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avelumab

Trade Name:

Bavencio™

Appearance:

solution

mixed into larger bags of fluids

Monograph Name:

avelumab

Monograph Body:

Drug Monograph

A - Drug Name

avelumab

COMMON TRADE NAME(S): Bavencio™

B - Mechanism of Action and Pharmacokinetics

Avelumab is a fully human monoclonal antibody (IgG1) that inhibits the suppressive effects of PD-L1 on cytotoxic T cells, thereby restoring the anti-tumour immune response.

Absorption

Time to reach steady state

4 to 6 weeks (2 to 3 cycles) when administered every 2 weeks

Distribution

Avelumab is distributed mainly in the systemic circulation, with less distribution to the extracellular space.

Avelumab exposure increases proportionally to dose in the range of 10-20 mg/kg every 2 weeks.

Metabolism

Monoclonal antibodies are degraded into small peptides and amino acids via catabolic pathways.

Elimination

Half-life

6.1 days (terminal)

C - Indications and Status

Health Canada Approvals:

Merkel cell carcinoma (MCC)
Urothelial carcinoma (UC)

(Includes conditional approvals)
Refer to the product monograph for a full list and details of approved indications.

D - Adverse Effects

Emetogenic Potential:

Minimal

Extravasation Potential: None

The following table lists adverse effects that occurred in ≥ 1% of patients in an unresectable locally advanced or metastatic urothelial carcinoma (UC) study, where higher incidences were observed in the avelumab arm. Adverse effects marked with “†” were reported in previously untreated Merkel cell carcinoma. It also includes severe, life-threatening and post-marketing adverse effects from other indications.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Hypertension (10%) †	E
	Hypotension (2%)	E
	Myocarditis (rare)	E D
Dermatological	Erythema multiforme (rare)	E
	Rash, pruritus (20%) (1% severe)	E
Gastrointestinal	Abdominal pain (13%) †	E
	Anorexia, weight loss (14%)	E
	Constipation (16%)	E
	Diarrhea (17%) (may be severe, 2% colitis)	E D
	Nausea, vomiting (16%)	E
General	Edema (13%)	E
	Fatigue (36%)	E
	Fever, chills (15%)	I
Hematological	Anemia (16%) †	E D
Hepatobiliary	↑ LFTs (5%) (2% severe; 1% autoimmune hepatitis)	E D
	Pancreatitis (rare, in combination with axitinib)	E
Hypersensitivity	Hypersensitivity (2%)	I E
	Infusion related reaction (10%) (may be severe)	I
Immune	Antibody response (4%)	E D
Metabolic / Endocrine	Adrenal insufficiency (2%)	E D
	Hyperglycemia (4%) ; diabetes mellitus (type 1; rare)	E D
	Hyperthyroidism (6%)	E D
	Hypothyroidism (12%)	E D
Musculoskeletal	Musculoskeletal pain (24%)	E
	Other - Rheumatoid arthritis (rare)	E
Nervous System	Guillain-Barre syndrome (rare)	E
	Myasthenia gravis (rare)	E
	Myositis (<1%)	E D
Ophthalmic	Uveitis (rare)	E
Renal	Nephrotoxicity (2%) (nephritis - rare)	E D
Respiratory	Cough, dyspnea (14%)	E
	Pneumonitis (3%)	E D
Urinary	Urinary tract infection (20%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for avelumab include fatigue, musculoskeletal pain, rash/pruritus, diarrhea, anemia, constipation, nausea/vomiting, fever, chills, anorexia/weight loss, cough/dyspnea.

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.

Presentation of immune-mediated reactions may be different compared to other anti-cancer agents and early diagnosis and appropriate management is critical.

Immune-mediated reactions such as rash, pneumonitis, colitis, hepatitis, nephritis, endocrinopathies and neuropathies were reported in patients who received avelumab and may be severe or fatal.

Anti-drug antibodies have been reported, but did not appear to impact the risk of infusion-related reactions.

E - Dosing

Refer to protocol by which patient is being treated.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Avoid the use of corticosteroids or immunosuppressants before starting treatment.

Premedication with an antihistamine and acetaminophen prior to the first 4 infusions is recommended. Consider for subsequent infusions based on clinical judgement and prior infusion reactions.

Adults:

Avelumab 10 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity

Dosage with Toxicity:

Healthcare professionals should also consult the most recent avelumab product monograph for additional information.

Dose reductions are not recommended for avelumab . Doses may be delayed or discontinued based on toxicity.

Summary of Principles of Management of Immune-Related Adverse Effects (irAEs):

Immune-related adverse effects (irAEs) are different in their presentation, onset and duration compared to conventional chemotherapy. Patient and provider education is essential.
Initial irAEs presentation can occur months after completion of treatment and affect multiple organs.
Dose escalation or reduction is not recommended.
If no other cause can be identified (such as infection), any new symptom should be considered immune-related and prompt treatment initiated.
Organ-specific system-based toxicity management is recommended.

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.

Infusion-related reactions:

Toxicity Grade	Action
1	Slow infusion rate by 50%
2	Interrupt infusion until ≤ grade 1; restart at 50% lower infusion rate.
≥3	Discontinue

Dosage with Hepatic Impairment:

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related hepatic toxicity management.

