therapy; also correct and treat other disorders affecting mineral metabolism (such as vitamin D deficiency); in patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored

Use of injection for treatment of Paget’s disease or postmenopausal osteoporosis recommended in conjunction with adequate intake of calcium and vitamin D

Overall incidence of malignancies reported to be higher in clinical trials among calcitonin-salmon-treated patients; this suggests increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients; not possible to exclude increased risk when calcitonin-salmon administered long-term subcutaneously, intramuscularly, or intravenously; benefits for individual patients should be carefully considered against possible risks

Circulating antibodies reported with treatment; consider possibility of antibody formation in any patient with an initial response to injection who later stops responding to treatment

Coarse granular casts and casts containing renal tubular epithelial cells reported in young adult volunteers at bed rest given injectable calcitonin-salmon to study effect of immobilization on osteoporosis; no other evidence of renal abnormality reported; urine sediment normalized after therapy was stopped; consider performing periodic examinations of urine sediment

Miacalcin nasal spray is not indicated for use in females of reproductive potential; there are no data with use of in pregnant women

Nasal spray is not indicated for use in females of reproductive potential; there is no information on presence in human milk

Adults

200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.

Geriatric

200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously.

Adolescents

Safety and efficacy have not been established; off-label use reported for selected conditions.

Children

Safety and efficacy have not been established; off-label use reported for selected conditions.

Infants

Safety and efficacy have not been established.

Calcitonin salmon

injectable solution

  • 200 IU/mL

nasal spray

  • 200 IU/actuation

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