All About Prolia


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What is Prolia?

If you have osteoporosis or bone loss, your doctor may discuss Prolia as a treatment option.

It’s a prescription drug that’s used to treat osteoporosis and other forms of bone loss. It’s given to adults who are at high risk for bone fractures.

Specifically, Prolia is used to:

  • treat osteoporosis in males and in females who’ve gone through menopause
  • treat osteoporosis caused by long-term use of glucocorticoids (a type of steroid) in males* and females*
  • increase bone mass in females using certain breast cancer treatments
  • increase bone mass in males using certain treatments for prostate cancer that hasn’t spread in the body

For more information about the uses of Prolia, see the “Is Prolia used for osteoporosis?” and “Is Prolia used for other conditions?” sections below.

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Prolia basics

Prolia contains the active ingredient denosumab. It comes as a liquid solution that’s given as an injection.

You’ll receive Prolia from a healthcare professional as an injection under the skin in one of the following areas:

  • thigh
  • upper arm
  • belly

Prolia contains the active drug denosumab, which is a biologic medication. A biologic drug is made from parts of living organisms.

Prolia isn’t available in a biosimilar form. (Biosimilars are like generic drugs. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs.) Instead, denosumab is available only as the brand-name drugs Prolia and Xgeva. (Xgeva is a brand-name drug that also contains denosumab, but it’s used in people with certain cancers. You can learn more about Xgeva in this article.)

In this article we’ll discuss the uses, side effects, safety precautions, and other important information about Prolia.

What are Prolia’s side effects?

Like most drugs, Prolia may cause mild or serious side effects. The lists below describe some of the more common side effects that Prolia may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you may be taking

Additionally, you may experience different side effects from those listed below based on the condition you’re treating with Prolia. Your side effects from Prolia may also vary depending on your gender.

Your doctor or pharmacist can tell you more about the potential side effects of Prolia and ways to reduce them.

Mild side effects

Here’s a short list of some of the mild side effects that Prolia can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Prolia’s medication guide.

Mild side effects of Prolia that have been reported include:

  • back pain
  • headache
  • cold symptoms, such as runny nose, cough, and sore throat
  • pain in your arms and legs
  • hair loss*

Mild side effects of many drugs may go away within a few days or a few weeks. But if they become bothersome, talk with your doctor or pharmacist.

* For more information on this side effect, see the “Side effect focus” section below.

Serious side effects

Serious side effects from Prolia can occur, but they aren’t common. If you have serious side effects from Prolia, call your doctor right away. But if you think you’re having a medical emergency, call 911 or your local emergency number.

Serious side effects of Prolia that have been reported include:

  • serious infection, such as urinary tract infection (UTI) and skin infection
  • unusual bone fractures in your thigh
  • increased risk of bone fracture after stopping Prolia treatment, such as having multiple spine fractures
  • severe pain in your joints, bones, and muscles
  • skin-related side effects, such as rash, dry skin, or blisters
  • decreased bone production, which means your bones take longer to make new bone tissue
  • dental problems and jaw-related side effects*
  • allergic reaction*

* For more information on this side effect, see the “Side effect focus” section below.

How long Prolia’s side effects last

For most people, Prolia’s side effects are mild and go away after a few days to a few weeks.

It’s important to tell your doctor if you have serious or ongoing side effects.

For example, if you have a serious UTI or other infection, call your doctor right away. They can treat the infection as needed. Your risk for infection with Prolia may be higher if you have a weakened immune system. So be sure to tell your doctor about all your health conditions before taking Prolia.

Certain side effects of Prolia that may last longer than others include:

  • jaw or dental side effects*
  • increased cholesterol level
  • low calcium level
  • unusual thigh bone fractures

Ask your doctor about serious or long-lasting side effects of Prolia and what you should know before starting this drug. Your doctor can discuss with you how to manage side effects and whether you’ll need to stop taking Prolia due to side effects.

* For more information on this side effect, see the “Side effect focus” section below.

Side effect focus

Learn more about some of the side effects Prolia may cause.

Hair loss

Hair loss with Prolia was reported after the drug’s initial studies were done and it was approved for use. Because these reports happened after the studies, it isn’t known for sure whether Prolia caused hair loss, or if it was due to another reason.

Hair loss with Prolia is rare, and whether Prolia is responsible for this effect isn’t known. It’s thought that hair loss could occur due to how Prolia affects your immune system.

Also, hair loss may be related to other medications you take or health conditions you have.

What might help

If you’re concerned about hair loss with Prolia, talk with your doctor. They can give you more details about this possible side effect and suggest ways to manage it.

