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 denosumab injection (prolia); any part of denosumab injection (prolia); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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. Do not take denosumab injection (prolia) if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

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

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 denosumab injection (prolia) 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 (prolia). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of a broken leg. Talk with the doctor.
• If treatment with denosumab injection (prolia) is stopped, skipped, or delayed, 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, skip, or delay treatment with denosumab injection (prolia) without talking to your doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Take calcium and vitamin D as you were told by your doctor.
• Have a dental exam before starting denosumab injection (prolia).
• Take good care of your teeth. See a dentist often.
• Very bad infections have been reported with use of denosumab injection (prolia). If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with your doctor.
• Rarely, a pancreas problem (pancreatitis) has happened with denosumab injection (prolia). This has included 1 death. Call your doctor right away if you have signs of pancreatitis like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• This medicine may lower blood calcium levels. If you already have low blood calcium, it may get worse with denosumab injection (prolia). Sometimes, blood calcium levels have stayed low for weeks or months after use of denosumab injection (prolia). Talk with the doctor.
• This medicine is not approved for use in children. Talk with the doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start denosumab injection (prolia) to show that you are NOT pregnant.
• Women must use birth control while taking denosumab injection (prolia) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is this medicine (Denosumab Injection) best taken?

Use denosumab injection (prolia) 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.

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, swallowing, 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.
• 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 skin infection like oozing, heat, swelling, redness, or pain.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Small bumps or patches on your skin, dry skin, or if your skin feels like leather.
• Bladder pain or pain when passing urine or change in how much urine is passed.
• Passing urine more often.
• 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.
• This medicine may cause jawbone problems. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting problems, or infection. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone problems. Many drugs can do this. Talk with your doctor if any of these apply to you, or if you have questions. Call your doctor right away if you have jaw swelling or pain.

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.
• Headache.
• Signs of a common cold.
• Muscle or joint pain.
• 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 the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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 denosumab injection (prolia) 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 all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time denosumab injection (prolia) is refilled. If you have any questions about denosumab injection (prolia), 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.

Frequently asked questions

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