calcitonin salmon (Rx)

Brand and Other Names:Miacalcin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 200 IU/mL

nasal spray

  • 200 IU/actuation
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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

Safety and efficacy not established

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Interactions

Interaction Checker

and calcitonin salmon

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

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            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

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            Pregnancy & Lactation

            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.

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            Pharmacology

            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

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            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

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            Images

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            Formulary

            FormularyPatient Discounts

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            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.

            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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