Evenity

Evenity is a prescription medication for the treatment of osteoporosis in women after menopause.

Evenity belongs to a group of drugs called monoclonal antibodies. Evenity works by increasing bone formation and decreasing bone loss.

This medication is available in an injectable form to be given directly under the fatty layer of the skin (subcutaneously). It is given as 2 injections, given one right after the other in the same office appointment, once a month, for 12 office visits.

Common side effects of Evenity include joint pain and headache. 

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Evenity. See the "Evenity Precautions" section.

Common side effects of Evenity include the following:

• headache 
• joint pain

This is not a complete list of Evenity side effects. Ask your doctor or pharmacist for more information.

Tell your doctor  if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicinces you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Evenity including the following:

• 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.

• 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

Do not take Evenity if you:

• have low calcium levels
• are allergic to any of its ingredients
• are breastfeeding or plan to breastfeed
• are pregnant or may become pregnant
• have had a stroke or heart attack in the past year

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Evenity, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Evenity, tell your healthcare provider about all your medical conditions, including if you:

• have a history of other heart or blood vessel problems
• have low blood calcium
• cannot take daily calcium and vitamin D
• have kidney problems or are on kidney dialysis
• plan to have dental surgery or teeth removed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

Evenity is not indicated for use in women of reproductive potential. No studies have been done in animals, and no well-controlled studies have been done in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

Evenity is not indicated for use in women of reproductive potential. It is not known whether Evenity is found in human milk.

• Evenity is an injection that will be given to you by your healthcare provider. Evenity is injected under your skin (subcutaneous).
• You will receive an Evenity dose (2 injections) 1 time every month for 12 doses.
• You should take calcium and vitamin D while you receive Evenity.
• If you miss a dose of Evenity, contact your healthcare provider as soon as possible to schedule your next dose.
• Your next dose of Evenity should then be scheduled every month from the date of the last injection.
• You should take good care of your teeth and gums while you receive Evenity. You should tell your dentist that you are receiving Evenity before you have dental work.

The dose of Evenity is 210 mg once per month. It is given as 2 injections that are 105 mg each, given one right after the other, directly into the skin (subcutaneously) by a healthcare provider. It is necessary to supplement vitamin D and calcium during treatment with Evenity.

Evenity is administered by a healthcare provider in a medical setting therefore it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Keep Evenity in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect it from light.
• Do not freeze Evenity.
• Do not shake Evenity.
• When you remove Evenity from the refrigerator, Evenity must be kept at room temperature up to 77°F (25°C) in the original carton and must be used within 30 days. Evenity should be thrown away if taken out of the refrigerator and not used within 30 days.
• Do not keep Evenity at temperatures above 77°F (25°C). Warm temperatures will affect how Evenity works.
• Keep Evenity and all medicines out of the reach of children.

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.