Denosumab is used to treat bone problems that may occur with cancer that has spread to the bones or to treat high blood calcium levels (hypercalcemia) that may occur with cancer. It may also be used by adults (and teenagers who have reached their final adult height) to treat a certain disease called giant cell tumor of the bone, if they cannot use surgery to treat the disease. This medication should not be used in people with multiple myeloma.
This medication is given by injection under your skin in the upper arm, upper thigh, or abdomen by a healthcare professional as directed by your doctor, usually every 4 weeks. If you are using this medication to treat giant cell tumor of the bone or high blood calcium levels, your doctor may also direct you to receive additional doses once a week during weeks 2 and 3 of the first month of treatment.
Use this medication regularly in order to get the most benefit from it. Remember to receive it every 4 weeks. It may help to mark your calendar with a reminder.
You may also be instructed to take calcium and vitamin D supplements. Follow your doctor's instructions carefully.
Tiredness, weakness, headache, back pain, diarrhea, and nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
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, shortness of breath.
Denosumab may cause very serious (rarely fatal) low levels of calcium in the blood, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Get medical help 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), seizures, severe dizziness/fainting.
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 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.
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.
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.
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.
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: low level of calcium in the blood (hypocalcemia), kidney disease.
Infrequently, people using this medication 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 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 except for the treatment of giant cell tumor of the bone (see also Uses section). 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 immediately.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. 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 overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (such as calcium/phosphorus 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 immediately to establish a new dosing schedule.
Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.
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.
Information last revised December 2014. Copyright(c) 2014 First Databank, Inc.
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