Evenity

 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

 Limitations of Use

The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration (2.2) and Clinical Studies (14.1)].

 Important Dosage and Administration Instructions

• Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the other.
• EVENITY should be administered by a healthcare provider.

 Recommended Dosage

• The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer 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 with EVENITY [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.

 Preparation and Administration Instructions

Step 1: Prior to Administration:

• Remove two syringes from the carton.
• Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colorless to light yellow solution. Do not use if the solution is cloudy or discolored or contains particles.
• Do not use the syringe if
  • any part appears cracked or broken
  • the gray needle cap is missing or not securely attached
  • the expiration date printed on the label has passed
  • the syringe has been dropped on a hard surface
• Always hold the prefilled syringe by the syringe barrel to remove the syringe from the tray. See Figure A.
  • Do not grasp the plunger rod.
  • Do not grasp the gray needle cap.
  • 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 warm in 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.

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 with scars or stretch marks.

Choose the first syringe. Pull the gray needle cap straight off and away from your body when you are ready to inject. See Figure C.

Figure C

• Do not put the gray needle cap back onto the syringe.
• Do not leave the cap off for more than 5 minutes as this can dry out the solution.
• The prefilled syringe may contain air bubbles. Do not try to push air bubbles out as it is normal to see air bubbles.

Step 3: Inject EVENITY

Insert needle and inject all the liquid subcutaneously. Do not administer into muscle or blood vessel. See Figure D.

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.

 Pregnancy

Lactation

 Pediatric Use

Safety and effectiveness of EVENITY have not been established in pediatric patients.

 Geriatric Use

Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

 Renal Impairment

No dose adjustment is required in patients with renal impairment.

Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m2 by MDRD equation) or receiving dialysis are at greater risk of developing hypocalcemia [see Contraindications (4), Warnings and Precautions (5.3) and Adverse Reactions (6.1)]. Monitor calcium concentrations and adequately supplement calcium and vitamin D in patients who have severe renal impairment or are receiving dialysis.