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Medication Safety Issues

Sound-alike/look-alike issues:

Calcitonin may be confused with calcitriol

Miacalcin® may be confused with Micatin®

Calcitonin nasal spray is administered as a single spray into one nostril daily, using alternate nostrils each day.

Pronunciation

(kal si TOE nin)

U.S. Brand Names

• Fortical®
• Miacalcin®

Index Terms

• Calcitonin (Salmon)

Generic Available

Yes: Intranasal solution

Canadian Brand Names

• Apo-Calcitonin®
• Calcimar®
• Caltine®
• Miacalcin® NS
• Pro-Calcitonin

Pharmacologic Category

• Antidote
• Hormone

Use: Labeled Indications

Calcitonin (salmon): Treatment of Paget's disease of bone (osteitis deformans); adjunctive therapy for hypercalcemia; treatment of osteoporosis in women >5 years postmenopause

Pregnancy Risk Factor

C

Pregnancy Considerations

Decreased birth weight was observed in animal studies. Calcitonin does not cross the placental barrier. There are no adequate and well-controlled studies in pregnant women.

Lactation

Excretion in breast milk unknown/not recommended

Breast-Feeding Considerations

Has been shown to decrease milk production in animals.

Contraindications

Hypersensitivity to calcitonin salmon or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Salmon-derived products: Have epinephrine immediately available for a possible hypersensitivity reaction. A skin test should be performed prior to initiating therapy of calcitonin salmon in patients with suspected sensitivity; a detailed skin testing protocol is available from the manufacturer.

Special populations:

• Pediatrics: Safety and efficacy have not been established in children.

Dosage form specific issues:

• Nasal spray: Temporarily withdraw use of nasal spray if ulceration of nasal mucosa occurs. Patients >65 years of age may experience a higher incidence of nasal adverse events with calcitonin nasal spray.

Adverse Reactions

Unless otherwise noted, frequencies reported are with nasal spray.

>10%: Respiratory: Rhinitis (12%)

1% to 10%:

Cardiovascular: Flushing (nasal spray: <1%; injection: 2% to 5%), angina (1% to 3%), hypertension (1% to 3%)

Central nervous system: Depression (1% to 3%), dizziness (1% to 3%), fatigue (1% to 3%)

Dermatologic: Erythematous rash (1% to 3%)

Gastrointestinal: Abdominal pain (1% to 3%), constipation (1% to 3%), diarrhea (1% to 3%), dyspepsia (1% to 3%), nausea (injection: 10%; nasal spray: 1% to 3%)

Genitourinary: Cystitis (1% to 3%)

Local: Injection site reactions (injection: 10%)

Neuromuscular & skeletal: Back pain (5%), arthrosis (1% to 3%), myalgia (1% to 3%), paresthesia (1% to 3%)

Ocular: Conjunctivitis (1% to 3%), lacrimation abnormality (1% to 3%)

Respiratory: Bronchospasm (1% to 3%), sinusitis (1% to 3%), upper respiratory tract infection (1% to 3%)

Miscellaneous: Flu-like syndrome (1% to 3%), infection (1% to 3%), lymphadenopathy (1% to 3%)

<1%: Agitation, allergic reactions, alopecia, anaphylaxis, anemia, anorexia, anxiety, appetite increased, arthritis, blurred vision, bronchitis, bundle branch block, cerebrovascular accident, cholelithiasis, cough, diaphoresis, dyspnea, earache, eczema, fever, flatulence, gastritis, goiter, hearing loss, hematuria, hepatitis, hyperthyroidism, insomnia, migraine, myocardial infarction, neuralgia, nocturia, palpitation, parosmia, periorbital edema, pharyngitis, pneumonia, polymyalgia rheumatica, pruritus, pyelonephritis, rash, renal calculus, skin ulceration, stiffness, tachycardia, taste perversion, thirst, thrombophlebitis, tinnitus, vertigo, vitreous floater, vomiting, weight gain, xerostomia

Drug Interactions

There are no known significant interactions.

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase risk of osteoporosis).

Storage

Injection: Store under refrigeration at 2°C to 8°C (36°F to 46°F); protect from freezing.

Nasal: Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze.

