Version May 2024
Hypercalcemia, severe (adjunctive agent):
Note: For use in combination with other appropriate agents (ie, IV hydration, bisphosphonates) in patients with severe hypercalcemia (eg, symptomatic and albumin-corrected serum calcium >14 mg/dL [>3.5 mmol/L]) to rapidly reduce serum calcium while bisphosphonate therapy provides a long-term effect (Ref).
IM, SUBQ: Initial: 4 units/kg every 12 hours; if calcium reduction is inadequate after 6 to 12 hours, may increase to 8 units/kg every 6 to 12 hours (Ref). Limit total duration of therapy to 24 to 48 hours due to tachyphylaxis (Ref).
Osteoporosis, postmenopausal, fracture risk reduction (labeled use) or osteoporotic vertebral fracture pain relief (off-label use):
Note: May be used to reduce pain associated with acute osteoporotic vertebral fractures; switch to a more effective agent (eg, a bisphosphonate) once pain has abated. For fracture risk reduction, reserve use for patients in whom alternative agents are contraindicated or cannot be taken due to limited efficacy compared to other therapies; ensure adequate calcium and vitamin D intake during therapy (Ref).
IM, SUBQ: 100 units once daily (Ref).
Intranasal: 200 units (1 spray) in one nostril once daily (Ref).
Paget disease (alternative agent): IM, SUBQ: 100 units daily; dosage range: 50 to 100 units administered 3 to 7 days per week (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: Calcitonin levels are elevated in patients with chronic kidney disease (CKD), either because of decreased metabolism by the kidney or increased secretion; however, the clinical implications of this are unknown (Ref).
Injectable, intranasal:
Altered kidney function:
eGFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary (Ref).
eGFR <30 mL/minute/1.73 m2: No dosage adjustment necessary (Ref). Consider use in conjunction with guidance from the patient’s nephrology team, as disorders of calcium homeostasis and bone metabolism can be difficult to distinguish from CKD mineral and bone disorder (Ref).
Hemodialysis, intermittent (thrice weekly): Not likely to be significantly dialyzable (high molecular weight) (Ref): Dose as for eGFR <30 mL/minute/1.73 m2 (Ref).
Peritoneal dialysis: Not likely to be significantly dialyzable (high molecular weight) (Ref): Dose as for eGFR <30 mL/minute/1.73 m2 (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Calcitonin: Pediatric drug information")
Osteogenesis imperfecta: Infants >6 months, Children, and Adolescents: IM, SubQ: 2 units/kg/dose 3 times/week (Ref)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Unless otherwise noted, frequencies reported are with nasal spray.
>10%:
Immunologic: Antibody development (injection: ~50%; nasal spray: 69%; drug efficacy can be affected)
Respiratory: Rhinitis (12%)
1% to 10%:
Cardiovascular: Facial flushing (injection: 2% to 5%), flushing of hands and feet (injection: 2% to 5%)
Dermatologic: Erythematous rash (1% to 3%)
Gastrointestinal: Abdominal pain (1% to 3%), nausea (injection: 10%; nasal spray: 1% to 3%)
Hematologic & oncologic: Lymphadenopathy (1% to 3%), malignant neoplasm (4%)
Infection: Infection (1% to 3%)
Local: Inflammation at injection site (injection: 10%)
Nervous system: Depression (1% to 3%), dizziness (1% to 3%), paresthesia (1% to 3%)
Neuromuscular & skeletal: Back pain (5%), myalgia (1% to 3%), osteoarthritis (1% to 3%)
Ophthalmic: Abnormal lacrimation (1% to 3%), conjunctivitis (1% to 3%)
Respiratory: Bronchospasm (1% to 3%), epistaxis (4%), flu-like symptoms (1% to 3%), sinusitis (2%), upper respiratory tract infection (1% to 3%)
Postmarketing (all routes):
Cardiovascular: Chest pain, edema, facial edema, flushing, hypertension, pedal edema, peripheral edema, syncope, vasodilation
Dermatologic: Alopecia, dermatitis, diaphoresis, earlobe pruritus, pruritus, skin rash, urticaria
Endocrine & metabolic: Hypocalcemia, hypocalcemia tetany
Gastrointestinal: Ageusia, decreased appetite, diarrhea
Genitourinary: Casts in urine, nocturia
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction (including severe hypersensitivity reaction)
Nervous system: Anosmia, fatigue, headache, salty taste, seizure
Neuromuscular & skeletal: Arthralgia, musculoskeletal pain, tremor
Ophthalmic: Eye pain, visual disturbance
Otic: Auditory impairment, tinnitus
Renal: Polyuria
Respiratory: Cough, dyspnea
Miscellaneous: Fever
Hypersensitivity to calcitonin salmon or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity reactions: Salmon-derived products: Anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat have been reported; 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.
