Evenity

Evenity (romosozumab-aqqg) is a prescription injection used to treat osteoporosis in postmenopausal women who are at high risk of breaking a bone. It builds new bone and reduces bone loss at the same time, which lowers the risk of spine fractures and increases bone mineral density (BMD).

Evenity is a sclerostin inhibitor.

Evenity is given as two injections under the skin (subcutaneous), once a month for 12 months, by a healthcare provider. You should also take calcium and vitamin D supplements every day while you are receiving it.

Evenity is FDA-approved to treat osteoporosis in postmenopausal women who are at high risk of fracture. The label defines high risk as:

• a history of an osteoporotic fracture (a broken bone caused by weak bones), or
• multiple risk factors for fracture, or
• having tried other osteoporosis medicines that did not work or could not be tolerated.

Evenity is not approved for men, for children, or for women who can still become pregnant.

Evenity works by blocking sclerostin, a protein that normally slows down bone formation. Blocking sclerostin lets the body form new bone faster while also reducing the breakdown of existing bone. Evenity is a humanized monoclonal antibody and is a sclerostin inhibitor. This makes it different from bisphosphonates such as Fosamax (alendronate) and from denosumab (Prolia), which only slow bone loss and do not build new bone.

In the clinical trial called Study 1 (NCT01575834), 7,180 postmenopausal women with osteoporosis received either Evenity or a placebo for 12 months. Women taking Evenity had a 73% lower risk of a new spine fracture at 12 months compared with placebo.

Effect on fractures

• New spine fractures at 12 months: 0.5% of women on Evenity compared with 1.8% on placebo, a 73% relative risk reduction.
• New spine fractures at 24 months: 0.6% compared with 2.5%, a 75% relative risk reduction. Women in this trial took Evenity for 1 year and then switched to denosumab (Prolia) for a second year.

Evenity also lowered the number of clinical fractures at 12 months. However, 88% of these were fractures outside the spine, and the rate of fractures outside the spine was not significantly different between Evenity and placebo at either 12 or 24 months.

Effect on bone mineral density (BMD)

After 12 months, women on Evenity had higher bone mineral density than women on placebo. The differences between the two groups were:

• 12.7% at the lumbar spine (lower back)
• 5.8% at the total hip
• 5.2% at the femoral neck (top of the thigh bone)

After Evenity is stopped, bone mineral density returns to about its starting level within 12 months unless you move on to another osteoporosis medicine.

Evenity and Prolia are both injections for osteoporosis, and both are made by Amgen. The main difference is what they do to bone. Evenity builds new bone and slows bone loss. Prolia (denosumab) only slows bone loss.

The two medicines are often used one after the other. Because the bone-building effect of Evenity wears off after 12 months, doctors usually follow it with an anti-resorptive medicine such as Prolia or a bisphosphonate to hold on to the bone that was gained. Prolia also should not be stopped on its own, so your doctor will plan what comes next before you start either medicine.

The cost of prescription medicines varies depending on your insurance plan and which pharmacy you use. Evenity is usually given in a clinic or doctor's office, so it may be billed as a medical benefit rather than a pharmacy benefit. Refer to the Evenity Prices, Coupons, Copay Cards & Patient Assistance page for more information about the cost of this medicine.

Evenity is given by a healthcare provider as two separate injections under the skin, one after the other. Two syringes are needed for each monthly dose. The injections go into the stomach area (abdomen), thigh or outer upper arm, and a different spot is used each time.

• Evenity is given once a month for 12 months.
• You should take calcium and vitamin D supplements every day while you are receiving it.
• The syringe is taken out of the fridge and left at room temperature for at least 30 minutes before the injection. It should not be warmed any other way.
• Evenity should not be shaken.
• Each syringe is used once and then thrown away in a sharps container, even if some medicine is left inside.

Brush and floss your teeth regularly while receiving Evenity. If you need dental work, especially surgery, tell your dentist ahead of time that you are receiving this medicine.

Risk of heart attack, stroke and cardiovascular death

Evenity has a boxed warning for the risk of heart attack (myocardial infarction), stroke and death from heart or blood vessel disease. A boxed warning is the strongest safety warning the FDA issues.

In the trial that compared Evenity with alendronate (Study 2, NCT01631214), serious heart and blood vessel events were reported in 2.0% of women on Evenity and 1.1% of women on alendronate over 12 months. In the trial that compared Evenity with placebo (Study 1), the rates were similar in both groups at 0.8%.

Evenity should not be started if you have had a heart attack or stroke in the past year. If you have a heart attack or stroke while receiving Evenity, treatment should be stopped.

Other warnings

• Do not use Evenity if you have low blood calcium. Low calcium must be corrected before you start treatment.
• Take calcium and vitamin D supplements every day during treatment to lower the risk of low blood calcium.
• Treatment is limited to 12 monthly doses because the bone-building effect wears off after that.
• Evenity is not for use in women who can become pregnant, and it is not for use while breastfeeding.

You should not receive Evenity if you have:

• An allergy to romosozumab-aqqg or any of the other ingredients in this medicine; see the ingredients at the bottom of this page.
• Low levels of calcium in your blood (hypocalcemia).

Evenity should not be started if you have had a heart attack or stroke in the past 12 months.

