Important Safety Information
Do not take XGEVA® if
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
are allergic to denosumab or any of 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
Severe jaw bone problems
- 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 XGEVA®. 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.
Possible harm to your unborn baby
- You should not become pregnant while taking XGEVA®.
Tell your doctor right away if you are pregnant, plan to become
pregnant, or suspect you are pregnant. XGEVA® can harm
your unborn baby. Women of child bearing age should use highly
effective contraception while taking XGEVA® and at
least 5 months after the last dose of XGEVA®.
Tell your doctor if you:
- Are taking a medicine called Prolia®
(denosumab) because it contains the same medicine as XGEVA®
- Have symptoms of low blood calcium such as muscle stiffness
- Have symptoms of severe jaw bone problems such as pain or
- Have ongoing pain or slow healing after dental surgery
- Are pregnant, plan to become pregnant, suspect you are
pregnant, or breastfeeding
While taking XGEVA®, you
- Take good care of your teeth and gums and visit a dentist as
- Tell your dentist that you are taking XGEVA®
- Tell your doctor if you plan to have dental surgery or teeth
- Women of child bearing age should use highly effective
contraception while taking XGEVA® and at least 5
months after the last dose of XGEVA®
What are the possible side effects of
The most common side effects in patients receiving XGEVA® for the
prevention of serious bone problems 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 pharmacist.
Call your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
Visit www.fda.gov/medwatch, or call