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.
Why am I using EXKIVITY?
EXKIVITY contains the active ingredient mobocertinib. EXKIVITY is used to treat adult
patients with a kind of lung cancer called non-small cell lung cancer (NSCLC) whose
tumours have a certain type of abnormal epidermal growth factor receptor (EGFR) gene
and, who have received prior platinum-based chemotherapy.
What should I know before I use EXKIVITY?
Do not use if you have ever had an allergic reaction to EXKIVITY 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.
What if I am taking other medicines?
Some medicines may interfere with EXKIVITY and affect how it works.
How do I use EXKIVITY?
The recommended dosage of EXKIVITY is 160 mg orally once daily. EXKIVITY can be taken
with or without food. Swallow EXKIVITY capsules whole. Do not open, chew or dissolve
the contents of the capsules.
Follow all directions given to you by your doctor or pharmacist carefully.
What should I know while using EXKIVITY?
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Things you should do
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Remind any doctor or dentist you visit that you are using EXKIVITY. If you become
pregnant while using this medicine, tell your doctor immediately.
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Things you should not do
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Do not stop using EXKIVITY or change the dosage without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how EXKIVITY affects you.
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Looking after your medicine
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Keep the EXKIVITY in a cool dry place where the temperature stays below 25°C.
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Are there any side effects?
Less serious side effects include diarrhoea, rash, nausea, mouth sores, vomiting,
dry skin, loss of appetite, nail inflammation, tiredness.
Serious side effects include heart problems including abnormal heart beat (electrical
activity of your heart called QTc prolongation and Torsades de Pointes) or heart failure,
lung problems, diarrhoea.
This medicine is subject to additional monitoring due to provisional approval. 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): mobocertinib
This medicine has provisional approval in Australia to treat adults with a type of lung cancer called non-small cell lung
cancer (NSCLC). 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 leaflet provides important information about using EXKIVITY. 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 EXKIVITY.
The information in this leaflet was last updated in July 2022. More recent information
on the medicine may be available. You should ensure that you speak to your pharmacist
or doctor to obtain the most up to date information on this medicine.
Where to find information in this leaflet:
8. Instructions for preparing and injecting EXKIVITY
Why am I using EXKIVITY?
EXKIVITY contains the active ingredient mobocertinib. EXKIVITY is used to treat adults with a type of lung cancer called non-small cell
lung cancer (NSCLC). It is used if:
the tumour has a defect (mutation) within the epidermal growth factor receptor (EGFR)
gene, and
it has spread to other parts of the body (metastatic), and
your previous treatment was a specific type of chemotherapy that contains platinum
(e.g., cisplatin or carboplatin).
Your healthcare provider will perform a test to make sure that EXKIVITY is right for
you.
What should I know before I use EXKIVITY?
Warnings
Do not use EXKIVITY if you:
1. are allergic to mobocertinib, 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 or had any of these medical conditions: lung or breathing problems other than
lung cancer; heart problems (including a condition called long QTc syndrome and Torsades
de Pointes); problems with your electrolytes (such as sodium, potassium, calcium or
magnesium)
take any medicines for any other condition
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 are pregnant or intend to become pregnant. EXKIVITY
can harm your unborn baby.
Females who are able to become pregnant:
Your doctor should do a pregnancy test before you start treatment with EXKIVITY.
You should use an effective form of non-hormonal birth control during treatment and
for 1 month after your last dose of EXKIVITY.
Birth control pills (oral contraceptives) and other hormonal forms of birth control
may not work as well during treatment with EXKIVITY.
Talk to your doctor about birth control methods that might be right for you during
this time.
Tell your doctor right away if you become pregnant or think you may be pregnant during
treatment with EXKIVITY.
Males who have female partners who are able to become pregnant:
You should use effective birth control during treatment and for 1 week after your
last dose of EXKIVITY.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
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 be affected by EXKIVITY or may affect how EXKIVITY works. Some
examples include:
ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole: medicines to
treat fungal infections
efavirenz, etravirine, ritonavir, saquinavir, cobicistat: medicines to treat HIV
infection
clarithromycin, ciprofloxacin, erythromycin: medicines to treat bacterial infections
bosentan, diltiazem, verapamil: medicines to treat irregular heart rhythm and high
blood pressure
St. John’s wort: an herbal product used to treat depression. It is also known as hypericum
perforatum.
alfentanil, fentanyl: medicines to treat pain
modafinil: a medicine to treat excessive sleepiness
carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain
pain conditions
phenobarbital, phenytoin, primidone: medicines to treat epilepsy
rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
ciclosporin, sirolimus, tacrolimus: medicines to suppress the immune system
simvastatin: medicine to treat high cholesterol
estrogen, progesterones: hormonal birth control such as the pill, the patch, hormone-containing
intrauterine device, or vaginal ring
medicines that prolong the QTc interval: for example, amiodarone, azithromycin, moxifloxacin,
ondansetron
Your doctor may have to change your dose of other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using this medicine.
