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Evenity (Cold)
Romosozumab
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FDA boxed warningPotential risk of myocardial infarction, stroke and cardiovascular death
EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death. EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.
About Evenity (Cold)
Overview
Evenity (romosozumab) is a prescription medicine supplied in a pre-filled syringe for injection under the skin. It treats osteoporosis in postmenopausal women at high risk of fracture, including those with a previous osteoporotic fracture or multiple fracture risk factors, or those whose other osteoporosis treatments have failed or were not tolerated. It blocks a protein called sclerostin, increasing new bone formation and, to a lesser extent, reducing bone breakdown.
What it treats
Osteoporosis in postmenopausal women at high risk of fracture because of a previous osteoporotic fracture or multiple fracture risk factors, or when other osteoporosis treatments have not worked or cannot be tolerated.
Safety information
Side effects
The most common side effects are joint pain and headache, each reported in at least 5% of people in clinical trials. Serious risks include major heart-related events, including heart attack and stroke. Seek prompt medical attention if symptoms of a heart attack or stroke occur. Contact a doctor if you develop an allergic reaction, such as swelling, a rash, hives or skin inflammation. Evenity should be stopped if a clinically significant allergic reaction occurs. Other serious risks include low blood calcium, damage to the jawbone (osteonecrosis) and unusual fractures of the thigh bone. Contact a doctor about jaw symptoms or new or unusual thigh, hip or groin pain. Calcium and vitamin D supplementation is needed during treatment.
FDA boxed warning
Potential risk of myocardial infarction, stroke and cardiovascular death
EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death. EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Evenity if you have low blood calcium or a history of a systemic allergic reaction to romosozumab or any ingredient in the medicine. Low blood calcium must be corrected before treatment begins. Evenity carries warnings for heart attack and stroke. Seek prompt medical attention if symptoms occur. Clinically significant allergic reactions require treatment to be stopped. Calcium and vitamin D supplementation is needed during treatment. People with severe kidney impairment or receiving dialysis have a greater risk of low blood calcium and need blood calcium monitoring. Other warnings include damage to the jawbone (osteonecrosis) and unusual thigh-bone fractures. Report symptoms affecting the jaw, or new or unusual thigh, hip or groin pain, so these can be assessed. Your prescriber may consider stopping treatment if jawbone damage occurs, based on the benefits and risks.
Using Evenity (Cold)
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label EVENITY (ROMOSOZUMAB-AQQG) INJECTION, SOLUTION [AMGEN, INC] (DailyMed, retrieved 19 September 2026).
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