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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.
Denosumab is used to treat bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause. It is also used to treat bone loss in men who are at high risk for bone fracture. 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 corticosteroid medications (such as prednisone) for long periods.
Denosumab is also used to treat bone loss in women who are at high risk for bone fracture while receiving certain treatments for breast cancer. Denosumab is also used to treat bone loss in men who are at high risk of bone fracture while receiving certain treatments for prostate cancer that has not spread to other parts of the body. 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. Your healthcare provider will inject this medication under your skin in the upper arm, upper thigh, or abdomen as directed by your doctor, usually every 6 months. Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily. Use this medication regularly in order to get the most benefit from it. It is important to keep receiving this medication even if you feel well. Most people with osteoporosis do not have symptoms. Remember to receive it every 6 months. It may help to mark your calendar with a reminder. Continue to take other medications for your condition as directed by your doctor.
See also Precautions section. Remember that your doctor has prescribed this medication because he or she 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 may cause low calcium levels, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Your doctor will order calcium blood tests before your first injection and during treatment.
Tell your doctor right away if you have any symptoms of low calcium such as:
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, seizures.
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. Therefore, get medical help right away if you develop any rash or if any of these symptoms persist or worsen. 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.
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 (such as latex), 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: low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, stomach/intestinal problems (such as malabsorption, surgery), kidney problems, 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. It is important to prevent pregnancy while using this medication and for at least 5 months after treatment. Therefore, 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 breast-feeding.
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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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. Laboratory and/or medical tests (such as bone density tests, calcium/phosphorus/magnesium levels, kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Do not take this medication with any other product that contains denosumab.
For the best possible benefit, it is important to receive each dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish 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 between 36-46 degrees F (2-8 degrees C) until the day of your appointment. Keep all medications away from children and pets.
If you have any questions about storage, ask your pharmacist. 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 for more details about how to safely discard your medication.
DENOSUMAB – INJECTION