Fortical®: After opening, store for up to 30 days at 20?C to 25?C (68?F to 77?F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in upright position.

Miacalcin®: After opening, store for up to 35 days at room temperature of 15°C to 30°C (59°F to 86°F). Store in upright position.

Reconstitution

Injection: NS has been recommended for the dilution to prepare a skin test in patients with suspected sensitivity.

Mechanism of Action

Peptide sequence similar to human calcitonin; functionally antagonizes the effects of parathyroid hormone. Directly inhibits osteoclastic bone resorption; promotes the renal excretion of calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption; increases the jejunal secretion of water, sodium, potassium, and chloride

Pharmacodynamics/Kinetics

Hypercalcemia: I.M. or SubQ:

Onset of action: ~2 hours

Duration: 6-8 hours

Absorption: Nasal: ~3% of I.M. level (range: 0.3% to 31%)

Distribution: Does not cross placenta

Half-life elimination: SubQ: 1.2 hours; Nasal: 43 minutes

Time to peak: Nasal: ~30-40 minutes

Excretion: Urine (as inactive metabolites)

Dosage

Children: Dosage not established

Adults:

Paget's disease (Miacalcin®): I.M., SubQ: Initial: 100 units/day; maintenance: 50 units/day or 50-100 units every 1-3 days

Hypercalcemia (Miacalcin®): Initial: I.M., SubQ: 4 units/kg every 12 hours; may increase up to 8 units/kg every 12 hours to a maximum of every 6 hours

Postmenopausal osteoporosis:

I.M., SubQ: Miacalcin®: 100 units/every other day

Intranasal: Fortical®, Miacalcin®: 200 units (1 spray) in one nostril daily

Administration: I.M.

Administer injection solution I.M. or SubQ; intramuscular route is recommended over the subcutaneous route when the volume of calcitonin to be injected exceeds 2 mL.

Administration: Inhalation

Nasal spray: Before first use, allow bottle to reach room temperature, then prime pump by releasing at least 5 sprays until full spray is produced. To administer, place nozzle into nostril with head in upright position. Alternate nostrils daily. Do not prime pump before each daily use. Discard after 30 doses.

Monitoring Parameters

Serum electrolytes and calcium; alkaline phosphatase and 24-hour urine collection for hydroxyproline excretion (Paget's disease), urinalysis (urine sediment); bone mineral density

Nasal formulation: Visualization of nasal mucosa, turbinate, septum, and mucosal blood vessels)

Reference Range

Therapeutic: <19 pg/mL (SI: 19 ng/L) basal, depending on the assay

Dietary Considerations

Adequate vitamin D and calcium intake is essential for preventing/treating osteoporosis. Patients with Paget's disease and hypercalcemia should follow a low calcium diet as prescribed.

Patient Education

Do not take any new medication during therapy unless approved by prescriber. If administered by injection, you or a significant other will be instructed on how to give the injections and dispose of syringes/needles (follow directions exactly). Keep drug vials in refrigerator; do not freeze. May cause increased warmth and flushing (this should only last about 1 hour after administration; taking drug in evening may minimize these discomforts). Report significant nasal irritation if using nasal spray. Immediately report twitching, muscle spasm, dark-colored urine, hives, significant skin rash, palpitations, or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Geriatric Considerations

Studies have shown calcitonin's effects on bone density and fracture rates are beneficial, particularly in women unable to tolerate estrogens. Calcium and vitamin D supplements should also be given. Calcitonin may also be effective in steroid-induced osteoporosis and other states associated with high bone turnover. Nasal spray may provide faster onset of analgesic effects than I.M.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause depression, dizziness, or fatigue. Rarely associated with agitation, anxiety, and insomnia.

Mental Health: Effects on Psychiatric Treatment

May cause GI side effects; concomitant use with SSRIs, carbamazepine, valproic acid, and lithium may produce additive effects.

