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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using TECVAYLI?
TECVAYLI is a cancer medicine that contains the active ingredient teclistamab.
TECVAYLI is used to treat adults with cancer of the bone marrow called multiple myeloma.
It is used for patients who have had at least three other kinds of treatment which
have not worked or have stopped working.
2. What should I know before I use TECVAYLI?
Do not use if you have ever had an allergic reaction to teclistamab or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have had a stroke or seizure within the past 6 months or
have had a recent vaccination or are going to have a vaccination.
Tell your doctor if you notice any new or worsening symptoms of Progressive Multifocal
Leukoencephalopathy or have ever had hepatitis B infection or might now have hepatitis
B infection.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How is TECVAYLI given?
Your doctor or other healthcare professional will give the injection under the skin
(called subcutaneous injection) in the stomach area or thigh. More information can
be found in Section
4. How is TECVAYLI given? in the full CMI.
5. What should I know while using TECVAYLI?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TECVAYLI.
Look out for serious side effects such as signs of a condition known as 'cytokine
release syndrome' (CRS), infection, 'immune effector cell-associated neurotoxicity
syndrome' (ICANS)
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Things you should not do
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Do not receive live vaccines within 4 weeks before, during, or 4 weeks after treatment
with TECVAYLI
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Driving or using machines
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Do not drive, use tools, or operate heavy machinery.
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Looking after your medicine
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TECVAYLI will be stored refrigerated at the hospital or clinic.
Do not use this medicine after the expiry date which is stated on the carton after
"EXP".
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6. Are there any side effects?
There are a number of side effects associated with this medicine. It is important
to be aware of them so that you can identify any symptoms if they occur (see the full
CMI for more details). The most common and serious side effects are: serious immune
reaction called 'cytokine release syndrome'; low level of antibodies (hypogammaglobulinaemia);
low levels of a type of white blood cells (neutropenia); infection; and serious immune
reaction called ‘immune effector cell-associated neurotoxicity syndrome’ that have
effects on your nervous system. 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 .
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WARNING: TECVAYLI may cause side effects that are serious, life-threatening or lead
to death including Cytokine Release Syndrome (CRS). Call your healthcare professional
right away if you develop any of the signs or symptoms of CRS listed below:
Fever, nausea, headache, fast heartbeat, feeling dizzy, and difficulty breathing
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Active ingredient(s):
teclistamab
TECVAYLI as monotherapy has provisional approval in Australia and is indicated for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least three prior therapies, including
a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The decision to approve this medicine has been made on the basis of promising results
from preliminary study. 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 leaflet provides important information about using TECVAYLI. 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 TECVAYLI.
Where to find information in this leaflet:
1. Why am I using TECVAYLI?
TECVAYLI is a cancer medicine that contains the active ingredient teclistamab.
TECVAYLI is a prescription medication for adults with cancer of the bone marrow, called
multiple myeloma.
It is used for patients who have had at least three other kinds of treatment.
These treatments have not worked or have stopped working.
TECVAYLI is given alone to treat multiple myeloma.
TECVAYLI is an antibody, which is a type of protein. It has been designed to recognise
and attach to specific targets in your body.
TECVAYLI targets proteins found on cells in the blood:
BCMA (B cell maturation antigen), found on cancer cells
CD3 (cluster of differentiation 3), found in your immune system
TECVAYLI works by attaching to these proteins so that your immune system can destroy
the multiple myeloma cancer cells.
2. What should I know before I use TECVAYLI?
Warnings
Do not use TECVAYLI if:
you are allergic to teclistamab or any of the ingredients listed at the end of this
leaflet.
Check with your healthcare professional if you:
have had a recent vaccination or are going to have a vaccination
Do not receive live vaccines:
four weeks before beginning treatment with TECVAYLI
during treatment with TECVAYLI
four weeks after your final dose of TECVAYLI.
have had a stroke or seizure within the past 6 months
notice any new or worsening symptoms of Progressive Multifocal Leukoencephalopathy
(PML). PML is a serious and potentially fatal brain infection. Symptoms may include,
but are not limited to, blurred, loss of or double vision, difficulty speaking, weakness
in an arm or a leg, a change in the way you walk or problems with your balance, persistent
numbness, decreased sensation or loss of sensation, memory loss or confusion.
have ever had or might now have hepatitis B infection. This is because TECVAYLI could
cause hepatitis B virus to become active again. Your healthcare professional will
check you for signs of this infection before, during and for some time after treatment
with TECVAYLI. Tell your healthcare professional if you get worsening tiredness, or
yellowing of your skin or white part of your eyes.
