Bavencio

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using BAVENCIO?

BAVENCIO contains the active ingredient, avelumab. BAVENCIO is used to treat certain types of cancer.

For more information, see Section 1. Why am I using BAVENCIO? in the full CMI.

2. What should I know before I use BAVENCIO?

Do not use if you have ever had an allergic reaction to BAVENCIO or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use BAVENCIO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BAVENCIO and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use BAVENCIO?

You will receive BAVENCIO as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, once every 2 weeks.

More instructions can be found in Section 4. How do I use BAVENCIO? in the full CMI.

5. What should I know while using BAVENCIO?

Things you should do	Remind any doctor, nurse, dentist or pharmacist you visit that you are using BAVENCIO.
Driving or using machines	Treatment-related symptoms can affect your concentration and ability to react.

For more information, see Section 5. What should I know while using BAVENCIO? in the full CMI.

6. Are there any side effects?

Common side effects include feeling tired or weak; muscle, back, stomach area or joint pain; loose stools, vomiting, nausea, constipation; swelling in the arms, feet or legs; feeling less hungry, weight loss; cough; rash, itching, redness of the skin; fever, chills; shortness of breath; dizziness, headache; high blood pressure; low blood pressure; flushing; difficulty in speaking or breathing, hoarseness; urinary tract infection such as burning sensation when urinating, strong or frequent urge to urinate.

Serious side effects include infusion-related reactions; problems due to inflammation of your lungs (pneumonitis); problems with your liver (hepatitis or liver toxicity when used in combination with axitinib); problems with your intestines (colitis) or diarrhoea; problems with your hormone producing glands (including the thyroid, pituitary, and adrenal glands); problems with your pancreas (pancreatitis); Type 1 diabetes, including a serious, sometimes life-threatening problem due to increased acid in the blood produced from diabetes (diabetic ketoacidosis); problems with your kidneys; problems with your muscles (myositis, myasthenia gravis/myasthenic syndrome, polymyalgia rheumatica); problems with your bile ducts (sclerosing cholangitis), problems with your joints (arthritis), problems with your glands that make moisture for the body (Sjögren’s syndrome), problems with your heart (myocarditis or major adverse cardiovascular events when used in combination with axitinib); problems with your eyes (uveitis); an immune system disorder that can cause nerve inflammation (Guillain-Barré Syndrome).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .

Active ingredient: avelumab (rch)

Full Consumer Medicine Information (CMI)

This leaflet provides important information about using BAVENCIO. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using BAVENCIO.

Where to find information in this leaflet:

1. Why am I using BAVENCIO?

2. What should I know before I use BAVENCIO?

3. What if I am taking other medicines?

4. How do I use BAVENCIO?

5. What should I know while using BAVENCIO?

6. Are there any side effects?

7. Product details

1. Why am I using BAVENCIO?

BAVENCIO contains the active ingredient, avelumab. BAVENCIO is a monoclonal antibody, which is a protein designed to recognise and attach to a specific target in the body to help the immune system attack and destroy cancer cells.

BAVENCIO is used to treat a rare type of skin cancer called metastatic Merkel cell carcinoma (mMCC) where the disease has spread; a type of cancer in the bladder or urinary tract called urothelial carcinoma, when the disease is advanced or metastatic but has not progressed with platinum-based chemotherapy; or a type of kidney cancer called renal cell carcinoma (RCC), when it is advanced, in combination with another medicine, axitinib. It is important that you also read the Consumer Medicine Information for axitinib. If you have any questions about axitinib, ask your doctor.

2. What should I know before I use BAVENCIO?

Warnings

Do not use BAVENCIO if:

you are allergic to avelumab, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have any other medical conditions, including an autoimmune disease (a condition where the body attacks its own cells) like Crohn's, Guillain- Barré, ulcerative colitis or lupus. If you already have an autoimmune disease, your risk of immune-mediated side effects may be higher as BAVENCIO may cause inflammation in parts of your body. You may also experience frequent flares of your autoimmune disease, which in the majority of cases are mild; human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS); hepatitis B or hepatitis C; have had an organ transplant

take any medicines for any other condition, including medicines that suppress your immune system

Once you are treated with BAVENCIO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Talk to your doctor or nurse before receiving BAVENCIO as it may cause:

problems due to inflammation of your lungs (pneumonitis)

problems with your liver (hepatitis or liver toxicity when used in combination with axitinib)

problems with your intestines (colitis) or diarrhoea

problems with your hormone producing glands (including the thyroid, pituitary, and adrenal glands)

problems with your pancreas (pancreatitis)

Type 1 diabetes, including a serious, sometimes life-threatening problem due to increased acid in the blood produced from diabetes (diabetic ketoacidosis).

