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Denosumab Injection (Prolia)

Pronunciation

Generic Name: Denosumab Injection (Prolia) (den OH sue mab)
Brand Name: Prolia

Uses of Denosumab Injection:

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

What do I need to tell my doctor BEFORE I take Denosumab Injection?

  • If you have an allergy to denosumab or any other part of denosumab injection (prolia).
  • 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.
  • If you are using another drug that has the same drug in it.
  • If you are pregnant or may be pregnant. Some brands of this medicine are not for use during pregnancy.

This is not a list of all drugs or health problems that interact with denosumab injection.

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 medicine 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 Denosumab Injection?

  • Tell all of your health care providers that you take denosumab injection. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may raise the chance of a broken leg. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Take calcium and vitamin D as you were told by your doctor.
  • Have a dental exam before starting this medicine.
  • Take good care of your teeth. See a dentist often.
  • Very bad infections have been reported with use of denosumab injection. 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.
  • This medicine may lower blood calcium levels. If you already have low blood calcium, it may get worse with this medicine. Sometimes, blood calcium levels have stayed low for weeks or months after use of denosumab injection. Talk with the doctor.
  • After this medicine is stopped, the chance of a broken bone is raised. This includes bones in the spine. The chance of having more than 1 broken bone in the spine is raised if you have ever had a broken bone in your spine. Do not stop treatment with denosumab injection without talking to your doctor.
  • This medicine is not approved for use in children. Talk with the doctor.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine.
  • 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.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are pregnant or you get pregnant while taking denosumab injection, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Denosumab Injection) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

See also: Dosage Information (in more detail)

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:

  • 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.
  • Swelling in the arms or legs.
  • Feeling very tired or weak.
  • Any new or strange groin, hip, or thigh pain.
  • Very bad bone, joint, or muscle pain.
  • Shortness of breath.
  • Dizziness or passing out.
  • This medicine may cause jawbone problems. The chance may be higher the longer you take denosumab injection (prolia). 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, getting chemo or radiation, or taking other drugs that may cause jawbone problems like some steroid drugs. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure. Call your doctor right away if you have jaw swelling or pain.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Very bad skin irritation.
  • Bladder pain or pain when passing urine or change in how much urine is passed.
  • Passing urine more often.

What are some other side effects of Denosumab Injection?

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:

  • Back pain.
  • Joint pain.
  • Muscle pain.
  • Pain in arms or legs.
  • Nose or throat irritation.

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 the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

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.

How do I store and/or throw out Denosumab Injection?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

  • 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.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about denosumab injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about denosumab injection, please talk with the 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.

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 denosumab injection. 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 denosumab injection.

Review Date: October 4, 2017

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