Uses
What is Prolia used for?
Prolia (denosumab) is commonly used to treat osteoporosis, a condition in which the bones are thinner, weaker, and more prone to breakage. Prolia may be prescribed for people at high risk for fractures in the following situations.
- Postmenopausal people with osteoporosis
- People who take a medicine called a corticosteroid such as prednisone
Prolia is also used to increase bone mass in people at high risk for fracture in men with osteoporosis and people who take certain medicines for either breast or prostate cancer.
Prolia may also be used for other conditions as determined by your healthcare provider.
How does Prolia work (mechanism of action)?
Prolia helps to strengthen bone by preventing the breakdown of bone.
How is Prolia supplied (dosage forms)?
Prolia is available as a 60 mg/mL prefilled syringe that is injected under the skin (subcutaneous).
How should I store Prolia?
Prolia is usually given by a healthcare provider in a hospital or clinic. If you will store Prolia at home, store it in the refrigerator at 36 F to 46 F (2 C to 8 C). It should be stored in the original container and away from light. Do not freeze Prolia. Prolia can be kept up to 77 F (25 C) for up to 14 days. After 14 days, Prolia must be thrown away.
Side Effects
What are the most common side effects of Prolia?
The most common side effects of Prolia are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Back pain, muscle pain, joint pain, or pain in the arms and legs
- High cholesterol levels
- Bladder infection
- High blood pressure
- Headache
- Bronchitis
- Runny nose or sore throat
There may be other side effects of Prolia that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Prolia?
While less common, the most serious side effects of Prolia are described below, along with what to do if they happen.
Severe Allergic Reactions. Prolia may cause allergic reactions, which can be serious. Tell your healthcare provider right away if you have any of the following symptoms of a serious allergic reaction. Get emergency help if you are no longer where you received Prolia.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Low Calcium Level (Hypocalcemia). Prolia can cause low calcium levels, which can be serious. Make sure that you take calcium and vitamin D that your healthcare provider may recommend. Keep all appointments to have your blood checked. Stop using Prolia and call your healthcare provider right away if you have any of the following symptoms.
- Changes in your heart rate or rhythm, such as a fast or skipping heartbeat
- Muscle pain, twitches, or spasms
- Numbness or tingling in your fingers, toes, or around your mouth
- Seizures
Severe Jawbone Problems (Osteonecrosis). Prolia can cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), have poor oral health, or have cancer or certain other conditions. You may be told to see a dentist before starting Prolia and to practice good mouth care. Call your healthcare provider right away if you experience any of the following symptoms of jaw osteonecrosis.
- Jaw pain or discomfort
- Mouth sores
- Loose teeth
Unusual Thigh Bone Fractures. Prolia can cause stress fractures or tiny cracks in the thigh bones. Notify your healthcare provider right away if you develop new or unusual pain or swelling in your thigh, hip, or groin.
Serious Infections. Prolia may affect your immune system and the ability of your body to fight off infections. This can increase your risk of developing serious infections including infections of the skin, bladder, ear, and lower stomach area. Prolia may also cause endocarditis, an infection that affects the lining of the heart. Call your healthcare provider right away if you develop any of the following symptoms of an infection.
- Fever or chills
- Skin that is red, swollen, or hot
- Severe abdominal pain
- Shortness of breath or cough
- Burning or stinging when you pee or frequent and urgent need to pee.
Increased Risk of Broken Bones after Stopping Prolia. If you stop taking Prolia or miss a dose, your risk of having a broken bone (including in the spine) increases. Talk to your healthcare provider if you missed a dose or plan on stopping Prolia.
Skin Problems. You may get a skin problem such as dermatitis, eczema, or a rash when you use Prolia. Call your healthcare provider right away if you have any of the following symptoms that do not go away or get worse.
- Skin redness, dryness, peeling, or itching
- Skin blisters that may ooze or become crusty
- Skin rash that may look like small bumps or patches
Bone, Joint, or Muscle Pain. Prolia can cause severe bone, joint, or muscle pain. Talk to your healthcare provider right away if you have severe pain.
Warnings & Precautions
Who should not use Prolia?
Allergies to Ingredients. People who are allergic to any of the following should not take Prolia.
- Prolia
- Denosumab
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Prolia.
Pregnancy. Do not take Prolia if you are pregnant. If you become pregnant, tell your healthcare provider right away. See the Pregnancy section below for more details.
Low Blood Calcium. People with hypocalcemia (low blood calcium) should not get Prolia until calcium levels have been corrected.
What should I know about Prolia before using it?
Do not use Prolia unless it has been prescribed to you by a healthcare provider. Use it as prescribed.
Do not share Prolia with other people, even if they have the same condition as you. It may harm them.
Do not shake Prolia.
Brush and floss your teeth daily. Tell your dentist you are using Prolia before having any dental work done.
Talk to your healthcare provider if you plan on stopping Prolia. Your risk of having a broken bone increases if you stop Prolia and do not take another medicine.
Keep Prolia out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
Talk to your doctor before starting Prolia. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels.
What should I tell my healthcare provider before using Prolia?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Prolia is right for you.
In particular, make sure that you discuss any of the following.
Kidney Problems. If you have advanced chronic kidney disease or are receiving dialysis, you are at greater risk for low blood calcium.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Low blood calcium
- Parathyroid or thyroid surgery
- Hypoparathyroidism
- Plan to have dental surgery or teeth removed
- Have been told you have trouble absorbing minerals
- Cannot take calcium and vitamin D
- Immune system problems
- Removal of part of your small intestine
Other Medicines and Supplements. Prolia may interact with other medicines and supplements. Before using Prolia, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not take Prolia, and tell your healthcare provider if you are or plan to become pregnant. Prolia may cause harm to your unborn baby. If you can become pregnant, you must use contraception during Prolia treatment and for 5 months after stopping Prolia. Your healthcare provider will make sure you have a negative pregnancy test before starting Prolia.
Breastfeeding. Prolia should not be used if you are breastfeeding. It is not known if Prolia passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Prolia.
How can I get more information about Prolia?
For more information about Prolia, you can visit the manufacturer’s website at www.prolia.com or call them at 877-477-6542.
Interactions
Does Prolia interact with foods or drinks?
There are no known interactions between Prolia and foods or drinks.
There are no known interactions between Prolia and alcohol. It is best to limit the amount of alcohol you drink.
Does Prolia interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Prolia.
- A corticosteroid such as prednisone, which is a medicine used for certain inflammatory conditions.
- A medicine used to treat hyperparathyroidism and hypercalcemia (high levels of calcium) such as cinacalcet.
- A medicine that suppresses the immune system such as methotrexate or cyclosporine.
- A denosumab medicine such as Xgeva, Wyost, or Jubbonit.
This may not be a complete list of medicines that can interact with Prolia. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Prolia?
If you or someone else has used too much Prolia, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Prolia?
Prolia is usually given by a healthcare provider every 6 months. Your healthcare provider will make sure you are receiving Prolia as scheduled. If you miss your appointment to get Prolia, call to make an appointment as soon as possible.