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
Check with your doctor if you or your partner are pregnant or intend to become pregnant.
Men: if your partner could become pregnant, you must use effective contraception during
and for 3 months after stopping treatment with TECVAYLI. If your partner becomes pregnant
while you are being treated with this medicine, tell your doctor right away.
Women: you must use effective contraception during and for 5 months after stopping
treatment with TECVAYLI. If you become pregnant while being treated with this medicine,
tell your doctor right away.
You and your doctor will decide if the benefit of breastfeeding is greater than the
risk to your baby. If you and your doctor decide to stop taking this medicine, you
should not breastfeed for 5 months after stopping treatment.
Children and Adolescents
Do not give TECVAYLI 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?
Some medicines may interfere with TECVAYLI and affect how it works.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TECVAYLI.
4. How is TECVAYLI given?
How much to use
Your doctor or healthcare professional will work out your dose of TECVAYLI based on
your body weight.
The recommended dose of TECVAYLI is:
First dose-0.06 mg for each kilogram of body weight
Second dose-0.3 mg for each kilogram of body weight
Treatment dose-1.5 mg for each kilogram of body weight
TECVAYLI is given as follows:
You will receive your First dose of TECVAYLI to begin treatment
You will receive your Second dose 2-4 days later
You will then receive a 'Treatment dose' 2-4 days after your second dose
You will continue receiving a 'Treatment dose' once a week for as long as you are
getting benefit from TECVAYLI
Your healthcare professional will monitor you for side effects after each of your
first three doses-they will do this for 2 days after each dose. You should stay near
a healthcare facility after each of the first three doses in case you have side effects.
Your healthcare professional will tell you if you need to be monitored after other
doses.
How to use TECVAYLI
TECVAYLI will be given to you by your healthcare professional as an injection under
the skin (subcutaneous injection) in the stomach area or thigh.
Before you have TECVAYLI your healthcare professional will check:
Your blood counts
For signs of infection - an infection will be treated before you have TECVAYLI
If you are pregnant or breastfeeding
After you have TECVAYLI your healthcare professional will:
Monitor you for side effects
Regularly check your blood counts, as the number of blood cells and other blood components
may decrease
Medicines given during treatment with TECVAYLI
Before each of your first three injections of TECVAYLI, you will be given medicines
to help lower the chance of side effects. These may include:
Medicines for an allergic reaction (antihistamines)
Medicines for inflammation (corticosteroids)
Medicines for fever (such as paracetamol)
You may be given these medicines for later doses of TECVAYLI based on any symptoms
you have.
You may be given additional medicines based on any symptoms you experience or your
medical history.
If you forget to use TECVAYLI
If you cannot keep your appointment with the doctor, make sure you call your doctor
right away so another appointment can be made as soon as possible.
If you use too much TECVAYLI
This medicine will be given by your healthcare professional. In the unlikely event
that you are given too much (an overdose) your healthcare professional will check
you for side effects.
5. What should I know while using TECVAYLI?
Things you should do
Follow your doctor's instructions carefully.
Tell your doctor if you become pregnant or intend to become pregnant.
Call your doctor straight away if you experience any of the following:
Signs of a condition known as 'cytokine release syndrome' (CRS). A patient card to
inform you of CRS is available from your doctor and you need to always carry this
card with you whilst on treatment.
Effects on your nervous system, which can occur days or weeks after you receive the
injection, and may initially be subtle. Some of these may be signs of a serious immune
reaction called 'immune effector cell-associated neurotoxicity syndrome' (ICANS).
Signs and symptoms of an infection.
Tell your healthcare professional if you notice any signs of the above. The symptoms
are listed under “Serious side effects” in Section
6. Are there any side effects.
Remind any doctor, dentist or pharmacist you visit that you are using TECVAYLI.
