What are the management strategies for adverse reactions to Evenity (romosozumab)?

Management of Adverse Reactions to Evenity (Romosozumab)

For patients experiencing adverse reactions to Evenity (romosozumab), immediate assessment and appropriate management based on reaction severity is essential, with permanent discontinuation required for serious cardiovascular events, hypersensitivity reactions, or other severe adverse effects.

Common Adverse Reactions and Management

Hypersensitivity Reactions

• Mild to moderate reactions: Rash, pruritus, urticaria

  • Management:
    • Temporarily interrupt treatment
    • Administer antihistamines and topical steroids
    • Consider short courses of systemic steroids for moderate reactions 1
    • Monitor vital signs until symptoms resolve

• Severe reactions: Angioedema, erythema multiforme

  • Management:
    • Immediately discontinue Evenity permanently
    • Initiate appropriate emergency therapy
    • Do not rechallenge 1

Cardiovascular Events

• Evenity is associated with increased risk of major adverse cardiac events (MACE)
• Contraindicated in patients with:
  • Myocardial infarction or stroke within the preceding year 1
  • Monitor for signs/symptoms of MI or stroke
  • Permanently discontinue if patient experiences MI or stroke during therapy 1

Hypocalcemia

• Correct hypocalcemia before initiating Evenity 1
• Management:
  • Ensure adequate calcium and vitamin D supplementation throughout treatment
  • Monitor serum calcium levels, especially in patients with:
    • Severe renal impairment (eGFR 15-29 mL/min/1.73m²)
    • Patients on dialysis
  • Educate patients about symptoms of hypocalcemia 1

Osteonecrosis of the Jaw (ONJ)

• Risk factors:
  • Concomitant use of medications associated with ONJ
  • Poor oral hygiene, pre-existing dental disease
  • Cancer, radiotherapy, anemia, coagulopathy 1
• Management:
  • Perform routine oral examination before starting treatment
  • For patients requiring dental procedures, develop management plan with oral surgeon
  • For suspected ONJ:
    • Refer to dentist or oral surgeon
    • Consider discontinuation based on benefit-risk assessment 1

Atypical Femoral Fractures

• Monitor for new or unusual thigh, hip, or groin pain
• Evaluate patients with these symptoms for incomplete femur fractures
• Consider discontinuation based on individual benefit-risk assessment 1

Infusion/Injection Site Reactions

• Management:
  • Ensure proper administration technique
  • Allow Evenity to reach room temperature before injection
  • Rotate injection sites (thigh, abdomen, outer area of upper arm)
  • Do not inject into areas where skin is tender, bruised, red, or hard 1

Monitoring Recommendations

• Regular assessment of:
  • Cardiovascular symptoms
  • Calcium levels (especially in renal impairment)
  • Bone pain or unusual skeletal symptoms
  • Signs of hypersensitivity

Special Considerations

Renal Impairment

• Patients with severe renal impairment require:
  • More frequent monitoring of serum calcium
  • Adequate calcium and vitamin D supplementation
  • Education about hypocalcemia symptoms 1

Concomitant Medications

• Exercise caution with medications that may increase risk of:
  • ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, corticosteroids)
  • Hypocalcemia
  • Cardiovascular events 1

When to Permanently Discontinue Evenity

1. Myocardial infarction or stroke during therapy
2. Severe hypersensitivity reactions
3. Severe, unmanageable hypocalcemia
4. Consider discontinuation for ONJ or atypical femoral fractures based on benefit-risk assessment 1

Remember that Evenity is typically administered for only 12 months as a bone-forming treatment in the therapeutic sequence for postmenopausal women with very high fracture risk 2. After completing the Evenity treatment course, patients should transition to an antiresorptive agent to maintain bone density gains 3.