Daily: at least Calcium 500 mg & Vitamin D 400 IU

For: __________________________________________ Date: _________________

Read the Important Safety Information on the reverse for

additional safety considerations while taking XGEVA

Or at a dose of: Calcium ______ mg Vitamin D ______ IU

Daily: at least Calcium 500 mg

& Vitamin D 400 IU

Call your doctor if you experience any of these symptoms of hypocalcemia:

• Spasms, twitches, cramps, or stiness in your muscles

• Numbness or tingling in your ngers, toes, or around your mouth

Also, tell your doctor if you:

• Have symptoms of severe jaw bone problems such as pain

or numbness

• Have ongoing pain or slow healing after dental surgery

• Are pregnant, plan to become pregnant, suspect you are

pregnant, or breastfeeding

*This illustration is for reminder purposes only.

Your doctor typically

recommends that you

take daily:

Take at least:

Or at a dose of: mg IU

Calcium

500 mg

Vitamin D

400 IU

For patients with cancer and bone metastases from solid tumors

Your doctor has prescribed XGEVA

to help prevent bone

complications that are fractures, spinal cord compression,

the need for radiation, or surgery to bone

Do not take XGEVA

if you have low blood calcium (hypocalcemia).

• XGEVA

can signicantly lower the calcium levels in your blood and some deaths have been reported.

Your low blood calcium must be treated before you receive XGEVA

Do not take XGEVA

if you are allergic to denosumab or any of the ingredients of XGEVA

XGEVA

contains the same medicine as Prolia

(denosumab). If you are taking XGEVA

do not take Prolia

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

USA-162X-80521 03-20

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 signicantly

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 stiness in

your muscles or numbness or tingling in your ngers,

toes, or around your mouth.

Do not take XGEVA

if you 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

Do not take XGEVA

if you take Prolia. XGEVA

contains

the same medicine as Prolia

(denosumab).

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 XGEVA

. It is important for

you to practice good mouth care during treatment with

XGEVA

. In studies of patients with bone involvement, 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 with Giant Cell

Tumor of Bone and in patients who are still growing

Patients with a type of cancer called Giant Cell Tumor of

Bone and 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.

Increased risk of broken bones in the spine after

discontinuing XGEVA

After your treatment with XGEVA

is stopped, your risk

for breaking bones in your spine can increase, especially

if you have a history of risk factors such as osteoporosis

or prior fractures.

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.

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

stiness 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:

• Tell your doctor about all medications you are taking.

Your doctor needs to know if you are taking other

medications that also lower blood calcium levels.

• 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

• Talk to your doctor before you stop taking XGEVA

about your risk for broken bones in your spine.

• Women of child bearing age should use highly eective

contraception while taking XGEVA

and for at least 5

months after the last dose of XGEVA

What are the possible side eects of XGEVA

In patients with bone metastases from solid tumors

using XGEVA

, the most common side eects were

tiredness/weakness, low phosphate levels in your blood,

and nausea. The most common serious side eect of

XGEVA

was shortness of breath.

In multiple myeloma patients receiving XGEVA

, the

most common side eects were diarrhea, nausea, low

red blood cells, low blood platelets and calcium levels,

back pain, swelling of the lower legs or hands, upper

respiratory tract infection, rash, and headache. The most

common serious adverse reaction in multiple myeloma

patients was pneumonia.

These are not all the possible side eects of XGEVA

For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side eects.

You are encouraged to report negative side eects

of prescription drugs to the FDA. Visit www.fda.gov/

medwatch, or call 1-800-FDA1088.

Please see accompanying Prescribing Information.

XGEVA

What is XGEVA

XGEVA

is a prescription medicine used to prevent fracture, spinal cord compression, or the need for radiation or

surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.