CIBACALCIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CIBACALCIN (CIBACALCIN).
Calcitonin-salmon is a polypeptide hormone that inhibits osteoclastic bone resorption and enhances renal excretion of calcium and phosphate.
| Metabolism | Metabolized primarily in the kidneys via proteolytic degradation. |
| Excretion | Primarily metabolized via proteolysis in the kidneys and other tissues; less than 5% excreted unchanged in urine. Biliary/fecal excretion is negligible. |
| Half-life | Approximately 1-2 hours after subcutaneous or intramuscular administration, with terminal half-life extending to about 1.5-2.5 hours; clinical effects (e.g., hypocalcemia) persist longer (up to 8-12 hours) due to sustained binding to calcitonin receptors. |
| Protein binding | 30-40% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.15-0.3 L/kg; indicates distribution primarily into extracellular fluid and minimal tissue binding. |
| Bioavailability | Subcutaneous: approximately 70%; Intramuscular: approximately 70%; Intranasal: approximately 3-5% relative to intramuscular injection (25% of the hypocalcemic effect). |
| Onset of Action | Subcutaneous: 15-20 minutes; Intramuscular: 15-20 minutes; Intranasal: rapid absorption but onset of hypocalcemic effect within 15-30 minutes. |
| Duration of Action | Subcutaneous/Intramuscular: serum calcium reduction lasts 6-12 hours; intranasal: similar duration, but intranasal bioavailability is lower, requiring dose adjustment. Duration may extend with repeated dosing. |
100 IU subcutaneously or intramuscularly once daily.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 15-29 mL/min: reduce dose by 50%. GFR <15 mL/min: use with caution, not recommended. |
| Liver impairment | Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: avoid use. |
| Pediatric use | Not established for children under 18 years. For hypercalcemia: 4 IU/kg subcutaneously every 12 hours. |
| Geriatric use | No specific dose adjustment required, but monitor renal function and electrolytes closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CIBACALCIN (CIBACALCIN).
| Breastfeeding | Calcitonin is excreted in human milk in small amounts. M/P ratio is not reported. Caution with breastfeeding; due to low oral bioavailability, effects on infant are unlikely but monitor for hypocalcemia. |
| Teratogenic Risk | CIBACALCIN (calcitonin-salmon) is not teratogenic in animal studies at doses up to 40 times the human dose. However, because calcitonin does not cross the placenta, the risk of fetal harm is low. Inadequate human data exist for first trimester; use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to calcitonin-salmon or any component of the formulation"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Hypocalcemia","Skin ulceration at injection site","Allergy to fish protein"] |
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| Monitor serum calcium, phosphate, and magnesium levels regularly. Assess for signs of hypocalcemia (tetany, paresthesias). If used in pregnancy, monitor fetal growth and amniotic fluid volume. |
| Fertility Effects | No known adverse effects on fertility in animal studies. In humans, no data available; theoretical risk of hypocalcemia-related reproductive dysfunction. |