Recommended Dosing of Evenity (Romosozumab) for Postmenopausal Osteoporosis
The recommended dosing of Evenity (romosozumab) is 210 mg administered subcutaneously once monthly for 12 months only, given as two separate 105 mg injections. 1
Dosing Details
- Dose: 210 mg once monthly
- Administration: Two separate subcutaneous injections of 105 mg each
- Duration: Limited to 12 monthly doses only
- Administration sites: Abdomen, thigh, or upper arm
- Provider: Must be administered by a healthcare provider 1
- Follow-up therapy: After completing the 12-month course, patients should transition to an anti-resorptive agent if osteoporosis therapy remains warranted 1
Patient Selection
Evenity is indicated for postmenopausal women with osteoporosis who are at high risk for fracture, defined as:
- History of osteoporotic fracture
- Multiple risk factors for fracture
- Failure or intolerance to other available osteoporosis therapy 1
Important Limitations and Considerations
Duration limit: The anabolic effect of romosozumab wanes after 12 monthly doses, so treatment must be limited to this duration 1, 2
Cardiovascular risk:
- Do not initiate in patients who have had a myocardial infarction or stroke within the preceding year
- Carefully consider benefits vs. risks in patients with other cardiovascular risk factors
- Discontinue if a patient experiences a myocardial infarction or stroke during therapy 1
Supplementation: Adequately supplement calcium and vitamin D during treatment 1
Contraindications:
- Hypocalcemia (must be corrected before initiating)
- Known hypersensitivity to romosozumab 1
Monitoring:
- Monitor for symptoms of MI and stroke
- Watch for hypersensitivity reactions
- Monitor calcium levels, especially in patients with severe renal impairment 1
Efficacy and Rationale
Romosozumab has a dual mechanism of action:
- Promotes bone formation
- Inhibits bone resorption 3
Clinical evidence shows that romosozumab:
- Significantly reduces vertebral and clinical fracture risk compared to placebo and alendronate 3, 4
- Significantly increases bone mineral density (BMD) compared to placebo, alendronate, and teriparatide 3, 4
The American College of Physicians suggests using romosozumab for females with primary osteoporosis at very high risk of fracture (conditional recommendation) 2.
Post-Treatment Considerations
After completing the 12-month course of romosozumab:
- Transition to an anti-resorptive agent (like a bisphosphonate or denosumab) to maintain BMD gains 1, 5
- Failure to transition to an anti-resorptive agent may result in loss of BMD gains 6
Adverse Effects
Common adverse reactions (≥5%) include:
- Arthralgia
- Headache 1
Potential serious adverse effects:
- Cardiovascular events (myocardial infarction, stroke)
- Hypersensitivity reactions
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fracture 1
Special Populations
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. 1
By following these dosing recommendations and considerations, you can optimize the benefits of Evenity while minimizing potential risks for your postmenopausal patients with osteoporosis.