Xgeva

DRUG DESCRIPTION

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 (denosumab) is a sterile, preservative-free, clear, colorless to pale yellow solution.

Each single-use vial of Xgeva contains 120 mg denosumab, 4.6% sorbitol, 18 mM acetate, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.

What are the precautions when taking denosumab (Xgeva)?

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.

Infrequently, people using this medication have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. Be sure to...

Read All Potential Precautions of Xgeva


Xgeva Consumer (continued)

SIDE EFFECTS: Tiredness, weakness, headache, diarrhea, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: jaw pain, shortness of breath.

Denosumab may cause low levels of calcium in the blood, especially if you have kidney problems. Tell your doctor right away if you have any symptoms of low calcium such as: muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), seizures.

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.

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

PRECAUTIONS: 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.

Infrequently, people using this medication have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. Be sure to brush and floss your teeth daily and get regular dental exams/cleaning. If you develop 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 during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

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



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