Evenity Dosing Interval
If a dose of Evenity is missed, it should be administered as soon as it can be rescheduled, and thereafter scheduled every month from the date of the last dose, making a 28-day interval acceptable. 1
FDA-Approved Dosing Schedule
The FDA label for romosozumab (Evenity) explicitly states: "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." 1
The standard recommended dosing is 210 mg administered subcutaneously once every month for 12 monthly doses total. 1
Each dose consists of two separate 105 mg/1.17 mL subcutaneous injections administered by a healthcare provider. 1
Clinical Implications of Dosing Flexibility
The FDA labeling provides flexibility in the dosing schedule by allowing rescheduling from the date of the last injection rather than requiring strict adherence to the original calendar schedule. 1
This means that administering Evenity 28 days (4 weeks) after the last injection is consistent with the "once every month" dosing recommendation and falls within acceptable practice. 1
The treatment duration is limited to 12 monthly doses because the anabolic effect of romosozumab wanes after this period, and continued therapy with an anti-resorptive agent should be considered after completion. 1
Important Safety Considerations
Patients must be adequately supplemented with calcium and vitamin D during treatment to prevent hypocalcemia, which is a contraindication to therapy. 1
Evenity carries a boxed warning for increased risk of myocardial infarction, stroke, and cardiovascular death, and should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. 1
Pre-existing hypocalcemia must be corrected prior to initiating therapy with Evenity. 1
Mechanism and Clinical Context
Romosozumab is a humanized monoclonal antibody that inhibits sclerostin, thereby increasing bone formation and decreasing bone resorption through a dual mechanism of action. 2, 3
Clinical studies demonstrated inhibition of new vertebral fractures at 12 months of treatment and increased bone mineral density at 6 months of treatment. 2
The bone-forming effect of romosozumab decreases after continued administration, which is why treatment duration is limited to 12 months. 2