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

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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              Serious - Use Alternative (0)

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                  Minor (5)

                  • magnesium chloride

                    calcitonin salmon increases levels of magnesium chloride by decreasing renal clearance. Minor/Significance Unknown.

                  • magnesium citrate

                    calcitonin salmon increases levels of magnesium citrate by decreasing renal clearance. Minor/Significance Unknown.

                  • magnesium hydroxide

                    calcitonin salmon increases levels of magnesium hydroxide by decreasing renal clearance. Minor/Significance Unknown.

                  • magnesium oxide

                    calcitonin salmon increases levels of magnesium oxide by decreasing renal clearance. Minor/Significance Unknown.

                  • magnesium sulfate

                    calcitonin salmon increases levels of magnesium sulfate by decreasing renal clearance. Minor/Significance Unknown.

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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 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

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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

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Miacalcin injection
                  -
                  200 unit/mL vial
                  calcitonin (salmon) nasal
                  -
                  200 unit/actuation aerosol
                  calcitonin (salmon) nasal
                  -
                  200 unit/actuation aerosol

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Select a drug:
                  Patient Education
                  calcitonin (salmon) nasal

                  CALCITONIN SPRAY - NASAL

                  (KAL-si-TOE-nin)

                  COMMON BRAND NAME(S): Fortical, Miacalcin

                  USES: This medication is used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past "the change of life" (menopause). Calcitonin works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.This product has been withdrawn from the Canadian market due to safety problems.

                  HOW TO USE: Read the patient and product information sheets if available from your pharmacist before you start using calcitonin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.This medication is for use in the nose as directed, usually one spray in one nostril each day, alternating nostrils daily. It is recommended to use this medication at the lowest effective dosage and for the shortest possible duration to treat your condition. Patients treated long-term with this medication have shown a rare risk of developing cancer. Discuss the benefits and risks of long term treatment with this medication.Remove a new bottle from the refrigerator and allow it to reach room temperature. Follow the instructions on how to prime the pump the first time you use a new bottle. Once the pump is primed, it does not have to be reprimed if the bottle is properly stored in an upright position. Consult your pharmacist if you have any questions.To use the nasal spray, remove the protective cap, keep your head upright and insert the tip into a nostril. Press down firmly on the pump to deliver the medication. Replace the protective cap. Use the other nostril the next day.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

                  SIDE EFFECTS: (See also How to Use section).Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nasal sores, muscle cramps/spasms, numbness/tingling of the arms/legs.Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before taking calcitonin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low level of calcium in the blood.This medication is used mainly in women after menopause. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: lithium.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.Laboratory and/or medical tests (e.g., bone density tests, nasal exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                  MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                  STORAGE: Store unopened bottles in the refrigerator. Do not freeze. Once the bottle is opened and the pump is primed, store at room temperature in an upright position away from light and moisture. Discard the unused portion after the number of days/doses noted on the package. If you are unsure when to discard your brand, ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  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.
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                  • 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.

                  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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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.