Brand Prolia

Denosumab is used to treat bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, if someone in your family has osteoporosis, or if you take corticosteroid 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. 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.

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. Infrequently, people taking medications for bone loss (including denosumab) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. Be sure to brush and floss your teeth daily and get regular dental exams/cleaning. If you develop jaw pain, tell your doctor and dentist immediately. 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). This medication is usually used in women after menopause. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Denosumab is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor if you have any questions about this medication. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

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 immediately to establish a new dosing schedule.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

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 immediately 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), seizures. Denusomab 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 immediately 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, frequent/painful/burning urination, pink/bloody urine. Tell your doctor immediately if this unlikely but serious side effect occurs: jaw pain. 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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.