minister EVENITY once every month.
• The treatment duration for EVENITY is 12 monthly doses.
• Patients should be adequately supplemented with calcium and vitamin D during treatment withEVENITY [see Warnings and Precautions (5.3) and Clinical Studies (14.1)].
• If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter,EVENITY can be scheduled every month from the date of the last dose.
2.3 Preparation and Administration InstructionsStep 1. Prior to Administration:
• Remove two syringes from the carton.
• Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is aclear to opalescent, colorless to light yellow solution. Do not use if the solution is cloudy ordiscolored or contains particles.
• Do not use the syringe if
o any part appears cracked or broken
o the gray needle cap is missing or not securely attached
o the expiration date printed on the label has passed
• Always hold the prefilled syringe by the syringe barrel to remove the syringe from the tray. SeeFigure A.
o Do not grasp the plunger rod.
o Do not grasp the gray needle cap.
o Do not remove the gray needle cap until you are ready to inject.
• Allow EVENITY to sit at room temperature for at least 30 minutes before injecting. Do not warmin any other way [see How Supplied/Storage and Handling (16)].
Figure A
Step 2: Select the Injection Site and Prepare the Syringe
Prepare and clean two injection sites, one for each of the two injections. See Figure B.
The recommended subcutaneous injection sites include:
• The thigh
• Abdomen, except for a two-inch area right around the navel
• Outer area of upper arm
Clean the injection sites with alcohol wipes. Let the skin dry.
• Choose a different site each time you give an injection. If you want to use the same injection site,make sure it is not the same spot on the injection site you used for a previous injection.
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas withscars or stretch marks.
Choose the first syringe. Pull the gray needle cap straight off and away from your body when you areready to inject. See Figure C.
Figure C
• Do not put the gray needle cap back onto the syringe.
Step 3: Inject EVENITY
Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel. See
Figure D.
When done, gently lift the syringe off of the skin.
Step 4: Syringe and Needle Cap Disposal
Immediately dispose of the syringe and needle cap in the nearest sharps container.
Important: Repeat all steps with the second syringe to inject the full dose.
3 DOSAGE FORMS AND STRENGTHS
Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilledsyringe.
A full dose of EVENITY requires two single-use prefilled syringes.
4 CONTRAINDICATIONS
EVENITY is contraindicated in patients with:
• Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy withEVENITY [see Warnings and Precautions (5.3), Adverse Reactions (6.1) and Use in SpecificPopulations (8.7)].
• A history of systemic hypersensitivity to romosozumab or to any component of the productformulation. Reactions have included angioedema, erythema multiforme, and urticaria [seeWarnings and Precautions (5.2) and Adverse Reactions (6.1)
