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.

Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.

Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

Information on Self-Injecting Prolia®

Welcome. You’re here because your doctor has recommended the option to self-inject your Prolia® dose. We’re here to help with injection support once you’ve received instruction and supervision from your doctor, nurse, or pharmacist. We’ve got a temporary instruction guide and demonstration video to share with you. These materials don’t replace the direction your doctor should provide you, but we hope you will find them helpful. Let’s get started.

Prolia’s approved labeling states that it should be administered by a healthcare professional. Amgen has consulted with the U.S. Food and Drug Administration regarding temporary instructions for patient self-injection. FDA has informed Amgen that it does not intend to object to our dissemination of temporary Instructions for Use and a demonstration video only for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. After that time, please refer to Prolia’s approved labeling for instructions regarding dosage and administration.

Are you a healthcare professional? click here

How to Self-Inject Prolia®

Temporary Self-Injection Instructions for Use

We’ve put together this Instructions for Use to supplement your doctor’s direction on performing your self-injection. These are temporary instructions provided only during the COVID-19 public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. They should be discarded following the public health emergency.

Please be aware, the information contained in this guide is not intended to substitute any directions given to you by your doctor, nurse, or pharmacist.

It is important that you do not try to give yourself or someone else the injection unless you have received guidance from your healthcare provider.

Prior to injecting yourself with the Prolia® prefilled syringe, it’s important that you review the Instructions for Use in full and Sections 2.3 and 16 of the Prescribing Information on proper preparation, administration, storage, and handling.

Before you get started, if you have any questions, reach out to your doctor or call us at 800-77-AMGEN (800-772-6436).

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Demonstration Video

In addition to the Instructions for Use, we’ve also created this video demonstrating how to self-inject your Prolia® dose.

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.

Prolia® Nurse Partners

Prolia® Nurse Partners is a no-cost option available to answer questions on self-injection.

  • You can receive supplemental injection training via phone or video (available in other languages, including Spanish)
  • This is not intended to replace the guidance of your prescribing healthcare provider. Please check with your healthcare provider before using this service.

Prolia® Nurse Partners services are available by calling 866-844-4553 (Monday through Friday, 9am - 7pm EST)

Frequently Asked Questions

Below is a list of common questions and helpful answers. The information below is not medical advice or a consultation, diagnosis, or treatment recommendation. It is important to remember that if you are unsure of anything, your doctor is the best person to help answer your questions.

Prolia® is an injection that is given to you by a healthcare professional. However, due to the current COVID-19 situation, your doctor may determine, based on your individual medical situation, that self-injection is temporarily needed. Please follow up with your doctor to determine if this is an option for you.

Prolia’s approved labeling states that it should be administered by a healthcare professional. Amgen has consulted with the U.S. Food and Drug Administration (FDA) regarding temporary instructions for patient self-injection. FDA has informed Amgen that it does not intend to object to our dissemination of temporary Instructions for Use and a demonstration video only for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. After that time, please refer to Prolia’s approved labeling for instructions regarding dosage and administration.

Click to download the temporary Instructions for Use, and view the Self-Administration Demonstration video and Prolia® Nurse Partners information on this site to help support you with your self-injection at home.

Please ensure that you review the temporary Instructions for Use in full and Sections 2.3 and 16 in the Prolia® Prescribing Information on proper preparation, administration, storage, and handling. These materials do not replace the directions your doctor should provide you, but we hope you will find them helpful.

If you have additional questions, please reach out to your doctor or call Amgen Medical Information at 800-77-AMGEN (800-772-6436).

You will need to contact your pharmacy to determine when your Prolia® prescription will be ready. We recommend calling your health plan to confirm if a specific pharmacy is required for your medication and whether your insurance covers mail-order prescriptions. You can simply call your insurance company using the phone number on your insurance member ID card. If you are interested in home delivery options, we recommend calling your preferred pharmacy to see if home delivery is available.

You will need to contact your pharmacy to determine when your Prolia® prescription will be ready.

According to WHO, the likelihood of an infected person contaminating commercial goods is low and the risk of catching the virus that causes COVID-19 from a package that has been moved, traveled, and exposed to different conditions and temperatures is also low.1

Consider various options such as using gloves and/or wiping down the package with a disinfectant, and immediately discarding the package and then washing your hands.2 For additional COVID-19 guidance, kindly visit CDC (www.cdc.gov) or WHO (www.who.int) websites.

