Denosumab injection is used to treat osteoporosis (thinning of the bones) in women who have an increased risk for fractures after menopause, and osteoporosis in men. It is given when other medicines cannot be used or after other medicines did not work well.
Denosumab injection is also used to treat bone loss in men with prostate cancer and women with breast cancer who are receiving cancer treatment. It is used to prevent bone problems in patients with bone metastases (cancer that has spread) from tumors. Denosumab is used to treat giant cell tumor of the bone that cannot be removed by surgery. This medicine is also used to treat hypercalcemia of malignancy that has been treated with bisphosphonates (eg, alendronate, ibandronate, risedronate, Fosamax®) but did not work well.
This medicine is to be given only by or under the supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Use of denosumab injection is not recommended in the pediatric population, except for teenagers with giant cell tumor of the bone. The safety and efficacy of denosumab for other conditions have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of denosumab injection in the elderly.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper arm, upper thigh, or stomach.
Prolia® is usually given once every 6 months, and Xgeva® is usually given once every 4 weeks. Your doctor may also give you vitamin D and calcium supplements. Follow the instructions about how to take these medicines.
This medicine comes with a Medication Guide. Read the information carefully. Ask your doctor if you have any questions.
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Prolia® contains denosumab which can also be found in Xgeva®. Patients using Prolia® should not receive Xgeva®.
Your unborn baby could be harmed if you use this medicine while you are pregnant. Women receiving Xgeva® should use a highly effective form of birth control to keep from getting pregnant during treatment and for at least 5 months after the last dose. There is also a potential for this medicine to cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.
This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.
Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor right away if you have a fever or chills, red, swollen skin, severe abdominal or stomach pain, or burning or painful urination.
Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have any of the following symptoms that do not go away or get worse: blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, rash, or swollen skin.
It is important that you tell all of your doctors that you are receiving denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.
The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thigh, groin, or hips.
Check with your doctor right away if you have severe muscle, bone, or joint pain after receiving Prolia®.
Hypercalcemia may occur after stopping Xgeva® treatment in patients with growing bones. Tell your doctor right away if you have nausea, vomiting, headache, or decreased alertness.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.