Evenity (Romosozumab-Aqqg) - Subcutaneous

What Is Evenity?

Evenity (romosozumab-aqqg) is a prescription medication that is used to treat osteoporosis in postmenopausal people assigned female at birth. It is used for people who have a high risk of osteoporotic fracture or when prior osteoporosis treatments do not help or cannot be tolerated.

Evenity is a sclerostin inhibitor. Sclerostin is a protein that may block the making of new bone. This protein also plays a role in breaking down bone. Therefore, by blocking sclerostin, Evenity may help make more new bone and prevent bone breakdown.

Evenity is available as a subcutaneous (under the skin) injection.

What Is Evenity Used For?

The FDA approved Evenity to treat osteoporosis in postmenopausal people assigned female at birth.

These individuals using Evenity typically have a very high risk of fractures (breaks). You're at a high risk of fractures if you have a history of an osteoporosis-related fracture or if you have multiple risk factors for a fracture. The following are some example risk factors for fractures:

• Corticosteroid (steroid) use
• High risk of falls
• Very low bone strength and thickness

Frailty syndrome is also another risk factor for fractures. Outside stressors are more likely to negatively affect people with frailty syndrome because it's harder for their bodies to "bounce back."

For this reason, there's a higher chance of falls, injuries, and hospital visits. It's also harder for these individuals to quickly get better and feel healthy again.

Evenity is also an option for other people with osteoporosis if other medications didn't help.

Osteoporosis is a medical condition of low bone mass and density. Millions of people in the United States (U.S.) have this condition.

Many people with osteoporosis might not have any symptoms until they experience fractures from their brittle and weak bones.

How to Take Evenity

To receive Evenity, you'll need to see your healthcare provider. The following is additional information on what to expect during your visits with your healthcare provider:

• Your healthcare provider will ensure that you take enough calcium and vitamin D supplements throughout your treatment.
• The typical Evenity dose is 210 milligrams.
• You'll receive this dose in two separate 105 milligrams syringes every month.
• Your healthcare provider will give these injections subcutaneously in one of the following body areas: stomach, thigh, or upper arm.
• Your healthcare provider will not use the exact same injection spot for two months in a row.
• Your healthcare provider will also avoid areas that are red, tender, or bruised. They'll also avoid areas with scars, stretch marks, or hard bumps.
  

Storage

You can only receive Evenity from your healthcare provider.

Therefore, you do not need to worry about how to store the medication or how to travel with it.

What Are the Side Effects of Evenity?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects with Evenity may include:

• Headache
• Joint pain
  

Severe Side Effects

The FDA assigned a boxed warning to Evenity.

This medication may raise your risk of heart attacks and stroke. Evenity may also increase your chances of death from these heart-related problems.

Get medical help right away if you experience the following severe side effects:

• Serious allergic reaction: If you have a severe allergic reaction to Evenity, symptoms may include itchiness, swelling, and breathing difficulties.
• Heart-related problems: Evenity may raise your risk of heart attacks and stroke. This medication may also increase your chances of death from these heart-related problems.

Evenity is also linked to hypocalcemia (low calcium). The lower rate of bone turnover (breakdown) is likely leading to less calcium release into your bloodstream.

Some symptoms of low calcium levels in your blood may include:

• Abnormal heart rhythm
• Confusion or memory problems
• Mood changes
• Numbness or tingling sensation
• Seizures
• Trouble with breathing or speaking from a tightening throat
• Uncontrollable muscle twitching

Low bone turnover may also raise your risk for the following serious side effects:

• Abnormal femoral fractures: Evenity raises your risk of abnormal femoral fractures. These fractures happen with little to no trauma. You might experience a dull and aching pain in your thigh, hip, or groin area for months before a complete fracture happens.
• Osteonecrosis of the jaw: Evenity raises your risk for osteonecrosis of the jaw (ONJ). ONJ is a rare but serious complication where your gums no longer cover your jawbone, and the cells in your jawbone start to die slowly.

Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

Long-term side effects with Evenity may include:

• Abnormal fractures of the femoral bone that runs from the hip and groin areas to your knee
• Effectiveness problems with Evenity not working as well after 12 months of use
• Heart-related problems, such as heart attacks and strokes, may result in death
• ONJ

Dosage: How Much Evenity Should I Take?

A healthcare provider will determine the dosage of this medication and administer it to you through a subcutaneous injection.

Modifications

The following modifications (changes) should be kept in mind when using Evenity:

Severe allergic reaction: Avoid using Evenity if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In rat animal studies, romosozumab-aqqg was found to have negative effects on the fetus. We don't know enough about the safety and effectiveness of Evenity in pregnant people and on the unborn fetus.

Discuss with your healthcare provider if you plan to become pregnant or are pregnant. They will help you weigh the benefits and risks of Evenity during your pregnancy.

Breastfeeding: In rat animal studies, romosozumab-aqqg was present in breast milk, which was linked to negative effects in nursing pups. We don't know enough about the effects and safety of Evenity in human breast milk and nursing babies.