Dental problems and jaw-related side effects

Some people may have dental or jaw-related issues with Prolia use. But it’s believed that these side effects are rare. These problems may include:

  • jaw pain
  • increase in infections
  • loose teeth
  • jaw necrosis (death of tissue in the jawbone)

Your risk for mouth-related side effects may be higher if you have problems with your teeth. It may also be higher if you have dental work done while you’re taking Prolia. This could include having:

  • dental crowns
  • dental implants
  • tooth extractions

What might help

Before taking Prolia, share your dental history with your doctor. Tell them if you have any scheduled dental work coming up. Based on your dental history, your doctor can discuss with you the risks of using Prolia.

Also, it’s important to brush and floss your teeth regularly while you’re using Prolia. Doing so will help to prevent dental problems.

If you have jaw pain or other mouth problems while you’re using Prolia, tell your doctor or dentist.

Allergic reaction

Some people may have an allergic reaction to Prolia.

Symptoms of a mild allergic reaction can include:

  • rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

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. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Prolia. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What should I know about Prolia vs. Reclast and other alternatives?

You may wonder how Prolia compares with alternative drugs such as Reclast. To learn more about these two drugs, check out this drug article.

Read on for more information about other alternatives to Prolia.

All the medications listed below have different:

  • active ingredients
  • forms, such as pills or injections
  • dosage schedules, with some being given weekly, monthly, or yearly
  • side effects, but they also share certain side effects
  • costs, which vary depending on if you have insurance coverage for the medication

Your doctor can give you more information about the risks and benefits and how these drugs compare with Prolia.

Prolia vs. Evenity

If you’d like to know about the differences and similarities of Prolia and Evenity, see this comparison. Be sure to talk with your doctor about which medication is right for you.

Prolia vs. Fosamax

To see a side-by-side comparison of Prolia and Fosamax, view this drug article. Ask your doctor about which drug is right for your condition.

Prolia vs. Xgeva

For a detailed breakdown of Prolia versus Xgeva, check out this article. Let your doctor know if you have questions about which drug is recommended for you.

Prolia vs. Tymlos

To learn how Prolia and Tymlos are alike and different, see this comparison. Check with your doctor if you have more questions about these drugs.

Prolia vs. Boniva

If you’d like a detailed comparison of Prolia versus Boniva, view this article. Talk with your doctor about which medication is right for you.

Prolia vs. Zometa

For information about how Prolia and Zometa compare with each other, see this article. Tell your doctor if you’d like to know more about these drugs.

What are some frequently asked questions about Prolia?

Below are answers to some commonly asked questions about Prolia.

Is Prolia safe to take? Are there any dangers of using this drug?

Studies have found that Prolia is generally safe and effective to treat osteoporosis and certain types of bone loss.

For example, in the studies, people taking Prolia for up to 8 years didn’t have significant side effects compared with people taking a placebo. (A placebo is a treatment with no active drug.)

Side effects are possible with Prolia use, but in most cases they go away after a while. Some rare side effects of Prolia can be serious and need medical attention. These side effects include:

  • serious infections
  • unusual bone fractures
  • jaw necrosis (death of tissue in the jawbone)

Your risk for these serious side effects may be higher if you’re older and have certain dental procedures. Your risk may also be higher if you:

  • have other health conditions, such as kidney disease
  • take other medications, such as corticosteroids or chemotherapy drugs

Stopping Prolia treatment can also increase your risk for bone fractures. So, if you want to stop taking Prolia, talk with your doctor. They’ll discuss with you other treatments to help prevent bone loss.

It’s recommended that you take 400 international units of vitamin D and 1000 milligrams (mg) of calcium with Prolia. Doing so will help you avoid the risk for a low calcium level during treatment.

If you’re concerned about side effects with Prolia, talk with your doctor. They can explain the risks and benefits of this drug. And they’ll recommend if it’s the best option for your condition.

Is Prolia a bisphosphonate?

No, Prolia isn’t a bisphosphonate. Instead, it belongs to a different group of medications called biologics. (Biologic medications are made from living organisms).

Specifically, Prolia is a monoclonal antibody (a lab-made protein). It works with your immune system to help prevent bone loss.

Bisphosphonates, on the other hand, help increase bone thickness and prevent bone breakdown. They do this by slowing the loss of minerals such as calcium from your bones. They’re commonly used to treat osteoporosis. These types of medications come in forms that are taken by mouth and forms that are given by injection.

A few examples of bisphosphonates include:

  • alendronate (Fosamax)
  • ibandronate (Boniva)
  • risedronate (Actonel)
  • zoledronic acid (Reclast)

If you’d like to know more about using a bisphosphonate for your condition, talk with your doctor.

