Prolia

Pronunciation: den-OH-sue-mab
Generic Name: Denosumab
Brand Name: Prolia

Prolia is used for:

Treating osteoporosis (weak bones) in certain women who have gone through menopause. It is used to treat bone loss in certain men receiving treatment for prostate cancer, and in certain women receiving treatment for breast cancer. It may also be used for other conditions as determined by your doctor.

Prolia is a human receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor. It works by slowing bone loss and increasing bone strength. This helps to reduce the risk of certain bone fractures.

Do NOT use Prolia if:

• you are allergic to any ingredient in Prolia


• you have low calcium levels in your blood


• you are using another medicine that contains denosumab

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prolia:

Some medical conditions may interact with Prolia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of low blood calcium levels, high cholesterol, blood clotting problems, anemia, bone infection, thyroid or parathyroid problems (including thyroid or parathyroid surgery), or pancreas problems


• if you have a history of kidney problems or you are on dialysis, or if you have problems absorbing nutrients from food (malabsorption syndrome or removal of part of your small intestine)


• if you have immune system problems or if you take medicine to suppress your immune system


• if you cannot take daily calcium or vitamin D supplements


• if you have cancer or have had or will be receiving radiation or chemotherapy


• if you have poor dental hygiene or other dental problems, or plan to have dental surgery or teeth removed


• if you have recently had a broken bone

Some MEDICINES MAY INTERACT with Prolia. However, no specific interactions with Prolia are known at this time.

Ask your health care provider if Prolia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prolia:

Use Prolia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Prolia comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Prolia refilled.


• Prolia is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• If you miss a dose of Prolia, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Prolia.

Important safety information:

• Prolia may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection (eg, fever, sore throat, chills, rash) or skin infection (eg, warm, red, swollen, or painful skin).


• Talk to your doctor about taking a calcium or vitamin D supplement while you use Prolia.


• Tell your doctor or dentist that you take Prolia before you receive any medical or dental care, emergency care, or surgery.


• It is not known what effect the long-term use of Prolia may have on your bones (eg, whether the risk of certain fractures or slow healing of broken bones may be increased). Discuss any questions or concerns with your doctor.


• Prolia may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infection). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use Prolia. Ask your doctor any questions you may have about dental treatment while you use Prolia.


• Proper dental care is important while you are taking Prolia. Brush and floss your teeth and visit the dentist regularly.


• Certain dental procedures should be avoided if possible while you are using Prolia. Check with your doctor and dentist before having any dental treatments while using Prolia.


• Prolia should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• Lab tests, including blood calcium and mineral levels, blood cholesterol, and bone density, may be performed while you use Prolia. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: It is not known if Prolia can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prolia while you are pregnant. It is not known if Prolia is found in breast milk. Do not breast-feed while taking Prolia.

Possible side effects of Prolia:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; mild joint pain; mild skin inflammation (eg, red, dry, itchy, or flaky skin); muscle pain; pain in the arms or legs.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bladder infection (eg, frequent or urgent need to urinate, burning during urination); ear pain; red, swollen, blistered, or peeling skin; severe bone or joint pain; severe stomach pain; signs of infection (eg, fever, sore throat, chills) or skin infection (eg, warm, red, swollen, or painful skin); signs of low blood calcium (eg, muscle spasms, twitches, or cramps; numbness or tingling in your fingers, toes, or around your mouth); swelling or pain in your jaw.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prolia side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prolia:

Store Prolia in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store in the original container. Do not freeze. Do not shake Prolia. Prolia may also be stored at room temperature up to 77 degrees F (25 degrees C) for up to 14 days. Do not keep Prolia at temperatures above 77 degrees F (25 degrees C). Keep Prolia out of the reach of children and away from pets.

General information:

• If you have any questions about Prolia, please talk with your doctor, pharmacist, or other health care provider.


• Prolia is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prolia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prolia resources

• Prolia Side Effects (in more detail)
• Prolia Use in Pregnancy & Breastfeeding
• Prolia Drug Interactions
• Prolia Support Group
• 0 Reviews for Prolia - Add your own review/rating

• Prolia Prescribing Information (FDA)


• Prolia Consumer Overview


• Prolia Monograph (AHFS DI)


• Prolia Advanced Consumer (Micromedex) - Includes Dosage Information


• Denosumab Professional Patient Advice (Wolters Kluwer)


• Xgeva Prescribing Information (FDA)


• Xgeva Consumer Overview

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