• Hypocalcemia: Hypocalcemia with tetany and seizure activity has been reported. Hypocalcemia and other disorders affecting mineral metabolism (eg, vitamin D deficiency) should be corrected before initiating therapy; monitor serum calcium and symptoms of hypocalcemia during therapy. Administer in conjunction with calcium and vitamin D when treating Paget disease or postmenopausal osteoporosis.
• Malignancy: Analyses of randomized controlled trials (in osteoporosis and osteoarthritis) using the nasal spray and oral formulations have demonstrated a statistically significant increase in the risk of the development of cancer in calcitonin-treated patients (compared to placebo). The risk for malignancies is associated with long-term use of calcitonin (trials ranged from 6 months to 5 years in duration). Periodically reassess continued use of calcitonin therapy, carefully considering the risks versus benefits. Similar risk for other routes (subcutaneous, IM, IV) cannot be ruled out.
• Urinary sediment abnormalities: Coarse granular casts and casts containing renal tubular epithelial cells were observed following use in young adults on bed rest during a study to examine the effect of immobilization on osteoporosis; no other renal abnormalities were reported and sediment normalized after discontinuation; consider monitoring urine sediment periodically; however, the clinical significance of this finding is unknown.
Disease-related concerns:
• Osteoporosis: Risk vs benefit: Fracture reduction efficacy has not been demonstrated; use has not been shown to increase spinal bone mineral density in early postmenopausal patients (eg, ≤5 years postmenopause). Use should be reserved for postmenopausal patients for whom alternative treatments are not suitable (eg, patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). Consider potential benefits of therapy against risks, including the potential risk for malignancy with long-term use. Short-term treatment may provide analgesic effect in patients with acute painful vertebral fractures (AACE/ACE [Camacho 2020]).
Dosage form specific issues:
• Nasal spray: Rhinitis and epistaxis have been reported; mucosal alterations may occur. Temporarily withdraw use if ulceration of nasal mucosa occurs. Discontinue for severe ulcerations >1.5 mm, those that penetrate below the mucosa, or those associated with heavy bleeding. Patients >65 years of age may experience a higher incidence of nasal adverse events with calcitonin nasal spray.
Other warnings/precautions:
• Antibody formation: Antibody formation to calcitonin-salmon has been reported with the injection and nasal spray. Consider the possibility of antibody formation in patients who initially respond to therapy but later do not respond to treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Miacalcin: 200 units/mL (2 mL) [contains phenol]
Generic: 200 units/mL (2 mL)
Solution, Nasal:
Generic: 200 units/actuation (3.7 mL)
Yes
Solution (Calcitonin (Salmon) Injection)
200 units/mL (per mL): $1,878.60
Solution (Calcitonin (Salmon) Nasal)
200 units/ACT (per mL): $32.04
Solution (Miacalcin Injection)
200 units/mL (per mL): $1,879.26
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Calcimar: 200 units/mL (2 mL) [contains phenol]
Generic: 200 units/mL (2 mL)
Injection: May be administered IM or SUBQ. IM route is preferred if the injection volume is >2 mL (use multiple injection sites if dose volume is >2 mL). SUBQ route is preferred for outpatient self-administration unless the injection volume is >2 mL.
Nasal spray: Before first use, allow bottle to reach room temperature, then prime pump by releasing until a 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.
Intranasal: 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. Spray into one nostril daily; alternate nostrils to reduce irritation. Do not prime pump before each daily use. Discard after 30 doses.
Parenteral: May be administered SubQ or IM; do not exceed 2 mL volume per injection site; SubQ is preferred for outpatient self administration unless the injection volume is >2 mL; IM is preferred if the injection volume is >2 mL (use multiple injection sites if dose volume is >2 mL).
Hypercalcemia, severe (injection): Adjunctive therapy for hypercalcemia. May be used in hypercalcemic emergencies when a rapid decrease in serum calcium is required or until more specific treatment of underlying disease is accomplished.
Osteoporosis, postmenopausal (intranasal or injection): Treatment of osteoporosis in patients >5 years postmenopause.
