Generic Name: denosumab (den-OH-sue-mab)
Brand Name: Xgeva
Denosumab is used for:
Preventing certain bone-related events in patients who have a certain type of tumor that has spread to the bones (bone metastases). It may also be used to treat certain patients with giant-cell tumor of bone that cannot be removed by surgery.
Denosumab is a receptor activator of nuclear factor kappa B ligand (RANKL) inhibitor. It works by slowing bone loss and increasing bone strength. This helps to reduce the risk of bone-related events in patients with cancer that has spread to the bone.
Do NOT use denosumab if:
- you are allergic to any ingredient in denosumab
- you have low calcium levels in your blood
- you are using another medicine that contains denosumab
Contact your doctor or health care provider right away if any of these apply to you.
Before using denosumab:
Some medical conditions may interact with denosumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of low blood calcium levels, high cholesterol, blood clotting problems, anemia, a bone infection, thyroid or parathyroid problems (including thyroid or parathyroid surgery), or pancreas problems
- if you have a history of kidney problems or you are on dialysis, if you have had part of your small intestine removed, or if you have problems absorbing nutrients from food (malabsorption syndrome)
- if you cannot take daily calcium or vitamin D supplements
- if you have had or will be receiving radiation or chemotherapy
- if you have poor dental hygiene or other dental problems, or plan to have dental surgery or teeth removed
- if you have multiple myeloma (a certain type of cancer)
- if you are taking a corticosteroid (eg, prednisone)
Some MEDICINES MAY INTERACT with denosumab. However, no specific interactions with denosumab are known at this time.
Ask your health care provider if denosumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use denosumab:
Use denosumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Denosumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using denosumab at home, a health care provider will teach you how to use it. Be sure you understand how to use denosumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
- Denosumab is a colorless to pale yellow solution that may contain a very small amount of clear to white particles. Do not use denosumab if it contains many particles or any foreign matter. Do not use it if the solution is cloudy or discolored, or if the vial is cracked or damaged.
- Do not vigorously shake denosumab.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of denosumab, contact your doctor right away.
Ask your health care provider any questions you may have about how to use denosumab.
Important safety information:
- Talk to your doctor about taking a calcium or vitamin D supplement while you use denosumab.
- Tell your doctor or dentist that you take denosumab before you receive any medical or dental care, emergency care, or surgery.
- Denosumab may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infection). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use denosumab. Ask your doctor any questions you may have about dental treatment while you use denosumab.
- Proper dental care is important while you are taking denosumab. Brush and floss your teeth and visit the dentist regularly.
- Certain dental procedures should be avoided if possible while you are using denosumab. Check with your doctor and dentist before having any dental treatments while using denosumab.
- Certain fractures of the thigh bone (femur) have been reported in patients using denosumab. Some of these patients were also receiving glucocorticoids (eg, prednisone). Contact your doctor right away if you experience new or unusual hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.
- Low calcium levels may occur from treatment with denosumab. In severe cases, this can be deadly. Call your doctor right away if you have muscle stiffness, spasms, twitches, or cramps; burning, numbness, or tingling in your fingers, toes, or around your mouth; or seizures.
- It is not known how much of denosumab is found in semen. Men who take denosumab and have unprotected sex with a pregnant woman may expose denosumab to the fetus. Discuss any questions or concerns with your doctor.
- If you are able to become pregnant, you must use effective birth control while you use denosumab and for at least 5 months after your last dose. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including blood calcium and mineral levels, may be performed while you use denosumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Denosumab should not be used in CHILDREN with bone growth that is not complete; denosumab may affect bone growth and tooth development in children. Discuss any questions or concerns with your doctor.
- PREGNANCY and BREAST-FEEDING: Denosumab may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using denosumab while you are pregnant. It is not known if denosumab is found in breast milk. Do not breast-feed while taking denosumab.
Possible side effects of denosumab:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; headache; joint pain; nausea; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough; fainting; new or unusual hip, groin, or thigh pain; severe or persistent dizziness; shortness of breath; symptoms of low blood calcium levels (eg, muscle stiffness, spasms, twitches, or cramps; burning, numbness, or tingling in your fingers, toes, or around your mouth; seizures); symptoms of low blood phosphate levels (eg, new or worsening loss of appetite, muscle weakness or pain, seizures); symptoms of jaw bone problems (eg, jaw swelling, pain, or numbness; drainage from the mouth or teeth; sores in the mouth).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of denosumab:
Store denosumab in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store in the original container. Do not freeze. Do not shake denosumab. Denosumab may also be stored at room temperature up to 77 degrees F (25 degrees C) for up to 14 days. Do not expose denosumab to temperatures above 77 degrees F (25 degrees C). Keep denosumab out of the reach of children and away from pets.
- If you have any questions about denosumab, please talk with your doctor, pharmacist, or other health care provider.
- Denosumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take denosumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about denosumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to denosumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using denosumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.