EVENITY® (Romosozumab)

EVENITY®

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Important Safety Information

EVENITY® (romosozumab) is an injection medication used to treat osteoporosis in post-menopausal women who are at a high risk of fracture. It’s also used to treat patients who are intolerant of other osteoporosis medications or have failed other types of osteoporosis therapy. EVENITY® works by inhibiting sclerostin, a major suppressor to bone formation.

Patients who have low blood-calcium levels, or who have had a stroke or heart attack within the past 12 months should not use EVENITY®. Risks of receiving Romosozumab can include heart attack, stroke, and cardiovascular problems resulting in death, so consult with your healthcare provider before starting therapy with EVENITY®.

The recommended treatment duration for EVENITY® is 12 months, with the patient receiving a monthly dosage of 210 mg via injection in the abdomen, thigh, or upper arm. Patients should supplement their treatments with calcium and Vitamin D over the course of their EVENITY® injection. EVENITY® should always be administered by a healthcare provider.

What is the most important information I should know about EVENITY®?

The use of EVENITY® can lead to serious side effects, such as increased risk of heart attack, stroke, or cardiovascular death. If you’ve suffered from any of these conditions in the past 12 months you may not be a good candidate for EVENITY® injection therapy. Consult with your doctor prior to use, especially if you:

  • Have a history of cardiovascular problems
  • Have low blood calcium
  • Are unable to take daily vitamin D and/or calcium
  • Have planned any kind of dental surgery
  • Have kidney problems or are on kidney dialysis

Do not use EVENITY® if you are allergic to romosozumab or any of its ingredients.

Tell your doctor about all medications you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements, as some drugs may not react well when mixed with EVENITY®.

In rare cases, EVENITY® may cause osteonecrosis — particularly in patients with blood cell disorders, cancer, or dental problems, or who are treating with steroids, chemotherapy, or radiation therapy.

EVENITY® should not be used by women during child-bearing years or by those who are breastfeeding. Talk to your doctor if you’re pregnant, planning on becoming pregnant, or breastfeeding your child to discuss your options.

Side Effects of EVENITY®

The most common side effects of EVENITY® injection are:

  • Joint pain
  • Headaches

However, more severe side effects from EVENITY® have been known to occur, such as:

  • Serious allergic reactions
  • Hypocalcemia (low blood calcium)
  • Severe osteonecrosis (bone cell death) in the jaw bone
  • Unusual thigh bone fractures

If you experience signs of an allergic reaction, heart attack, or stroke, seek immediate emergency medical help. These symptoms may include chest tightness, breathing difficulties, skin rash, hives, swelling of the mouth, tongue, or lips, pain or discomfort in your neck, jaw, arms, or stomach, lightheadedness, sudden numbness on one side of the body, confusion, slurred speech, loss of balance or coordination, or double vision.

If you are experiencing any of the other side effects, please contact your healthcare professional for medical advice.

While this list gives many of the most prevalent side effects of EVENITY®, it is not exhaustive.

Report any adverse side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Please refer to the full prescribing information.