Xgeva 120 mg/1.7 mL (70 mg/mL) subcutaneous solution

Generic name:
Denosumab 4 week (120 mg) - injection

Pronunciation
(den-OH-sue-mab)

Brand name(s)
Xgeva

Denosumab is used to treat bone problems that may occur in people with multiple myeloma or in people with cancer that has spread to the bones. It is also used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. It may also be used by adults (and teenagers who have reached their final adult height) to treat a certain disease called giant cell tumor of the bone, if they cannot use surgery to treat the disease.

This medication is given by injection under the skin in the upper arm, upper thigh, or abdomen by a healthcare professional. It is given as directed by your doctor, usually once every 4 weeks. If you are using this medication to treat giant cell tumor of the bone or high blood calcium levels, your doctor may also direct you to receive additional doses once a week during weeks 2 and 3 of the first month of treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

You may also be instructed to take calcium and vitamin D supplements. Follow your doctor's instructions carefully.

Tiredness, weakness, headache, back pain, diarrhea, and nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• jaw pain
• new or unusual thigh/hip/groin pain
• bone/joint/muscle pain
• shortness of breath

Denosumab may cause very serious (rarely fatal) low levels of calcium in the blood, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Get medical help right away if you have any symptoms of low calcium such as:

• severe muscle spasms/cramps
• mental/mood changes (such as irritability or confusion)
• numbness/tingling (especially around lips/mouth or in fingers/toes)
• seizures
• severe dizziness/fainting
• fast/irregular heartbeat

Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as:

• fever/chills
• red/swollen/tender/warm skin (with or without pus)
• severe abdominal pain
• ear pain/discharge
• trouble hearing
• frequent/painful/burning urination
• pink/bloody urine

Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash or if any of these symptoms last or get worse.

Denosumab may cause high levels of calcium in the blood weeks to months after treatment has stopped, especially if you have not reached your final adult height. Tell your doctor right away if you have any symptoms of high calcium after you have stopped using denosumab such as:

• nausea
• vomiting
• headache
• unusual tiredness

After your treatment with denosumab is stopped, you may be at increased risk for bone fractures in your spine. This risk is greater if you have bone loss (osteoporosis) or have had broken bones. If your treatment is stopped, talk with your doctor about other medicines you can take.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• low level of calcium in the blood (hypocalcemia)
• kidney disease

Some people using denosumab may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).

Denosumab is not recommended for use in children except for the treatment of giant cell tumor of the bone (see also Uses section). It may slow down a child's growth and affect tooth development.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using denosumab. Denosumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 5 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as calcium/phosphorus levels, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Do not take this medication with any other product that contains denosumab.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.