Evenity (romosozumab or romosozumab-aqqg) is a once-monthly injection used to treat bone loss (osteoporosis) in women after menopause with high fracture risk, who can’t take other medications for bone loss, or when those other medications haven’t worked. The injection must be given by a healthcare provider. And you’ll need to look out for symptoms of serious risks such as heart attack and stroke.
To treat bone loss (osteoporosis) in women after menopause:
With high risk for fracture
Who can’t take other medications for bone loss
Who tried other medications for bone loss that didn’t work
Evenity (romosozumab) is a sclerostin inhibitor, which means it blocks sclerostin from working. Sclerostin is a protein in your body that normally stops bone growth and promotes bone decay. So by blocking sclerostin, this medication helps your bones grow and prevents bone breakdown at the same time.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Promotes bone growth and prevents bone loss at the same time
Given just once a month
Only need 1 year of treatment
Needs to be injected
Requires a provider visit
Only available as a brand medication
You will be given two injections of Evenity (romosozumab), one after the other, at each appointment. These injections will be given in two different spots. They can be given under the skin around the stomach, in the thigh, or in the back of the upper arm.
If you accidentally miss your scheduled Evenity (romosozumab) injection, reschedule your appointment as soon as possible. Moving forward, the next dose should be given one month from the last injection date.
It’s common to experience pain or swelling at the injection site after you receive Evenity (romosozumab). Let your provider know if these symptoms don’t go away or become bothersome.
You’ll need to take calcium and vitamin D supplements while you’re taking Evenity (romosozumab). While it’s true that Evenity (romosozumab) can lower blood calcium levels, it’s also strongly recommended that people with low bone mass (osteoporosis) take these supplements anyway. You need calcium to build bone and vitamin D to absorb calcium better.
Evenity (romosozumab) may cause heart problems. Seek medical attention if you are having any signs of a heart attack, such as chest pain, shortness of breath, or feeling dizzy.
Evenity (romosozumab) may cause a stroke. Get emergency help if you are having any signs of a stroke, such as headache, vision changes, loss of balance, trouble talking, or weakness or numbness in the arms, legs, or face, especially on one side of the body.
Practice good oral hygiene to help lower the risk of jawbone breakdown from Evenity (romosozumab). Brushing your teeth and flossing regularly can help prevent jaw problems. Also, tell your provider if you’re having dental surgery, and let your dentist know that you’re taking Evenity (romosozumab).
If you are picking up Evenity (romosozumab) from the pharmacy, remember to store it in the refrigerator. If you take it out of the refrigerator, you can keep it at room temperature, but make sure to use it within 30 days. Keep Evenity (romosozumab) in its original packaging to protect it from light.
Evenity (romosozumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Heart attack or stroke in the previous year | High blood pressure | High cholesterol | Diabetes | High body weight | Smoking
In clinical trials, there was a higher rate of heart attack, stroke, and heart-related death in women after menopause taking Evenity (romosozumab) compared to those taking alendronate. For this reason, you can't take Evenity (romosozumab) if you've had a heart attack or stroke within the past year. If you have other risk factors for heart attack or stroke, such as high blood pressure, high cholesterol, diabetes, are overweight or obese, or smoke cigarettes, talk to your provider before starting Evenity (romosozumab). While taking this medication, watch for signs and symptoms of a heart attack such as chest pain, shortness of breath, and dizziness. Also watch out for signs of a stroke such as headache, vision changes, loss of balance, trouble talking, weakness or numbness in the arms, legs, or face, especially if only on one side of the body. If you are having any signs or symptoms above, get emergency medical attention right away.
Risk factors: History of severe kidney problems | Receiving dialysis
Some people have had low blood calcium levels while taking Evenity (romosozumab). If you have kidney damage or are on dialysis, you are at a higher risk for low blood calcium. Get medical attention if you experience symptoms such as muscle pain, spasms, cramps, twitches, or numbness in the fingers, toes, or around your mouth. Your provider should also order bloodwork to test your calcium levels regularly. You’ll also need to take calcium and vitamin D supplements while taking Evenity (romosozumab).
Risk factors: Cancer | Radiation treatment | Poor oral hygiene | Current dental infection or problem | Anemia | Bleeding condition | Taking other medications associated with jawbone problems
People taking Evenity (romosozumab) have reported jawbone breakdown, called osteonecrosis of the jaw (ONJ). An infection in the mouth and/or jaw may cause ONJ, which is why good oral hygiene is important. Symptoms of ONJ include pain, swelling, exposed bone, and drainage from the mouth. You should have a dental exam before starting Evenity (romosozumab). Tell your provider if you’re having a dental procedure, and always let your dentist or oral surgeon know that you’re taking Evenity (romosozumab).
Risk factors: Age 65 years or older | History of fracture | Family history of fracture | Low body weight | Currently smoking | Long-term use of oral steroids | Early menopause
Some people taking Evenity (romosozumab) have had fractures in the thigh. You may have a higher risk for fracture if you are 65 years of age or older, have low body weight, went through early menopause, are a current smoker, or take oral steroids. You’re also at higher risk if you have had a previous fracture or have a parent who has had a fracture. These fractures may occur anywhere in your thigh bone and usually happen even with little or no trauma to the thigh. In fact, you may experience a dull or aching pain in the area weeks to months before a fracture happens. For this reason, it’s important to look for and tell your provider about any new or uncommon hip, thigh, or groin pain.
This medication needs to be given by your healthcare provider.
The typical dose is two injections (210 mg total) under the skin once a month for 12 months.
Low calcium levels (hypocalcemia)
To treat bone loss (osteoporosis) in women after menopause:
With high risk for fracture
Who can’t take other medications for bone loss
Who tried other medications for bone loss that didn’t work
Osteoporosis in women who have gone through menopause (postmenopause)
Osteoporosis in men
Osteoporosis in females who've gone through menopause
Osteoporosis in males
Osteoporosis caused by certain steroid medications
Bone loss in males taking certain medications for prostate cancer
Bone loss in females taking certain breast cancer medications
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Cosman, F., et al. (2016). Romosozumab treatment in postmenopausal women with osteoporosis. The New England Journal of Medicine.
Harvey, N. C., et al. (2017). The role of calcium supplementation in healthy musculoskeletal ageing: An experts consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF). Osteoporosis International.
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Saag, K. G., et al. (2017). Romosozumab or alendronate for fracture prevention in women with osteoporosis. The New England Journal of Medicine.
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