BAVENCIO® (avelumab)
BAVENCIO 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 and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
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 delay or completely stop treatment with BAVENCIO if you have severe side effects.
Call or see your healthcare provider right away if you get any symptoms of the following problems, or if these symptoms get worse.
BAVENCIO can cause serious side effects, including:
Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include:
Liver problems, including hepatitis–signs and symptoms of liver problems may include:
Intestinal problems (colitis)–signs and symptoms of colitis may include:
Hormone gland problems (especially the adrenal glands, thyroid, and pancreas)–signs and symptoms that your hormone glands are not working properly may include:
Kidney problems, including nephritis–signs and symptoms of kidney problems may include:
Problems in other organs–signs and symptoms may include:
Severe infusion reactions–signs and symptoms of severe infusion reactions may include:
Heart problems–when BAVENCIO is used with the medicine INLYTA, severe heart problems can happen and can lead to death. Signs and symptoms of heart problems may include:
Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
INLYTA® (axitinib)
INLYTA may cause serious side effects, including:
High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA
Problem with blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider if you get any of the following symptoms:
Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your healthcare provider right away or get medical help if you develop any of the following signs or symptoms:
Heart failure. Your healthcare provider should check you for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
Tear in your stomach or intestinal wall (perforation). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider if you have any of the following symptoms during your treatment with INLYTA:
Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen while taking INLYTA. Call your healthcare provider right away if you get:
Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment
Change in liver function. Your healthcare provider should do blood tests before and during your treatment with INLYTA to check your liver function
Before taking INLYTA, tell your healthcare provider about all of your medical conditions, including if you:
For females, tell your healthcare provider if you:
For males with female partners who are able to become pregnant:
INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INLYTA and certain other medicines can affect each other causing serious side effects.
Talk with your healthcare provider before you start taking any new medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.
The most common side effects of BAVENCIO when given with INLYTA in people with RCC include:
These are not all the possible side effects of BAVENCIO in combination with INLYTA. Ask your healthcare provider or pharmacist for more information. You may report side effects to the FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.