Recommended Dosage of Romosozumab (Evenity) for Osteoporosis Treatment
The recommended dosage of romosozumab is 210 mg administered subcutaneously once monthly for a maximum duration of 12 months only, followed by transition to an antiresorptive agent. 1
Administration Protocol
- Administer as two separate 105 mg/1.17 mL subcutaneous injections (total 210 mg) once monthly 1
- Injection sites include the abdomen, thigh, or upper arm 1
- Administration should be performed by a healthcare provider 1
- Treatment duration is strictly limited to 12 monthly doses as the anabolic effect wanes after this period 2, 1
- If a dose is missed, administer as soon as possible and reschedule subsequent doses monthly from that date 1
Patient Selection
- Indicated for postmenopausal women with osteoporosis at high risk for fracture 1
- High risk is defined as having a history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other osteoporosis therapies 1
- The American College of Physicians suggests romosozumab for women with primary osteoporosis at very high risk of fracture (conditional recommendation) 2
- Should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year 1
Concurrent Supplementation
- Patients should be adequately supplemented with calcium and vitamin D during treatment 1
- Pre-existing hypocalcemia must be corrected prior to initiating therapy 1
Sequential Therapy Requirement
- After completing the 12-month romosozumab regimen, patients must transition to an antiresorptive agent 1, 3
- This transition is essential to maintain bone density gains and fracture risk reduction 3
- Bisphosphonates (particularly alendronate) are the preferred sequential therapy 3
- Failure to transition to an antiresorptive agent after romosozumab may result in loss of bone density gains 2
Safety Considerations
- Romosozumab carries a black box warning for potential increased risk of myocardial infarction, stroke, and cardiovascular death 1
- Contraindicated in patients with hypocalcemia or history of systemic hypersensitivity to romosozumab 1
- Use should be limited to 12 monthly doses as the anabolic effect diminishes after this period 2
- The FDA safety warnings recommend avoiding use in patients with high risk for major cardiovascular events 2
Clinical Efficacy
- In clinical trials, romosozumab followed by alendronate showed superior fracture risk reduction compared to alendronate alone 4
- Romosozumab significantly increases bone mineral density through its dual mechanism of increasing bone formation and decreasing bone resorption 5, 6
- The sequential use of romosozumab followed by alendronate was more effective than alendronate alone in reducing hip fracture risk for 24 months 2
Remember that romosozumab is a unique osteoporosis medication with a strictly defined treatment duration and requires careful patient selection due to its cardiovascular risk profile.