Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Evenity Prescribing Information
- EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death[see. EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.]
5.1 Major Adverse Cardiac Events (MACE)In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those treated with alendronate
[see Boxed Warningand Adverse Reactions (6.1)].EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.
Dosage and Administration (Step 1: Prior to Administration:
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:
Clean the injection sites with alcohol wipes. Let the skin dry.
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.
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. Figure A Figure B Figure C Figure D | 4/2024 |
EVENITY is a sclerostin inhibitor 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. (
EVENITY is a sclerostin inhibitor 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: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.
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.
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
Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. (
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
- Two separate subcutaneous injections are needed to administer the total dose of 210 mg. Inject two syringes, one after the other. ()
2.1 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.
- Should be administered by a healthcare provider. ()
2.1 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.
- Administer 210 mg subcutaneously once every month for 12 doses in the abdomen, thigh, or upper arm. ()
2.2 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.
- Adequately supplement calcium and vitamin D during treatment. ()
2.2 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.
Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilled syringe.
A full dose of EVENITY requires two single-use prefilled syringes.
Renal Impairment: Patients with severe renal impairment or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and supplement with calcium and vitamin D. (
Hypocalcemia has occurred in patients receiving EVENITY. Correct hypocalcemia prior to initiating EVENITY
Monitor patients for signs and symptoms of hypocalcemia. Patients should be adequately supplemented with calcium and vitamin D while on EVENITY
Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m2) or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and adequately supplement patients who have severe renal impairment or are receiving dialysis with calcium and vitamin D. Instruct patients with severe renal impairment, including those receiving dialysis, about the symptoms of hypocalcemia and the importance of maintaining calcium levels with adequate calcium and vitamin D supplementation.
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 m2by MDRD equation) or receiving dialysis are at greater risk of developing hypocalcemia