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Important Safety Information
Do not take XGEVA® if you have low blood calcium
(hypocalcemia). Your low
blood calcium must be treated before you receive XGEVA®. XGEVA® can significantly lower
the calcium levels
in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell
your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or
tingling in your fingers, toes, or around your mouth.
Do not take XGEVA® if you are allergic to denosumab or any
the ingredients of XGEVA®. Serious allergic reactions have happened in people who take
XGEVA®. Call your
doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction,
including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or
tongue, rash; itching; or hives.
What is the most important information you should know about XGEVA®?
XGEVA® contains the same medicine as Prolia® (denosumab). If you are taking
XGEVA® do not take Prolia®.
Severe jaw bone problems (osteonecrosis)
Severe jaw bone problems may happen when you take XGEVA®. Your doctor should examine your mouth
before you start, and while you are taking XGEVA®. Tell your dentist that you are taking
It is important for you to practice good mouth care during treatment with XGEVA®. In studies of
patients with bone
metastases, the rate of severe jaw problems was higher the longer they were being treated with XGEVA®.
Unusual thigh bone fracture
Unusual thigh bone fracture has been reported. Symptoms of a fracture include new or unusual pain in your
hip, groin, or thigh.
Risk of high calcium levels in patients who are still growing
Patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after
they stop taking XGEVA®, that can be serious.
Possible harm to your unborn baby
You should not become pregnant while taking XGEVA®. Tell your doctor right away if you are
plan to become pregnant, or suspect you are pregnant. XGEVA® can harm your unborn baby. Women of
bearing age should use highly effective contraception while taking XGEVA® and for at least 5 months
last dose of XGEVA®.
Tell your doctor if you:
Are taking a medicine called Prolia® (denosumab) because it contains the same medicine as
Have symptoms of low blood calcium such as muscle stiffness or cramps
Have symptoms of severe jaw bone problems such as pain or numbness
Have ongoing pain or slow healing after dental surgery
Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding
While taking XGEVA®, you should:
Take good care of your teeth and gums and visit a dentist as recommended
Tell your dentist that you are taking XGEVA®
Tell your doctor if you plan to have dental surgery or teeth removed
Women of child bearing age should use highly effective contraception while taking XGEVA® and for at
least 5 months after the last dose of XGEVA®
What are the possible side effects of XGEVA®?
The most common side effects in patients receiving XGEVA® for the prevention of serious bone
were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of
XGEVA® was shortness of breath.
These are not all the possible side effects of XGEVA®. For more information, ask your doctor or
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.