Paget disease (injection): Treatment of symptomatic Paget disease of bone (osteitis deformans) in patients who cannot tolerate or whose disease does not respond to alternative therapy.
Vertebral fracture, osteoporotic, pain relief
Calcitonin may be confused with calcitriol
Fortical may be confused with Foradil
Miacalcin may be confused with Micatin
Calcitonin nasal spray is administered as a single spray into one nostril daily, using alternate nostrils each day.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Lithium: Calcitonin may decrease the serum concentration of Lithium. Risk C: Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Zoledronic Acid: Calcitonin may enhance the hypocalcemic effect of Zoledronic Acid. Risk C: Monitor therapy
Endogenous calcitonin does not cross the placenta (Dochez 2015).
Outcome data following maternal use of calcitonin for the treatment of hypercalcemia (Bilezikian 2022; Koren 2018; Krysiak 2011; Richa 2018) or other indications during pregnancy (Kovacs 2016; O’Regan 2001; Turek 2012) are limited. Postpartum use of calcitonin for the treatment of pregnancy associated osteoporosis has been described (Kovacs 2015; Ozturk 2014; Stumpf 2007).
Calcitonin is endogenous to breast milk in breastfeeding patients (Bucht 1986; Koldovský 1995); concentrations following administration of calcitonin-salmon are not known.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Patients with Paget's disease and hypercalcemia should follow a low calcium diet as prescribed. Recommended amounts of vitamin D and calcium intake is essential for preventing/treating osteoporosis. If dietary intake is inadequate, dietary supplementation is recommended. Patients should consume:
Calcium: 1,000 mg/day (males: 50 to 70 years of age) or 1,200 mg/day (females ≥51 years of age and males ≥71 years of age) (IOM 2011; NOF [Cosman 2014]).
Vitamin D: 800 to 1,000 units/day (age ≥50 years) (NOF [Cosman 2014]). Recommended dietary allowance (RDA): 600 units/day (age ≤70 years) or 800 units/day (age ≥71 years) (IOM 2011).
Osteoporosis: Serial bone mineral density (BMD) should be evaluated at baseline and every 1 to 3 years (usually at ~2 years following initiation of therapy, then more or less frequently depending on patient-specific factors and stability of BMD) (AACE/ACE [Camacho 2020]; ES [Eastell 2019]; NOF [Cosman 2014]); serum calcium and 25(OH)D; may consider monitoring biochemical markers of bone turnover (eg, fasting serum CTX or urinary NTX) at baseline, 3 months, and 6 months, to assess treatment response and/or adherence to therapy (ES [Eastell 2019]).
Paget disease: Serum total alkaline phosphatase at 6 to 12 weeks for initial response to treatment (when bone turnover will have shown a substantial decline) and potentially at 6 months (maximal suppression of high bone turnover) and then at ~6 to 12-month intervals (ES [Singer 2014]); monitoring more specific biochemical markers of bone turnover (eg, serum P1NP, NTX, serum beta-CTx) is generally only warranted in patients with Paget disease who have abnormal liver or biliary tract function or when early assessment of response to treatment is needed (eg, spinal compression, very active disease) (ES [Singer 2014]); serum calcium and 25(OH)D; pain (posttreatment pain may not strictly correlate with increased biochemical markers [Ralston 2019]).
Nasal formulation: Perform nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessels prior to initiation of therapy, periodically during therapy, and at any time nasal symptoms occur.
Consider periodic examinations of urine sediment.
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
Onset of action:
Hypercalcemia: IM, SUBQ: ~2 hours.
Paget's disease: Within a few months; may take up to 1 year for neurologic symptom improvement.
Duration: Hypercalcemia: IM, SUBQ: 6 to 8 hours; following multiple doses, hypercalcemic effect diminishes within 24 to 48 hours (Nilsson 1978; Stevenson 1988).
Absorption: Intranasal: Rapidly but highly variable and lower than IM administration.
Distribution: Vd: 0.15 to 0.3 L/kg.
Metabolism: Metabolized in kidneys, blood, and peripheral tissue.
Bioavailability: IM: 66%; SUBQ: 71%; Nasal: ~3% to 5% (relative to IM).
Half-life elimination (terminal): IM: 58 minutes; SUBQ: 59 to 64 minutes; Nasal: ~18 to 23 minutes.
Time to peak, plasma: SUBQ: ~23 minutes; Nasal: ~10 to 13 minutes.
Excretion: Urine (as inactive metabolites).
Clearance: Salmon calcitonin: 3.1 mL/kg/minute.
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