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. Please report side effects. See the full CMI for further details.
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’.
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.
3. What if I am taking other medicines?
Some medicines may interfere with RYBREVANT and affect how it works.
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.
5. What should I know while receiving RYBREVANT?
|
Things you should do
|
Call your doctor or nurse straight away if you experience any of the following: any side effect during the intravenous infusion (drip into a vein) of RYBREVANT; sudden
difficulty in breathing, cough, or fever that may suggest inflammation of the lungs;
skin or nail problems; eye problems.
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.
|
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.
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(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.
Full 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:
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
|
Serious side effects
|
What to do
|
|
Signs of a reaction to the infusion, such as:
chills
nausea
feeling short of breath
flushing
chest discomfort
vomiting
This can happen especially with the first dose. Your doctor may give you other medicines,
or the infusion may need to be slowed down or stopped.
|
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.
|
|
Signs of an lung problems, such as:
sudden difficulty in breathing or shortness of breath
cough
fever
Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away
if you get any new or worsening lung symptoms.
Your doctor may wish to stop RYBREVANT if you get this side effect.
|
|
Skin problems, such as:
rash (including acne)
infected skin around the nails
dry skin
itching
pain
redness
life threatening rash with blisters and peeling skin over much of the body (toxic
epidermal necrolysis).
Tell your doctor if your skin or nail problems get worse, or if it is accompanied
by fever, chills, aching muscles and generally feeling unwell.
|
|
Eye problems, such as:
dry eye
eye redness
itchy eyes
problems with vision
growth of eyelashes
inflamed cornea (front part of the eye)
inflammation inside the eye that may affect vision
|
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
|
Active ingredient
(main ingredient)
|
Amivantamab
350 mg in each 7 mL vial
|
|
Other ingredients
(inactive ingredients)
|
Disodium edetate
Histidine
Histidine hydrochloride monohydrate
Methionine
Polysorbate 80
Sucrose
Water for injections
|
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.