1. Why am I receiving RYBREVANT?

RYBREVANT contains the active ingredient amivantamab.

RYBREVANT is used in adults with a type of cancer called ‘non-small cell lung cancer’. It is used when the cancer has spread in your body and has gone through certain cancer changes (Exon 20 insertion mutations) in a gene called ‘EGFR’.

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

2. What should I know before I receive RYBREVANT?

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

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

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

3. What if I am taking other medicines?

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

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I receive RYBREVANT?

RYBREVANT will be given to you by a doctor or nurse. It is given as a drip into a vein (‘intravenous infusion’) over several hours.

Your doctor will work out your dose of RYBREVANT. The dose of RYBREVANT will depend on your body weight at the start of your therapy.

More information can be found in Section 4. How do I receive RYBREVANT? in the full CMI.

5. What should I know while receiving RYBREVANT?

For more information, see Section 5. What should I know after receiving RYBREVANT? in the full CMI.

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.

Common and less serious side effects are: constipation or diarrhoea; sores in mouth; nausea or vomiting; decreased appetite; abdomen or stomach pain; feeling very tired or weak; dizziness; swollen hands, ankles, feet, face, or all of your body; muscle or joint pain; numbness or weakness of the arms and legs; changes in certain blood tests; bleeding.

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

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RYBREVANT®

Active ingredient(s): amivantamab

This medicine has provisional approval in Australia for the treatment locally advanced or metastatic non-small cell lung cancer with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The decision to approve this medicine has been made on the basis of promising results from preliminary studies. More evidence is required to be submitted when available to fully confirm the benefit and safety of the medicine for this use.

Consumer Medicine Information (CMI)

This CMI provides important information about using RYBREVANT. 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 RYBREVANT.

Where to find information in this CMI:

1. Why am I receiving RYBREVANT?

RYBREVANT contains the active ingredient amivantamab.

Amivantamab is an antibody, that is a type of protein, that has been designed to recognise and attach to specific targets in the body. Amivantamab targets two proteins found on cancer cells:

• epidermal growth factor receptor (EGFR), and
• mesenchymal-epithelial transition factor (MET).

RYBREVANT works by attaching to these proteins. This may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour.

RYBREVANT is used in adults with a type of cancer called ‘non-small cell lung cancer’. It is used when the cancer has spread in your body and has gone through certain cancer changes (Exon 20 insertion mutations) in a gene called ‘EGFR’.

2. What should I know before I receive RYBREVANT?

Warnings

Do not receive RYBREVANT if:

• you are allergic to amivantamab, 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, pharmacist or nurse if you:

• have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease’ or ‘pneumonitis’)
• have any other medical conditions
• take any medicines for any other condition

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given RYBREVANT.

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?

Pregnancy and breastfeeding

Like most medicines used to treat cancer, RYBREVANT is not recommended for use during pregnancy. If a pregnant person takes RYBREVANT, it could harm the unborn baby.

Tell your doctor if you are pregnant or intend to become pregnant.

Tell your doctor if you are trying to make your partner pregnant.

Both men and women receiving RYBREVANT and their partners must use a reliable method of contraception (such as condoms) during and for 3 months after ceasing treatment with RYBREVANT.

If you or your partner becomes pregnant while you are being treated with this medicine, tell your doctor or nurse straight away.

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

You should not breastfeed while being treated with this medicine and for 3 months after ceasing treatment with RYBREVANT.

Children and adolescents below 18 years of age

Do not give RYBREVANT to children or young people below 18 years of age. This is because it is not known how the medicine will affect them.

3. What if I am taking other medicines?

Tell your doctor 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.

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

4. How do I receive RYBREVANT?

How much you will be given

• Your doctor will work out your dose of RYBREVANT. The dose of RYBREVANT will depend on your body weight at the start of your therapy.
• The recommended dose of RYBREVANT is:
  • 1050 mg if you weigh less than 80 kg.
  • 1400 mg if you weigh more than or equal to 80 kg.

If your weight changes, it does not mean that the dose has to be changed.

How it is given

RYBREVANT will be given to you by a doctor or nurse. It is given as a drip into a vein (‘intravenous infusion’) over several hours.

When it is given

RYBREVANT is given as follows:

• once a week for the first 4 weeks
• then once every 2 weeks starting at Week 5 as long as you are getting benefit from the treatment.

In the first week your doctor will give you the RYBREVANT dose split over two days.

Medicines given during treatment with RYBREVANT

Before each infusion of RYBREVANT, you will be given medicines which help to lower the chance of infusion-related reactions. These may include:

• medicines for an allergic reaction (antihistamines)
• medicines for inflammation (corticosteroids)
• medicines for fever (such as paracetamol)

You may also be given additional medicines based on any symptoms you may experience.

If you miss an appointment to receive RYBREVANT

• It is very important to go to all your appointments to make sure your treatment is working. If you miss an appointment, tell your doctor and arrange another visit as soon as possible.
• If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

If you are given too much RYBREVANT

This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.

5. What should I know while receiving RYBREVANT?

Things you should do

Call your doctor or nurse straight away while receiving RYBREVANT if you get any of the following side effects:

• Any side effect during the intravenous infusion (drip into a vein) of RYBREVANT (see Section 6. Are there any side effects?).
• Sudden difficulty in breathing, cough, or fever that may suggest inflammation of the lungs.
• Skin or nail problems. To reduce the risk of skin or nail problems, keep out of the sun, wear protective clothing, apply sunscreen, and use alcohol-free moisturisers regularly on your skin and nails while taking RYBREVANT. You also need to do this for 2 months after you stop treatment.
• Eye problems. If you have vision problems or eye pain contact your doctor or nurse straight away. If you use contact lenses and have any new eye symptoms, stop using contact lenses and tell your doctor straight away.

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

Both men and women receiving RYBREVANT and their partners must use a reliable method of contraception (such as condoms) during and for 3 months after ceasing treatment with RYBREVANT.

If you become pregnant or your partner becomes pregnant while receiving RYBREVANT, tell your doctor immediately.

Driving or using machines

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

Some of the side effects of RYBREVANT listed in section 6 may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.

Looking after your medicine

RYBREVANT is usually stored in the hospital, clinic or at the pharmacy.

Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly.

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.

Less serious side effects

Serious side effects

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

What RYBREVANT contains

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

What RYBREVANT looks like

RYBREVANT is a colourless to pale yellow liquid.

RYBREVANT is available in cartons containing 1 glass vial with a rubber stopper and aluminium seal with a flip off cap.

AUST R 376832

Who distributes RYBREVANT

JANSSEN-CILAG Pty Ltd

1-5 Khartoum Rd

Macquarie Park NSW 2113 Australia

Telephone: 1800 226 334

NZ Office: Auckland, New Zealand

Telephone: 0800 800 806

This CMI was prepared on 01 December 2022.