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EVENITY

EVENITY® (romosozumab-aqqg) is a prescription monoclonal antibody indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. It is a sclerostin inhibitor that both stimulates bone formation and decreases bone resorption, resulting in improved bone mass and strength. It is used when patients either have a history of osteoporotic fracture, multiple risk factors for fracture, or cannot tolerate or have failed other osteoporosis therapies.
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EVENITY
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What is the Administration Protocol for EVENITY®?

EVENITY is administered via subcutaneous injection and has a limited use duration of 12 monthly doses, after which patients should be transitioned to antiresorptive therapy to maintain bone gains. It is not intended for pediatric use or for women of childbearing potential due to potential risks to fetal development.
  • Dosage: 210 mg once monthly
  • Injection Method: Two separate 105 mg/1.17 mL prefilled syringes (injected consecutively)
  • Injection Sites: Abdomen, thigh, or outer upper arm
  • Treatment Duration: Maximum of 12 monthly doses
  • Supplementation: Adequate calcium and vitamin D required throughout treatment
Do not inject into areas with bruises, scars, or infections. The product should be brought to room temperature for at least 30 minutes prior to use. Learn more about Evenity Dosing and Administration instructions here.

What are the Indications for EVENITY®?

EVENITY is approved for:
  • Treatment of osteoporosis in postmenopausal women at high risk of fracture due to: 
    • Prior osteoporotic fractures
    • Multiple fracture risk factors
    • Intolerance or failure of other therapies

Contraindications:

  • Hypocalcemia
  • Known hypersensitivity to romosozumab or excipients

Warnings:

  • Boxed Warning: Increased risk of myocardial infarction, stroke, and cardiovascular death
  • Do not initiate in patients with recent (within 1 year) MI or stroke
  • Discontinue if a cardiovascular event occurs during therapy

What is the Composition of EVENITY®?

Each prefilled syringe contains:
  • Active ingredient: 105 mg of romosozumab-aqqg
  • Excipients:
    • Acetate (3.8 mg)
    • Calcium (0.61 mg)
    • Polysorbate 20 (0.07 mg)
    • Sucrose (70 mg)
    • Water for Injection, pH adjusted to 5.2
The full dose of 210 mg is delivered via two injections, each from a single-use prefilled syringe.

What Comes in the EVENITY® Package?

Here’s the list of items that come in the EVENITY® Package:
  • Carton containing two 105 mg/1.17 mL single-use prefilled syringes
  • Not made with natural rubber latex
  • Solution is clear to opalescent, colorless to light yellow
  • For subcutaneous use only, under healthcare provider supervision

Does EVENITY® Cause Side Effects?

Yes, both common and serious side effects have been reported.

Common Side Effects (≥5%):

  • Joint pain (arthralgia)
  • Headache
  • Muscle spasms
  • Injection site reactions: Pain, redness, swelling

Serious Side Effects:

  • Myocardial infarction, stroke, cardiovascular death
  • Hypocalcemia
  • Hypersensitivity reactions (angioedema, rash, urticaria)
  • Osteonecrosis of the jaw
  • Atypical femur fractures
A higher incidence of cardiovascular events was observed in clinical trials compared to alendronate.

How Should EVENITY® Be Stored?

Proper storage is essential to maintain product efficacy and safety.
  • Refrigerate: 2°C to 8°C (36°F to 46°F)
  • Do not freeze or shake
  • Protect from light
  • Can be stored at room temperature (≤25°C/77°F) for up to 30 days
  • Must be used within 30 days of removal from refrigeration
Unused syringes should be discarded after this period. Keep out of reach of children.
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