EVENITY Side Effects
EVENITY (romosozumab) carries a significant risk of major adverse cardiovascular events including heart attack, stroke, and cardiovascular death, along with other serious side effects including hypersensitivity reactions, hypocalcemia, osteonecrosis of the jaw, and atypical femoral fractures. 1
Cardiovascular Events (Black Box Warning)
The FDA has issued a black box warning for increased risk of cardiovascular events with EVENITY. 1
- Major adverse cardiac events (MACE) occur at higher rates compared to alendronate (2.5% vs 1.9%) 2
- Contraindicated in patients with myocardial infarction or stroke within the preceding year 2, 1
- Symptoms requiring immediate medical attention include: 1
- Chest pain or pressure
- Shortness of breath
- Feeling light-headed or dizzy
- Headache, numbness or weakness in face/arm/legs
- Difficulty talking or changes in vision
Clinical Pitfall: The cardiovascular risk was identified in the ARCH trial comparing romosozumab to alendronate, making this a critical consideration when selecting patients for therapy. 3, 4
Serious Allergic Reactions
- Hypersensitivity reactions including angioedema, erythema multiforme, dermatitis, rash, and urticaria can occur 1
- Patients should seek immediate medical attention for: 1
- Rash or hives
- Swelling of face, lips, mouth, tongue, or throat
- Difficulty swallowing or breathing
Hypocalcemia (Low Blood Calcium)
Pre-existing hypocalcemia must be corrected before initiating EVENITY. 1, 5
- Mandatory supplementation: Patients must take daily calcium and vitamin D throughout treatment 1
- Symptoms requiring immediate attention include: 1
- Muscle spasms, twitches, or cramps
- Numbness or tingling in fingers, toes, or around mouth
Osteonecrosis of the Jaw (ONJ)
- Dental examination recommended before starting EVENITY 1
- Patients should maintain good oral hygiene and inform dentists of EVENITY use before dental procedures 1
- Risk increases with invasive dental procedures 1
Atypical Femoral Fractures
- Unusual thigh bone fractures can occur with romosozumab 1
- Patients should report new or unusual pain in: 1
- Thigh
- Hip
- Groin
Common Side Effects
The most frequently reported adverse effects include: 1
Safety Profile from Clinical Trials
Romosozumab followed by alendronate probably did not increase risk for serious harms or withdrawal due to adverse effects compared with bisphosphonate alone at 12-36 month assessment (moderate to low certainty evidence). 6
Critical Treatment Limitations
- Treatment duration strictly limited to 12 monthly doses as the anabolic effect wanes after this period 6, 7
- Sequential therapy required: Patients must transition to an antiresorptive agent (preferably alendronate) after completing romosozumab to maintain bone density gains 2, 7
- Failure to transition results in loss of bone density benefits 7
Patient Selection Considerations
EVENITY should be reserved for postmenopausal women at very high risk of fracture who cannot use or have failed other osteoporosis therapies. 6
Avoid in patients with: 2, 1, 3
- History of myocardial infarction or stroke (especially within past year)
- High cardiovascular risk
- Documented coronary heart disease
- Uncorrected hypocalcemia