kal-si-TOE-nin

• IM, SC: Treatment of Paget’s disease of bone.
• Adjunctive therapy for hypercalcemia.
• IM, SC, Intranasal: Management of postmenopausal osteoporosis.

• Inhibits osteoclastic bone resorption and promotes renal excretion of calcium.

• Decreased rate of bone turnover.
• Lowering of serum calcium.

Absorption: Completely absorbed from IM and subcut sites. Rapidly absorbed from nasal mucosa; absorption is 3% compared with parenteral administration.

Distribution: Unknown.

Metabolism/Excretion: Rapidly metabolized in kidneys, blood, and tissues.

Half-life: 40–90 min.

Contraindicated in:

• Hypersensitivity to calcitonin, salmon protein or gelatin diluent (in some products)
• OB: Lactation: Use not recommended.

Use Cautiously in:

• Pedi: Safety not established.

CNS: nasal only: headaches.

Derm: facial flushing, rash.

EENT: nasal only: rhinitis, epistaxis, nasal irritation.

GI: IM, subcut: nausea, vomiting.

GU: IM, subcut: urinary frequency.

Local: injection site reactions.

MS: nasal: arthralgia, back pain.

Misc: MALIGNANCY, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Previous bisphosphonate therapy, including alendronate, risedronate, etidronate, ibandronate, or pamidronate, may ↓ response to calcitonin.
• May ↓ lithium levels.

Postmenopausal osteoporosis

• IM, SC (Adults): 100 units every other day.
• Intranasal (Adults): 1 spray (200 units)/day in alternating nostrils.

Paget’s disease

• IM, SC (Adults): 100 units/day initially, after titration, maintenance dose is usually 50 units/day or every other day.

Hypercalcemia

• IM, SC (Adults): 4 units/kg every 12 hr; if adequate response not achieved, may ↑ dose after 1–2 days to 8 units/kg every 12 hr, and if necessary after 2 more days may be ↑ to 8 units/kg every 6 hr.

• In patients with suspected sensitivity to calcitonin, consider skin test before starting therapy. Prepare test dose in a dilution of 10 units/mL by withdrawing 0.05 mL in a tuberculin syringe and filling to 1 mL with 0.9% NaCl for injection. Mix well and discard 0.9 mL. Administer 0.1 mL intradermally on inner aspect on forearm and observe site for 15 min. More than mild erythema or wheal constitutes positive response.
• IM, SC: Inspect injection site for the appearance of redness, swelling, or pain. Rotate injection sites. Subcut is the preferred route. Use IM route if dose exceeds 2 mL in volume. Use multiple sites to minimize inflammatory reaction. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter.
• Intranasal: Store injection and unopened nasal spray bottle in refrigerator. Nasal spray bottle in use can be stored at room temperature.

Miacalcin

Calcimar

Therapeutic Classification: hypocalcemics

Pharmacologic Classification: hormones

(Generic available)

• Injection: 200 units/mL;
• Nasal spray: 200 units/actuation;

†Effects on serum calcium; effects on serum alkaline phosphates and urinary hydroxyproline in Paget's disease may require 6–24 mo of continuous treatment.

†Serum levels of administered calcitonin.

• Observe patient for signs of hypersensitivity (skin rash, fever, hives, anaphylaxis, serum sickness). Keep epinephrine, antihistamines, and oxygen nearby in the event of a reaction.
• Assess patient for signs of hypocalcemic tetany (nervousness, irritability, paresthesia, muscle twitching, tetanic spasms, seizures) during the first several doses of calcitonin. Keep parenteral calcium (calcium gluconate), available in case of this event.
• Intranasal: Assess nasal mucosa, septum, turbinates, and mucosal blood vessels periodically during therapy. Discontinue calcitonin if severe ulceration occurs.

• Monitor serum calcium and alkaline phosphatase periodically during therapy. Levels should normalize within a few mo of initiation of therapy.
  • Urine hydroxyproline (24 hr) may be monitored periodically in patients with Paget’s disease.

• Acute pain (Indications).
• Risk for injury (Indications, Side Effects).

• Advise patient to take calcitonin as directed. If dose is missed and medication is scheduled for twice a day, take only if possible within 2 hr of correct time. If scheduled for daily dose, take only if remembered that day. If scheduled for every other day, take when remembered and restart alternate day schedule. If taking 1 dose 3 times weekly (Mon, Wed, Fri), take missed dose the next day and set each injection back 1 day; resume regular schedule the following week. Do not double doses.
  • Instruct patient in the proper method of self-injection and care and disposal of equipment.
  • Caution patient to notify health care professional and seek emergency help immediately if sign and symptoms of serious hypersensitivity reaction occur.
  • Advise patient to report signs of hypercalcemic relapse (deep bone or flank pain, renal calculi, anorexia, nausea, vomiting, thirst, lethargy) or allergic response promptly.
  • Reassure patient that flushing and warmth following injection are transient and usually last about 1 hr.
  • Explain that nausea following injection tends to decrease even with continued therapy.
  • Instruct patient to follow low-calcium diet if recommended by health care professional (see Appendix M). Women with postmenopausal osteoporosis or patients with Paget's disease should adhere to a diet high in calcium (1000 mg elemental calcium/day) and vitamin D (400 IU/day).
  • Inform patient of increased risk of malignancy.
• Osteoporosis: Advise patients receiving calcitonin for the treatment of osteoporosis that exercise has been found to arrest and reverse bone loss. Encourage patient to discuss any exercise limitations with health care professional before beginning program.
• Intranasal: Instruct patient on correct use of nasal spray. Demonstrate procedure for use. Before first use, activate pump by holding upright and depressing white side arms down toward bottle 5 times until a full spray is emitted. Following activation, place nozzle firmly in nostril with head in an upright position and depress the pump toward the bottle. The pump should NOT be primed before each daily use. Discard bottle 30 days after first use.
  • Advise patient to notify health care professional if significant nasal irritation occurs.

• Lowered serum calcium levels.
• Decreased bone pain.
• Slowed progression of postmenopausal osteoporosis. Significant increases in bone marrow density may be seen as early as 6 mo after initiation of therapy.

NDC Code^*

• 49884- Par Pharmaceutical, Inc.
  • 49884-161- CALCITONIN SALMON
    • 49884-161-11- 3.8 mL in 1 BOTTLE, GLASS (49884-161-11)

• 60505- Apotex Corp.
  • 60505-0823- Calcitonin Salmon
    • 60505-0823-0- 1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) > 14 SPRAY, METERED in 1 BOTTLE, GLASS

• 60505- Apotex Corp.
  • 60505-0823- Calcitonin Salmon
    • 60505-0823-6- 1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) > 30 SPRAY, METERED in 1 BOTTLE, GLASS

• 67457- Mylan Institutional LLC
  • 67457-675- Miacalcin
    • 67457-675-02- 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) > 2 mL in 1 VIAL, MULTI-DOSE