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Calcitonin-Salmon

Pronunciation

Pronunciation: kal-sih-TOE-nin-salmon
Class: Endocrine-Metabolic agent

Trade Names

Fortical
- Nasal Spray 200 units/activation (0.09 mL/dose)

Miacalcin
- Injection 200 units/mL
- Nasal Spray 200 units/activation (0.09 mL/dose)

Apo-Calcitonin (Canada)
Caltine (Canada)
Miacalcin NS (Canada)
Sandoz Calcitonin NS (Canada)

Pharmacology

Decreases rate of bone turnover, presumably by regulating bone metabolism (blocking bone resorption). In conjunction with parathyroid hormone, endogenous calcitonin regulates serum calcium.

Slideshow: Flashback: FDA Drug Approvals 2013

Pharmacokinetics

Absorption

Injection

T max is 16 to 25 min.

Nasal

Rapidly absorbed. T max is 31 to 39 min. Bioavailability is approximately 3%.

Distribution

Calcitonin does not cross the placenta.

Metabolism

Rapidly metabolized to inactive fragments, primarily by the kidneys but also in the blood and peripheral tissues.

Elimination

A small amount is excreted in the urine. The t ½ is 43 min.

Duration

5 to 8 days (hypocalcemic effect after chronic dosing).

Indications and Usage

Injection and nasal spray

Treatment of postmenopausal osteoporosis in women more than 5 yr of age postmenopause who cannot tolerate estrogens.

Injection only

Treatment of moderate to severe Paget disease of bone; early treatment of hypercalcemic emergencies.

Contraindications

Standard considerations.

Dosage and Administration

Postmenopausal Osteoporosis
Adults

Subcutaneous / IM 100 units every other day with supplemental calcium and adequate vitamin D. Nasal 200 units/day (1 spray) with supplemental calcium and vitamin D, alternating nostrils.

Paget Disease
Adults Initial dose

Subcutaneous / IM 100 units/day.

Maintenance dose

Subcutaneous / IM 50 units/day or every other day is usually sufficient.

Hypercalcemia
Adults Starting dose

Subcutaneous / IM 4 units/kg every 12 h. Titrate gradually on basis of response to max dose of 8 units/kg every 6 h.

General Advice

  • For skin testing, dilute injection to 10 units/mL by withdrawing 0.05 mL of the 200 units/mL injection solution into a tuberculin syringe and fill to 1 mL with sodium chloride injection; mix well, then discard 0.9 mL of diluted solution; inject 0.1 mL on inner aspect of forearm and observe for 15 min; appearance of more than mild erythema or wheal constitutes positive response.
  • Injection
  • For subcutaneous or IM administration only. Not for intradermal, IV, or intra-arterial administration.
  • Do not administer if particulate matter, cloudiness, or discoloration noted.
  • If volume of injection exceeds 2 mL, use multiple sites with IM injection.
  • Nasal
  • Delivery system contains enough medication for at least 30 doses. Discard any unused solution after 30 doses because spray may not deliver correct dose.
  • Before priming pump and using new bottle, allow assembled bottle to come to room temperature.
  • Prime pump before first use by holding upright. Depress pump until full spray is produced. Do not prime pump before each daily dose.
  • To administer dose, carefully place nozzle in nostril, with head in upright position, and firmly depress pump.

Storage/Stability

Refrigerate injection (36° to 46°F). Refrigerate new, unassembled bottles of nasal spray. Protect from freezing. Store bottle in use at controlled room temperature (59° to 86°F) in upright position, for up to 35 days.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Nasal spray

Angina pectoris, hypertension (1% to 3%).

CNS

Nasal spray: Fatigue, depression, dizziness, paresthesia (1% to 3%). Injectable: Poor appetite; abdominal pain.

Dermatologic

Nasal spray

Erythematous rash (1% to 3%).

Injectable

Pruritus of ear lobes; skin rash.

EENT

Nasal spray

Rhinitis (12%); abnormal lacrimation, conjunctivitis (1% to 3%).

Injectable

Eye pain.

GI

Nasal spray

Abdominal pain, constipation, diarrhea, dyspepsia, nausea (1% to 3%).

Injectable

Nausea with or without vomiting (10%); salty taste.

Genitourinary

Nasal spray

Cystitis (1% to 3%).

Injectable

Nocturia.

Hematologic-Lymphatic

Nasal spray

Infection, lymphadenopathy (1% to 3%).

Local

Injectable

Inflammation at subcutaneous or IM site (10%).

Musculoskeletal

Nasal spray

Back pain (5%); arthralgia (4%); arthrosis, myalgia (1% to 3%).

Respiratory

Nasal spray

Epistaxis (4%); bronchospasm, sinusitis, upper respiratory tract infection (1% to 3%).

Miscellaneous

Nasal spray

Influenza-like symptoms (1% to 3%).

Injectable

Death caused by anaphylaxis (1 case), feet edema, feverish sensation.

Precautions

Monitor

Monitor serum electrolytes and calcium.

Injection

Monitor drug effect in Paget disease with periodic measurement of serum alkaline phosphatase and 24-h urinary hydroxyproline, and evaluation of symptoms. Evaluate urine sediment periodically in patients on chronic therapy.

Nasal

Periodically measure lumbar vertebral bone density to document stabilization of bone loss or increase in bone density. Monitor for nasal ulcerations.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Allergy

Systemic allergic reactions, including anaphylaxis, may occur. Consider skin testing for patients with suspected sensitivity to calcitonin.

Antibody formation

Circulating antibodies to calcitonin-salmon may occur after 2 to 18 mo of treatment. Treatment of Paget disease may or may not remain effective.

Hypocalcemic tetany

May occur with calcitonin. Although no cases have been reported, have parenteral calcium available during first several injections of calcitonin.

Osteogenic sarcoma

Incidence increased in Paget disease.

Overdosage

Symptoms

Nausea, vomiting.

Patient Information

  • Advise patient or caregiver to review patient information leaflet before starting therapy and with each refill.
  • Advise patient with osteoporosis of the following interventions, which help treat osteoporosis: 1,500 mg/day of calcium (diet and supplements); vitamin D supplementation; weight-bearing exercises; reduction of cigarette smoking and excessive alcohol consumption.
  • Advise patient that follow-up visits and laboratory tests may be required to monitor therapy and to keep appointments.
  • Nasal Spray
  • Ensure patient understands how to prepare nasal spray, prime the pump, and administer the spray. If possible, have patient demonstrate technique to confirm understanding. Remind patient that pump is only primed before first dose and not before each dose.
  • Instruct patient to keep track of total number of doses of nasal spray used and to discard the bottle after 30 doses have been used, even if some medicine remains in the bottle. Inform patient that even though some medicine may remain in the bottle, the pump may no longer be able to deliver the correct dose.
  • Advise patient to notify health care provider if nasal irritation, redness, sores, or bleeding develops.
  • Injection
  • Ensure patient who will be self-administering calcitonin understands how to store, prepare and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health care professional.
  • Remind patient to rotate injection sites and never to inject into tissue that is inflamed, irritated, or bruised.
  • Advise patient to notify health care provider if any of the following occur: persistent or recurrent nausea with or without vomiting, injection site reactions, or any unexplained symptoms or feelings.

Copyright © 2009 Wolters Kluwer Health.

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