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Chemotherapy and other systemic treatment regimens may change due to COVID-19. Find out more at Systemic Treatment Regimens During COVID-19.

avelumab

( a VEL ue mab )
Funding:
New Drug Funding Program
  • Avelumab - Metastatic Merkel Cell Carcinoma
  • Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma
Other Name(s): Bavencio™
Appearance: solution mixed into larger bags of fluids

Medication Information Sheet
avelumab (a VEL ue mab)
This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Bavencio®

Appearance:
solution

mixed into larger bags of fluids

What is this medication for?
  • For treating certain types of skin and bladder or urinary tract cancers.

  • Avelumab is an immunotherapy medication. For more information on immunotherapy medications, click here.

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), such a

  • an organ transplant

  • immune conditions (such as ulcerative colitis, Crohn's, rheumatoid arthritis or lupus)

  • problems with your hormone producing glands (such as the thyroid or adrenal glands)

  • diabetes

  • liver, heart, kidney or lung problems

  • active infections or

  • any allergies

 

Remember to:

  • Tell your health care team about all of the other medications you are taking.
  • Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.
How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

  • How this medication may affect your sexual health.
  • How this medication may affect your ability to have a baby, if this applies to you.

This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

  • If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until at least 1 month after your last dose. Talk to your health care team about which birth control options are best for you.

     
  • Do not breastfeed while on this medication and for at least 1 month after the last dose.
How is this medication given?
  • This drug is given through an IV (injected into a vein), usually every 2 weeks. Talk to your health care team about your treatment schedule.

  • You may be given this treatment along with other medication(s) to help prevent a reaction.

  • If you miss your treatment appointment, talk to your health care team to find out what to do.

 

To Prevent Allergic Reaction

You will be given medications before your first 4 treatments to help prevent allergic reactions before they start.  Your health care team will let you know if you need these medications after your first 4 treatments.

There are different types of medications to stop allergic reactions. They are called:

  • antihistamines (such as diphenhydramine or Benadryl®)
  • analgesics/antipyretics (such as acetaminophen or Tylenol®)
What else do I need to know while on this medication?
  • Will this medication interact with other medications or natural health products?

    • Although this medication is unlikely to interact with other medications, vitamins, foods and natural health products, tell your health care team about all of your:

      • prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)

      • natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements

    • Check with your health care team before starting or stopping any of them.

  • What should I do if I feel unwell, have pain, a headache or a fever?

    • Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).

      • Fever can be a sign of infection that may need treatment right away.

      • If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
         

    How to check for fever:

    Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

    • You have a fever if your temperature taken in your mouth (oral temperature) is:
       
      • 38.3°C (100.9°F) or higher at any time

        OR
         
      • 38.0°C (100.4°F) or higher for at least one hour.


    If you do have a fever:

    • Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
    • Ask your health care team for the Fever pamphlet for more information. 
       

    If you do not have a fever but have mild symptoms such as headache or mild pain:

    • Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.

    • Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.

    • Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.
       

What to DO while on this medication:

  • DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
     

  • DO consider asking someone to drive you to and from the hospital on your treatment days especially for your first 4 treatments. You may feel drowsy or dizzy after your treatment.
     

  • DO tell your healthcare team about ANY new symptom you may develop. You may need urgent medical treatment.
     

What NOT to DO while on this medication:

  • DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

  • DO NOT drive, operate machinery or do any tasks that need you to be alert if you feel tired.

What are the side effects of this medication?

The following table lists side effects that you may have when getting avelumab. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

  • Avelumab makes your immune system work harder. Your immune system is what fights infections and your cancer.
     
  • When your immune system is working harder, you may have side effects in your bowels, liver, lungs, skin, and other organs. You may also have changes in hormone levels in your body.
     
  • These side effects may be mild or may become serious or life-threatening in rare cases.
     
  • They may happen during your treatment or weeks to months after your treatment ends.

     
  • Some things to watch for are:
    • diarrhea
    • a new cough
    • problems with breathing
    • rash
    • any other new symptom
       
  • If you have side effects, you must talk to your health care team right away. You may need urgent treatment.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on avelumab.

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do When to contact health care team

Fatigue 

What to look for?

  • Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep.
     

What to do?

  • Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days.
  • Check with your health care team before starting any new exercise.
  • Pace yourself, do not rush. Put off less important activities. Rest when you need to.
  • Ask family or friends to help you with things like housework, shopping, and child or pet care.
  • Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less).
  • Avoid driving or using machinery if you are feeling tired.

Ask your health care team for the Fatigue pamphlet for more information. 

Talk to your health care team if it does not improve or if it is severe

 

 

 

 

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do When to contact health care team

Mild joint, muscle pain or cramps 

What to look for?

  • New pain in your muscles or joints, muscle cramps, or feeling achy.
     

What to do?

  • Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed.
  • Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding.
  • Rest often and try light exercise (such as walking) as it may help.

Ask your health care team for the Pain pamphlet for more information.

Talk to your health care team if it does not improve or if it is severe

Rash; itchiness

What to look for?

  • Your skin may look red or feel warm, like a sunburn.
  • Your skin may have bumps, itch, burn, sting or feel very tender when touched.
     

What to do?

To prevent and treat dry skin:

  • Use fragrance-free skin moisturizer.
  • Protect your skin from the sun and the cold.
  • Use sunscreen with UVA and UVB protection and a SPF of at least 30.
  • Avoid perfumed products and lotions that contain alcohol.
  • Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less.
  • Talk to your health care team for advice.

 



In rare cases, rash may be severe if:

  • The rash covers more than a third of your skin (for example your whole trunk, or an arm AND a leg) or
  • The rash causes your skin to blister or peel, or marks may appear as "bulls-eyes".

If this happens, talk to your health care team or go to the emergency room right away.
 

Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.

Talk to your health care team for advice

 

 

 

 

 

 

 

 

 

 

 

Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.

Diarrhea

What to look for?

  • Loose watery, unformed stool (poo) that may happen days to weeks after you get your treatment.

 

What to do?

If you have diarrhea:

  • Take anti-diarrhea medication if your health care team prescribed it or told you to take it.
  • Do not eat foods or drinks with artificial sweetener (like chewing gum or “diet” drinks), coffee and alcohol.
  • Eat many small meals and snacks instead of 2 or 3 large meals.
  • Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less.
  • Talk to your health care team if you can’t drink 6-8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy.
  • Talk to your health care team for advice.


Ask your health care team for the Diarrhea pamphlet for more information.

 

In rare cases, your diarrhea may be severe due to inflammation of the intestines if:

  • You have blood in your stool (poo) or
  • You have more than 4 bowel movements (going poo) a day (if that is not normal for you)

Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.

Talk to your health care team for advice

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away

Anemia (low red blood cells)

What to look for?

  • You may feel more tired or weaker than normal.
  • Pale skin and cold hands and feet.
  • You may feel short of breath, dizzy or lightheaded.
  • This may occur in days to weeks after your treatment starts.
     

What to do?

If your health care team has told you that you have anemia (low red blood cells):

  • Rest often and eat well.
  • Light exercise, such as walking may help.
  • You may need medication or a blood transfusion.
  • If it is very bad, your doctor may need to make changes to your treatment regimen.
Talk to your health care team if it does not improve or if it is severe

Flu-like symptoms

You may feel like you have the flu for around 2 days after your IV treatment. These flu-like symptoms may not be signs of an infection.
 

What to look for?

  • You may have fever, chills, headache and muscle pain.
  • You may feel tired and have a poor appetite.
  • Symptoms may happen at any time after you receive your treatment and usually go away as your body gets used to the medication.
     

What to do?

  • Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?"
  • If you do have a fever, try to speak to your health care team. If you are unable to talk to them for advice, you MUST get emergency medical help right away.
If you do have a fever, try to speak to your health care team. If you are unable to talk to them for advice, you MUST get emergency medical help right away.

Constipation

What to look for?

  • Having bowel movements (going poo) less often than normal.
  • Small hard stools (poo) that look like pellets.
  • The need to push hard and strain to have any stool (poo) come out.
  • Stomach ache or cramps.
  • A bloated belly, feeling of fullness, or discomfort.
  • Leaking of watery stools (poo).
  • Lots of gas or burping.
  • Nausea or vomiting.
     

What to do?

To help prevent constipation:

  • Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains.
  • Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less.
  • Be active. Exercise can help to keep you regular.
  • If you take opioid pain medication, ask your health care team if eating more fibre is right for you.
     

To help treat constipation:

  • If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do.

