FORTICAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FORTICAL (FORTICAL).
Fortical (calcitonin salmon) is a synthetic polypeptide hormone that lowers blood calcium by inhibiting osteoclast-mediated bone resorption and increasing renal excretion of calcium and phosphate.
| Metabolism | Primarily metabolized in the kidneys and liver via proteolytic degradation; not extensively metabolized by cytochrome P450 enzymes. |
| Excretion | Renal: 50-70% of absorbed dose excreted unchanged in urine; fecal: 30-50% as unabsorbed drug. |
| Half-life | Terminal elimination half-life: 43-51 minutes. Rapid clearance; requires twice-daily dosing for sustained calcium-lowering effect. |
| Protein binding | 30-40% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.15-0.3 L/kg. Indicates limited distribution primarily to extracellular fluid; minimal tissue binding. |
| Bioavailability | Intranasal: 3-5% relative to subcutaneous injection due to degradation at mucosal surface; Subcutaneous: 100%. |
| Onset of Action | Intranasal: 15 minutes; Subcutaneous: 15-30 minutes. Onset of hypocalcemic effect. |
| Duration of Action | Intranasal: 6-8 hours; Subcutaneous: 8-12 hours. Clinical effect on serum calcium lasts up to 12 hours post-dose. |
50 IU (0.25 mL) subcutaneously once daily, with calcium and vitamin D supplementation.
| Dosage form | SPRAY, METERED |
| Renal impairment | Contraindicated in patients with creatinine clearance <35 mL/min. No dose adjustment required for mild to moderate impairment (CrCl 35-60 mL/min). |
| Liver impairment | No specific guidelines; use with caution in severe hepatic impairment due to limited data. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; monitor serum calcium and renal function regularly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FORTICAL (FORTICAL).
| Breastfeeding | Calcium is naturally present in breast milk. FORTICAL (calcium supplement) is considered safe during lactation. M/P ratio not applicable as calcium is an endogenous substance. Excretion into breast milk is minimal and not expected to cause adverse effects in breastfed infants. |
| Teratogenic Risk | Teratogenic effects are not expected based on animal studies and limited human data. Calcium salts do not cross the placenta in significant amounts to cause fetal harm. However, excessive maternal calcium intake may lead to hypercalcemia, which could theoretically affect fetal development. No specific trimester risks identified. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to calcitonin salmon or any component of the formulation"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Hypocalcemia risk","Nasal ulceration or irritation with nasal spray","Potential for allergic reactions due to salmon calcitonin","Use in renal impairment requires caution"] |
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| Fetal Monitoring | Monitor serum calcium levels periodically to avoid hypercalcemia. In pregnant women with calcium deficiency, monitor for signs of hypocalcemia. Fetal monitoring not routinely indicated unless maternal hypercalcemia occurs. |
| Fertility Effects | No known adverse effects on fertility. Adequate calcium is essential for normal reproductive function. Calcium supplementation may be beneficial in conditions associated with calcium deficiency affecting fertility. |