calcitonin-salmon (recombinant) [Nasal]

Adult Dosing

Treatment of postmenopausal osteoporosis

Notes:

Use in conjunction with an adequate calcium (at least 1000 mg/day elemental calcium) and vitamin D (400 IU/day)
Assess lumbar vertebral bone mass periodically to document stabilization of bone loss or increases in bone density to predict drug effect

Pediatric Dosing

[Outline]

Indications ⬆ ⬇

Treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Therapy may cause systemic allergic reactions, including anaphylaxis, anaphylactic shock, a few serious allergic-type reactions (bronchospasm, swelling of the tongue or throat, anaphylactic shock), and very rare cases of death due to anaphylaxis. Emergency treatment measures should be readily available for management of such reactions and allergic reaction should be differentiated from generalized flushing and hypotension
Perform skin testing prior to treatment initiation for patients with suspected sensitivity to calcitonin
Use of lithium with calcitonin may lead to reductions in plasma lithium concentrations; consider adjusting the dose of lithium
Development of mucosal alterations or transient nasal conditions may occur during therapy; perform periodic assessment of nasal mucosa, turbinates, septum and mucosal blood vessel status
In postmenopausal patients receiving this therapy, nasal adverse events such as rhinitis, epistaxis, and sinusitis have been reported
Discontinue treatment if severe ulceration of the nasal mucosa occurs associated with heavy bleeding, indicated by ulcers >1.5 mm in diameter or penetrating below the mucosa
Use therapy in conjunction with an adequate calcium (at least 1 g/day) and vitamin D (400 IU/day)

Cautions: Use cautiously in:

Supplemental Patient Information

Instruct patients and provide demonstrations regarding pump assembly, priming of the pump, and nasal introduction of the nasal spray
Advise patients to promptly consult their physician if they develop significant nasal irritation
Instruct patients to seek emergency medical help if they experience symptoms of a serious allergic reaction such as breathing problem, swelling of the face, tongue or throat, rapid heartbeat, chest pain, or feeling of dizziness

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety undetermined; use not recommended.

Adverse Reactions ⬆ ⬇

EENT: Rhinitis, epistaxis, sinusitis, swelling of the tongue or throat; nasal symptoms including nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling, sore across bridge of nose
CNS: Headache
MUSC: Arthralgia, back pain
RESP: Bronchospasm
HYPERSENSITIVITY: Hypersensitivity reaction, anaphylaxis

Clinical Pharmacology ⬆ ⬇

Polypeptide of 32 amino acids manufactured by recombinant DNA technology; binds to calcitonin receptors found primarily in osteoclasts which then enhances the production of vitamin D producing enzymes, leading to greater calcium retention and enhanced bone density; augments bone formation by directly inhibiting osteoclastic bone resorption and increasing osteoblastic activity
Bio-availability is approximately 3% (injectable calcitonin)
Metabolism: Primarily in the kidneys and in the blood and peripheral tissues
Excretion: Urine
Half-life: 23 minutes

Brands and Availability ⬆ ⬇