How does Prolia work? And how long does it stay in your system?

Prolia works by blocking osteoclasts (certain bone cells) from breaking down bone tissue in your body. This is the drug’s mechanism of action.

Specifically, Prolia works by blocking a protein called RANK. The drug attaches to the RANK protein and helps prevent osteoclasts from breaking down bone.

Over time, Prolia helps to improve the density and strength of your bones by slowing bone loss. This lowers your risk for bone fractures.

You’ll get Prolia injections from a healthcare professional once every 6 months. The drug stays in your system and continues to slow bone breakdown over this period of time. Every 6 months you’ll get another dose of Prolia.

How does Prolia compare with Forteo?

Prolia and Forteo are both used to treat osteoporosis. They have some similar uses and side effects, but they also have some differences.

These medications have different active ingredients and they belong to different groups of drugs. For instance:

  • Prolia’s active ingredient is denosumab. It’s a biologic medication that works with your immune system to help slow bone loss.
  • Forteo’s active ingredient is teriparatide. It does the same thing that parathyroid hormone does, which is helping your body to make more bone tissue.

Both Prolia and Forteo are given as injections under your skin. Forteo is given as a self-injection once daily. But Prolia is given as once every 6 months by a healthcare professional.

There aren’t any studies that have compared these two drugs to each other. But they’re each effective in treating osteoporosis and preventing bone loss.

For more information about how these medications compare with each other, ask your doctor. They can tell you more about benefits and risks of Prolia and Forteo. Your doctor can help you decide which drug is better for your needs.

Is Prolia used for osteopenia or arthritis?

Prolia isn’t approved to treat osteopenia or arthritis.

With osteopenia, your bone mineral density (BMD) is lower than normal. (BMD is a measurement of the amount of minerals such as calcium in your bones.) This means your bones may be weaker than normal. As you age, your BMD is reduced, and this may increase your risk for osteoporosis.

With arthritis, you have pain and inflammation of your joints. The two most common forms of arthritis are osteoarthritis and rheumatoid arthritis (RA). RA is an autoimmune condition in which your immune system attacks your joints.

Prolia may be used off-label for RA, if you have a high risk for bone fractures. (With off-label use, a drug is used to treat conditions other than those it’s been approved to treat.)

The drug may also be used off-label for osteopenia, but usually, you don’t need medications for osteopenia. Instead, your doctor may recommend that you make certain changes to your diet, such as increasing your calcium and vitamin D intake. They may also suggest exercises to help improve your bone strength and lower your risk for fractures and osteoporosis.

If you have questions about treatment options for osteopenia or arthritis, talk with your doctor.

Can you ever stop taking Prolia? If so, will you have withdrawal symptoms?

Yes, if recommended by your doctor, you can stop taking Prolia. But doing so can cause more bone breakdown and increase your risk for bone fractures. In fact, bone breakdown is higher in the first several months after you stop Prolia.

If you want to stop taking Prolia, tell your doctor. They’ll discuss with you other treatments to help protect you from fractures and bone loss.

Stopping Prolia doesn’t cause withdrawal symptoms. Stopping some drugs leads to withdrawal symptoms because your body is used to the drug and needs it for you to feel normal. But this isn’t the case with Prolia.

If you have bothersome or severe side effects or other problems while taking Prolia and need to stop the medication, your doctor will monitor your bone mineral density. They’ll also discuss with you how to lower your risk for fractures by adding other treatments or making certain lifestyle or diet choices.

Does Prolia cause weight gain?

Studies of Prolia didn’t report weight gain as a side effect of the drug. But weight gain may occur with other medications you take or other health conditions you have.

If you’re concerned about weight gain with Prolia, talk with your doctor. They may give you tips on managing a body weight that’s healthy for you.

How is Prolia administered?

Your doctor will explain how Prolia will be given to you. They will also explain how much you’ll be given and how often. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

Receiving Prolia

Prolia comes as a solution that’s given as an injection under your skin. You’ll receive Prolia doses from a healthcare professional.

Prolia solution is available in one strength: 60 milligrams per milliliter (mg/mL).

Prolia injection sites

Your doctor or another healthcare professional will inject Prolia under the skin in one of the following areas:

  • upper arm
  • thigh
  • belly

Dosage

You’ll receive doses of 60 mg of Prolia.

How often Prolia is given

Prolia doses are given as an injection by healthcare professionals once every 6 months.

Receiving Prolia with other drugs

It’s recommended that calcium and vitamin D supplements be taken with Prolia. These supplements help to prevent a low calcium level while you’re taking Prolia. (A low blood calcium level is a possible side effect of Prolia.)

