calcitonin salmon (Rx)

>10%

Rhinitis (12%)

1-10%

Arthralgia (4%)

Back pain (5%)

Expistaxis (4%)

Injection site reactions (10%)

Nausea (10%)

Headache (3%)

Flushing of face or hands (2-5%)

<1%

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

Frequency Not Defined

Tremors

Contraindications

Hypersensitivity to calcitonin-salmon

Cautions

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

Pregnancy

Miacalcin nasal spray is not indicated for use in females of reproductive potential; there are no data with use of in pregnant women; in an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 4- 18 times the recommended parenteral human dose caused a decrease in fetal birth weights; no adverse developmental outcome was observed in rat with subcutaneous administration of cal-citonin-salmon at 9 times recommended human parenteral dose based on body surface area

Lactation

Nasal spray is not indicated for use in females of reproductive potential; there is no information on presence in human milk, effects on breastfed child, or on milk production; shown to inhibit lactation in rats

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Inhibits osteoclastic bone resorption, decreases serum calcium, and increases renal excretion of phosphate, calcium, sodium magnesium and potassium by decreasing tubular reabsorption

Absorption

Duration of action (hypercalcemia): 6-8 hr

Peak plasma time: 16-25 minutes (IM/SC), 31-39 minutes (intranasal)

Bioavailability: 3% (intranasal)

Onset of action

• Hypercalcemia (IM/SC): Initial effect takes 2 hr; max effect: 30 week
• Paget disease: Few months to a year for neurologic symptoms to improve

Metabolism

Kidney

Elimination

Half-life: 43 min

Excretion: Urine

IM/SC Administration

Patients should receive adequate calcium (at least 1000 mg/day elemental calcium) and vitamin D (at least 400 IU/day)

Intranasal Administration

Store unopened nasal spray in the refrigerator

Before using the first dose, wait until the bottle has reached room temperature and prime the pump before it is used for the first time

To administer, the nozzle should be carefully placed into the nostril with the patient’s head in the upright position, then the pump should be firmly depressed toward the bottle

The pump should not be primed before each daily use