Talk with your healthcare provider if you plan to breastfeed. They will help you weigh the benefits and harms of Evenity while nursing. They can also discuss the different ways to feed your baby.

Older adults over 65: There are no response differences to Evenity between older and younger adults. However, older adults with several medical conditions or taking several medications should use caution. In addition, older adults might be more sensitive to side effects from medications.

Children: There is little information about the effectiveness or safety of Evenity in children. If needed, consult with your healthcare provider to find alternative treatments.

Kidney problems: There is no need to adjust Evenity doses for any degree of kidney impairment. If you have severe kidney impairment or are on dialysis, however, you're more likely to have low calcium in your blood.

For this reason, your healthcare provider will closely monitor your calcium levels. They'll also ensure you're taking enough calcium and vitamin D supplements.

Missed Dose

To receive Evenity every month, you'll need to see your healthcare provider during office visits. If you miss any appointments, reach out to your healthcare provider as soon as possible to reschedule. Once you receive this rescheduled dose, you can receive the next dose one month later.

Try to find ways that work for you to help yourself remember to keep your appointments and receive your medication routinely. If you miss too many doses, Evenity might be less effective at treating osteoporosis and preventing fractures.

After 12 months of Evenity, however, your healthcare provider will likely switch you to another medication for osteoporosis.

Overdose: What Happens If I Take Too Much Evenity?

There is limited information available about Evenity overdoses.

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Evenity?

Before taking Evenity, talk with your healthcare provider if any of the following applies to you:

• Severe allergic reaction: If you have a severe allergic reaction to Evenity or any of its ingredients, then this medication isn't a viable option for you.
• Evenity use for over 12 months: Evenity doesn't work as well to treat osteoporosis after 12 months. For this reason, it shouldn't be used after 12 months.
• Hypocalcemia: If you have low calcium in your blood, your healthcare provider will need to make sure that this is corrected before recommending Evenity.
• Pregnancy: We don't know enough about the safety and effectiveness of Evenity in pregnant people and on the unborn fetus. Discuss with your healthcare provider about the benefits and risks of Evenity while pregnant.
• Breastfeeding: We don't know enough about the safety and effects of Evenity in human breast milk and nursing babies. Talk with your healthcare provider to help you weigh the benefits and harms of Evenity while nursing.
• Older adults over 65: There are no response differences to Evenity between older and younger adults. In general, however, older adults should use caution.
• Children: There is little information about the effectiveness or safety of Evenity in children.

What Other Medications Interact With Evenity?

There is limited information about medications that interact with Evenity.

However, if you think you're experiencing a life-threatening drug interaction, seek immediate medical attention.

Talk with your healthcare provider for more detailed information about medication interactions with Evenity.

Ask your healthcare provider or pharmacist for a complete list of drug interactions that can occur with Rexulti. Tell your healthcare provider about all prescription drugs, over-the-counter (OTC) drugs, vitamins, and herbal supplements you take.

What Medications Are Similar?

Evenity is a sclerostin inhibitor. Presently, there is no other sclerostin inhibitor used for osteoporosis.

Evenity, however, is also a biologic (non-chemical-based) medication. A biologic medication is made from naturally occurring sources, such as proteins and tissues.

Of all the available treatment options for osteoporosis, there is another biologic option called Prolia (denosumab).

The following is some interesting information about Evenity and Prolia:

• Evenity is given as two injections every month, instead of a twice-yearly injection like Prolia.
• Prolia and Evenity need to be given by your healthcare provider during office visits.
• Both Prolia and Evenity lower bone fractures in the vertebral (back or spine) and nonvertebral areas. Evenity also has evidence that it can lower your risk of hip fractures.
• Experts consider Prolia as a go-to choice to treat osteoporosis in high-risk people with no previous fractures.
• Experts support either Prolia or Evenity as go-to options to treat osteoporosis in very high-risk people with or without prior fractures.
• While Prolia can be used until you're no longer at a high risk of fractures, Evenity should only be used for one year.
• After stopping Evenity or Prolia, your healthcare provider will switch you to another medication for osteoporosis.
• The FDA assigned black box warnings to Evenity—but not Prolia.

These two medications are not typically used together.

How Can I Stay Healthy While Taking Evenity?

If you're taking Evenity, chances are osteoporosis has been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with osteoporosis does have its challenges, there are ways to help improve your quality of life.

Refer below for some general tips to support your health:

• Take osteoporosis-related medications as recommended by your healthcare provider.
• Make sure you're getting enough calcium and vitamin D. If you're not getting enough calcium and vitamin D through your diet, ask your healthcare provider whether you'll benefit from supplements.
• Limit your alcohol intake.
• Quit smoking if you smoke.
• Participate in weight-bearing and balancing exercises.
• Prevent falls and fractures.
• Consider support groups or work with a mental healthcare professional to help you find coping strategies to change the way you think, feel, or respond to living with osteoporosis.