Generic name: denosumab
Drug class: Miscellaneous bone resorption inhibitors
Medically reviewed by A Ras MD.
What is Xgeva?
Xgeva is a prescription medicine that is used when treating some cancers. It is used to treat high calcium levels in patients with cancer. Xgeva may be given to you for other reasons.
Xgeva (denosumab) is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Xgeva is a sterile, preservative-free, clear, colorless to pale yellow solution.
Each single-dose vial of Xgeva contains 120 mg denosumab, acetate (18 mM), polysorbate 20 (0.01%), sorbitol (4.6%), Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
Mechanism of Action
Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth. Xgeva prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells.
Before taking Xgeva, tell your doctor:
- If you are allergic to Xgeva; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have low calcium levels.
- If you are using another drug that has the same drug in it.
- If you are pregnant or may be pregnant. Do not take Xgeva if you are pregnant.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xgeva with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Xgeva?
- Tell all of your health care providers that you take Xgeva. This includes your doctors, nurses, pharmacists, and dentists.
- This medicine may raise the chance of a broken leg. Talk with the doctor.
- If treatment with Xgeva is stopped, skipped, or delayed, the chance of a broken bone is raised. This includes bones in the spine. The chance of having more than 1 broken bone in the spine is raised if you have ever had a broken bone in your spine. Do not stop, skip, or delay treatment with Xgeva without talking to your doctor.
- Have a bone density test as you have been told by your doctor. Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Take calcium and vitamin D as you were told by your doctor.
- Have a dental exam before starting Xgeva.
- Take good care of your teeth. See a dentist often.
- Very low blood calcium levels have happened with Xgeva. Sometimes, this has been deadly. If you have questions, talk with the doctor.
- High calcium levels have happened after Xgeva was stopped in people whose bones were still growing and people with giant cell bone tumor. Call your doctor right away if you have signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
- This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Xgeva to show that you are NOT pregnant.
- Women must use birth control while taking Xgeva and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
How is Xgeva best taken?
Use Xgeva as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of Xgeva that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
- Signs of low phosphate levels like change in eyesight, feeling confused, mood changes, muscle pain or weakness, shortness of breath or other breathing problems, or trouble swallowing.
- Very bad dizziness or passing out.
- Any unexplained bruising or bleeding.
- Mouth sores.
- Swelling in the arms or legs.
- Feeling very tired or weak.
- Any new or strange groin, hip, or thigh pain.
- Very bad bone, joint, or muscle pain.
- Shortness of breath.
- This medicine may cause jawbone problems. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting problems, or infection. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone problems. Many drugs can do this. Talk with your doctor if any of these apply to you, or if you have questions. Call your doctor right away if you have jaw swelling or pain.
What are some other side effects of Xgeva?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Back pain.
- Signs of a common cold.
- Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
- Feeling tired or weak.
- Joint pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Xgeva?
- If you need to store Xgeva at home, talk with your doctor, nurse, or pharmacist about how to store it.
PRINCIPAL DISPLAY PANEL
- 1 x 120 mg Single-Dose Vial
- NDC 55513-730-01
- 120 mg/1.7 mL
- (70 mg/mL)
- For Subcutaneous Use Only
- 120 mg/1.7 mL
- Single-Dose Vial. Discard Unused Portion.
- Sterile Solution – No Preservative
- Refrigerate at 2° to 8°C (36° to 46°F).
- Do not freeze. Avoid excessive shaking.
- Protect from direct light.
- Manufactured by: Amgen Inc.
- Thousand Oaks, CA 91320-1799
- U.S. License No. 1080
- Product of Singapore
SRC: NLM .