Hepatic impairment	Avelumab dose
Mild (bilirubin ≤ ULN and AST > ULN OR bilirubin 1-1.5 x ULN)	no change
Moderate (bilirubin 1.5-3 x ULN)	no change
Severe (bilirubin > 3 x ULN)	no data

Dosage with Renal Impairment:

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related renal toxicity management.

Creatinine clearance (ml/min)	Avelumab dose
≥ 60	no change
30-59
15-29

Dosage in the elderly:

Metastatic Merkel Cell Carcinoma:
Differences in safety or efficacy between patients aged 65 and older compared to younger patients have not been evaluated

Locally Advanced or Metastatic Urothelial Carcinoma:
No overall differences in safety or efficacy were reported between elderly patients and younger patients. There is limited safety data in patients ≥ 75 years of age in maintenance treatment after first-line platinum-based chemotherapy.

Children:

Safety and efficacy in pediatric patients have not been established.

F - Administration Guidelines

DO NOT administer as an IV push or bolus.
Dilute avelumab with 0.9% or 0.45% saline solution (preferably 250 mL) prior to infusion. It must not be mixed with other products or diluents.
Mix the diluted solution by gentle inversion; do not shake.
Infuse over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micrometer in-line or add-on filter.
Do not co-administer with other drugs through the same IV line; flush the line with 0.9% or 0.45% saline after administration.

Avelumab is compatible with polyethylene, polypropylene and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes and pore sizes of 0.2 micrometer.

Avelumab vials should be stored at 2-8^oC; do not freeze.
Store in the original container and protect from light.

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to this drug or any components of the formulation.

Other Warnings/Precautions:

Use with caution and monitor closely in patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders, such as hypo or hyperthyroidism or diabetes mellitus.
Avelumab may cause fatigue; patients should be advised not to drive or operate machinery/tools until they are sure of feeling well.

Other Drug Properties:

Carcinogenicity: Unknown

Pregnancy and Lactation:

Crosses placental barrier: Yes
Fetotoxicity: Likely

Avelumab may cause fetal harm and is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for at least 1 month after the last dose.
Excretion into breast milk: Likely

Breastfeeding is not recommended during treatment and for at least 1 month after the last dose.
Fertility effects: Unknown

H - Interactions

No formal pharmacokinetic drug-drug interaction studies have been conducted. Avelumab is mainly metabolized through catabolic pathways; it is not expected that avelumab will have drug-drug interactions with other medications.

Use of systemic corticosteroids or immunosuppressants should be avoided prior to starting avelumab because of the potential for interference with avelumab's efficacy. They can be used to treat immune-mediated reactions after starting the drug.

Acetaminophen may affect the response to immune checkpoint inhibitors. Further clinical studies are needed to determine the exact mechanism and the appropriate clinical management (Bessede et al, 2022).

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
CBC	Baseline, before each dose and as clinically indicated
Liver function tests	Baseline, before each dose and as clinically indicated; frequent with severe toxicity
Renal function tests	Baseline, periodically during treatment and as clinically indicated; frequent with severe toxicity
Thyroid function tests	Baseline and before each dose, or at least once monthly
Blood glucose	Baseline, periodically during treatment and as clinically indicated
Clinical toxicity assessment for infusion-related reactions, fatigue, immune-mediated reactions, including GI, skin, respiratory, neurologic, cardiac, ophthalmic and endocrine toxicities	At each visit and as clinically indicated

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

New Drug Funding Program (NDFP Website )

Avelumab - Metastatic Merkel Cell Carcinoma
Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma

K - References

Avelumab (Bavencio®) product monograph, EMD Serono, January 2021.

Bessede A, Marabelle A, Guegan JP, et al. Impact of acetaminophen on the efficacy of immunotherapy in cancer patients. Ann Oncol 2022;33(9):909-15.

D'Angelo SP, Lebbé C, Mortier L, et al. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer 2021 Jul;9(7):e002646.

Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385.

Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol 2018;19:51–64.

Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med . 2020 Sep 24;383(13):1218-30.

April 2024 Updated Pregnancy and Lactation section

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.

The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for 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.

The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.

Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.

While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.

CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.

Info Sheet Name:

avelumab (patient)

Info Sheet Introduction:

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.

Info Sheet Date: Jeudi, octobre 13, 2022 Info Sheet body:

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)
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

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)
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

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:

____________________________________________________________________________

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.

Info Sheet (English):

avelumab patient.pdf Info Sheet (French):

avelumab pour le patient.pdf Monograph:

avelumab.pdf Funding Program: New Drug Funding Program Funding Instance:

Avelumab - Metastatic Merkel Cell Carcinoma
Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma

Phonetic Spelling:

a VEL ue mab

Eligibility Form:

Avelumab - Metastatic Merkel Cell Carcinoma

Avelumab - Maintenance Treatment for Unresectable Locally Advanced or Metastatic Urothelial Carcinoma Cancer Type: Genitourinary Bladder / Urothelial Skin Merkel Cell Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Lundi, avril 29, 2024 Universal Date: 2024-04-29 00:00:00 AddThis: Title URL: avelumab Drug Display Status: Active Revision Summary:
Drug Monograph: Updated Pregnancy and Lactation section