Dosing & Administration

Convenient once-monthly dosing with self-administration option

Recommended Dose

180 mg
Subcutaneous injection once monthly (every 4 weeks)

Administration

  • Administer as a single subcutaneous injection
  • Injection sites: abdomen, thigh, or upper arm
  • Rotate injection sites with each dose
  • Do not inject into areas where the skin is tender, bruised, red, or hard
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DEMOZUMAB Pre-filled Pen

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DEMOZUMAB is available as a pre-filled pen for self-administration following appropriate training by a healthcare professional.

Self-Administration Requirements

  • Patients should receive training on subcutaneous injection technique prior to first self-administration
  • First injection should be performed under supervision of a healthcare professional
  • Patients should be instructed to read the Instructions for Use before each injection
  • Caregivers may also be trained to administer DEMOZUMAB

Preparation and Administration

1

Remove from refrigerator

Allow pen to reach room temperature for 30 minutes before injection

2

Inspect visually

Solution should be clear to slightly opalescent, colourless to pale yellow

3

Select injection site

Clean area with alcohol wipe and allow to dry

4

Administer injection

Follow Instructions for Use provided with the pre-filled pen

Missed Dose

If a dose is missed, administer DEMOZUMAB as soon as possible.

Missed by <2 weeks Administer missed dose immediately, then resume normal schedule
Missed by ≥2 weeks Skip the missed dose and administer next dose at the regularly scheduled time

Do not administer two doses within 2 weeks of each other.

Dosing Schedule Example

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Storage

Refrigerated Storage

  • Store at 2°C to 8°C
  • Keep in original carton to protect from light
  • Do not freeze
  • Do not shake

Room Temperature Storage

  • May be stored at up to 25°C for a single period of up to 14 days
  • Once removed from refrigeration, do not return to refrigerator
  • Discard if not used within 14 days at room temperature

Do Not Use If:

  • The solution is cloudy, discoloured, or contains visible particles
  • The pen has been frozen
  • The expiry date has passed
  • The pen has been stored at room temperature for more than 14 days

Dose Adjustments in Special Populations

Population Recommendation
Mild-to-moderate renal impairment No dose adjustment required
Severe renal impairment Not studied; use with caution
Mild-to-moderate hepatic impairment No dose adjustment required
Severe hepatic impairment Use with caution; limited data available
Elderly (≥65 years) No dose adjustment required
Body weight No dose adjustment required based on body weight

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