denosumab 60 mg/mL subcutaneous syringe

Generic name:
Denosumab - injection

Pronunciation
(den-OH-sue-mab)

Brand name(s)
Prolia

Denosumab may cause serious (rarely fatal) low calcium levels and may also worsen low calcium levels, especially if you have kidney problems. You may also be at increased risk if you have a history of low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, or stomach/intestinal problems (such as malabsorption/surgery). Take calcium and vitamin D as directed by your doctor to help prevent low levels of calcium. Your doctor will order blood tests before your first injection and during treatment to monitor you closely. Tell your doctor right away if you have any symptoms of low calcium such as severe muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), fast/irregular heartbeat, severe dizziness/fainting, or seizures.

Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods.

This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.

Read the Medication Guide provided by your pharmacist before you start using denosumab and before each injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin in the upper arm, upper thigh, or abdomen by a healthcare professional. It is given as directed by your doctor, usually once every 6 months.

You may also be instructed to take calcium and vitamin D supplements. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. Keep receiving this medication even if you feel well. Most people with osteoporosis do not have symptoms. To help you remember, mark your calendar with a reminder.

See also Warning and Precautions sections.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as:

• fever/chills
• red/swollen/tender/warm skin (with or without pus)
• severe abdominal pain
• ear pain/discharge
• trouble hearing
• frequent/painful/burning urination
• pink/bloody urine

Tell your doctor right away if you have any serious side effects, including:

• jaw pain
• new or unusual thigh/hip/groin pain
• bone/joint/muscle pain

After your treatment with denosumab is stopped, you may be at increased risk for bone fracture, including bones in your spine. Do not stop using this medication without first talking with your doctor. If your treatment is stopped, talk with your doctor about other medicines you can take.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash or if any of these symptoms last or get worse.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• recent or planned dental surgery/tooth removal

Some people using denosumab may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).

Denosumab is not recommended for use in children. It may slow down a child's growth and affect tooth development.

This medication must not be used during pregnancy. It may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. It is important to prevent pregnancy while using this medication and for at least 5 months after treatment. Females must use reliable forms of birth control during treatment and for at least 5 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make other lifestyle changes, consult your doctor for specific advice.

Lab and/or medical tests (such as bone density tests, calcium/phosphorus/magnesium levels, kidney function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Do not take this medication with any other product that contains denosumab.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

This medication is given in a hospital or clinic or doctor's office and usually will not be stored at home.

If you are picking up this medication at the pharmacy to bring to your medical appointment, store in the refrigerator until the day of your appointment. If you have any questions about storage, ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.