problems with your kidneys

problems with your muscles (myositis, myasthenia gravis/myasthenic syndrome, polymyalgia rheumatica)

problems with your bile ducts (sclerosing cholangitis)

problems with your joints (arthritis)

problems with your glands that make moisture for the body such as tears and saliva (Sjögren’s syndrome)

problems with your heart (myocarditis or major adverse cardiovascular events such as trouble breathing, chest discomfort, or swelling of lower legs or hands when used in combination with axitinib)

problems with your eyes (uveitis)

an immune system disorder that can cause nerve inflammation (Guillain-Barré Syndrome)

infusion-related reactions

In addition, autoimmune haemolytic anaemia (headaches, short of breath, looking pale, and yellowing of the skin and/or eyes) and systemic inflammatory response syndrome (redness and swelling in the affected parts of your body, pain, loss of function of parts of your body, fatigue, fast heart rate, abnormal breathing, fever or low body temperature, shaking or chills, warm or clammy/sweaty skin, rash, confusion, agitation or other mental changes, loss of consciousness) have been reported with BAVENCIO or other products in this class (PD-1/PD-L1 blocking antibodies).

Should any of the above occur, your doctor may give you other medicines in order to prevent complications and reduce your symptoms; withhold the next dose of BAVENCIO; or stop your treatment with BAVENCIO altogether.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

BAVENCIO must not be used during pregnancy as it may cause harm to your unborn baby.

Make sure you maintain adequate contraception during treatment and for at least one month after your last dose.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is unknown if BAVENCIO is passed into your breast milk. A risk to the breast-fed infant cannot be excluded.

You should not breastfeed during treatment and for at least one month after your last dose.

Use in children

For mMCC, the effectiveness of BAVENCIO in children under the age of 12 years has not been established.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with BAVENCIO and affect how it works.

These include medicines that make your immune system weak, such as steroids.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BAVENCIO.

4. How do I use BAVENCIO?

Prior to the first four infusions of BAVENCIO, you will be given paracetamol and an antihistamine. For subsequent infusions, these medicines will only be given if your doctor believe this is necessary. These premedications are given to help minimise potential reactions to the BAVENCIO infusion.

How much to use

A doctor experienced in the use of medicines for cancer will supervise your treatment with BAVENCIO.

Depending on your cancer, the recommended dose is either 10 mg per kg of your body weight or 800 mg of BAVENCIO.

BAVENCIO has to be diluted with 0.9% or 0.45% saline solution before use.

Your doctor will calculate the correct dose and dilution for you.

When to use BAVENCIO

You will receive BAVENCIO as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, once every 2 weeks.

Your doctor will decide how long you will receive BAVENCIO based on your response to the medicine and the type of cancer you have.

If you use too much BAVENCIO

As BAVENCIO is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you think that you have used too much BAVENCIO, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or

contact your doctor, or

go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using BAVENCIO?

Things you should do

Keep all appointments with your doctor so that your progress can be checked. Your doctor may do blood tests or other laboratory tests from time to time to prevent unwanted side effects during your treatment with BAVENCIO.

If you miss an appointment, talk to your doctor or nurse and arrange another visit as soon as possible.

Call your doctor straight away if you:

Become pregnant while you are being treated with BAVENCIO

Remind any doctor, nurse, dentist or pharmacist you visit that you are using BAVENCIO.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BAVENCIO affects you.

Treatment-related symptoms can affect your concentration and ability to react.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Be aware of important symptoms of inflammation. BAVENCIO acts on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of BAVENCIO.

Less serious side effects

Less serious side effects	What to do
feeling tired or weak muscle or back pain, stomach area pain, joint pain loose stools, vomiting, nausea, constipation swelling in the arms, feet or legs feeling less hungry, weight loss cough rash, itching, redness of the skin fever, chills shortness of breath dizziness, headache high blood pressure low blood pressure flushing difficulty in speaking or breathing, hoarseness urinary tract infection (UTI) such as burning sensation when urinating, strong or frequent or urge to urinate	Speak to your doctor if you have any of these less serious side effects and they worry you.

Less serious side effects

What to do

feeling tired or weak

muscle or back pain, stomach area pain, joint pain

loose stools, vomiting, nausea, constipation

swelling in the arms, feet or legs

feeling less hungry, weight loss

cough

rash, itching, redness of the skin

fever, chills

shortness of breath

dizziness, headache

high blood pressure

low blood pressure

flushing

difficulty in speaking or breathing, hoarseness

urinary tract infection (UTI) such as burning sensation when urinating, strong or frequent or urge to urinate

