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Denosumab (den OH sue mab)

Adult Medication

Brand Names: U.S.

Prolia; Xgeva

Brand Names: Canada

Prolia; Xgeva

What is this drug used for?

  • It is used to treat soft, brittle bones (osteoporosis).
  • It is used for bone growth.
  • It is used when treating some cancers.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

All products:

  • If you have an allergy to denosumab or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have low calcium levels.

Prolia™:

  • If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • This drug may raise the chance of a broken leg. Talk with your doctor.
  • Have your blood work checked. Talk with your doctor.
  • Have a bone density test. Talk with your doctor.
  • Take calcium and vitamin D as you were told by your doctor.
  • Have a dental exam before starting this drug.
  • Take good care of your teeth. See a dentist often.
  • If you smoke, talk with your doctor.
  • Do not give to a child. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Xgeva®:

  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you get pregnant while taking this drug, call your doctor right away.

Prolia™:

  • Very bad infections have been reported with use of this drug. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with your doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Use birth control that you can trust to prevent pregnancy while taking this drug.
  • If you are a man and your sex partner is pregnant or gets pregnant at any time while you are being treated, talk with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

All products:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
  • Mouth sores.
  • Any new or strange groin, hip, or thigh pain.
  • This drug may cause jawbone problems. The chance may be higher the longer you take this drug. The chance may be higher if you have cancer, dental problems, dentures that do not fit well, anemia, blood clotting problems, or an infection. The chance may also be higher if you are having dental work or if you are getting chemo, some steroid drugs, or radiation. Call your doctor right away if you have jaw swelling or pain.

Xgeva®:

  • Not hungry.
  • Muscle pain or weakness.
  • Seizures.
  • Shortness of breath.

Prolia™:

  • Signs of infection. These include a fever of 100.4°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Very bad skin irritation.
  • Feeling very tired or weak.
  • Bladder pain or pain when passing urine or change in how much urine is passed.
  • Passing urine often.
  • Swelling in the arms or legs.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Xgeva®:

  • Feeling tired or weak.
  • Headache.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Cough.

Prolia™:

  • Back pain.
  • Muscle or joint pain.
  • Sore throat.
  • Runny nose.
  • Pain in arms or legs.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.
  • It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

  • Call the doctor to find out what to do.

How do I store and/or throw out this drug?

  • This drug will be given to you in a hospital or doctor’s office. You will not store it at home.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

Copyright © 2014 Clinical Drug Information, LLC and Lexi-Comp, Inc.