Your doctor may also recommend other treatments with Prolia to help increase your bone mass. Some examples of these treatments include:

  • alendronate (Fosamax)
  • raloxifene (Evista)
  • romosozumab-aqqg (Evenity)
  • teriparatide (Forteo)

Talk with your doctor about other drugs you may need to take with Prolia. And be sure to let your doctor know about all the medications you’re currently taking.

Questions about taking Prolia

Below, we answer some common questions about taking Prolia.

  • What if I miss a dose of Prolia? Prolia is given by a healthcare professional once every 6 months. You’ll go to your doctor’s office to receive your dose of the drug. And their office will regularly schedule your doses. If you miss an appointment for a dose, call the office to reschedule the missed dose as soon as possible. Additionally, you can use a reminder app or your phone to keep track of your Prolia injection appointments.
  • How long can you take Prolia? Is there a set number of years you should take it? No, there isn’t a set number of years you can take Prolia. In studies, people have safely taken Prolia for up to 8 years. If the drug is working to improve your condition, your doctor may have you take it long term. They’ll discuss with you the long-term benefits of Prolia and how long you should continue treatment.

    • Note: Stopping Prolia can increase your risk for bone fractures due to bone loss. If you want to stop taking Prolia, your doctor will talk with you about other treatment options. These other treatments can help protect you from fractures and bone loss.
  • Should I take Prolia with food? How well Prolia works in your body isn’t affected by food. It’s given as an injection, and it keeps working in your body for several months. Talk with your doctor if you have questions about eating around the time you’ll receive a Prolia dose.
  • How long does Prolia take to work? Prolia starts working to improve bone mass and treat osteoporosis soon after you get your first injection. Your doctor will check your bone mineral density (BMD). (BMD is a measurement of the amount of minerals such as calcium in your bones.) Your doctor will then discuss your treatment progress with Prolia. Each dose of Prolia continues to work for 6 months.

Questions for your doctor

You may have questions about Prolia and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

  • Before your appointment, write down questions, such as:
    • How will Prolia affect my body, mood, or lifestyle?
  • Bring someone with you to your appointment if doing so will help you feel more comfortable.
  • If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So, don’t be afraid to ask questions or offer feedback on your treatment.

What does Prolia cost?

Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers. They also include any added costs of the drug being given by a healthcare professional.

Most Medicare plans and other insurance plans cover Prolia. Ask your plan if they cover the drug, and the what the cost will be for you.

To find current prices for Prolia in your area, visit GoodRx.com.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Prolia manufacturer’s website to see if they have support options.

What should be considered before taking Prolia?

Before beginning treatment with Prolia, ask your doctor about the benefits and risks of the drug. Talk with them about your health and any concerns you have about Prolia and its effects.

You should also ask your doctor if Prolia is safe for you if you have or have had:

  • a history of thyroid disease
  • kidney disease
  • jaw problems
  • low calcium level
  • trouble absorbing minerals
  • weakened immune system activity

Additionally, let your doctor know if you’re pregnant or breastfeeding.

Interactions

Taking medications, vaccines, foods, and other things with a certain drug can affect how the drug works. These effects are called interactions.

There are no known interactions with Prolia and other medications, supplements, or other products.

But before taking Prolia, be sure to tell your doctor about all medications you take (including prescription and over-the-counter types). Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these may cause with Prolia.

Warnings

Prolia may not be right for you if you have certain medical conditions or other factors that affect your health. In certain cases, Prolia may have contraindications (not be recommended) for you due to a higher risk for side effects.

Factors to consider include those in the list below.

  • Low calcium level. Prolia may not be safe for you if your calcium level is low. Taking Prolia may lower your calcium level even more. Your doctor will check your calcium level before you start treatment with Prolia. They may also recommend treatment to increase your calcium level before you take Prolia. In addition, it’s recommended that you take calcium and vitamin D supplements while you’re taking Prolia. This helps to prevent a low calcium level. Some people have a higher risk for low calcium level. For example, you’re at an increased risk if you’ve had:

    • hypoparathyroidism
    • parathyroid surgery
    • thyroid surgery
  • Allergic reaction. If you’ve had an allergic reaction to Prolia or any of its ingredients, you shouldn’t take Prolia. Ask your doctor what other medications are better options for you.
  • Kidney problems. If you have kidney disease, Prolia may not be safe for you to take. Serious kidney problems can cause low calcium levels. And treatment with Prolia can also lower these levels. Before taking Prolia, be sure to talk with your doctor if you have any kidney problems.
  • Dental work. Talk with your doctor if you plan to have any dental work before or during treatment with Prolia. Prolia can increase your risk for jaw-related side effects, such as jaw necrosis (tissue death in your jaw). And this risk is increased if you have certain dental procedures done. Your doctor can tell you about the risk of jaw-related side effects and the safety of dental procedures during Prolia treatment. Examples of these procedures include:

    • dental crowns
    • dental implants
    • tooth extractions
    • dental surgery

This is not a complete list of warnings for Prolia. Talk with your doctor about your health history and discuss your risks with Prolia treatment.