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Signs of problems with your liver: yellowing of the whites of the eyes or skin (jaundice), severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests Signs of problems with your thyroid, adrenal or pituitary glands (hormone producing glands): extreme tiredness, rapid heartbeat, increased sweating, weight changes, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), headache Signs of problem with your intestines: diarrhoea (loose stools), more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness Signs of problems with your lungs: breathing difficulties, coughing Type 1 diabetes including a serious, sometimes life-threatening problem due to increase acid in the blood produced from diabetes (diabetic ketoacidosis)): feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired, having difficulty thinking clearly, breath that smells sweet or fruity, feeling sick or being sick, stomach pain, deep or fast breathing Signs of problems with your kidneys: abnormal kidney function tests, needing to urinate less than usual, blood in your urine, or swelling in your ankles Signs of problems with your heart: trouble breathing, dizziness or fainting, fever, chest pain, chest tightness, swelling in lower legs or hands, or flu-like symptoms Signs of problems with your muscles: muscle pain, stiffness, or weakness Signs of problems with your pancreas: abdominal pain, nausea, vomiting Signs of problems with your eyes: eye pain, eye redness, sensitivity to light, blurred or cloudy vision, small shapes moving across your field of vision (floaters), loss of peripheral vision (the ability to see objects at the side of your field of vision) Signs of problems with your bile ducts: pain in the upper right part of the stomach swelling of the liver or spleen fatigue itching yellowing of the skin or the whites of the eyes Signs of problems with your joints: joint pain, stiffness or swelling Signs of problems with your glands that make moisture for the body: dry eyes dry mouth Guillain-Barré Syndrome (an immune system disorder that can cause nerve inflammation): pain, numbness, muscle weakness, difficulty walking Signs of an allergic reaction (anaphylactic reaction and/or hypersensitivity): shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin Infusion-related: fever back and/or abdominal pain chills or shaking shortness of breath or wheezing bumpy rash or skin wheals (hives) flushing low blood pressure (dizziness, fatigue, nausea) Sometimes these symptoms may occur up to several hours later. To recognise early signs of these side effects, you will be monitored closely while you are receiving each infusion. Your doctor may consider reducing the infusion rate, stop the infusion temporarily or permanently in order to manage these symptoms.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.

Serious side effects

What to do

Signs of problems with your liver:

yellowing of the whites of the eyes or skin (jaundice), severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests

Signs of problems with your thyroid, adrenal or pituitary glands (hormone producing glands):

extreme tiredness, rapid heartbeat, increased sweating, weight changes, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), headache

Signs of problem with your intestines:

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

Signs of problems with your lungs:

breathing difficulties, coughing

Type 1 diabetes including a serious, sometimes life-threatening problem due to increase acid in the blood produced from diabetes (diabetic ketoacidosis)):

feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired, having difficulty thinking clearly, breath that smells sweet or fruity, feeling sick or being sick, stomach pain, deep or fast breathing

Signs of problems with your kidneys:

abnormal kidney function tests, needing to urinate less than usual, blood in your urine, or swelling in your ankles

Signs of problems with your heart:

trouble breathing, dizziness or fainting, fever, chest pain, chest tightness, swelling in lower legs or hands, or flu-like symptoms

Signs of problems with your muscles:

muscle pain, stiffness, or weakness

Signs of problems with your pancreas:

abdominal pain, nausea, vomiting

Signs of problems with your eyes:

eye pain, eye redness, sensitivity to light, blurred or cloudy vision, small shapes moving across your field of vision (floaters), loss of peripheral vision (the ability to see objects at the side of your field of vision)

Signs of problems with your bile ducts:

pain in the upper right part of the stomach

swelling of the liver or spleen

fatigue

itching

yellowing of the skin or the whites of the eyes

Signs of problems with your joints:

joint pain, stiffness or swelling

Signs of problems with your glands that make moisture for the body:

dry eyes

dry mouth

Guillain-Barré Syndrome (an immune system disorder that can cause nerve inflammation):

pain, numbness, muscle weakness, difficulty walking

Signs of an allergic reaction (anaphylactic reaction and/or hypersensitivity):

shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin

Infusion-related:

fever

back and/or abdominal pain

chills or shaking

shortness of breath or wheezing

bumpy rash or skin wheals (hives)

flushing

low blood pressure (dizziness, fatigue, nausea)

Sometimes these symptoms may occur up to several hours later. To recognise early signs of these side effects, you will be monitored closely while you are receiving each infusion.

Your doctor may consider reducing the infusion rate, stop the infusion temporarily or permanently in order to manage these symptoms.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What BAVENCIO contains

Active ingredient (main ingredient)	avelumab (rch)
Other ingredients (inactive ingredients)	Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections
Potential allergens	N/A

Do not take this medicine if you are allergic to any of these ingredients.

What BAVENCIO looks like

BAVENCIO is a clear, colourless, to slightly yellow solution. It is supplied in 10 mL colourless glass vials with a rubber stopper and aluminium seal. Each pack contains 1 vial. (Aust R 282729).