Evenity

Primary Indications

Evenity is specifically approved for postmenopausal women with osteoporosis who meet certain criteria for high fracture risk. This includes individuals who:

• Have a history of osteoporotic fractures.
• Have multiple risk factors for bone breaks.
• Have not responded well to other available osteoporosis treatments.
• Cannot tolerate other osteoporosis medications due to side effects or medical reasons.

The medication works by both increasing new bone formation and decreasing bone loss, which helps to strengthen bones and reduce the likelihood of future fractures in the spine and other areas.

Because the bone-building effects of this medication decrease over time, it is typically used for a limited duration. After completing the course of treatment, healthcare providers often transition patients to a different type of osteoporosis medication to maintain bone density gains.

Mechanism of Action

Evenity (romosozumab-aqqg) is a type of medication called a sclerostin inhibitor. Sclerostin is a naturally occurring protein in the body that helps regulate bone growth by signaling the body to limit the formation of new bone.

This medication works through a dual process to improve bone strength:

• Increasing bone formation: By blocking the effects of sclerostin, Evenity allows the body to increase the production of new bone tissue.
• Decreasing bone breakdown: The medication also helps slow down the process of bone resorption, which is when the body breaks down and removes old bone cells.

By simultaneously building new bone and reducing the loss of existing bone, Evenity increases bone mineral density. This helps to strengthen the skeleton and lower the risk of fractures in postmenopausal women with osteoporosis who are at high risk for bone breaks.

Common Side Effects

Many people using Evenity experience mild side effects. The most common include:

• Joint pain
• Headache
• Muscle spasms
• Neck pain
• Swelling in the arms or legs
• Cold-like symptoms

Some people also experience reactions at the site of the injection, such as pain, redness, or itching.

Serious Side Effects

Evenity can cause serious side effects that require immediate medical care. These include:

• Heart and blood vessel problems: Symptoms may include chest pain, shortness of breath, sudden numbness or weakness (especially on one side of the body), or difficulty speaking.
• Jaw bone issues: Severe jaw pain or slow healing after dental work may indicate a condition called osteonecrosis of the jaw.
• Atypical bone fractures: New or unusual pain in the hip, groin, or thigh should be reported to a healthcare provider.
• Low calcium levels: Signs include muscle cramps, spasms, or tingling in the hands, feet, or around the mouth.
• Severe allergic reactions: Seek emergency help for hives, swelling of the face or throat, or trouble breathing.

Boxed Warning: Cardiovascular Risk

Evenity may increase the risk of serious cardiovascular events, including heart attack, stroke, and death related to heart or blood vessel problems. This medication should not be initiated in patients who have experienced a heart attack or stroke within the preceding year. For patients with other cardiovascular risk factors, healthcare providers will consider whether the benefits of treatment outweigh the potential risks. If a patient has a heart attack or stroke while on Evenity, the medication is usually discontinued.

Hypocalcemia

Low blood calcium levels (hypocalcemia) can occur during treatment. Any existing low calcium must be corrected before starting Evenity. Patients are typically advised to take calcium and vitamin D supplements to help maintain adequate levels. Symptoms of low calcium may include muscle spasms, twitches, or numbness and tingling in the fingers, toes, or around the mouth.

Hypersensitivity

Serious allergic reactions have been reported, including swelling of the face, lips, mouth, or tongue (angioedema) and severe skin reactions. If signs of a serious allergic reaction occur, the medication should be stopped and medical care sought immediately.

Jaw and Bone Concerns

• Osteonecrosis of the jaw: This is a rare condition where the jawbone is exposed and begins to weaken or die, often following dental surgery or tooth extraction. A dental exam and preventive dentistry may be recommended before starting treatment.
• Atypical femoral fractures: Some patients may develop unusual fractures in the thigh bone with little or no trauma. New or unusual pain in the hip, groin, or thigh should be evaluated by a healthcare professional.

Pregnancy

Evenity is not indicated for use in women of reproductive potential. Because the medication is specifically approved for postmenopausal women with osteoporosis, it has not been studied in pregnant humans. In animal studies, high doses of the drug were associated with skeletal abnormalities in the offspring. It is unknown if these effects would occur in human pregnancies.

Breastfeeding

It is not known whether the active ingredient in Evenity passes into human breast milk or if it could affect a nursing infant. There is currently no data regarding the effects of the drug on milk production. Because the medication is intended for postmenopausal women, its use is generally not expected during lactation. Patients should discuss their health history and any concerns about breastfeeding with a healthcare provider.

Available Forms

Evenity is supplied as a sterile, preservative-free liquid solution. It is available in the following form:

• Single-use prefilled syringe: This medication is intended for subcutaneous injection, which is an injection administered just under the skin.

A full dose of this medication requires two separate injections given one after the other. The solution is clear to opalescent and colorless to light yellow in appearance.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Evenity in April 2019. It is specifically indicated for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture. This high-risk category includes women with a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapies.

Boxed Warning

Evenity includes a Boxed Warning, which is the FDA's most serious warning for medications. This warning highlights an increased risk of myocardial infarction (heart attack), stroke, and cardiovascular death.

• Evenity should not be initiated in patients who have had a heart attack or stroke within the preceding year.
• Healthcare providers must consider whether the benefits of treatment outweigh the risks in patients with other cardiovascular risk factors.
• If a patient experiences a heart attack or stroke during treatment, the medication should be discontinued.

Usage Limitations

The FDA-approved duration of use for Evenity is limited to 12 monthly doses. The bone-forming effect of the drug begins to wane after 12 months of treatment. Once the 12-month course is completed, regulatory guidelines suggest transitioning to another osteoporosis treatment, such as an antiresorptive agent, to help maintain the bone mineral density gained during therapy.

Factors Influencing Cost

The price of Evenity is influenced by several factors, including:

• Insurance Coverage: Most private insurance plans and Medicare cover Evenity, but out-of-pocket costs like deductibles, copayments, or coinsurance will vary.
• Administration Fees: Because Evenity must be administered by a healthcare professional, patients may be responsible for costs associated with the office visit or the injection procedure itself.
• Treatment Duration: Evenity is typically prescribed as a course of 12 monthly doses. The total cost of treatment is generally calculated based on this one-year period.

Financial Assistance

The manufacturer may offer support programs to help reduce costs for eligible patients. These options often include:

• Copay Cards: Patients with commercial insurance may qualify for programs that lower their monthly out-of-pocket expenses.
• Patient Assistance Programs: Individuals without insurance or those who are underinsured may be eligible for programs that provide the medication at a reduced cost or for free based on financial need.

Patients are encouraged to contact their insurance provider and healthcare team to obtain a specific estimate of their expected costs.