This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0369.
Calquence 100 mg film-coated tablets
Calquence® 100 mg film-coated tablets
▼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. See the end of section 4 for how to report side effects.
1. What Calquence is and what it is used for
2. What you need to know before you take Calquence
3. How to take Calquence
4. Possible side effects
5. How to store Calquence
6. Contents of the pack and other information
Calquence is a medicine used to treat cancer.
Calquence is used to treat adults with chronic lymphocytic leukaemia (CLL).
CLL is a cancer of white blood cells called B-lymphocytes (or B-cells). These cells are part of the immune system (the body’s defences).
Calquence works by blocking BTK, a protein in the body that helps these cancer cells grow and survive. By blocking BTK, Calquence helps to kill and can reduce the number of cancer cells which can slow down the worsening of the disease.
If you have any questions about how Calquence works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Calquence.
Talk to your doctor, pharmacist or nurse before taking Calquence if you:
Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin as you are at a high risk of developing skin cancer, see section 4. Use sun protection and make regular skin examination.
Your doctor will check your blood cell counts as needed during treatment.
Do not give this medicine to children or adolescents aged less than 18 years. This is because it has not been studied in this age group.
Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines, especially if you take any of the following:
You can take stomach acid reducing medicines such as antacids (calcium carbonate), histamine-2 receptor blockers (ranitidine and famotidine) and proton pump inhibitors (omeprazole) with Calquence tablets.
Calquence may make you bleed more easily. Tell your doctor, pharmacist, or nurse if you take other medicines that increase your risk of bleeding:
Talk to your doctor before taking Calquence if you are pregnant, think you may be pregnant, or are planning on having a baby. This is because Calquence may harm your unborn baby.
Do not breast-feed during treatment with Calquence and for 2 days after your last dose of Calquence. It is not known if Calquence passes into your breast milk.
Calquence is unlikely to affect the ability to drive and use machines. However, if you feel dizzy, weak or tired while taking Calquence, you must not drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Calquence will only be prescribed to you by a doctor with experience in the use of medicines for cancer. Always take Calquence exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
If you have taken more Calquence than you should, see a doctor or go to the nearest hospital straight away. Take the tablets and this leaflet with you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common serious side effects (may affect up to 1 in 10 people)
Uncommon serious side effects (may affect up to 1 in 100 people)
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people)
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister foil and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is acalabrutinib. Each film-coated tablet contains 100 mg of acalabrutinib (as acalabrutinib maleate).
The other ingredients are:
Calquence is an orange, 7.5 x 13 mm, oval, biconvex tablet, debossed with ‘ACA 100’ on one side and plain on the reverse.
Calquence is supplied in aluminium blisters containing either 8 or 10 film-coated tablets. On each blister there are sun/moon symbols to help you to take your dose at the right time — the sun for the morning dose and the moon for the evening dose. Both the sun and the moon blisters contain the same medicine. Each carton contains either 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in August 2023
© AstraZeneca 2023
Calquence is a registered trademark of the AstraZeneca group of companies.
ONC 23 0076
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Calquence® 100 mg film-coated tablets PLGB 17901/0369
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