References

  1. https://www.who.int/news-room/q-a-detail/q-a-coronaviruses
  2. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cleaning-disinfection.html

If you are already receiving Prolia® from a pharmacy, this option should not have an impact on your out-of-pocket (OOP) cost. In some cases, your OOP costs may be higher if you are used to getting Prolia® injected at your doctor’s office. The pharmacy can help confirm your coverage and OOP cost prior to filling your prescription.

If you are planning to inject Prolia® within 14 days of receipt, there is no need to refrigerate it. It is stable at room temperature, 68°F to 77°F, for 14 days. If you are not injecting your Prolia® within 14 days, store it in the refrigerator at 36ºF to 46ºF. Do not freeze or shake it. If you have additional questions, please reach out to your doctor or call Amgen Medical Information at 800-77-AMGEN (800-772-6436).

In most cases, you can find alcohol swabs at your pharmacy. Alternatively, if you are not able to obtain alcohol swabs it may be appropriate to use soap and water to clean your skin prior to injection. Please check with your healthcare provider prior to injecting Prolia®.

You should not use the Prolia® prefilled syringe if the medicine is discolored, cloudy, or there are particles in it. Also, do not use the syringe if it has been dropped on a hard surface, or any part appears cracked or broken. Discard your Prolia® injection immediately in an FDA-cleared sharps disposal container. To obtain a replacement Prolia® injection, please contact Amgen Medical Information at 800-77-AMGEN (800-772-6436).

You need to dispose of the syringe right after use. Do not reuse the syringe. Put it in an FDA-cleared sharps disposal container you can get from your doctor or pharmacy. Ask your doctor if he/she can prescribe an FDA-cleared sharps disposal container for you that may be delivered with your medicine. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out, is upright and stable during use, and is leak-resistant, and properly labeled to warn of hazardous waste inside the container. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

You can find FDA-cleared sharps disposal containers from your doctor or at the pharmacy. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out, is upright and stable during use, and is leak-resistant and properly labeled to warn of hazardous waste inside the container. You can also visit http://www.fda.gov/safesharpsdisposal to learn more about local guidelines for disposal.

If you are a caregiver and are able and choose to inject a Prolia® patient, we recommend consulting with your own healthcare provider and the patient’s healthcare provider.

Need more support information?

Call us at 800-77-AMGEN
(800-772-6436)

Receiving Prolia® Through Home Delivery

Please read these important steps carefully for guidance on how to get Prolia® sent to your home, and how to store it once it arrives. It is important to select a pharmacy that offers this service if you will be unable to pick up your Prolia® in person.

Step 1:

Your doctor will send your prescription to the pharmacy.

Step 2:

The pharmacy will call you to confirm home delivery and collect payment for Prolia®.

  • Be sure to answer this call—it may come from a phone number that you don’t recognize
  • If you don’t normally get Prolia® from a pharmacy, your out-of-pocket costs may be more than what you’re used to paying
  • If you need help paying for Prolia®, your doctor’s office may be able to help you find programs that can lower your out-of-pocket costs

Storage Instructions

If you are planning to inject Prolia® within 14 days of receipt, there is no need to refrigerate it. It is stable at room temperature, 68°F to 77°F, for 14 days. If you are not injecting your Prolia® within 14 days, store it in the refrigerator at 36°F to 46°F in the original carton, and take it out 15 to 30 minutes before use. Do not freeze or shake it. If you have additional questions, please reach out to your doctor or call Amgen Medical Information at 800-77-AMGEN (800-772-6436).

Save the date

After you’ve completed your self-injection, it is important to let your doctor know. And note the date on your calendar to help keep track of your next injection appointment in 6 months. It is important to take your Prolia® 1 time every 6 months.

You should take calcium and vitamin D as your doctor tells you to while you receive Prolia®.

After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Do not stop, skip or delay taking Prolia® without first talking with your doctor.

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Other COVID-19 Support

We’re always committed to your health. And at this challenging time, more than ever, we want to connect with you directly about it and help answer questions you may have.

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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:
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, skipping or delaying Prolia®. Talk with your doctor before starting Prolia® treatment. After your treatment with Prolia® is stopped, or if you skip or delay taking a dose, 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, skip or delay 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
  • Are taking medicine that can lower your blood calcium levels
  • 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).

The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.

The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.

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.

Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.

Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

Please see Prolia® full Prescribing Information and Medication Guide.

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). 
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