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:
(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:
How to keep your mouth healthy5
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
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:
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:
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®.
For the full list of side effects, see the Important Safety Information section below.