Usual Adult Dose for Paget's Disease

100 International Units subcutaneously or intramuscularly once a day

Comments:

• There is no evidence that the prophylactic use is beneficial in asymptomatic patients.
• This drug should be reserved for use in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., contraindicated, not tolerated, or patient unwilling to use).

Use: For the symptomatic treatment of Paget's disease of the bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion.

Usual Adult Dose for Hypercalcemia

Initial dose: 4 International Units/kg subcutaneously or IM every 12 hours

• For unsatisfactory response after 1 or 2 days, increase to 8 International Units/kg subcutaneously or IM every 12 hours
• For unsatisfactory response after 2 or more days, may increase to 8 International Units/kg subcutaneously or IM every 6 hours

Maximum Dose: 48 International Units/kg in 24 hours

Comments:

• This drug may be used with other agents until more specific treatment of the underlying disease can be accomplished; it may be added to existing hypercalcemia regimens such as IV fluids and furosemide, oral phosphate, or corticosteroids, or other agents.

Use: For the early treatment of hypercalcemic emergencies, when a rapid decrease in serum calcium is required.

Usual Adult Dose for Osteoporosis

Parenteral:
100 International Units subcutaneously or intramuscularly once a day

• Minimum effective dose for prevention of vertebral bone mineral density loss has not been established

Nasal:

• 1 spray (200 International Units) intranasally once a day; alternate nostrils

Comments:

• Patients should receive adequate calcium and vitamin D supplementation during therapy.
• Evidence for treatment of postmenopausal osteoporosis is based on total body calcium increases observed in clinical trials; fracture reduction efficacy has not been demonstrated.
• This drug should be reserved for use in patients for whom alternative agents are not suitable (e.g., contraindicated, not tolerated, or patient unwilling to use).

Use: For the treatment of postmenopausal osteoporosis in women greater than 5 years post menopause.

Renal Dose Adjustments

Use caution

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Nasal Spray:

• Administer into one nostril once a day; alternate nostrils
• Pump must be primed prior to first use; hold bottle upright and depress 2 white side arms of pump until full spray is released; pump only needs to be primed once
• For daily dose, allow bottle to come to room temperature
• Place nozzle into nostril while head is in upright position, firmly depress pump

Parenteral:

• For IM or subcutaneous administration
• If volume of injection exceeds 2 mL, IM injection is preferable; total dose should be distributed across multiple sites
• Patients should receive instruction on self-administration

Storage requirements:
Vials: Store refrigerated at 36F to 46F (2C to 8C)
Nasal Spray:

• Unopened bottle: Store refrigerated at 36F to 46F (2C to 8C)
• After opening: Store at room temperature 59F to 86F (15C to 30C); stable for 35 days; store upright
• Each bottle contains 30 doses; discard after 30 doses

General:

• Due to a possible association with increased malignancy; continued therapy should be re-evaluated for risks and benefits on a periodic basis.

Monitoring:

• Monitor for signs and symptoms of hypocalcemia; serum calcium levels should be obtained as clinically indicated

Patient advice:

• Patients should be instructed to read the approved patient labeling.
• Patients should be informed of the potential increase in risk of malignancy.
• Patients with postmenopausal osteoporosis or Paget's disease should be instructed to maintain an adequate calcium (1000 g elemental calcium per day) and vitamin D intake (400 International Units per day).
• Patients should be instructed to seek emergency medical help if they develop signs or symptoms of a serious allergic reaction.
• Patients using the nasal spray should be instructed to report significant nasal irritation.