Brand and Other Names:Fortical, Miacalcin
- Classes: Calcium Metabolism Modifiers
Dosing & Uses
Dosage Forms & Strengths
- 200 IU/mL (Miacalcin)
- 200 IU/actuation (Fortical, Miacalcin)
May increase to 8 IU/kg SC/IM q12hr; may increase up to a maximum 8 IU/kg q6hr if unresponsive
Initial dose: 100 IU SC/IM qDay
Maintenance: 50 IU/day or 50-100 IU every 1-3 days
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
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
Patients should receive adequate calcium (at least 1000 mg/day elemental calcium) and vitamin D (at least 400 IU/day)
- 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
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Back pain (5%)
Injection site reactions (10%)
Flushing of face or hands (2-5%)
Possible allergic reactions
Edema of feet
Possible local irritative effects in the respiratory tract
Frequency Not Defined
Hypersensitivity to calcitonin-salmon
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 & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown/not recommended
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.
Hypercalcemia: IM/SC: Initial effect takes 2 hour; max effect: 30 week
Paget's disease: Few months to a year for neurologic symptoms to improve
Duration: hypercalcemia: 6-8 hours
Peak Plasma Time: IM/SC: 16-25 minutes, Intranasal: 31-39 minutes
Bioavailability: Intranasal: 3%
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
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs