Evenity injection (romosozumab-aqqg)

What is Evenity?

Evenity is a brand-name prescription medication. It’s FDA-approved to treat osteoporosis (a condition that causes weak, brittle bones). For this use, Evenity is given to females* who’ve gone through menopause and:

• have a high risk of fracture, or
• have tried and stopped other osteoporosis treatments because the treatments either:
  • weren’t effective enough, or
  • caused side effects that were bothersome or severe

For more information about risk factors for fracture and to learn how Evenity is used, see the “Evenity for postmenopausal osteoporosis” section below.

* Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

Drug details

Evenity works to strengthen your bones by targeting a protein that regulates bone breakdown and repair. Evenity contains the active drug romosozumab-aqqg, which is a type of drug called a monoclonal antibody. (For more information, see the “How Evenity works” section below.)

Evenity comes as a solution inside a single-use, prefilled syringe. It’s given by a healthcare professional as a subcutaneous injection (an injection under the skin).

Injections of Evenity are given once per month for 12 months. And each monthly dose consists of two injections.

During Evenity treatment, you should also take a daily calcium and vitamin D supplement.

FDA approval

In 2019, Evenity was approved by the Food and Drug Administration (FDA) to treat osteoporosis that occurs after menopause. It’s a new treatment that works in the body in a different way than other treatments for osteoporosis.

Specifically, Evenity both increases new bone formation and reduces bone loss. Other osteoporosis drugs either increase new bone formation or reduce bone loss. But they don’t do both of these things.

Effectiveness

In clinical studies, Evenity was effective at increasing bone strength and lowering people’s risk for fractures. For more information about Evenity’s effectiveness, see the “Evenity for postmenopausal osteoporosis” section below.

Evenity side effects

Evenity can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Evenity. These lists do not include all possible side effects.

For more information about the possible side effects of Evenity, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Evenity, you can do so through MedWatch.

Mild side effects

Mild side effects of Evenity can include:*

• joint pain†
• headache†
• muscle spasm (sudden, involuntary muscle tightening)
• peripheral edema (swelling of the legs, ankles, or arms due to fluid buildup)
• weakness
• neck pain
• insomnia (trouble sleeping)
• pins and needles, tingling, or burning sensations
• injection site reactions, such as pain, redness, or discoloration†

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Evenity. To learn about other mild side effects, talk with your doctor or pharmacist or check Evenity’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Evenity aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Hypocalcemia (low blood calcium levels). Symptoms can include:
  • muscle cramps, spasms, or twitching
  • numbness or tingling in your fingers or toes or around your mouth
• Osteonecrosis (death of bone tissue) in the jaw. Symptoms can include:
  • loosening of a tooth
  • pain in your jaw, teeth, or mouth
  • gum pain, swelling, or discharge
  • sores on your gums that don’t heal
  • numbness or a feeling of heaviness in your jaw
• Atypical femur fracture (a thigh bone fracture that occurs after a minor injury or with no clear cause). Symptoms can include:
  • new or unusual thigh, hip, or groin pain
  • trouble walking
• Heart attack or stroke.*†
• Allergic reaction.†

* Evenity has a boxed warning for these side effects. This is the most serious warning from the Food and Drug Administration (FDA).
† For more information about this side effect, see “Side effect details” below.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects are associated with it. Here’s some detail on certain side effects this drug may or may not cause.

Note: In the clinical studies of Evenity described below, people taking Evenity for osteoporosis were compared with people taking one of the following treatments:

• A placebo, which is a treatment with no active drug.
• Alendronate (Fosamax, Binosto), which is a drug that’s used to treat and prevent osteoporosis. Alendronate belongs to a different group of medications than Evenity, but both drugs work to strengthen your bones.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Evenity. This may also be called a hypersensitivity reaction.

In clinical studies, allergic reactions occurred in 6.5% of people who took Evenity. Allergic reactions also occurred in 6.5% of people who took either alendronate or a placebo.

Symptoms of a mild allergic reaction can include:

• a rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Evenity, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Heart attack and stroke

Evenity can increase your risk for heart attack and stroke. It can also increase your risk for death due to a cardiovascular (heart or blood vessel) problem. In fact, Evenity has a boxed warning for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Clinical studies have compared Evenity with alendronate and with a placebo. In these studies, the following results were seen:

You should not take Evenity if you’ve had a heart attack or stroke in the past year. And if you have any risk factors for cardiovascular problems, talk with your doctor about whether Evenity is right for you. These risk factors include hypertension (high blood pressure), diabetes, smoking, and obesity.

Call 911 or your local emergency number if you have symptoms of a heart attack or stroke while taking Evenity. These symptoms may include:

• chest pain or pressure, which may spread to your arm or jaw
• shortness of breath
• dizziness
• a sudden fall
• numbness or weakness on one side of your face or body
• slurred speech
• sudden vision changes, such as blurred vision or loss of vision

* This percentage varies because it was recorded from two separate clinical studies. The first value represents results compared with females who took a placebo. The second value represents results compared with females who took alendronate. For more information, see Evenity’s prescribing information.

Joint pain

It’s possible to have joint pain as a side effect of Evenity. This is one of the more common side effects of the drug.

In clinical studies, joint pain was reported by:

• 8.1% to 13.1% of females who took Evenity*
• 12.1% of females who took a placebo
• 9.6% of females who took alendronate

If you have new or worsening joint pain while taking Evenity, talk with your doctor about ways to manage this side effect.

* This percentage varies because it was recorded from two separate clinical studies. The first value represents results compared with females who took a placebo. The second value represents results compared with females who took alendronate. For more information, see Evenity’s prescribing information.

Headache

Headaches may occur while taking Evenity. In fact, headaches are one of the more common side effects associated with this drug.

In clinical studies, headache was reported by:

• 5.2% to 6.6% of females who took Evenity*
• 5.8% of females who took a placebo
• 5.5% of females who took alendronate

Headaches can typically be relieved by taking over-the-counter pain relievers, such as acetaminophen (Tylenol). But if you have headaches that are bothersome or getting worse while you’re taking Evenity, talk with your doctor. They may suggest ways to manage this side effect.

* This percentage varies because it was recorded from two separate clinical studies. The first value represents results compared with females who took a placebo. The second value represents results compared with females who took alendronate. For more information, see Evenity’s prescribing information.

Injection site reactions

It’s possible to have a reaction at the site where you have your Evenity injection. This is called an injection site reaction.

In clinical studies, injection site reactions occurred in 4.9% of females who took Evenity. In comparison, injection site reactions occurred in 2.8% of females who took either alendronate or a placebo.

The most common symptoms of an injection site reaction in these studies were:

• Pain. Among females taking Evenity, 1.7% had pain at their injection site. This is compared with 1.3% of females who took alendronate or a placebo.
• Redness or discoloration. Among females taking Evenity, 1.4% had redness at their injection site. This is compared with 0.3% of females who took alendronate or a placebo.

In addition, other possible symptoms can include swelling, hives, or itching at the site of injection.

When an injection site reaction occurs, it’s typically minor. Symptoms may occur immediately or a few hours after you receive an injection.

To help prevent injection site reactions, your healthcare professional should inject Evenity into a different site each time you have an injection. And injections shouldn’t be given in areas of skin that are tender, red, discolored, bruised, or hard.

Symptoms of an injection site reaction after a dose of Evenity usually improve after a few days. If you have symptoms that last longer than a few days or are severe, talk with your doctor.

Note: In some cases, skin redness, discoloration, swelling, and certain other symptoms can indicate an allergic reaction. However, injection site reactions are specific to the area where you received an injection. In contrast, an allergic reaction tends to affect larger areas of the body, where you may not have received an injection. See the section “Allergic reaction” above for details.

Weight gain (not a side effect)

Weight gain wasn’t a reported side effect in clinical studies of Evenity. However, some females had peripheral edema while taking Evenity in clinical trials. And edema can lead to sudden water weight gain.

Peripheral edema is swelling of the legs, ankles, or arms due to fluid buildup. In clinical studies, peripheral edema was reported in:

• 1.7% to 2.4% of females who took Evenity*
• 1.9% of females who took a placebo
• 1.9% of females who took alendronate

If you have swelling in your feet, hands, ankles, legs, or arms while taking Evenity, talk with your doctor. They can recommend ways to manage this. And you can talk with your doctor if you’re concerned about weight gain with Evenity.

* This percentage varies because it was recorded from two separate clinical studies. The first value represents results compared with females who took a placebo. The second value represents results compared with females who took alendronate. For more information, see Evenity’s prescribing information.

Evenity vs. Prolia

You may wonder how Evenity compares with other medications that are prescribed for similar uses. Here, we look at how Evenity and Prolia are alike and different. For further information, see this in-depth article.

Ingredients

Evenity contains the active drug romosozumab-aqqg. Prolia contains the active drug denosumab.

Both Evenity and Prolia are biologics (drugs made using living cells rather than chemicals). But the drugs work in these different ways in the body:

• Prolia works to slow bone breakdown.
• Evenity primarily works to rebuild bone. It also works to slow bone breakdown.

Uses

Evenity and Prolia are both approved to treat osteoporosis. (Osteoporosis is a condition that causes weak, brittle bones.) For this use, both drugs can be given to females* who’ve gone through menopause, and who either:

• have a high risk of bone fracture, or
• have tried and stopped other osteoporosis treatments because the treatments either:
  • weren’t effective enough, or
  • caused side effects that were bothersome or severe

Prolia is also approved to treat osteoporosis and reduce bone loss in certain adults who have a high risk of fracture. For more information about Prolia’s approved uses, see the drug’s prescribing information.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Drug forms and administration

Evenity and Prolia are both given by healthcare professionals as a subcutaneous injection (an injection under the skin). You’ll get injections of either drug in your doctor’s office.

Evenity injections are given once per month for 12 months. Prolia injections are given once every 6 months for as long as your doctor recommends. And both drugs should be taken with a daily calcium and vitamin D supplement.

Side effects and risks

Evenity and Prolia both contain drugs that increase bone strength. This means that these medications can cause some similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, as well as mild side effects that both drugs may share.

• Can occur with Evenity:
  • muscle spasm (sudden, involuntary muscle tightening)
  • neck pain
  • pins and needles, tingling, or burning sensations
  • injection site reactions, such as pain, redness, or discoloration
• Can occur with Prolia:
  • back pain
  • pain in your bones or muscles
  • high cholesterol levels
  • hypertension (high blood pressure)
  • infections such as the common cold, bronchitis, or urinary tract infections
• Can occur with both Evenity and Prolia:
  • joint pain
  • headache
  • peripheral edema (swelling of the legs, ankles, or arms due to fluid buildup)
  • insomnia (trouble sleeping)
  • weakness

Serious side effects

These lists contain examples of serious side effects that can occur with Evenity or Prolia, as well as serious side effects that both drugs may share.

• Can occur with Evenity:
  • heart attack and stroke*
• Can occur with Prolia:
  • serious infections, such as skin infections or urinary tract infections
  • severe pain in your joints, muscles, or bones
  • slowed bone formation, which may lead to slow healing of fractures
  • multiple fractures in your spine after stopping Prolia
• Can occur with both Evenity and Prolia:
  • allergic reaction
  • hypocalcemia (low blood calcium levels)
  • osteonecrosis (death of bone tissue) in the jaw
  • atypical femur fracture (a thigh bone fracture that occurs after a minor injury or with no clear cause)

* Evenity has a boxed warning for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Evenity side effects” section above.

Effectiveness

Evenity and Prolia have different FDA-approved uses, but they’re both used to treat osteoporosis in certain females* who’ve gone through menopause. For this use, studies have found both Evenity and Prolia to be effective.

These drugs haven’t been directly compared in clinical studies. But a recent review of studies found that Evenity’s and Prolia’s active drugs† may be similarly effective in preventing spinal fractures. This review also found that Evenity may be more effective than Prolia for preventing hip fractures or other non-spinal fractures.

Also, the active drugs in both Evenity and Prolia are recommended in current treatment guidelines for osteoporosis in females who’ve gone through menopause.

If you’re interested in taking Evenity or Prolia, talk with your doctor about which drug might be the best option for you.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
† Romosozumab-aqqg is the active drug in Evenity. Denosumab is the active drug in Prolia.

Costs

The actual price you’ll pay for Evenity or Prolia depends on your insurance plan, your location, and the medical facility where you receive either drug.

Evenity and Prolia are both brand-name biologic drugs. There are currently no biosimilar forms of either drug. (A biosimilar is a drug that’s similar to a brand-name biologic medication. Biosimilars tend to cost less than the brand-name drugs they’re based on.)

Evenity generic or biosimilar

Evenity is a biologic drug that’s available only as a brand-name medication. It doesn’t come in biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. So, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive than brand-name medications.

Evenity cost

As with all medications, the cost of Evenity can vary. The actual price you’ll pay depends on your insurance plan, your location, and the medical facility where you receive this drug.

It’s important to note that your doctor or healthcare professional will order Evenity for you. And you’ll receive doses of the drug in a medical facility. You won’t pick up this medication from a traditional pharmacy or administer it to yourself.

Before approving coverage for Evenity, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Evenity, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Evenity, or if you need help understanding your insurance coverage, help is available.

Amgen, Inc., the manufacturer of Evenity, offers several ways to help lower the cost of this drug. These vary depending on whether you have commercial insurance, Medicare coverage, or no insurance. For more information and to find out if you’re eligible for support, visit the manufacturer’s website.

Generic or biosimilar version

Evenity is only available as a brand-name medication. It’s not currently available in biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. So, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive than brand-name medications.

Evenity dosage

The following information describes the dosing schedule of Evenity that’s commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. They’ll determine the best dosage to fit your needs.

Drug forms and strengths

Evenity comes as a solution inside a single-use, prefilled syringe. Each syringe contains 105 milligrams (mg) of active drug in 1.7 milliliters of solution. Evenity’s active drug is called romosozumab-aqqg.

Evenity is given by a healthcare professional as a subcutaneous injection (an injection under the skin).

Dosage for postmenopausal osteoporosis

The recommended dosage of Evenity for treating osteoporosis after menopause is 210 mg (which is two injections), given once every month for 12 months.

What if I miss a dose?

If you miss an appointment to get your Evenity injections, call your doctor’s office right away to reschedule your appointment. You should get your missed dose as soon as possible. And your next appointment should be 1 month from the date that you received your missed dose.

It’s important to keep your appointments with your doctor for your Evenity injections. To help make sure you don’t miss a dose, try setting a reminder for your appointments on your phone.

Will I need to use this drug long term?

Evenity is meant to be taken for 12 months only. After 12 months, the drug becomes less effective at rebuilding bone. (Evenity works to treat osteoporosis by rebuilding bone and slowing bone breakdown.)

If you still need treatment for osteoporosis after stopping Evenity, your doctor can recommend a different treatment for you.

Alternatives to Evenity

Other drugs are available that can treat osteoporosis. Some may be a better fit for you than others. If you’re interested in finding an alternative to Evenity, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Examples of other drugs that may be used to treat osteoporosis* include:

• drugs that help rebuild bone, such as:
  • abaloparatide (Tymlos)
  • teriparatide (Forteo)
• drugs that slow bone breakdown, such as:
  • denosumab (Prolia)
  • alendronate (Fosamax, Binosto)
  • risedronate (Actonel, Atelvia)
  • ibandronate (Boniva)
  • zoledronic acid (Reclast)
  • raloxifene (Evista)
  • calcitonin salmon (Miacalcin)

* Evenity is only approved to treat osteoporosis in certain females who’ve gone through menopause. But some of the drugs listed above are used to treat osteoporosis in other situations. For more information about how Evenity is used, see the “Evenity for postmenopausal osteoporosis” section above.

Evenity vs. Forteo

You may wonder how Evenity compares with other medications that are prescribed for similar uses. Here, we look at how Evenity and Forteo are alike and different.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Ingredients

Evenity contains the active drug romosozumab-aqqg. Forteo contains the active drug teriparatide. The drugs work in these different ways in your body:

• Forteo works to rebuild bone.
• Evenity also works to rebuild bone. It also works to slow bone breakdown.

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Evenity and Forteo to treat.

• Both Evenity and Forteo are approved to treat:
  • osteoporosis in certain females who’ve gone through menopause
• Forteo is also approved to treat:
  • osteoporosis in males
  • osteoporosis (in males or females) that’s caused by taking certain corticosteroid drugs

For these uses, both Evenity and Forteo are approved for use in certain people who:

• have a high risk of fracture, or
• have tried and stopped other osteoporosis treatments because the treatments either:
  • weren’t effective enough, or
  • caused side effects that were bothersome or severe

Drug forms and administration

Evenity and Forteo are both given as a subcutaneous injection (an injection under the skin).

Evenity will be administered by your healthcare professional in their office. On the other hand, Forteo will be administered by your healthcare professional when you first start taking the drug. But you (or a caregiver) may be able to learn how to give yourself Forteo injections at home over time.

Evenity is taken once per month for 12 months. Forteo is taken once per day for up to 2 years. Evenity should be taken with a daily calcium and vitamin D supplement. But Forteo doesn’t need to be taken with these other treatments.

Side effects and risks

Evenity and Forteo both contain drugs that increase bone strength. This means that these medications can cause some similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

• Can occur with Evenity:
  • muscle spasm (sudden, involuntary muscle tightening)
  • insomnia (trouble sleeping)
  • pins and needles, tingling, or burning sensations
  • peripheral edema (swelling of the legs, ankles, or arms due to fluid buildup)
  • injection site reactions, such as pain, redness, or discoloration
• Can occur with Forteo:
  • body pain
  • nausea
  • hypertension (high blood pressure)
  • dizziness
  • a runny or stuffy nose
  • cough
• Can occur with both Evenity and Forteo:
  • joint pain
  • weakness
  • neck pain
  • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Evenity or Forteo, as well as serious side effects that both drugs may share.

• Can occur with Evenity:
  • heart attack and stroke*
  • hypocalcemia (low blood calcium levels)
  • osteonecrosis (death of bone cells) in the jaw
  • atypical femur fracture (a thigh bone fracture that occurs after a minor injury or with no clear cause)
• Can occur with Forteo:
  • hypercalcemia (high blood calcium levels)
  • risk of osteosarcoma (a type of bone cancer)†
  • orthostatic hypotension (low blood pressure that occurs when changing positions, such as standing up)
• Can occur with both Evenity and Forteo:
  • allergic reaction

* Evenity has a boxed warning for these side effects. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Evenity side effects” section above.
† Forteo has a boxed warning for this side effect. For more information, see Forteo’s prescribing information.

Effectiveness

Evenity and Forteo have different FDA-approved uses. But they’re both used to treat osteoporosis in certain females who’ve gone through menopause.

The use of Evenity and Forteo in treating postmenopausal osteoporosis has been directly compared in clinical studies. These studies compared the effect of the drugs on bone mineral density (BMD). BMD is a measurement of how strong your bones are. But it’s worth noting that these studies didn’t compare how effective the drugs were in preventing fractures.

One clinical study looked at females with low BMD who took either Evenity’s active drug (romosozumab-aqqg) or Forteo’s active drug (teriparatide). In this study, Evenity’s active drug was more effective than Forteo’s at increasing BMD in certain parts of the spine and hip. Specifically, BMD was measured in cortical bone, which forms the hard outer shell of the bone. BMD was also measured in trabecular bone, which forms the honeycomb-like interior of the bone.

In this study, the following results were seen:

Another clinical study looked at females who’d been through menopause and had previously taken a bisphosphonate drug* for osteoporosis. In this study, Evenity’s active drug increased hip BMD by an average of 2.6%. In comparison, Forteo’s active drug decreased hip BMD by 0.6%.

A recent review of studies has indirectly compared the effectiveness of these active drugs in preventing fractures. Researchers found that Evenity’s active drug may be slightly less effective than Forteo’s in preventing spinal and non-spinal fractures. But they also found that Evenity’s active drug may be more effective than Forteo’s in preventing hip fractures.

Both Evenity’s and Forteo’s active drugs† are recommended in current treatment guidelines for osteoporosis in females who’ve been through menopause. If you’re interested in taking Evenity or Forteo, talk with your doctor about which drug might be the best option for you.

* Bisphosphonate drugs are a group of medications that work to slow bone breakdown. Bisphosphonate drugs belong to a different group of medications than Evenity or Forteo.
† Romosozumab-aqqg is the active drug in Evenity. Teriparatide is the active drug in Forteo.

Costs

The actual price you’ll pay for Evenity or Forteo depends on your insurance plan, your location, and the pharmacy you use or the medical facility where you receive the medication.

Evenity and Forteo are both brand-name biologic drugs. There are currently no biosimilar forms of either drug. (A biosimilar is a drug that’s similar to a brand-name biologic medication. Biosimilars tend to cost less than the brand-name drugs they’re based on.)

Evenity for postmenopausal osteoporosis

The Food and Drug Administration (FDA) approves prescription drugs such as Evenity to treat certain conditions. Evenity may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Evenity is FDA-approved to treat osteoporosis in females who’ve gone through menopause, and:

• have a high risk of bone fracture, or
• have tried and stopped other osteoporosis treatments because the treatments either:
  • weren’t effective enough, or
  • caused side effects that were bothersome or severe

Note: Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth. (There is ongoing research about the risk of osteoporosis in transgender individuals. However, it’s not known how hormone or surgical transitions might affect osteoporosis risk. For more information, talk with your doctor).

What happens with postmenopausal osteoporosis?

Osteoporosis is a condition that causes your bones to become weak and brittle. It can also cause your bones to fracture easily. Osteoporosis develops when bone is broken down more quickly than it’s rebuilt.

Throughout your life, your body breaks down old bone and forms new bone. This process of remodeling keeps your bones strong and healthy. Bone can also be broken down to release calcium into your bloodstream. (This can happen if you don’t get enough calcium in your diet.)

As you age, your body breaks down old bone more quickly than it forms new bone. This is especially true for females who’ve been through menopause. This is because estrogen (a female reproductive hormone) helps regulate bone breakdown and keep your bones strong. And as you go through menopause, your estrogen levels decrease. This decrease in estrogen can weaken your bones after menopause. And this can eventually lead to osteoporosis.

