Prolia 60 mg SC Injection (Denosumab 60 mg SC Injection)

– Denosumab is intended for subcutaneous route ONLY

– Should not be administered intravenously, intramuscularly, or intradermally.

– Prior to administration, bring to room temperature in original container (allow to stand ~15 to 30 minutes); do not warm by any other method.

– Solution may contain trace amounts of translucent to white protein particles; do not use if cloudy, discolored (normal solution should be clear and colorless to pale yellow), or contains excessive particles or foreign matter.

– Avoid vigorous shaking.

– Administer via SC injection in the upper arm, upper thigh, or abdomen.

– If a dose is missed, administer as soon as possible, then continue dosing every 6 months from the date of the last injection.

– Store in original carton at 2°C to 8°C (36°F to 46°F)

– Do not freeze

– Prior to use, bring to room temperature of 25°C (77°F) in original container (usually takes 15 to 30 minutes); do not use any other methods for warming

– Use within 14 days once at room temperature

– Protect from direct heat and light; do not expose to temperatures >25°C (77°F)

– Avoid vigorous shaking.