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Safety Information

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:

  • new or worsening cough
  • shortness of breath
  • chest pain

Liver problems, including hepatitis–signs and symptoms of liver problems may include:

  • yellowing of your skin or the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your stomach-area (abdomen)
  • drowsiness
  • dark urine (tea colored)
  • bleeding or bruising more easily than normal

Intestinal problems (colitis)–signs and symptoms of colitis may include:

  • diarrhea (loose stools) or more bowel movements than usual
  • blood in your stools or dark, tarry, sticky stools
  • severe stomach-area (abdomen) pain or tenderness

Hormone gland problems (especially the adrenal glands, thyroid, and pancreas)–signs and symptoms that your hormone glands are not working properly may include:

  • rapid heart beat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • hair loss
  • changes in mood or behavior, such as irritability or forgetfulness
  • constipation
  • your voice gets deeper
  • very low blood pressure
  • urinating more often than usual
  • dizziness or fainting
  • nausea or vomiting
  • stomach-area (abdomen) pain
  • feeling cold

Kidney problems, including nephritis–signs and symptoms of kidney problems may include:

  • decrease in your amount of urine
  • blood in your urine
  • swelling in your ankles
  • loss of appetite

Problems in other organs–signs and symptoms may include:

  • severe muscle weakness
  • severe or persistent muscle or joint pains
  • chest pain and tightness
  • trouble breathing
  • skin rash, blisters or peeling
  • changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
  • tiredness, sleepiness
  • swelling of the feet and legs
  • dizziness or fainting
  • fever, flu like symptoms
  • changes in eyesight

Severe infusion reactions–signs and symptoms of severe infusion reactions may include:

  • chills or shaking
  • hives
  • flushing
  • shortness of breath or wheezing
  • low blood pressure
  • fever
  • back pain
  • abdominal pain

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:

  • swelling of your stomach-area, legs, hands, feet or ankles
  • shortness of breath
  • nausea or vomiting
  • chest discomfort, including pain or pressure
  • weight gain
  • pain or discomfort in your arms, back, neck or jaw
  • breaking out in a cold sweat
  • feeling lightheaded or dizzy

Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease or ulcerative colitis
  • have had an organ transplant
  • have lung or breathing problems
  • have liver or kidney problems
  • have diabetes
  • have heart problems or high blood pressure
  • have a high cholesterol level in your blood
  • are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO
  • are breastfeeding or plan to breastfeed. It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the final dose of BAVENCIO 

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:

  • chest pain or pressure
  • pain in your arms, back, neck, or jaw
  • shortness of breath
  • numbness or weakness on one side of your body
  • trouble talking
  • headache
  • vision changes

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:

  • unexpected bleeding or bleeding that lasts a long time, such as:
    • unusual bleeding from the gums
    • menstrual bleeding or vaginal bleeding that is heavier than normal
    • bleeding that is severe or you cannot control
    • pink or brown urine
    • red or black stools (looks like tar)
    • bruises that happen without a known cause or get larger
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
  • unexpected pain, swelling, or joint pain
  • headaches, feeling dizzy or weak

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:

  • tiredness
  • swelling of your stomach-area (abdomen), legs, or ankles
  • shortness of breath
  • protruding neck veins

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:

  • severe stomach-area (abdominal) pain or stomach-area pain that does not go away
  • vomit blood
  • red or black stools

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:

  • tiredness that worsens or does not go away
  • feeling hot or cold
  • your voice deepens
  • weight gain or weight loss
  • hair loss
  • muscle cramps and aches

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.

  • You should stop taking INLYTA at least 2 days before planned surgery
  • Your healthcare provider should tell you when you may start taking INLYTA again after surgery

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:

  • headache
  • seizures
  • weakness
  • confusion
  • high blood pressure
  • blindness or change in vision
  • problems thinking

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:

  • have high blood pressure
  • have thyroid problems
  • have liver problems
  • have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
  • have any bleeding problems
  • have a history of heart failure
  • have an unhealed wound
  • plan to have surgery or have had a recent surgery. You should stop taking INLYTA for at least 2 days before planned surgery
  • have any other medical conditions

For females, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can harm your unborn baby. You should not become pregnant while taking INLYTA. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are able to become pregnant. You should have a pregnancy test before you start treatment with INLYTA. Use effective birth control during treatment and for at least 1 week after your last dose of INLYTA. Talk to your healthcare provider about birth control methods that you can use to prevent pregnancy during this time
  • are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. Do not breastfeed during treatment and for at least 2 weeks after your last dose of INLYTA

For males with female partners who are able to become pregnant:

  • use effective birth control during treatment and for at least 1 week after your last dose of INLYTA
  • if your female partner becomes pregnant during your treatment with INLYTA, tell your healthcare provider right away

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:

  • diarrhea
  • feeling tired
  • high blood pressure
  • muscle and bone pain
  • nausea
  • mouth sores
  • liver problems
  • blisters or rash on the palms of your hands and soles of your feet
  • hoarseness
  • decreased appetite
  • low levels of thyroid hormone
  • rash
  • shortness of breath
  • cough
  • stomach-area (abdomen) pain
  • headache

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.