Indications  

Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. Read More

Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. Read Less

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If you have postmenopausal osteoporosis and a high risk for fracture, and are struggling to strengthen your bones, you’re not alone. Watch these inspiring stories from real patients to hear how Prolia® helped them move in the right direction.

“I was tired of not seeing results, so I pressed for a treatment that worked for me.”

– Carole, actual Prolia® patient since 2015

See How Carole Made a Treatment Change
“When I was first diagnosed,
I thought—what do I do now?”

– Anita, actual Prolia® patient since 2011

See How Anita Discovered Prolia®

For women with osteoporosis after menopause at high risk for fracture whose osteoporosis medicine is not working well.

Get to Know Carole

Carole started treating her postmenopausal osteoporosis after being diagnosed in 2012, but when her bone density scores weren't improving, she and her doctor decided it was time for something different.

Watch Carole's videos to learn about how she switched to Prolia®.

When Carole learned Prolia® is taken just once every 6 months, she felt it was a good fit for her active lifestyle. See why switching to Prolia® made sense for her.

  • Take calcium and vitamin D as your doctor tells you while your receive Prolia®
  • The risk for breaking bones, including bones in the spine, is increased after treatment with Prolia® is stopped. Do not stop taking Prolia® without first talking with your doctor

While on another medication, Carole saw her bone density scores dropping and she became more concerned about fractures. See why she and her doctor decided it was time for a change.

Meet Anita

When Anita was first diagnosed with postmenopausal osteoporosis and a high risk for fracture, a number of thoughts were racing through her head. Then, she found out about Prolia® from her doctor.

Watch Anita’s videos to see how Prolia® helped her get stronger bones.

Anita had tried other treatments before, but wasn’t seeing good results. Find out what happened after she started Prolia®.

Anita had always been an active person and took her calcium. Learn about the steps Anita took to get her postmenopausal osteoporosis under control after she was diagnosed.

Patient testimonials represent individual experiences with Prolia®. Results may vary.

  Read Text Version

My family is one of the most important things to me and I love being able to create experiences with them that we’ll always remember—whether it’s going to national parks together or being able to travel to my grandchildren’s t-ball games to cheer them on. And I didn’t want that to come to an end.

I was diagnosed with postmenopausal osteoporosis in 2000; so I’ve been dealing with it for years. I remember, I went for my annual exam at my OB/GYN and she said that I should get tested for osteoporosis.

I had a bone density test, a DXA scan. The results came back showing my lumbar 4 in my lower back had a t-score of -4.1. I had postmenopausal osteoporosis and a high risk for fracture.

I thought, what do I do now?

When you have osteoporosis, you’re more likely to break a bone—which I knew.

My family was also aware of the challenges of having postmenopausal osteoporosis. When we were together they would say, “Watch, Ma, watch.” I hated having them worry constantly about me breaking a bone. That was a difficult time for me.

I had tried other treatments before, but I wasn’t seeing great results. I thought, with a -4 anything, I have to keep trying. So I talked to my doctor about Prolia®.

After I started treatment with Prolia®, I started getting some results. I know that Prolia® works differently for everyone, but my scan showed improvement within that first year.

I was so happy that Prolia® was helping my bones get stronger—finally, I found the right treatment for me.

My mindset is, if I don’t get my shot of Prolia® my bones may begin to get weak again. Having strong bones is really important to me, so I keep up with my Prolia® treatment by getting my shot every 6 months and I take my calcium and my vitamin D, as directed by my doctor.

I’m doing well and I can’t wait for my next adventure with my family.

Here’s some important safety information you should know about Prolia®.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA®&bnsp;(denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Since I started treatment with Prolia®, my doctor says my scans are showing improvement in my bone density score.

One shot every six months works for me. Maybe it could be right for someone else.

  Read Text Version

Oh, I’ve done a lot of different things over the years, but my heart lies with theater and museums—so that’s been a big part of my life.

I was also a massage therapist for 16 years. That’s how I first learned about postmenopausal osteoporosis—through my training as a massage therapist. I did think about it and I also knew that it happened to small-framed people, but here I was massaging every day and that works your muscles. I took my calcium, drank milk, I exercised.

I just never thought it would happen to me.

When I found out that I had postmenopausal osteoporosis, I thought, what do I do now? I was young. Only old people get that.

My doctor put me on an oral treatment and told me to exercise, but I was already an active person.

When I was on that treatment, my doctor told me my postmenopausal osteoporosis was getting worse. My DXA scan showed more bone loss on the lumbar 4 in my lower back than before I had started treatment. I knew if I didn't change my treatment I'd be more likely to break a bone.

I had a lot to look forward to in life—I had to keep trying. So, my doctor suggested Prolia®.

After discussing with my doctor the benefits and the risks of taking Prolia® we decided I should make the switch.

After I started Prolia®, I began to see results. Every year, my doctor tells me that my scans are showing improvement in my bone density score. Prolia® worked for me.

Here’s some important safety information you should know about Prolia®.

Here’s some important safety information you should know about Prolia®.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA®&bnsp;(denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

I know if I don’t continue to treat my osteoporosis, there’s a higher chance I may break something. So I do the recommended exercises to help strengthen my bones, I take my calcium and my vitamin D, and get my shot of Prolia® every 6 months, like my doctor tells me to.

