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Important Safety Information for BAVENCIO® (avelumab)

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 may include:

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

Liver problems, including hepatitis

Signs and symptoms 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 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 heartbeat
  • 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 getting 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 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, seeming to skip a beat, or a 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 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 axitinib, 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; or 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.

The most common side effects of BAVENCIO in people with MCC include:

  • feeling tired
  • muscle and bone pain
  • diarrhea
  • nausea
  • infusion-related reaction including chills, fever, and back pain 
  • rash 
  • decreased appetite 
  • swelling in your hands, feet, or ankles 

The most common side effects of BAVENCIO in people with UC include:

  • feeling tired
  • infusion-related reaction including chills, fever, back pain, redness, and shortness of breath 
  • muscle and bone pain 
  • nausea
  • decreased appetite 
  • urinary tract infection

These are not all the possible side effects of BAVENCIO. Ask your healthcare provider or pharmacist for more information. You may report side effects to EMD Serono at 1-800-283-8088 ext 5563. You may also report side effects to the FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.

Please see full Prescribing Information, including Medication Guide for patients.