Use with alcohol

There aren’t any reported interactions between Prolia and alcohol.

But, in some cases, alcohol can affect your balance and increase your risk for falls. Keep in mind that Prolia is used to help strengthen your bones and prevent fractures, which may happen with falls.

If you plan to drink alcohol while using Prolia, ask your doctor how much is safe to drink.

Pregnancy and breastfeeding

Prolia should not be used during pregnancy. This is because the drug may be harmful to a growing fetus. Talk with your doctor about the risks of using this drug during pregnancy.

If you’re able to become pregnant, your doctor will order a pregnancy test for you before you take Prolia. In addition, you should use effective birth control while you’re taking Prolia. And you should continue using birth control for at least 5 months after stopping Prolia.

There’s no information available to know whether Prolia is passed into breast milk or if it’s safe to take while breastfeeding.

If you’d like more information about Prolia use during pregnancy or while breastfeeding, talk with your doctor.

Is Prolia used for osteoporosis?

If you’ve been diagnosed with osteoporosis, your doctor may discuss Prolia with you. Prolia also has other uses, which are described in the next section below.

For osteoporosis, Prolia is used:

  • to treat osteoporosis in males* and in females* who’ve gone through menopause
  • to treat osteoporosis caused by long-term use of glucocorticoids (a type of steroid) in males and females

Osteoporosis is a condition that causes your bones to become thin and weak. This is because your body doesn’t make enough bone, or it loses bone faster than it makes new bone.

With osteoporosis, your bones become porous, meaning there are large holes within your bone tissue. This makes your bones weak and increases your risk for bone fractures or breaks.

Symptoms of osteoporosis can include:

  • brittle and weak nails
  • weakened grip strength
  • receding gums

Prolia is a RANKL inhibitor. It blocks the effects of certain bone cells called osteoclasts in breaking down bone tissue. This helps treat osteoporosis by improving bone mass and strengthening your bones.

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Is Prolia used for other conditions?

In addition to treating osteoporosis, which is described just above, Prolia also has other uses.

It’s used to lower the risk of bone fractures in people with certain other conditions. Specifically, it’s used to increase bone mass in:

  • females* using certain breast cancer treatments
  • males* using certain treatments for prostate cancer that hasn’t spread in the body

Osteopenia (low bone mass), and low bone mineral density (BMD) can occur with older age. They can also happen if you have certain conditions or if you take certain medications.

With low BMD your bone tissues have less mineral, which means they become weaker. With bone loss, your body loses old bone tissue faster than it makes new bone tissue. So, your bones become weak and brittle. This increases your risk for bone fractures.

If you’ve already gone through menopause, your risk for bone loss is increased.

Your doctor can check if you have osteoporosis, have low BMD, or have osteopenia by measuring your bone density. They’ll do this with certain tests, such as a bone scan or ultrasound.

Prolia improves bone mass and increases bone mineral density. It strengthens your bones by stopping certain bone cells called osteoclasts from breaking down your bones.

In addition, Prolia may also be used off-label for other conditions that cause bone loss or loss of bone mineral density. (With off-label use, a drug is used to treat conditions other than those it’s been approved to treat.) Examples of conditions Prolia is used off-label to treat include:

  • rheumatoid arthritis
  • metabolic bone disease, such as Hajdu-Cheney syndrome and juvenile Paget’s disease

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

What to ask your doctor

Prolia is one option available to treat osteoporosis and reduce bone loss in people with a high risk for bone fracture.

Your doctor can provide more information to you about the benefits and risks of using Prolia for your condition. They can also tell you about other treatment options available for osteoporosis and bone loss prevention.

You’ll likely have questions about your condition and treatment choices. Ask your doctor about the pros and cons of using Prolia.

Here are a few questions to consider asking your doctor:

  • Do natural alternatives work for osteoporosis?
  • Will my fracture risk come back if I stop Prolia treatment?
  • How long will I need to keep taking Prolia?
  • Are there lifestyle changes that can help my osteoporosis?

You can also learn more about osteoporosis treatment options here.

Ask a pharmacist

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.


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