Evenity

Doctors need to monitor the response of patients taking Evenity. This is done with a Bone Mineral Density test, at the start and at the end of treatment.

Evenity can slightly increase the risk of heart attack or stroke. Patients who have had a recent heart attack or stroke or experienced serious chest pain from heart disease should not take Evenity.

Evenity has been associated with a very rare problem with the jaw called osteonecrosis. This problem is sometimes seen after dental work. Patients should let their doctor know if they develop sudden pain in the jaw.

Alcohol is known to increase fracture risk by decreasing bone mineral density and promoting osteoporosis.

Patients who are prescribed Evenity should stop drinking alcohol, or at least significantly reduce the amount of alcohol that they drink.

The body features an ongoing process called bone remodeling where bones are constantly broken down (bone resorption) and built back up (bone formation). Bones are broken down by a type of cell called osteoclasts and are built back up by a type of cell called osteoblasts. In patients with osteoporosis, too much bone is being broken down too quickly.

Some medications used to treat osteoporosis slow down the bone resorption process – they slow down osteoclasts. Others increase the bone formation process – they help osteoblasts. Evenity primarily increases the bone formation process and to a lesser extent reduces bone resorption.

Sclerostin is a small protein made by bone cells. Sclerostin binds to a receptor on the surface of the osteoblast and slows bone formation.

Evenity is a protein called a monoclonal antibody that binds to sclerostin. This prevents sclerostin from binding to the osteoblast. The effect is that the osteoblast is not slowed down by sclerostin and the bone building process is increased. The result is the body has more time to build up and strengthen its bones.

Patients taking Evenity should talk to their doctor if they are concerned about any side effects.

The most common side effect of this medication are joint pain and headache.

Patients should let their doctor know if they develop chest pain or shortness of breath, develop jaw pain, or experience muscle cramps, twitching or weakness.

Possible side effects include:

• Headache – Evenity can cause a headache
• Muscle & bone pain – Evenity can cause bone, muscle, or joint pain
• Low calcium – Evenity can very rarely lower the calcium in the blood. Patients should tell their doctor if they develop:
  • Tingling in the hands, feet, or around the mouth
  • Muscle cramps or twitching
  • Muscle weakness
• Jaw problem – Evenity has very rarely been associated with a jaw problem called osteonecrosis
• Patients have very rarely developed allergic reactions (feeling faint, trouble breathing or throat tightness, chest tightness, and swelling of the face, eyelids, lips, mouth, tongue, or throat) or hives while taking Evenity. Evenity should be stopped if this occurs.

Evenity should not be taken during pregnancy or breastfeeding. Patients who become pregnant should stop taking this medication and contact their doctor.

People who should NOT take Evenity include:

• Those allergic to Evenity or any ingredient in the medicine
• Those with low calcium levels
• Pregnant or breast-feeding women

Anyone who becomes pregnant while taking Evenity should notify their doctor immediately.

Patients taking Evenity should call their doctor if they feel sick and want to stop, or if they are concerned about any side effects.

Other reasons to call a doctor while taking Evenity include:

• Tingling in hands, feet or around mouth
• Becoming pregnant or planning pregnancy
• New severe pain in the jaw
• New chest pain or shortness of breath
• Recent heart attack or stroke