Prolia (denosumab) is a prescription drug that’s used to treat osteoporosis and bone loss. Prolia comes as a liquid solution that’s given as an injection under the skin.
Prolia is prescribed for adults who are at high risk for bone fractures. It’s prescribed in certain situations to:
- treat osteoporosis
- increase bone mass
To learn more about Prolia’s uses, see the “What is Prolia used for?” section below.
Prolia contains the active ingredient denosumab. (An active ingredient is what makes a drug work.)
Prolia is a biologic medication, which means it’s made from parts of living organisms. Prolia is not 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 comes only as the brand-name drugs Prolia and Xgeva.
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 biological sex.
Your doctor or pharmacist can tell you more about the potential side effects of Prolia. They can also suggest ways to reduce side effects.
Mild side effects
Here’s a 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 prescribing information. You can also see this article for more details.
Mild side effects of Prolia that have been reported include:
- back pain
- cold symptoms, such as runny nose, cough, and sore throat
- pain in your arms and legs
- hair loss
- mild allergic reaction*
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.
* To learn more about this side effect, see the “Allergic reaction” 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, such as jaw pain and an increase in infections
- severe allergic reaction*
* To learn more about this side effect, see the “Allergic reaction” section below.
Some people may have an allergic reaction to Prolia.
Symptoms of a mild allergic reaction can include:
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.
Your doctor will recommend the dosage of Prolia that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.
Form and strength
Prolia comes as a solution that’s given as an injection under your skin. To learn how you’ll receive Prolia doses, see “How it’s administered” below.
Prolia solution is available in one strength: 60 milligrams per milliliter (mg/mL).
You’ll receive 60 mg/mL of Prolia once every 6 months.
To learn more about Prolia’s dosage, see this article.
How it’s administered
Your doctor will explain how Prolia will be given to you. They’ll also explain how much you’ll be given and how often.
You’ll likely receive Prolia doses from a healthcare professional. They’ll inject Prolia under the skin in one of the following areas:
- upper arm
Your doctor may also recommend other treatments with Prolia to help increase your bone mass. Examples of these treatments include:
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 Prolia’s dosage
Below, we answer some common questions about receiving Prolia.
- Should I receive 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.
- What if I miss a dose of Prolia? You’ll likely go to your doctor’s office to receive Prolia injections. Their office will schedule your doses every 6 months. If you miss an appointment for a dose, call the office to reschedule the missed dose as soon as possible.
- Will I need to receive Prolia long term? If Prolia’s working to improve your condition, you may receive it long term. There isn’t a set number of years for Prolia treatment. Your doctor will discuss with you the long-term benefits of Prolia and how long you should continue treatment.
You may wonder how Prolia compares with the alternative drug Reclast. To learn more about these two drugs, check out this article.
Prolia contains the active drug denosumab, and Reclast contains the active drug zoledronic acid. Both medications are approved to treat certain people with osteoporosis, as well as people with other conditions.
Your doctor can give you more information about the risks and benefits of these drugs. They can also tell you more about how Reclast compares with Prolia.
You might like to know how Prolia and the drug Evenity compare.
Prolia and Evenity are both biologic medications. But Prolia contains the active drug denosumab, while Evenity contains the active drug romosozumab-aqqg.
If you’d like to know more about the differences and similarities between Prolia and Evenity, see this in-depth article. Be sure to talk with your doctor about which medication is right for you.
To see a side-by-side comparison of Prolia and Fosamax, view this article. And ask your doctor about which drug is right for your condition.
You might wonder how Prolia and the drug Xgeva compare. Prolia and Xgeva both contain the active drug denosumab, but they are not approved to treat all of the same conditions.
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.
Below are answers to some commonly asked questions about Prolia.
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:
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, or how it works.
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?
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. (Biologic medications are made from living organisms.)
- 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 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.
Whether you have health insurance or not, cost may be a factor when you’re considering Prolia. What you’ll pay for Prolia may depend on several things, such as your treatment plan and the pharmacy you use.
Most Medicare plans and other insurance plans cover Prolia. A savings program called the Amgen SupportPlus CoPay Program and other resources may also be available. For savings and support options as well as details about insurance coverage, you can visit the Prolia manufacturer’s website.
Below is important information you should consider before using Prolia.
Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.
Before starting Prolia treatment, 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 take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.
Pregnancy and breastfeeding
Prolia is not safe to receive during pregnancy. This is because the drug may be harmful to a fetus.
If you can become pregnant, your doctor will order a pregnancy test for you before they prescribe Prolia. You can also talk with your doctor about the risks of receiving this drug during pregnancy.
It’s not known whether Prolia passes into breast milk or whether it’s safe to take while breastfeeding. If you’re breastfeeding or planning to breastfeed, your doctor will recommend another treatment for you.
If you’d like more information about Prolia treatment during pregnancy or while breastfeeding, talk with your doctor.
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.
Prolia can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Prolia is a good treatment option for you.
Talk with your doctor about your health history before you take Prolia. Be sure to tell them if any of the following factors apply to you:
Depending on your condition, your doctor may discuss Prolia with you. It’s used to lower the risk of bone fractures in people with certain other conditions. Specifically, it’s used in adults 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
* 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.
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. If you’ve already gone through menopause, your risk for bone loss is increased.
Osteopenia (low bone mass) and low bone mineral density (BMD) can occur with older age, if you have certain conditions, or if you take certain medications. These conditions weaken your bones and increase your risk for bone fractures.
Prolia may also be prescribed off-label for other conditions that cause bone loss or loss of bone mineral density. (With off-label use, a drug is prescribed to treat conditions other than those it’s been approved to treat.) Examples of conditions Prolia is prescribed off-label to treat include:
Other drugs are available that can treat your condition. If you’d like to explore an alternative to Prolia, talk with your doctor. They can tell you about other medications that might work well for you.
The following drugs are similar to Prolia:
If you have questions about receiving Prolia, talk with your doctor or pharmacist. Questions you may want to ask include:
- Do natural alternatives work for osteoporosis?
- Will my risk of bone fracture come back if I stop Prolia treatment?
- How long will I need to keep receiving Prolia?
- Are there lifestyle changes that can help my osteoporosis?
To learn more about Prolia, see these articles:
- All About Prolia’s Dosage
- Evenity vs. Prolia: What You Should Know
- Prolia and Cost: What You Need to Know
- Prolia vs. Xgeva: What You Should Know
- Side Effects of Prolia: What You Need to Know
To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.
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 another 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.