What is the recommended use and dosing of Evenity (romosozumab) for osteoporosis treatment?

Evenity (Romosozumab) for Osteoporosis Treatment: Recommended Use and Dosing

Evenity (romosozumab) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, with a recommended dose of 210 mg administered subcutaneously once monthly for a limited duration of 12 monthly doses, followed by transition to an anti-resorptive agent. 1

Indications

• Specifically indicated for postmenopausal women with:

  • History of osteoporotic fracture
  • Multiple risk factors for fracture
  • Failure or intolerance to other available osteoporosis therapy 1

• Should be considered for patients with very high fracture risk:

  • Prior fracture
  • T-score ≤ -3.5
  • FRAX score ≥30% for major osteoporotic fracture or ≥4.5% for hip fracture 2

Dosing and Administration

• Dose: 210 mg administered subcutaneously once monthly 1

• Administration method:

  • Two separate 105 mg/1.17 mL prefilled syringes injected one after the other
  • Injection sites: abdomen, thigh, or upper arm
  • Must be administered by a healthcare provider 1

• Duration: Limited to 12 monthly doses only

  • The anabolic effect wanes after 12 monthly doses 3, 1
  • After completing romosozumab therapy, patients should transition to an anti-resorptive agent 1

Important Safety Considerations

• Contraindications:

  • Hypocalcemia (must be corrected before initiating)
  • History of systemic hypersensitivity to romosozumab
  • History of myocardial infarction or stroke within the preceding year 1, 4

• Cardiovascular risk:

  • May increase risk of myocardial infarction, stroke, and cardiovascular death
  • Should not be initiated in patients with MI or stroke within the preceding year
  • Consider risk-benefit in patients with other cardiovascular risk factors
  • Discontinue if patient experiences MI or stroke during therapy 1

• Calcium and vitamin D supplementation:

  • Patients should be adequately supplemented with calcium (1,000-1,200 mg daily) and vitamin D (800-1,000 IU daily) during treatment 2, 1

Mechanism and Benefits

• Romosozumab is a humanized monoclonal antibody that inhibits sclerostin, providing a dual effect:

  • Increases bone formation
  • Decreases bone resorption 5, 4

• Clinical benefits:

  • Significantly reduces vertebral and clinical fracture risk compared to placebo and alendronate 5
  • Significantly increases bone mineral density compared to placebo, alendronate, and teriparatide 5

Sequential Therapy Approach

• After completing the 12-month romosozumab treatment:
  • Transition to an anti-resorptive agent (e.g., bisphosphonate, denosumab) 1
  • This sequential approach maintains or further increases bone mineral density gains 5

Practical Considerations

• If a dose is missed, administer as soon as possible and reschedule subsequent doses monthly from that date 1
• Monitor for hypocalcemia before and during treatment 1
• Cost consideration: £427.75 for two pre-filled pens (one monthly dose) 6

Key Takeaways

• Romosozumab represents a significant advancement in osteoporosis treatment with its dual mechanism of increasing bone formation and decreasing bone resorption 4, 7
• Limited to 12 monthly doses due to waning anabolic effect after this period 3, 1
• Cardiovascular safety concerns require careful patient selection 1, 8
• Should be followed by anti-resorptive therapy to maintain bone mineral density gains 1, 5