INDICATION

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.

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Possible Side Effects
With XGEVA®

To learn more about some of the possible XGEVA® side effects, please select an option from the list below:

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Osteonecrosis of the jaw

In clinical studies of XGEVA® vs another bone-targeting medicine called zoledronic acid (ZA), a serious condition called osteonecrosis (pronounced os•tee•oh•neh•CROW•sis) of the jaw (ONJ) was reported.1

Approximately 2 out of 100 patients got ONJ in the first year. It increased to approximately 5 out of 100 in the second year and about 5 out of 100 in year three and thereafter. The risk continues to increase the longer you take XGEVA®.1-3 Your doctor will keep a close eye on your mouth health to monitor for signs of ONJ.1

Your risk of ONJ increases the longer you use XGEVA®.1-3 The majority of people who have this side effect had a history of:

  • Tooth removal2
  • Poor dental hygiene3
  • Using a dental appliance (like dentures, implants, crowns, fillings, bridges, mouth guards, prosthetics, braces/retainers, or something to ease the airways for snoring)1,2
Tooth removal2
Poor dental hygiene3
Using a dental appliance

(like dentures, implants, crowns, fillings, bridges, mouth guards, prosthetics, braces/retainers, or something to ease the airways for snoring)1,2

It's important to tell your doctor if you have a history of the things listed above and about any planned dental procedures, as the risk of ONJ is higher if you're taking XGEVA® and have these types of dental problems.1-3

Tell your dentist you’re on XGEVA® at every dental visit.1

Signs and symptoms of ONJ
Call your doctor if you have any symptoms of ONJ:

  • Swelling of the gums, tongue area, or in and around the jaw or mouth4
  • Loose teeth4
  • Jaw pain4
  • Infection of gums or jaw1
  • Slow healing after dental work1

How to keep your mouth healthy5

Brush your teeth
two times a day
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Floss in between
your teeth
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Rinse with fluoride
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Visit your
dentist regularly
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ONJ Patient Education Tool

Download for helpful information about recognizing ONJ.

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Hypocalcemia1

In clinical studies of XGEVA® vs ZA, a condition called hypocalcemia (pronounced hi•po•cal•SEE•me•ah, also known as low calcium levels in the blood) was seen.1

It occurred in 18% of 2,841 people taking XGEVA®. It was also reported in 9% of 2,836 people taking ZA.1

Your doctor will test your blood calcium levels before starting treatment with XGEVA®. If your calcium levels test low, your doctor may provide you with supplements to help correct the condition before beginning treatment.1

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How to help avoid hypocalcemia1

Hypocalcemia can be life threatening, so be sure to take calcium and vitamin D supplements in order to reduce your risk of having seriously low blood calcium (hypocalcemia).

Your doctor will monitor calcium levels to help you avoid having seriously low blood calcium.

Signs and symptoms of hypocalcemia6
Call your doctor immediately if you have any symptoms of hypocalcemia:

  • Muscle
    • Stiffness
    • Twitching
    • Spasms
    • Cramps

Take calcium and vitamin D supplements as directed by your doctor to help reduce your risk of low blood calcium1

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Unusual thigh bone fracture1

Unusual thigh bone fracture was reported in clinical studies of XGEVA®. This means that your thigh bone may be at risk for breaking. It may break from minimal or no impact.

Signs and symptoms of unusual thigh bone fracture1
Call your doctor if you have any symptoms of unusual thigh bone fracture:

  • Pain in your
    • Hip
    • Groin
    • Thigh

Call your doctor right away if you have any symptoms of a fracture

 
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After stopping XGEVA®: increased risk of broken bones in the spine1

Risk for breaking bones in the spine is higher after stopping XGEVA®. If you have a history of broken bones (fractures) or osteoporosis, your risk may be higher. Be sure to discuss your potential risk for broken bones in the spine before you stop taking XGEVA®.

These are not all the possible side effects of XGEVA®.

For the full list of side effects, see the Important Safety Information section below.