Driving or using machines
Some people may feel tired, dizzy, or confused while taking TECVAYLI. Do not drive,
use tools, or operate heavy machinery. Also, do not do things that could pose a danger
to yourself.
Wait until at least 48 hours after receiving your third dose of TECVAYLI or as instructed
by your doctor.
Looking after your medicine
TECVAYLI is stored and administered by healthcare professionals so it is unlikely
that you will store this medicine at home.
TECVAYLI should be stored in a refrigerator (2°C-8°C) and kept in the original carton
in order to protect from light. Do not freeze.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
TECVAYLI will be disposed of appropriately by the healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton after
“EXP”. The expiry date refers to the last day of that month.
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
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Less serious side effects
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What to do
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decreased appetite
nausea, diarrhoea, constipation, vomiting
headache
fever
feeling very tired
nerve damage that may cause tingling, numbness, pain or loss of pain sensation
pain or muscle aches
bleeding, which can be severe (haemorrhage)
swollen hands, ankles or feet (oedema)
lung infection (pneumonia)
infected nose, sinuses or throat (upper respiratory tract infection)
skin infection causing redness (cellulitis)
skin reactions at or near the injection site, including redness of the skin, itching,
swelling, pain, bruising, rash, bleeding
low level of oxygen (hypoxia)
being short of breath (dyspnoea)
cough
high blood pressure (hypertension)
Abnormal blood test results such as:
a low levels of red blood cells (anaemia)
low levels of ‘platelets’ (cells that help blood to clot)
low number of white blood cells (leukopenia)
low levels of a type of white blood cells (lymphopenia)
low level of 'phosphate', 'magnesium' or 'potassium' in the blood (hypophosphataemia,
hypomagnesaemia or hypokalaemia)
increased level of 'calcium' (hypercalcaemia)
increased 'alkaline phosphatase' in the blood
low level of 'calcium' or 'sodium' in the blood (hypocalcaemia or hyponatraemia)
high level of 'potassium' in the blood (hyperkalaemia)
low level of ‘albumin’ in the blood (hypoalbuminaemia)
increased level of 'gamma-glutamyltransferase' in the blood (blood gamma-glutamyltransferase
increase)
increased level of liver enzymes 'transaminases' in the blood (blood transaminase
increase)
increased level of 'creatinine' in the blood (blood creatinine increase)
increased level of 'amylase' in the blood (hyperamylasaemia)
increased level of 'lipase' in the blood (hyperlipasemia)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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serious immune reaction that may cause fever, nausea, headache, fast heart beat, feeling
dizzy, and difficulty breathing ('cytokine release syndrome')
low level of antibodies called 'immunoglobulins' in the blood, which may make infections
more likely (hypogammaglobulinaemia)
low levels of a type of white blood cells (neutropenia)
low number of a type of white blood cell (neutrophils) with a fever
infection, which may include fever, chills, shivering, cough, shortness of breath,
rapid breathing and rapid pulse
severe infection throughout the body (sepsis)
COVID-19 infection caused by a virus called coronavirus (SARS-CoV-2)
effects on your nervous system, which may include headache, feeling confused, feeling
less alert, speaking slowly, having difficulty writing, reading and understanding
words. Some of these symptoms may be signs of a serious immune reaction called ‘immune
effector cell-associated neurotoxicity syndrome’ (ICANS)
change in brain function (encephalopathy)
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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.
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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 TECVAYLI contains
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Active ingredient
(main ingredient)
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teclistamab
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Other ingredients
(inactive ingredients)
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disodium edetate (EDTA)
glacial acetic acid
polysorbate 20
sodium acetate trihydrate
sucrose
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What TECVAYLI looks like
TECVAYLI is a solution for injection and is a colourless to light yellow liquid.
TECVAYLI is supplied as a carton pack containing 1 glass vial.
teclistamab 30 mg/3 mL (10 mg/mL) AUST R 387621
teclistamab 153 mg/1.7 mL (90 mg/mL) AUST R 387622
Who distributes TECVAYLI
Janssen-Cilag Pty Ltd
1-5 Khartoum Road Macquarie Park NSW 2113
Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared 21 May 2024.