Xgeva

Xgeva is a prescription medication used to prevent fractures from certain types of cancers that have spread to the bone. Xgeva is used to treat giant cell tumor of the bone that cannot be treated with surgery. It is also used to treat high levels of calcium due to cancer that have not been successfully treated with bisphosphonate therapy.

Xgeva belongs to a group of drugs called RANK ligand inhibitors. These work by decreasing the breakdown of bone and increasing bone strength and thickness.

This medication comes in an injectable form that is given as a single shot under the fatty layer of the skin in the upper arm, upper thigh, or stomach once every 4 weeks in your doctor's office.

Common side effects include tiredness/weakness, low phosphate levels in your blood, and nausea.

Since Xgeva can cause tiredness, do not drive or operate heavy machinery until you know how Xgeva affects you.

Xgeva is a prescription medication used to:

• prevent fractures, spinal cord compression, or the need for radiation or surgery to the bone in those with multiple myeloma or those with solid tumors that have spread to the bone
• treat giant cell tumor of the bone that cannot be treated surgically
• treat high levels of calcium due to cancer that has not been successfully treated with bisphosphonate therapy

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Amgen Inc

Serious side effects have been reported with Xgeva. See the "Drug Precautions" section.

Common side effects of Xgeva include the following:

• red, dry, itchy skin
• back pain
• nausea
• headache
• pain in arms or legs
• joint pain
• muscle pain
• fatigue
• increase in cholesterol
• upper respiratory tract infections
• decreased appetite 
• swelling in the hands or feet

This is not a complete list of Xgeva side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Xgeva including the following:

• Anaphylaxis. Anaphylaxis is a severe, life-threatening allergic reaction. Seek immediate medical attention if you experience any of the following symptoms: swelling of the lips, tongue, or throat, difficulty breathing, dizziness, or itching.
• Hypocalcemia. Hypocalcemia refers to low levels of calcium in the blood. Tell your doctor if you experience any of the following symptoms of hypocalcemia: muscle stiffness or spasms, dizziness, or numbness in the fingers. Your doctor may check your calcium level in your blood before you use Xgeva to make sure it is not too low. Your doctor should also instruct you to take calcium and vitamin D supplements during treatment to make sure your calcium does not get too low.
• Osteonecrosis of the jaw. Osteonecrosis is a serious bone disease that can degrade bone and limit its function. It typically occurs after tooth extraction or local infection. You should have a dental exam before you start treatment with Xgeva.
• Fractures of the femur. While Xgeva is intended to prevent fractures, patients using the drug have experienced fractures. Tell your doctor if you notice any new thigh, hip, or groin pain.
• Infection. Tell your doctor if you notice any signs of infection such as a cough, runny nose, sore throat, or fever.
• Skin reactions. Tell your doctor if you develop a rash or develop itching, burning, or redness of the skin.
• Bone, joint, and muscle pain. Stop taking Xgeva and tell your doctor if you experience pain in the joints, or deeper in the muscle or bone.
• Decreased bone remodeling. It is not known if Xgeva use over a long period of time slows the healing of broken bones.
• Multiple vertebral fractures (MVF) following treatment discontinuation. After treatment with Xgeva is stopped there may be an increased risk of having broken bones in the spine especially in patients who have had a fracture or who have had osteoporosis. It is  not recommended to interrupt Xgeva therapy without your doctor's advice. 
• Harm to your unborn baby. Women who are able to become pregnant are recommended to use effective contraception during therapy, and for at least 5 months after the last dose of Xgeva. 

Do not use Xgeva if you:

• are allergic to Xgeva or any of its ingredients
• have low calcium levels

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xgeva, there are no specific foods you must exclude from your diet when receiving this medication.

Before taking Xgeva, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Xgeva or any of its ingredients
• Have had recent dental work, or plan to have dental work or a tooth extraction in the future
• Have been told you have low calcium levels in your blood
• Have kidney problems
• Are unable to take calcium or vitamin D supplements
• Have been told you have trouble absorbing vitamins or minerals in your stomach or intestines
• Are taking another medicine that contains denosumab. Denosumab is marketed as Xgeva and Prolia, and patients receiving either one of these medications should not receive the other.
• Have an active infection
• Have had thyroid or parathyroid (glands located in your neck) surgery
• Are pregnant or are plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your dentist that you are receiving Xgeva before you have dental work done

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify possible risks of an unborn baby when a medication is taken during pregnancy.

Xgeva falls into category X. It has been shown that women taking Xgeva during pregnancy may have babies born with problems. There are no situations in which the benefits of the medication to the mother outweigh the risks of harm to the baby. These medications should never be used by pregnant women.

It is recommended for women, who are able to become pregnant, use effective contraception during therapy, and for at least 5 months after the last dose of Xgeva. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Xgeva crosses into human milk. Because many medications can cross into human milk and because the possiblity for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risks of using Xgeva.

Use Xgeva exactly as prescribed.

Xgeva comes in as an injectable and is to be injected under the fatty layer of the skin (subcutaneous injection) in the upper arm, upper thigh, or stomach by a healthcare professional once every 4 weeks. 

Your healthcare provider will probably recommend you take calcium and vitamin D as necessary to treat or prevent low levels of calcium. 

Use this medication exactly as prescribed by your doctor. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Xgeva (denosumab) to prevent fractures for those with multiple myeloma and those whose solid tumors have spread to the bone is 120 mg every 4 weeks. 

For the treatment Giant Cell Tumor of Bone and high calcium levels due to cancer, the recommended dose of Xgeva (denosumab) is 120 mg every 4 weeks. An additional 120 mg will be injected on days 8 and 15 of the first month of treatment.

Since Xgeva is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.