Ask your health care team for the Constipation Pamphlet for more information.

Talk to your health care team if it does not improve or if it is severe

Nausea and vomiting

(Generally mild)

What to look for?

  • Nausea is feeling like you need to throw up. You may also feel light-headed.
  • You may feel nausea within hours to days after your treatment.

What to do?

To help prevent nausea:

  • It is easier to prevent nausea than to treat it once it happens.
  • Drink clear liquids and have small meals. Get fresh air and rest.
  • Do not eat spicy, fried foods or foods with a strong smell.
  • Limit caffeine (like coffee, tea) and avoid alcohol.

If you have nausea or vomiting:

  • Take your rescue (as-needed) anti-nausea medication(s) as prescribed.
  • Ask your health care team for the Nausea & Vomiting pamphlet for more information.
  • Talk to your health care team if:
    • nausea lasts more than 48 hours
    • vomiting lasts more than 24 hours or if it is severe
Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe

Low appetite; weight loss

What to look for?

  • Loss of interest in food or not feeling hungry.
  • Weight loss.

What to do?

  • Try to eat your favourite foods.
  • Eat small meals throughout the day.
  • You may need to take meal supplements to help keep your weight up.
  • Talk to your health care team if you have no appetite.

Ask your health care team for the Loss of Appetite pamphlet for more information.

Talk to your health care team if it does not improve or if it is severe

Cough and feeling short of breath

What to look for?

  • You may have a cough and feel short of breath.
  • Symptoms that commonly occur with a cough are:
    • wheezing or a whistling breathing
    • runny nose
    • sore throat
    • heartburn
    • weight loss
    • fever and chills
  • Rarely this may be severe with chest pain, trouble breathing or coughing up blood.
     

What to do?

  • Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?".
  • If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
  • If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.
Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away

Mild swelling

What to look for?

  • You may have mild swelling or puffiness in your arms and/or legs. Rarely, this may be severe.

What to do?

To help prevent swelling:

  • Eat a low-salt diet.

If you have swelling:

  • Wear loose-fitting clothing.
  • For swollen legs or feet, keep your feet up when sitting.
Talk to your health care team if it does not improve or if it is severe

Changes in thyroid activity

Thyroid changes may happen weeks to months after you receive your treatment.

Your health care team may check your thyroid activity regularly with a blood test.

What to look for?

Underactive thyroid:

  • Unusual weight gain
  • A lack of energy or feeling tired
  • Getting cold easily
  • Dry skin, nails or hair that breaks easily
  • Constipation (having bowel movements (poo) less often than normal)

Overactive thyroid (rare):

  • Unusual weight loss
  • Feeling anxious, irritable or having trouble sleeping
  • Sweating a lot and having trouble dealing with hot weather
  • Increased appetite
  • Having bowel movements (poo) more than usual
  • Weakness (especially in the arms and thighs)
  • Fast or uneven heartbeats.

What to do?

Your health care team may give you prescription medication to treat your underactive or overactive thyroid.

If you have weight changes along with any of the other symptoms listed, talk to your health care team as soon as possible.

Talk to your health care team as soon as possible

Allergic reaction

(May be severe)

What to look for?

  • Fever, itchiness, rash, swollen lips, face or tongue, chest and throat tightness.
  • It may happen during or shortly after your treatment is given to you and may be severe.


What to do?

  • Tell your nurse right away if you feel any signs of allergic reaction during or just after your treatment.
  • Talk to your health care team for advice if you have a mild skin reaction.

 

Get emergency medical help right away for severe symptoms

High blood pressure

What to look for?

  • There are usually no signs of high blood pressure.
  • Rarely, you may have headaches, shortness of breath or nosebleeds.
     

What to do?

  • Check your blood pressure regularly.
  • Your doctor may prescribe medication to treat high blood pressure.

If you have a severe headache get emergency help right away as it may be a sign your blood pressure is too high.

Talk to your health care team if it does not improve or if it is severe

Other rare, but serious side effects are possible and have been described with avelumab or other similar drugs.

If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

  • New cough, chest pain, trouble breathing, shortness of breath or coughing up blood
     

  • Peeing more than normal and feeling very thirsty
     

Who do I contact if I have questions or need help?          

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

 

 

Other Notes:

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April 2022 Updated/Revised info sheet

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.