Dosing and uses of Miacalcin (calcitonin salmon)
Adult dosage forms and strengths
injectable solution
- 200 IU/mL
nasal spray
- 200 IU/actuation
Hypercalcemia
Initial dose: 4 IU/kg SC/IM q12hr
May increase to 8 IU/kg SC/IM q12hr; may increase up to a maximum 8 IU/kg q6hr if unresponsive
Paget Disease
Initial dose: 100 IU SC/IM qDay
Maintenance: 50 IU/day or 50-100 IU every 1-3 days
Osteoporosis, Postmenopausal
Indicated for the treatment of postmenopausal osteoporosis in women greater than 5 yr postmenopause
100 IU SC/IM every other day with calcium and vitamin d
Nasal Spray: 1 spray (200 IU) qDay, alternate nostrils daily
Dosing Considerations
Fracture reduction efficacy for postmenopausal osteoporosis has not been demonstrated
Reserve use for patients for whom alternative treatments are not suitable
Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis (see Cautions)
Calcitonin-salmon nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women
Pediatric dosage forms and strengths
Safety and efficacy not established
Miacalcin (calcitonin salmon) adverse (side) effects
>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
Warnings
Contraindications
Hypersensitivity to calcitonin-salmon
Cautions
Serious hypersensitivity reactions, including fatal anaphylaxis, reported; consider skin testing prior to treatment
Hypocalcemia associated with tetany has been reported; ensure adequate intake of calcium and vitamin d
A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon-treated patients
Circulating antibodies to calcitonin-salmon may develop, and may cause loss of response to treatment
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown/not recommended
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.
Pharmacology of Miacalcin (calcitonin salmon)
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
Administration
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