What Evenity does

Evenity works to increase the formation of new bone and slow the breakdown of old bone. It can be given to certain females who have a high risk of fracturing a bone.

With osteoporosis after menopause, you have a high risk for fracture if you:

• have had a fracture in the past
• are of an older age
• are very frail
• have a high risk of falling
• are taking corticosteroid drugs, such as prednisone (Rayos)
• have very low bone mineral density (BMD)

Evenity works to strengthen your bones by increasing your BMD. And having higher BMD lowers your risk for fracture. (For more information about how Evenity works in the body to treat osteoporosis, see the “How Evenity works” section below.)

BMD is a measurement of how strong your bones are. It’s measured using a test called a DEXA scan. The result of this test is called your T-score.

The lower your T-score, the lower your BMD and the higher your risk for fracture. According to the World Health Organization (WHO), a T-score of:

• -1.0 to 1.0 means that you have normal BMD
• -1.1 to -2.4 means that you have osteopenia (a condition in which you have low BMD or weak bones)
• -2.5 or lower means that you have osteoporosis

Evenity is approved for use in certain females with a T-score of -2.5 or lower. Evenity works to increase your T-score, which can lower your risk for fracture.

Effectiveness for postmenopausal osteoporosis

Evenity has been effective in lowering fracture rates and increasing BMD in certain females who’ve been through menopause and have osteoporosis.

In one clinical study, females took either Evenity or a placebo (a treatment with no active drug) for 12 months. Both groups of females then took a different osteoporosis drug for another 12 months. This drug was called denosumab (Prolia).*

Over the first 12 months of treatment, the following results were seen:

• 0.5% of females who took Evenity had a new spinal fracture, compared with 1.8% of females who took a placebo
• compared with females who took a placebo, females who took Evenity had an average BMD that was:
  • 12.7% higher in the lumbar (lower) spine
  • 5.8% higher in the hip
  • 5.2% higher in the femoral neck (the top of the thigh bone)

Over 24 months of treatment, new spinal fractures were reported in:

• 0.6% of females who took Evenity followed by denosumab
• 2.5% of females who took a placebo followed by denosumab

In another clinical study, females took either Evenity or a different osteoporosis drug called alendronate (Fosamax, Binosto) for 12 months. Both groups then took alendronate for another 12 months.

After 24 months, the following results were seen:

• 9.7% of females who took Evenity followed by alendronate had a fracture, compared with 13% of females who took alendronate only. Among these females, fractures affected the spine in:
  • 4.1% of females who took Evenity followed by alendronate
  • 8% of females who took alendronate only
• compared with females who took alendronate only, females who took Evenity followed by alendronate had an average BMD that was:
  • 8.1% higher in the lumbar spine
  • 3.8% higher in the hip
  • 3.8% higher in the femoral neck

* For more information about Prolia and how it compares with Evenity, see the “Evenity vs. Prolia” section above.

Evenity and children

Evenity is not approved for use in children. It’s only approved for use in certain females who’ve been through menopause and have osteoporosis.

Evenity use with other drugs

Evenity is used to treat osteoporosis after menopause. The drug works to rebuild bone and slow bone breakdown.

Taking Evenity can sometimes lower your calcium levels. For this reason, your doctor will prescribe a daily calcium and vitamin D supplement for you to take with Evenity. Calcium and vitamin D are nutrients that help your body build and maintain strong bones.

If you have questions about taking calcium and vitamin D supplements while you’re taking Evenity, talk with your doctor.

To learn more about low blood calcium levels and other side effects, see the “Evenity side effects” section above.

How to take Evenity

You should take Evenity according to your doctor’s or healthcare professional’s instructions.

Evenity is administered by a healthcare professional as a subcutaneous injection (an injection under the skin). You’ll get Evenity injections at your doctor’s office.

For each monthly dose, you’ll have two injections. The second injection is given immediately after the first. The injections may be given into your belly, thigh, or upper arm. Within these areas of the body, each injection should be given into a different site.

Injections shouldn’t be given in areas of skin that have scars or stretch marks. And the injections shouldn’t be given in areas of skin that are tender, red, discolored, bruised, or hard.

When to take

Evenity is taken once every month for 12 months.

It’s important to keep your appointments with your doctor for your Evenity injections. To help make sure you don’t miss a dose, try setting a reminder for your appointments on your phone.

Evenity and alcohol

Evenity isn’t known to interact with alcohol. However, regularly drinking large amounts of alcohol can increase your risk for osteoporosis and fractures. Doing this can also worsen osteoporosis, which Evenity is used to treat.