I enjoy helping people, which is why I want to spread the word so everyone knows—Prolia® has helped strengthen my bones.

  Read Text Version

I love getting all dressed up and going across town to meet up with friends on the weekends. And I do a lot of walking when we go out shopping together. I love to shop, and sometimes we'll go out for Mexican food since that's my favorite. You know, I work full-time so having a good work/life balance is important to me.

After I was diagnosed with postmenopausal osteoporosis in 2012, my doctor prescribed a medication, but it just didn't seem to be improving my bone density score.

And it went on like that for a few years and then I started losing height, which made me believe that the medication I was taking wasn't working.

I was tired of not seeing results with my medication, so I pressed my doctor to look for a treatment that worked for me.

And then I found out about Prolia®, which is a shot every 6 months. And I wanted to get a second opinion before I made that switch so I talked to my doctor about going to see a specialist, and she was supportive of that.

Prolia® was the right choice for me because it worked for me and it was one shot every 6 months.

And in my mind, that's no different than scheduling a visit to the dentist twice a year.

I just make my next appointment when I'm leaving, go home, put it on my calendar.

Before I was on Prolia®, my scores were declining—and that's just not happening anymore. Prolia® is helping my bones get stronger and that's…it's worth a shot every 6 months to me.

Here’s some important safety information you should know about Prolia®.

Here’s some important safety information you should know about Prolia®.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA®&bnsp;(denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Switching to Prolia® made sense to me, because of my lifestyle. It's just one shot every 6 months.

All I have to do is pull on my blue jeans, put on some lipstick and I'm ready for enchilada night.

  Read Text Version

I'm a fifth generation Texan. I've lived here all my life. I love doing things around my house, like decorating and taking care of my garden. It helps keep me centered. Especially back when I was first diagnosed with postmenopausal osteoporosis in 2012. I wasn't fearful when I found out—that's not how I am or how I raised my kids, but it did concern me.

Originally, I was going to my OB/GYN to treat my postmenopausal osteoporosis and my bone density score wasn't where I wanted it to be. I just was not happy with that—the medicine wasn't doing what it should've been.

It was during that time that I finally said, "Look, we've got to do something about this." I lived by myself and I supported myself financially, I just couldn't imagine what would happen if I broke a bone. I've always been independent and I raised my kids to be that way, too. I didn't want to have to depend on other people taking care of me, or my dog, if I broke a bone.

I knew that there had to be a treatment that could work for me and lessen my risk of having a fracture.

Oh, I was so tired of the complicated administration process and not seeing any results that I wanted from the medication I was on.

Right around this time, I remember seeing Prolia® in a magazine, and then again in a TV commercial. I wanted to know more about it so I went onto Prolia.com and I did my research.

And based on what I learned from the website, I knew that Prolia® was definitely something I wanted to talk to my doctor about since it was just a shot every 6 months to help strengthen your bones

That's why I went to my doctor and I asked about Prolia®. We talked it over and my doctor agreed that switching to Prolia® would be good for me.

In my mind, a shot every 6 months seems like the best option for my lifestyle and my bones. So that very next doctor's visit, I started on Prolia®.

Since I've started on Prolia® I feel like I've finally started to take control of my postmenopausal osteoporosis. Now I can focus on things that matter to me-like taking a trip to go see my kids and my grandkids on the weekends. Prolia® has helped strengthen my bones and I plan to stick with it going forward.

Here’s some important safety information you should know about Prolia®.

Here’s some important safety information you should know about Prolia®.

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA®&bnsp;(denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Now when I visit my doctor for my regular Prolia® shot every 6 months, it's usually a quick follow up. We chat about my bone density score and what's new with me, and I use that time with my doctor to schedule my next shot of Prolia®.

I'm glad that I was my own advocate and discovered Prolia®. It feels good knowing that I'm moving in the right direction now.

It’s time you knew about Prolia®

Prolia® is proven to help increase bone density and protect bones from fracture

Need help talking to your doctor?

Prepare for your next appointment with this helpful questionnaire

Important Safety Information Close

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

Prolia® can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia®. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping Prolia®. After your treatment with Prolia® is stopped, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop taking Prolia® without first talking with your doctor. If your Prolia® treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia® develop severe bone, joint, or muscle pain.

Before taking Prolia®, tell your doctor about all of your medical conditions, including if you:

  • Take the medicine XGEVA® (denosumab)
  • Have low blood calcium
  • Cannot take daily calcium and vitamin D
  • Had parathyroid or thyroid surgery (glands located in your neck)
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have kidney problems or are on kidney dialysis
  • Plan to have dental surgery or teeth removed
  • Are pregnant or plan to become pregnant

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Prolia®.
    • You should use an effective method of birth control (contraception) during treatment with Prolia® and for at least 5 months after your last dose of Prolia®.
    • Tell your doctor right away if you become pregnant while taking Prolia®.
  • Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection. The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).

These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

Indications

Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who:

  • are at high risk for fracture or
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well

Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who:

  • are at high risk for fracture

Please see Prescribing Information and Medication Guide for complete details about Prolia®.

See More
Important Safety Information
Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®..

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

Prolia® can cause serious side effects: