CALQUENCE® Tablets
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.
CALQUENCE tablets contains the active ingredient acalabrutinib maleate monohydrate.
CALQUENCE tablets is used to treat Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic
Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL).
For more information, see Section 1. Why am I using CALQUENCE tablets? in the full CMI.
Do not use if you have ever had an allergic reaction to CALQUENCE 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 CALQUENCE tablets? in the full CMI.
Some medicines may interfere with CALQUENCE tablets 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.
The usual dose is one 100 mg tablet twice a day. Doses should be taken about 12 hours
apart.
Swallow the tablet whole with water. Do not chew, crush, dissolve, or divide the
tablets.
More instructions can be found in Section 4. How do I use CALQUENCE tablets? in the full CMI.
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Things you should do
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Remind any doctor, dentist, nurse, surgeon or pharmacist you visit that you are using
CALQUENCE tablets.
You should be careful to protect yourself from the sun.
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Things you should not do
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Do not stop using this medicine or change the dose without checking with your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take it after the expiry date printed on the pack or if the packaging is torn
or shows signs of tampering.
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Driving or using machines
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Be careful driving or operating machinery until you know how CALQUENCE tablets affects
you.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store CALQUENCE tablets or any other medicine in the bathroom or near a sink.
Do not leave it on a windowsill or in the car.
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For more information, see Section 5. What should I know while using CALQUENCE tablets? in the full CMI.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Tell your doctor, nurse or pharmacist if you notice any of the following and they
worry you: fever, chills, headache, nausea, vomiting, dizziness, stomach pain, diarrhoea,
constipation, rash, bruising, bleeding, fatigue, muscle and bone pain, joint pain,
new cancers. Tell your doctor, nurse or pharmacist as soon as possible if you notice
any of the following: signs or symptoms of serious bleeding, infection or heart problems.
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.
This medicine has provisional registration in Australia for (CALQUENCE is indicated
for the treatment of patients with mantle cell lymphoma who have received at least
one prior therapy). The decision to provisionally register this new use of the medicine
has been made on the basis of promising results from preliminary studies. More evidence
is required to be submitted when available to substantiate the benefit of the medicine
for this use.
CALQUENCE® Tablets
Active ingredient(s):
acalabrutinib maleate monohydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using CALQUENCE tablets. 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 CALQUENCE tablets.
Where to find information in this leaflet:
CALQUENCE tablets contain the active ingredient acalabrutinib maleate monohydrate.
CALQUENCE belongs to a group of anti-cancer medicines called Bruton tyrosine kinase
(BTK) inhibitors. BTK is a protein in the body that helps cancer cells to grow.
CALQUENCE works by blocking BTK which may help to reduce the number of cancer cells
and may slow the spread of the cancer.
CALQUENCE tablets is used to treat:
Mantle Cell Lymphoma (MCL), a type of blood cancer that affects the lymph nodes (lymph
glands). It is used in patients who have had at least one other treatment for their
cancer.
Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL), a type of blood
cancer that affects lymphocytes (a certain type of white blood cell) and the lymph
nodes.
Do not use CALQUENCE tablets if:
you are pregnant or intend to become pregnant
you are breastfeeding
you are allergic to acalabrutinib, or any of the ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic reaction may include:
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.
There is not enough information to recommend the use of this medicine for children
or adolescents under the age of 18 years.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
have any other medical conditions such as:
any unusual bruising or bleeding, or you have any bleeding disorders
infections (bacterial, viral and/or fungal)
any liver problems
a liver infection (Hepatitis B), so that your doctor can look out for signs of reactivation
of this infection, such as fever, chills, weakness, confusion, vomiting and jaundice
(yellowing of the skin or eyeballs)
have or have had heart rhythm problems (such as atrial fibrillation)
any other medical conditions
take any medicines for any other condition
have recently undergone surgery or are planning any surgery or medical or dental procedures.
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.
You should not take CALQUENCE tablets if you are pregnant and you should not get pregnant
while you are taking CALQUENCE tablets.
CALQUENCE tablets may harm your unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed during treatment with CALQUENCE tablets.
It is not known if CALQUENCE tablets passes into your breast milk. Do not breast-feed
during treatment with CALQUENCE tablets and for at least 2 weeks after your final
dose of CALQUENCE tablets.
Tell your doctor, nurse 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 CALQUENCE tablets and affect how it works.
Medicines used to control heart rhythm disturbances (e.g. amiodarone, diltiazem, verapamil)
Antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin,
telithromycin, ciprofloxacin, rifampin)
Medicines to treat fungal infections (e.g. fluconazole, posaconazole, ketoconazole,
itraconazole, voriconazole)
Medicines used to treat HIV infection (e.g. ritonavir, cobicistat, indinavir, nelfinavir,
saquinavir, amprenavir, atazanavir, darunavir/ritonavir or fosamprenavir)
Medicines used to treat hepatitis C infection (e.g. telaprevir)
Medicines used to prevent seizures or to treat epilepsy (e.g. carbamazepine, phenytoin)
St. John’s wort - a herbal medicine used to treat depression
Methotrexate, a medicine used to treat other cancers or to treat immune disorders
such as rheumatoid arthritis or psoriasis.
Medicines used to control blood sugar in patients with diabetes (eg. metformin)
CALQUENCE tablets may make you bleed more easily. This means you should tell your
doctor if you take other medicines that increase your risk of bleeding. These include:
Medicines used to treat pain and inflammatory conditions (e.g. aspirin and non-steroidal
anti-inflammatory [NSAIDS] such as ibuprofen)
Medicines used to prevent blood clots, such as antiplatelet therapy or blood thinners
(e.g. aspirin, warfarin).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CALQUENCE tablets.
Your doctor has prescribed CALQUENCE film-coated tablets for you. Please note CALQUENCE
is also available as a 100 mg capsule and should not be interchanged with CALQUENCE
film-coated tablets.
How much to take
The usual dose is one 100 mg tablet twice a day.
Follow the instructions provided and use CALQUENCE tablets until your doctor tells
you to stop. Check with your doctor, nurse or pharmacist if you are not sure.
The instructions may differ from the information contained in this leaflet.
When to take CALQUENCE tablets
CALQUENCE tablets should be taken about 12 hours apart.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
You can check when you last took a tablet of CALQUENCE tablets by looking at the sun
and moon symbols on the blister pack. There is a sun (for the morning) and a moon
(for the evening). This will tell you whether you have taken the dose.
It is important that you tell your doctor that you are taking any of the medicines
mentioned in the ‘Taking other medicines section’, as you may need to:
avoid taking certain medicines including certain medicines used to treat fungal infections
take your medicine at a different time to CALQUENCE tablets
Temporarily decrease your dose of CALQUENCE depending on which other medicine.
How to take / use CALQUENCE tablets
Swallow the tablet whole with water. Do not chew, dissolve, divide, or crush the
tablets.
You can take CALQUENCE with or without food.
If you forget to use CALQUENCE tablets
CALQUENCE tablets should be used regularly at the same time each day.
If you miss a dose by more than 3 hours, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much CALQUENCE tablets
If you think that you have used too much CALQUENCE tablets, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
You should be careful to protect yourself from the sun.
If you are about to be started on any new medicine, remind your doctor, nurse and
pharmacist that you are taking CALQUENCE tablets.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
If you are about to have any blood tests, tell your doctor and nurse that you are
taking this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
become pregnant while taking this medicine,
Remind any doctor, nurse, dentist or pharmacist you visit that you are using CALQUENCE
tablets.
Things you should not do
Do not stop using this medicine or change the dose without checking with your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take it after the expiry date printed on the pack or if the packaging is torn
or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist
for disposal
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CALQUENCE
tablets affects you.
CALQUENCE may cause dizziness, weakness or tiredness in some people.
Looking after your medicine
Store it in a cool dry place where the temperature stays below 30°C. Keep CALQUENCE
tablets away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
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.
Do not use this medicine after the expiry date.
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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Infection, signs include fever, chills, or flu-like symptoms
headache
nausea, vomiting
dizziness
stomach pain
diarrhoea
constipation
rash
bruising
bleeding, including nose bleeds
feeling very tired (fatigue)
muscle and bone pain
joint pain
new cancers, including skin cancer
The above list includes the more common side effects of your medicine.
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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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signs or symptoms of serious bleeding, such as blood in your stools or urine or bleeding
that lasts for a long time or that you cannot control.
Signs or symptoms of an infection (fungal, viral or bacterial - eg pneumonia and aspergillosis)
such as fevers, chills, body aches, cold or flu symptoms, feel tired or feel short
of breath.
Signs and symptoms of heart problems (eg atrial fibrillation) such as chest discomfort,
shortness of breath or heart palpitations/change in rhythm (racing, pounding or fluttering).
The above list includes serious side effects that may require medical attention.
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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.
Like other cancer medicines, new cancers such as skin cancers have been known to occur
in patients taking CALQUENCE tablets.
Some side effects can also be found when your doctor or nurse does regular blood tests.
These include:
decreased number of white blood cells (neutropenia).
decreased number of red blood cells (anaemia).
decreased number of platelets which are cells that help your blood to clot (thrombocytopenia).
condition called tumour lysis syndrome (TLS), when there are unusual levels of chemicals
in the blood caused by the fast breakdown of cancer cells have happened during treatment
of cancer and sometimes even without treatment. Signs of TLS are changes in kidney
function, abnormal heartbeat, or seizures.
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.
This medicine is only available with a doctor's prescription.
What CALQUENCE tablets contains
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Active ingredient
(main ingredient) |
acalabrutinib maleate monohydrate
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Other ingredients
(inactive ingredients) |
mannitol
microcrystalline cellulose
hyprolose
sodium stearylfumarate
hypromellose
copovidone
titanium dioxide
macrogol 3350
medium chain triglycerides
iron oxide yellow
iron oxide red
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
What CALQUENCE looks like
The CALQUENCE 100 mg film-coated tablet is an orange, 7.5 x 13 mm, oval, biconvex
tablet, debossed with ‘ACA 100’ on one side and plain on the reverse (Aust R 377410).
CALQUENCE tablets is supplied in a carton containing 7 blister strips, each containing
8 tablets (a total of 56 tablets in a carton).