Alcohol can affect how well your body absorbs calcium. This decreased absorption can lead to a lack of calcium, which can weaken your bones. (Calcium helps your body build and maintain strong bones.)

If you drink alcohol, talk with your doctor about how much may be safe for you to drink while taking Evenity.

Evenity interactions

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Evenity and other medications

There aren’t any known medication interactions with Evenity. However, before taking Evenity, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you while taking Evenity, ask your doctor or pharmacist.

Evenity and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Evenity. But you should still check with your doctor or pharmacist before using any of these products while taking Evenity.

Evenity and foods

There aren’t any foods that have been specifically reported to interact with Evenity. If you have any questions about eating certain foods with Evenity, talk with your doctor.

How Evenity works

Evenity is used to treat osteoporosis after menopause. It works to rebuild bone and slow bone breakdown. (For more information about Evenity’s approved uses, see the “Evenity for postmenopausal osteoporosis” section above.)

How are bones formed and maintained?

Throughout your life, your body breaks down old bone and replaces it with new bone. This process of remodeling keeps your bones strong and healthy. It also helps maintain a healthy amount of calcium in your blood.

Specifically, cells called osteoclasts break down old bone, and cells called osteoblasts form new bone. Osteoclasts can also break down bone to release calcium into your bloodstream. This can happen if you don’t get enough calcium in your diet. (Calcium is a nutrient that helps your body build and maintain strong bones.)

What happens with postmenopausal osteoporosis?

As you age, your body forms new bone more slowly. As a result, forming new bone may take longer than breaking down old bone. This imbalance can lead to a loss of bone mineral density (BMD). BMD is a measurement of how strong your bones are.

When you lose BMD, the hard outer layer of your bones may become thin. The spaces that are normally inside of your bones may also become larger. These changes can make your bones weaker, and this can lead to osteoporosis.

Females* who’ve gone through menopause have a higher risk of osteoporosis. This is because estrogen (a female reproductive hormone) helps regulate bone breakdown and keep your bones strong. And as you go through menopause, your estrogen levels decrease. This decrease in estrogen can weaken your bones. And this can eventually lead to osteoporosis.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

What does Evenity do?

Evenity works to increase the formation of new bone and slow the breakdown of old bone.

Evenity is a type of drug called a monoclonal antibody. Monoclonal antibodies work on specific proteins in the body. Evenity works to block the function of a protein called sclerostin. Sclerostin helps regulate bone breakdown and repair in the body.

By keeping sclerostin from functioning properly, Evenity stimulates osteoblasts to form new bone. To a lesser extent, Evenity also works to stop osteoclasts from breaking down old bone. As a result, Evenity can increase your BMD. This increases the strength of your bones, both inside and out. Having higher BMD also makes your bones less likely to fracture.

How long does it take to work?

Evenity starts working to treat osteoporosis within about 2 weeks after your first injection. However, it takes longer than this for Evenity to strengthen your bones. You’ll need to take Evenity for 12 months for the drug to be most effective.

It’s unlikely that you’ll notice Evenity working, because it works over time to strengthen your bones. To make sure that the drug is treating your osteoporosis, your doctor may check your BMD. BMD is checked with a test called a DEXA scan, which is similar to an X-ray.

Evenity and pregnancy

It’s not known if Evenity is safe to take during pregnancy. However, Evenity is only approved for use in females* who’ve gone through menopause, meaning that they can no longer become pregnant.

Evenity hasn’t been studied in pregnant females. But in animal studies, Evenity caused congenital anomalies (commonly known as birth defects) when given to pregnant animals. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant and you have osteoporosis, talk with your doctor about your treatment options. And if you’re taking Evenity and become pregnant or think you could be pregnant, see your doctor right away.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Evenity and birth control

It’s not known if Evenity is safe to take during pregnancy. But the drug is only approved for use in certain females* who’ve gone through menopause, which means that they can no longer get pregnant. Talk with your doctor if you have questions about your birth control needs while you’re taking Evenity.

For more information about taking Evenity during pregnancy, see the “Evenity and pregnancy” section above.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Evenity and breastfeeding

It’s not known if Evenity is safe to use while breastfeeding. But keep in mind that the drug is only approved for use in certain females* who’ve gone through menopause. So, it’s not likely that someone using this drug would be breastfeeding.

Although Evenity hasn’t been studied in breastfeeding females, in animal studies, Evenity has been shown to pass into breast milk. But the drug’s potential effects on a breastfed child aren’t known. And animal studies don’t always predict what will happen in humans.

If you’re breastfeeding, talk with your doctor about your treatment options for osteoporosis.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Common questions about Evenity

Here are answers to some frequently asked questions about Evenity.

