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Pronunciation
(kal si TOE nin)
Generic Available (U.S.)
Yes: Intranasal solution
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
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 placenta.
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.
Dosage form specific issues:
• Nasal spray: Temporarily withdraw use of nasal spray if ulceration of nasal mucosa occurs. Discontinue for ulcerations >1.5 mm or those that penetrate below the mucosa. 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%, including ulcerative)
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: Nausea (injection: 10%; nasal spray: 2%), abdominal pain (1% to 3%), constipation (1% to 3%), diarrhea (1% to 3%), dyspepsia (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: Nasal ulcerations (3%), 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%, postmarketing, and/or case reports: Agitation, allergic reactions, allergic rhinitis, alopecia, anaphylactoid reaction, anaphylaxis/anaphylactic shock, anemia, anorexia, anxiety, appetite increased, arthralgia, arthritis, blurred vision, bronchitis, bundle branch block, cerebrovascular accident, cholelithiasis, cough, diaphoresis, dyspnea, earache, eczema, edema, eye pain, fever, flatulence, gastritis, goiter, hearing loss, hematuria, hepatitis, hypersensitivity, hyperthyroidism, insomnia, migraine, mucosal excoriation, myocardial infarction, nasal congestion, nasal odor, neuralgia, nocturia, palpitation, parosmia, periorbital edema, pharyngitis, pneumonia, polymyalgia rheumatica, polyuria, pruritus, pyelonephritis, rash, renal calculus, skin ulceration, sneezing, stiffness, tachycardia, taste perversion, thirst, thrombophlebitis, tinnitus, urine sediment abnormality, vertigo, visual disturbances, vitreous floater, vomiting, weight gain, xerostomia
Drug Interactions
Lithium: Calcitonin may decrease the serum concentration of Lithium. Risk C: Monitor therapy
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. The following stability information has also been reported: May be stored at room temperature for up to 14 days (Cohen, 2007).
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
Onset of action:
Hypercalcemia: I.M., SubQ: ~2 hours
Paget's disease: Within a few months; may take up to 1 year for neurologic symptom improvement
Duration: Hypercalcemia: I.M., SubQ: 6-8 hours
Distribution: Vd: 0.15-0.3 L/kg
Metabolism: Metabolized in kidneys, blood and peripheral tissue
Bioavailability: I.M.: 66%; SubQ: 71%; Nasal: ~3% to 5% (relative to I.M.)
Half-life elimination (terminal): I.M. 58 minutes; SubQ 59-64 minutes; Nasal: ~18 minutes
Time to peak, plasma: SubQ ~23 minutes; Nasal: ~13 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; if the response remains unsatisfactory, a further increase up to a maximum of 8 units/kg every 6 hours may be considered
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.
Injection solution: May be administered I.M. or SubQ; I.M route is preferred if the injection volume is >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.
Administration: Other
Injection solution: May be administered I.M. or SubQ. SubQ route is preferred for outpatient self-administration unless the injection volume is >2 mL.
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 (at baseline and with nasal complaints)
Dietary Considerations
Recommended amounts of 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
If administered by injection, you will be instructed on how to give the injections and dispose of syringes/needles (follow directions exactly). 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 chest pain, depression, unresolved nausea or constipation, skin rash, palpitations, or respiratory difficulty.
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 if using calcitonin solution (increased erythema or skin wheal indicates positive reaction and allergy). If prescribing the nasal form, instruct patient to monitor for nasal irritation.
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 [calcitonin-salmon/rDNA origin/spray]:
Fortical®: 200 int. units/actuation (3.7 mL) [contains benzyl alcohol; delivers 30 doses]
Solution, intranasal [calcitonin-salmon/spray]: 200 int. units/actuation (3.7 mL, 3.8 mL)
Miacalcin®: 200 int. units/actuation (3.7 mL) [contains benzalkonium chloride; delivers 30 doses]
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): $141.00
200 units/mL (2): $68.99
References
Bergqvist E, Sjoberg HE, Hjern B, et al, “Calcitonin in the Treatment of Hypercalcaemic Crisis,” Acta Med Scand, 1972, 192(5):385-9.
Cohen V, Jellinek SP, Teperikidis L, et al, “Room-Temperature Storage of Medications Labeled for Refrigeration,” Am J Health-Syst Pharm, 2007, 64(16):1711-15.
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
Lexi-Comp.com
Last full review/revision May 2011
Content last modified May 2011
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