How do I use EXKIVITY?
How much to take
The recommended daily dose is 160 mg (four capsules) taken once per day.
If you are not sure, ask your doctor or pharmacist for advice.
Follow the instructions provided and use EXKIVITY until your doctor tells you to stop.
When to take EXKIVITY
Take EXKIVITY at the same time each day. It is important to take EXKIVITY every day
for as long as your doctor tells you to.
How to take EXKIVITY
EXKIVITY can be taken with or without food. Swallow EXKIVITY capsules whole. Do not
open, chew or dissolve the contents of the capsules.
Avoid eating grapefruit or drinking grapefruit juice during treatment with EXKIVITY.
Grapefruit may increase the amount of EXKIVITY in your blood.
If you forget to take EXKIVITY
EXKIVITY should be used regularly at the same time each day. If you miss or vomit
your dose, take the next dose at its scheduled time.
Do not take a double dose to make up for the dose you missed.
If you use too much EXKIVITY
If you think that you have used too much EXKIVITY, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia; 0800 POISON or 0800 764766 in New Zealand), 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.
What should I know while using EXKIVITY?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using EXKIVITY.
Tell any other doctors, dentists, and pharmacists who treat you that you are using
this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
experience heart problem, including feeling like your heart is pounding or racing,
shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint.
experience lung or breathing problems including shortness of breath or difficulty
breathing, cough and/or fever.
have any loose stools (diarrhoea) or have stools more often than is normal for you
become pregnant while using this medicine.
Things you should not do
Do not stop using EXKIVITY or change the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how EXKIVITY
affects you.
Looking after your medicine
Store it in a cool dry place where the temperature stays below 30°C.
Do not store it in the bathroom or near a sink, or in the car or on window sills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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
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Serious side effects
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What to do
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Heart problems, including irregular heartbeats and heart failure.
EXKIVITY may cause heart problems that may lead to death. Your healthcare provider
should check the electrical activity and function of your heart before you start taking
EXKIVITY and during treatment as needed. Your doctor should also check electrolytes
in your blood. Tell your healthcare provider right away if you have any signs and
symptoms of a heart problem, including feeling like your heart is pounding or racing,
shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint.
Lung problems.
EXKIVITY may cause inflammation of the lungs that can cause death. Symptoms may be
similar to those symptoms from lung cancer. Tell your healthcare provider right away
if you develop any new or worsening symptoms, including trouble breathing or shortness
of breath, cough, or fever.
Diarrhoea.
Diarrhoea is common during treatment with EXKIVITY and should be treated right away.
Diarrhoea is generally mild to moderate, but may sometimes be severe. You should have
medicine to help control diarrhoea (such as loperamide) readily available to begin
treatment. Your healthcare provider may also recommend changes to your diet (such
as avoiding foods high in carbohydrates) and may tell you to start drinking more fluids.
Diarrhoea can cause loss of too much body fluid (dehydration) and kidney problems
and your healthcare provider may need to give you fluids and electrolytes to replace
body salts. Tell your healthcare provider right away if you have any loose stools
or have stools more often than is normal for you. In general, the sooner and better
diarrhoea is managed, the more likely it will be controlled and tolerable.
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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.
Product details
This medicine is only available with a doctor's prescription.
What EXKIVITY contains
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Active ingredient
(main ingredient)
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mobocertinib
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Other ingredients
(inactive ingredients)
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gelatin, titanium dioxide and TekPrint SW-9008
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Do not take this medicine if you are allergic to any of these ingredients.
What EXKIVITY looks like
EXKIVITY 40 mg capsule (AUST R 370160): White, size 2, imprinted with “MB788” on the
cap and “40mg” on the body in black ink.
Each pack contains 112 capsules.
Who distributes EXKIVITY
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney, NSW 2000
Australia
Telephone: 1800 012 612
This leaflet was prepared in July 2022.
EXKIVITY® and the EXKIVITY Logo® are registered trademarks of Takeda Pharmaceuticals International AG.. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.