Frequently Asked Questions about Xgeva® (Denosumab)
Class: Supportive Care
Generic Name: Denosumab
Trade Name: Xgeva®
How is Xgeva used? Xgeva is FDA approved for the prevention of skeletal-related events (such as fractures) in patients with bone metastases from solid (not blood-related) cancers. Xgeva is not approved for use in patients with multiple myeloma.
What is the mechanism of action? Xgeva targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone).
How is Xgeva given (administered)? Xgeva is given as a subcutaneous (under-the-skin) injection every four weeks.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Xgeva. Patients may undergo blood tests, physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Xgeva?
- Hypophosphatemia (low level of phosphorus in the blood)
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Xgeva?
- Hypocalcemia (low level of calcium in the blood)
- Dyspnea (shortness of breath)
Osteonecrosis of the Jaw
Some bone drugs, including Xgeva, have been linked with a condition known as osteonecrosis of the jaw (ONJ; death of bone in the jaw). In clinical trials, 2.2% of patients receiving Xgeva developed ONJ. Patients should receive an oral examination and appropriate preventive dentistry prior to starting treatment with Xgeva. During treatment with Xgeva, patients should practice proper oral hygiene, receive routine dental care, and avoid invasive dental procedures.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Maintain proper oral hygiene.
- Inform your dentist that you are taking Xgeva.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interact with treatment.
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future.
- Patients should inform their physician about all medical conditions.
- Patients should undergo an oral examination and receive appropriate preventive dentistry prior to starting treatment with Xgeva.
When should patients notify their physician?
Tell your doctor if you experience any unusual symptoms. Notify your healthcare provider immediately if you experience symptoms of hypocalcemia (low calcium levels), such as muscle stiffness, twitching, spasms, or cramps; symptoms of ONJ, such as pain, numbness, swelling, or slow healing of the jaw, mouth, or teeth; or if you become pregnant or begin nursing.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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