Can I use Evenity if I have kidney problems?

Yes, you typically can. But if you have severe kidney problems (such as kidney failure that requires dialysis), you’re more likely to have hypocalcemia while taking Evenity. Hypocalcemia refers to low blood calcium levels. Calcium is a mineral that helps your body build and maintain strong bones.

If you have kidney problems, you may have frequent blood tests to check your calcium levels while you take Evenity. And to help prevent hypocalcemia, Evenity should be taken with a daily calcium and vitamin D supplement. (Vitamin D helps your body absorb calcium.) Be sure to take your supplement as prescribed your doctor.

For more information about hypocalcemia while taking Evenity, see the “Evenity side effects” section above.

Is it safe to have dental procedures while I’m taking Evenity?

It might not be safe.

Rarely, Evenity can cause a severe side effect called osteonecrosis of the jaw. This is a serious condition in which bone cells in your jawbone die, causing damage to the jawbone. And having invasive dental procedures (such as dental surgery or tooth extraction) while taking Evenity increases your risk for this side effect. But having less invasive procedures (such as scaling and polishing) may not increase your risk for osteonecrosis of the jaw.

You should have a dental checkup before you start treatment with Evenity. That way, if you need any invasive dental work, it can be completed before you start Evenity. And if you need any dental work during Evenity treatment, be sure to tell your dentist that you’re taking Evenity.

Also, keep in mind that having gum disease or infections in your mouth can also increase your risk for osteonecrosis of the jaw with Evenity. So, it’s important to practice good oral hygiene while you’re taking Evenity. To do this, brush and floss your teeth regularly. And use mouthwash as recommended by your dentist.

Can Evenity be used by males with osteoporosis?

Maybe. Prolia could be prescribed by a doctor for this use. But this would be an off-label use of the drug. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for. But in some countries with approval from organizations other than the FDA, Evenity is approved for use in males.*

Evenity is currently only FDA-approved to treat osteoporosis in certain females* who’ve been through menopause. But a 2018 clinical study found that Evenity’s active drug, romosozumab-aqqg, may also be effective in treating osteoporosis in males.

This study looked at bone mineral density (BMD), which is a measurement of how strong your bones are. In males who took romosozumab-aqqg, BMD in the spine and hip increased more than it did in males who took a placebo. (A placebo is a treatment with no active drug.)

Note: This 2018 study didn’t look at whether Evenity’s active drug reduced fracture rates in males with osteoporosis. (Osteoporosis can cause your bones to fracture easily, such as with no known cause.)

If you’re a male with osteoporosis and you’re interested in taking Evenity, talk with your doctor about your treatment options.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth. (There is ongoing research about the risk of osteoporosis in transgender individuals. However, it’s not known how hormone or surgical transitions might affect osteoporosis risk. For more information, talk with your doctor.)

Is Evenity a long-term treatment?

Evenity is meant to be used for 12 months, and no longer than 12 months. This is because after 12 months, Evenity becomes less effective at helping your body build new bone.

If you still need treatment for osteoporosis after you stop taking Evenity, your doctor will likely prescribe a different drug. They’ll typically recommend a drug that works to reduce bone loss and keep your bones strong.

Why do I need to take calcium and vitamin D supplements with Evenity?

Calcium and vitamin D are minerals that help your body build and maintain strong bones. Evenity also works to strengthen your bones. But the drug can sometimes cause hypocalcemia (low blood calcium levels). So, taking a daily calcium and vitamin D supplement helps prevent your calcium levels from getting too low. (Vitamin D helps your body absorb calcium.)

Make sure to take your supplement as prescribed by your doctor while you’re taking Evenity.

How do I know if I have a high risk for fracture with osteoporosis?

Evenity is given to certain females* who’ve gone through menopause. Specifically, it’s approved for use in females who’ve tried and stopped other osteoporosis treatments or have a high risk of fracture.

With osteoporosis after menopause, you have a high risk for fracturing a bone if you:

• have had a fracture in the past
• are of an older age
• are very frail
• have a high risk of falling
• are taking corticosteroid drugs, such as prednisone (Rayos)
• have very low bone mineral density (BMD)

BMD is a measurement of how strong your bones are. It’s measured using a test called a DEXA scan. The result of this test is called your T-score. The lower your T-score, the lower your BMD and the higher your risk for fracture. If your T-score is -2.5 or lower, you have osteoporosis. Evenity works to increase your T-score, which can lower your risk for fracture.

If you have questions about your risk for fracturing a bone, talk with your doctor.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.