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For more information and resources, visit www.BAVENCIO.com.
BAVENCIO is a prescription medicine used to treat:
It is not known if BAVENCIO is safe and effective in children under the age of 12.
BAVENCIO® (avelumab) is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with BAVENCIO. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with BAVENCIO if you have severe side effects.
BAVENCIO can cause serious side effects. Call or see your healthcare provider right away if you get any new or worsening signs or symptoms, including:
Lung problems
Intestinal problems
Liver problems
Hormone gland problems
Kidney problems
Skin problems
Problems can also happen in other organs and tissues. These are not all of the signs or symptoms of immune system problems that can happen with BAVENCIO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
Infusion-related reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with BAVENCIO. Your healthcare provider will monitor you for these complications.
Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of BAVENCIO as maintenance treatment in people with urothelial carcinoma (UC) whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:
The most common side effects of BAVENCIO in people with UC after platinum-containing chemotherapy that did not work, or is no longer working, include:
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.