Tell your doctor if you have ever had:

• Heart problems, a blood vessel disorder, a heart attack or a stroke
• High blood pressure, high cholesterol, diabetes, or if you smoke
• Low levels of calcium in your blood
• Kidney disease, or if you are on dialysis
• Dental problems, gum disease or poor oral hygiene
• Any planned tooth removal or dental surgery
• Trouble taking calcium and vitamin D supplements every day

You may need a dental exam before you start Evenity. Jawbone problems are more likely in people with cancer, blood cell disorders, existing dental problems, or people treated with steroids, chemotherapy or radiation.

Pregnancy and breastfeeding

Evenity is not for use in women who can still become pregnant. It should not be used during pregnancy or while breastfeeding.

Common Evenity side effects

The most common Evenity side effects include:

• Joint pain 13.1%
• Headache 6.6%
• Muscle spasms 4.6%
• Swelling of feet or hands 2.4%
• Lack of energy and strength 2.3%
• Neck pain 2.2%
• Trouble sleeping 2.0%
• Pins and needles feeling 2.0%

These side effects occurred in 2% or more of women taking Evenity in Study 1 (NCT01575834), a randomized, double-blind, placebo-controlled trial. Injection site reactions occurred in 4.9% of women across both main trials.

Serious side effects

Evenity may cause serious side effects. Get emergency medical help if you have signs of an allergic reaction, such as hives, trouble breathing, or swelling of your face, lips, tongue or throat.

Call your doctor at once if you have:

• Heart attack or stroke. Evenity can raise the risk of heart attack, stroke and death from a heart or blood vessel problem. Seek emergency help for chest pain or pressure, shortness of breath, feeling light-headed, sudden numbness or weakness, trouble with vision or speech, or loss of balance. See the Warnings section below.
• Serious allergic reactions. Angioedema, erythema multiforme, dermatitis, rash and hives have been reported. Tell your doctor right away about any rash, itching, hoarseness, or swelling of the hands, face or mouth.
• Low blood calcium (hypocalcemia). Symptoms include muscle spasms or cramps, and numbness or a tingling feeling around your mouth or in your fingers and toes. The risk is higher if you have severe kidney disease or are on dialysis. Blood calcium is usually lowest about 1 month after a dose.
• Jawbone problems (osteonecrosis of the jaw). Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, poor healing after dental work, or an infected jaw. Tell your dentist you are receiving Evenity before you have any dental work.
• Unusual thigh bone fractures. Tell your doctor about new or unusual pain in your thigh, hip or groin. This pain can come weeks or months before a break.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual adult Evenity dose for postmenopausal osteoporosis

• Dose: 210 mg under the skin (subcutaneously) once a month.
• This is given as two 105 mg injections, one after the other, into the abdomen, thigh or upper arm.
• Treatment length: 12 monthly doses.
• Evenity should be given by a healthcare provider.
• Take calcium and vitamin D supplements every day during treatment.

After your 12 months of Evenity

The bone-building effect of Evenity wears off after 12 monthly doses, so treatment is not continued past 1 year. If you still need osteoporosis treatment, your doctor will usually start you on an anti-resorptive medicine such as denosumab or a bisphosphonate to keep the bone density you gained.

Call your doctor's office if you miss an Evenity appointment. The missed dose should be given as soon as it can be rescheduled. After that, your monthly schedule restarts from the date of that dose.

Each Evenity syringe holds a set amount of medicine and it is given by a healthcare provider, so an overdose is unlikely. If you are concerned about a dosing error, call the poison control helpline at 1-800-222-1222. If someone has collapsed, had a seizure, has trouble breathing or cannot be woken up, call 911.

Evenity comes as a single-use prefilled syringe containing 105 mg in 1.17 mL. Two syringes make up one 210 mg dose. Three presentations are available:

• Carton of two glass prefilled syringes with an automatic needle guard (NDC 55513-509-02)
• Carton of two glass prefilled syringes (NDC 55513-998-02)
• Carton of two plastic prefilled syringes (NDC 55513-880-02)

The syringes are not made with natural rubber latex.

No formal drug interaction studies have been done with Evenity. As a monoclonal antibody, it is not expected to interact with medicines the way that most tablets and capsules do.

Still, tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal products. Tell them about any medicine you start or stop while receiving Evenity.

Take extra care with calcium and vitamin D supplements. These are a required part of Evenity treatment, not an optional extra, and skipping them raises the risk of low blood calcium.

Healthcare professionals and patients often use the Evenity Package Insert (PI) for more detailed information about this medicine. The Package Insert covers Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions and more. It is sometimes called the Prescribing Information or the FDA label.

The Package Insert does not contain everything you need to know for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

• Store Evenity in a fridge at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light.
• Do not freeze. Do not shake.
• If taken out of the fridge, Evenity can be kept in its original carton at room temperature up to 25°C (77°F) and must be used within 30 days. Throw it away if it is not used within 30 days.
• Do not let Evenity get warmer than 25°C (77°F).
• Keep it out of the reach of children and pets.

Evenity is a clear to slightly cloudy solution that is colorless to light yellow. Your healthcare provider will check it before your injection and will not use it if it is discolored or has particles in it.

Active ingredient: romosozumab-aqqg

Inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose and water for injection.

Evenity is made by Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799.