For women with osteoporosis after menopause at high risk for fracture
After 12 months, women on EVENITY® significantly reduced their risk of spine fractures.
This study followed 7,180 women with postmenopausal osteoporosis receiving EVENITY® or placebo (a treatment without medicine) for 12 months. Women receiving EVENITY® had fewer new spine fractures (0.5%) than women receiving placebo (1.8%) at 12 months. Reductions in fractures other than the spine were not significant at 12 months.
In the same clinical study as above, women on EVENITY® experienced a significant increase in the BMD of their lower spine, hip, and femoral neck (thighbone), compared to women on placebo.
BMD results do not imply fracture risk reduction.
A pelvis bone sample taken at month 12 from a woman with postmenopausal osteoporosis receiving placebo.
A pelvis bone sample taken at month 12 from a woman with postmenopausal osteoporosis receiving EVENITY®.
For illustrative purposes only. Bone samples were taken from 2 different women from a substudy consisting of 139 women with postmenopausal osteoporosis. Images selected are from women who were close to the average in each group.
What is the most important information I should know about EVENITY®?
EVENITY® can cause serious side effects, including increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Call your healthcare provider or get emergency help right away if you have any of these symptoms: symptoms of heart attack, which may include: chest pain or pressure; shortness of breath; feeling light-headed or dizzy; or symptoms of stroke, which may include: headache; numbness or weakness in face, arm, or legs; difficulty talking; changes in vision or loss of balance. Before you receive EVENITY®, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year.
Do not receive EVENITY® if you: have low blood calcium; or are allergic to romosozumab or any of the ingredients in EVENITY®.
Before receiving EVENITY®, tell your healthcare provider about all your medical conditions, including if you:
What are the possible side effects of EVENITY®?
EVENITY® may cause serious side effects, including:
Serious allergic reactions have happened in people who receive EVENITY®. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of a serious allergic reaction including: rash; hives; swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing.
Low calcium levels in your blood (hypocalcemia). EVENITY® may lower the calcium levels in your blood. Your low blood calcium should be treated before you receive EVENITY®. Call your healthcare provider if you have symptoms of low blood calcium such as: spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes or around your mouth.
Severe jaw bone problems (osteonecrosis) may occur. Your healthcare provider should examine your mouth before you start EVENITY® and may tell you to see your dentist. Ask your healthcare provider or dentist about good mouth care.
Unusual thigh bone fractures. Symptoms of this type of fracture include new or unusual pain in your hip, groin, or thigh.
The most common side effects of EVENITY® include joint pain and headaches.
These are not all the possible side effects of EVENITY®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
EVENITY® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk of fracture, or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.