Nursing: Physical Assessment/Monitoring

Skin test should be administered before initiating therapy (increased erythema or skin wheal indicates positive reaction and allergy). Assess potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking. Assess results of laboratory tests and patient response (eg, hypocalcemic tetany, hypercalcemia) at regular intervals during therapy. Teach appropriate administration (eg, subcutaneous or I.M. injections or nasal spray), dietary requirements (low calcium diet if used for hypercalcemia), possible side effects/appropriate interventions, and adverse symptoms to report.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [calcitonin-salmon]:

Miacalcin®: 200 int. units/mL (2 mL)

Solution, intranasal [spray, calcitonin-salmon]: 200 int. units/0.09 mL (3.7 mL, 3.8 mL)

Fortical®: 200 int. units/0.09 mL (3.7 mL) [rDNA origin; contains benzyl alcohol; delivers 30 doses, 200 int. units/actuation]

Miacalcin®: 200 int. units/0.09 mL (3.7 mL) [contains benzalkonium chloride; delivers 30 doses, 200 int. units/actuation]

Pricing: U.S. (www.drugstore.com)

Solution (Calcitonin (Salmon))

200 units/ACT (3.7): $109.99

Solution (Fortical)

200 units/ACT (3.7): $74.99

Solution (Miacalcin)

200 units/ACT (3.7): $123.32

200 units/mL (2): $59.99

References

Bauwens SF, “Osteomalacia and Osteoporosis,” Pharmacotherapy: A Pathophysiologic Approach, 2nd ed, DiPiro JT, Talbert RL, Hayes PE, et al, eds, New York, NY, 1992, 1293-312.

Bergqvist E, Sjoberg HE, Hjern B, et al, “Calcitonin in the Treatment of Hypercalcaemic Crisis,” Acta Med Scand, 1972, 192(5):385-9.

Lyritis GP, Tsakalakos N, Magiasis B, et al, “Analgesic Effect of Salmon Calcitonin in Osteoporotic Vertebral Fractures: A Double-Blind, Placebo-Controlled Clinical Study,” Calcif Tissue Int, 1991, 49(6):369-72.

Pontiroli AE, Pajetta E, Scaglia L, et al, “Analgesic Effect of Intranasal and Intramuscular Salmon Calcitonin in Postmenopausal Osteoporosis: A Double-Blind, Double-Placebo Study,” Aging (Milano), 1994, 6(6):459-63.

Reginster JY, Deroisy R, Lecart MP, et al, “A Double-Blind, Placebo-Controlled, Dose-Finding Trial of Intermittent Nasal Salmon Calcitonin for Prevention of Postmenopausal Lumbar Spine Bone Loss,” Am J Med, 1995, 98(5):452-8.

Reginster JY, “Calcitonin for Prevention and Treatment of Osteoporosis,” Am J Med, 1993, 95(5A):44S-47S.

Stevenson JC, “Current Management of Malignant Hypercalcemia,” Drugs, 1988, 36(2):229-30.

International Brand Names

• Cadens (FR)
• Calci-10 (TH)
• Calcihexal [salmon] (PL)
• Calcinin (TW)
• Calcitonin [salmon] (PL)
• Calcitoran (JP)
• Calco (TH)
• Calco [salmon] (HU)
• Calsynar (BR, TW)
• Calsynar [salmon] (AU, HU, LU, PL)
• Cibacalcin (AE, AT, BH, CY, EG, GR, IL, IQ, IR, IT, JO, KW, LB, LY, MY, NL, OM, QA, SA, SY, YE)
• Cibacalcin [human] (AU)
• Cibacalcine (BE, FR)
• Cibacalcine [human] (LU)
• Citonina (AR)
• Forcaltonin (AT, BE, BG, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HN, IE, IL, IT, NL, NO, PT, RU, SE, TR)
• Karil (LU)
• Karil [salmon] (LU)
• Menocal (KP)
• Miacalcic (AE, AT, BE, BG, BH, BR, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HN, ID, IE, IL, IQ, IR, IT, JO, KW, LB, LY, MX, MY, NL, NO, NZ, OM, PE, PH, PT, QA, RU, SA, SE, SG, SY, TH, TR, TW, YE)
• Miacalcic [salmon] (AU, HR, HU, PL)
• Mycalcin (TH)
• Oseum (MX)
• Ostostabil [salmon] (PL)
• Salmocalcin (AR)
• Tonocalcin (ID, MY)
• Tonocalcin [salmon] (PL)
• Ucecal [salmon] (LU)
• Zycalcit (IN)

Lexi-Comp.com

Last full review/revision October 2009

Content last modified October 2009