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Generic Name: denosumab (den-OH-sue-mab)
Brand Name: Prolia

Prolia is used for:

Treating osteoporosis (weak bones) in certain women who have gone through menopause. It is also used to help build bone in certain men with osteoporosis. 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 RANK 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 pregnant or planning to become pregnant
  • you are using another medicine that contains denosumab

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

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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 able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances, including rubber or latex
  • 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, if you have had part of your small intestine removed, or if you have problems absorbing nutrients from food (malabsorption syndrome)
  • 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
  • if you are taking a corticosteroid (eg, prednisone)

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 given as an injection every 6 months at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Prolia is a colorless to pale yellow solution that may contain a very small amount of clear to white particles. Do not use Prolia if it contains many particles or any foreign matter. Do not use it if the solution is cloudy or discolored, or if the vial or syringe is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • 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, persistent sore throat, rash, chills) 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.
  • Certain fractures of the thigh bone (femur) have been reported in patients using Prolia. It is unknown if Prolia contributed to the fractures. Contact your doctor right away if you experience new or unusual hip, groin, or thigh pain. 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.
  • Men who use Prolia should talk with their doctor about the risk to the fetus if they have unprotected sex with a pregnant woman. If you think your sexual partner may be pregnant, contact your doctor right away.
  • PREGNANCY and BREAST-FEEDING: Do not use Prolia if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. 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; mild joint pain; mild muscle pain; mild skin inflammation (eg, red, dry, itchy, or flaky skin); mild sore throat; pain in the arms or legs; runny nose.

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 or throat; swelling of the mouth, face, lips, or tongue; fainting; severe dizziness); chest pain; ear pain; irregular heartbeat; new or unusual hip, groin, or thigh pain; red, swollen, blistered, or peeling skin; severe or persistent stomach or back pain (with or without nausea or vomiting); signs of infection (eg, fever, persistent sore throat, chills) or skin infection (eg, warm, red, swollen, or painful skin); symptoms of low blood calcium (eg, muscle stiffness, spasms, twitches, or cramps; numbness or tingling in your fingers, toes, or around your mouth; seizures); swelling of the hands, ankles, or feet; symptoms of bladder or urinary tract infection (eg, frequent or urgent need to urinate, burning during urination, difficult or painful urination); symptoms of jaw bone problems (eg, jaw swelling, pain, or numbness; drainage from the mouth or teeth; sores in the mouth); unusual tiredness or weakness; vision changes (eg, cloudy or blurred vision).

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.

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 expose Prolia to 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 should not be used to decide whether or not to take Prolia or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Prolia. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prolia. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Prolia.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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