SAFETY INFORMATION

Safety Information for BAVENCIO® (avelumab)

Important Safety Information for BAVENCIO

What is the most important information I should know about BAVENCIO?

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:

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  • cough
  • shortness of breath
  • chest pain

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  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness

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

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  • headache that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

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

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  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in mouth or nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes

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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:

  • chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight
  • persistent or severe muscle pain or weakness, muscle cramps
  • low red blood cells, bruising

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Signs and symptoms of infusion-related reactions may include:

  • chills or shaking
  • hives
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feel like passing out
  • fever
  • back pain
  • stomach-area (abdomen) pain

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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:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • 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

      Females who 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. Talk to your healthcare provider about birth control methods that you can use during this time
  • 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 as maintenance treatment in people with UC whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:

  • feeling tired
  • muscle and bone pain
  • urinary tract infection
  • rash

 

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:

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

Side effect management tips

Tips to help you manage certain side effects during treatment with BAVENCIO (avelumab)

When you’re going through cancer treatment, you may experience side effects.

If you’re having side effects, your doctor may decide to adjust or stop your treatment. That’s why it’s important to tell your doctor right away about ANY side effect you are experiencing while taking BAVENCIO® (avelumab). You can find a list of possible serious side effects in the Important Safety Information.

Here are some general tips that may help to manage certain side effects, based on published guidance, and are not specific to treatment with BAVENCIO. Always remember: Before making any changes to your diet, physical activity, or treatment plan, please consult with your doctor.

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While on treatment, you may feel tired. Call your healthcare provider for a full evaluation if you experience fatigue. Talk with your doctor if tiredness is a recurring problem.

Your doctor may recommend that you:

  • take short naps and breaks instead of long ones
  • eat well and drink plenty of fluids
  • stay physically active or introduce moderate physical activities
  • try to maintain normal work and social schedules
  • talk to your doctor about ways to help manage your fatigue

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While on treatment, you may experience new or worsening muscle or bone pain. The pain may be in a specific area or may be more widespread. Talk with your doctor if you’re experiencing any muscle or bone pain.

Your doctor may recommend that you:

  • take medications, if your doctor prescribes them for you
  • try massage or physical therapy
  • use hot or cold compresses
  • talk to your doctor about the pain relief that may be right for you

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While on treatment, you may experience signs and symptoms of a UTI, such as a burning feeling when you urinate, back pain, or fever. Call your doctor if you’re experiencing any signs or symptoms of a UTI.

Your doctor may recommend that you:

  • take medications, if your doctor prescribes them for you
  • drink plenty of liquids
  • go to the bathroom often
  • take showers instead of baths
  • wear cotton underwear and loose-fitting pants
  • talk to your doctor about steps to manage UTIs

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While on treatment, you may experience skin rashes on various parts of the body. Rashes can present in different ways such as flat or raised bumps or different colors. Rashes can also itch, burn, sting, or be painful. Talk with your doctor if you’re experiencing signs and symptoms of a rash.

Your doctor may recommend that you:

  • take medications, if your doctor prescribes them for you
  • use mild soaps and keep your skin moisturized with cream-based moisturizers
  • protect the affected area from heat and cold and wear loose-fitting, soft clothing
  • minimize sun exposure and use sunscreen
  • talk to your doctor about the steps to relieve rash that may be right for you