Calquence® 100 mg film-coated tablets – patient leaflet, side effects, dosage

What Calquence is used for

• 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 is used to treat adults with mantle cell lymphoma

(MCL) who have not been previously treated and are not candidates for stem cell transplant, or whose disease has come back, or has not responded to previous treatment. MCL is a type of blood cancer affecting the lymph nodes. How Calquence works

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.

2. What you need to know before you take Calquence

Do not take Calquence if:

• you are allergic to acalabrutinib or any of the other ingredients of

  this medicine (listed in section 6).

If you are not sure, talk to your doctor, pharmacist or nurse before taking Calquence.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Calquence if you:

• have ever had unusual bruising or bleeding or are on any medicines

  that increase your risk of bleeding (see section 4 ‘Possible side effects’).

• have an infection (see section 4 ‘Possible side effects’) • have recently had an operation or are about to have one. Your

  doctor may stop treatment with Calquence before and after a medical, surgical or dental procedure.

• have ever had hepatitis B (a liver infection) – this is because

  Calquence could cause hepatitis B to become active again and so that your doctor will look out for signs of this infection coming back (see section 4 ‘Possible side effects’).

• have or ever had irregular heart beat (see section 4 ‘Possible

  side effects’).

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.

Children and adolescents

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. Other medicines and Calquence

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:

• antibiotics for bacterial infections – such as clarithromycin • medicines for fungal infections – such as posaconazole, itraconazole,

  voriconazole

• ketoconazole – a medicine for Cushing’s syndrome (a condition

  in which the body produces too much of the hormone cortisol) • medicines for HIV infections – such as indinavir and ritonavir • medicines for hepatitis C – such as telaprevir

• rifampicin – an antibiotic for bacterial infections (tuberculosis) • ergotamine – a medicine for migraines
• conivaptan – a medicine for low blood sodium
• metformin – a medicine for high blood sugars

• cyclosporine – a medicine to prevent organ rejection • medicines for fits (seizures) or epilepsy – such as carbamazepine

  and phenytoin

• pimozide – a medicine used for Tourette (condition which causes

  uncontrolled movements and outbursts of words and sounds) • St. John’s wort – a herbal medicine for depression • theophylline – a medicine used for wheezing, shortness of

  breath, and chest tightness

• methotrexate – a medicine for diseases such as rheumatoid

  arthritis, psoriasis and ulcerative colitis,which are caused by the immune system working incorrectly.

• This medicine should be taken at least 6 hours before or after

  Calquence.

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.

Medicines that increase your risk of bleeding

Calquence may make you

bleed more easily. Tell your

doctor, pharmacist, or nurse if

you take other medicines that

increase your risk of bleeding:

• Antiplatelets (medicines

  that act against blood

  clotting) such as aspirin and

  clopidogrel.

• Anticoagulants (blood

  thinners) such as warfarin or

  enoxaparin.

Pregnancy

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.

Breast-feeding

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.

Driving and using machines

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.

Calquence contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How to take Calquence

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.

Depending on your type of cancer, Calquence may be given in combination with other anticancer medicines.

How much to take

• The usual dose is one tablet (100 mg) twice a day. Take doses

  about 12 hours apart.

How to take

• Swallow the tablet whole with water at about the same time

  each day.

• Do not chew, crush, dissolve or divide the tablets. • You can take Calquence with food or between meals. • You can check when you last took a tablet of Calquence by

  looking on the blister. Pictures on the blister will help you to take your dose at the right time — the sun for the morning dose and the moon for the evening dose.

If you take more Calquence than you should

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 forget to take a dose

• If less than 3 hours have passed after your usual time for taking

  a dose, take the missed dose right away. Take the next dose at your usual time.

• If more than 3 hours have passed after your usual time for

  taking a dose, skip the missed dose. Take the next dose at your usual time.

• Do not take a double dose of Calquence to make up for a

  forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Calquence and contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms:

Very common serious side effects (may affect more than 1 in 10 people):

• Bleeding in different sites, including skin, gut and brain. Symptoms

  may be black stools or stools with blood, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion.

• Infections. Signs may include fever, chills, feeling weak or confused,

  cough, shortness of breath [Pneumonia, a very common side effect (may affect more than 1 in 10 people) or Aspergillus infections, an uncommon side effect (may affect up to 1 in 100 people)].

Common serious side effects (may affect up to 1 in 10 people) • fast heart rate, missed heart beats, weak or uneven pulse,

dizziness, feeling faint, chest discomfort or shortness of breath (signs of heart rhythm problems known as atrial fibrillation and atrial flutter).

• fever, chills, nausea, vomiting, confusion, shortness of breath,

  seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. This can be symptoms of tumour lysis syndrome (TLS) – a condition caused by the fast breakdown of cancer cells.

Other side effects:

Very common (may affect more than 1 in 10 people): • muscle or joint pain

• headache
• rash

• feeling tired (fatigue), weakness or lack of energy • feeling sick to your stomach (nausea), vomiting, stomach

  pain, constipation (infrequent or hard to pass stool), diarrhoea (frequent or loose stools)

• decreased number of red blood cells, decreased number of

  neutrophils (a type of white blood cells) or decreased number of cells that help blood clot (platelets)

• swelling especially of the ankles and feet
• dizziness
• high blood pressure
• headache, pressure in the eyes, nose or cheek area (sinusitis) • sore throat and runny nose (nasopharyngitis)
• upper respiratory tract infection

• urinary tract infection (pain or burning feeling when passing urine)

  • new cancers, including cancers of the skin, may happen during treatment with Calquence (see section 2 ‘What you need to know before you take Calquence’)
  • herpes

Common (may affect up to 1 in 10 people):

• bronchitis

• increased levels of the liver enzymes

  (aspartate aminotransferase and alanine aminotransferase) in blood tests

• fever, chills, weakness, confusion, being sick and yellowing of the skin or eyeballs (jaundice) –these may be signs of hepatitis B (a liver infection) becoming active again
• inflammation of the lungs (pneumonitis) Uncommon side effects (may affect up to 1 in 100 people)
• memory loss, trouble thinking, difficulty walking or sight loss – these may be signs of a serious brain infection (Progressive Multifocal Leukoencephalopathy or PML).
• lymphocytosis (a higher than normal amount of lymphocytes, a type of white blood cells, in the blood)

Reporting of side effects

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.

5. How to store Calquence

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.

6. Contents of the pack and other information

What Calquence contains

The active substance is acalabrutinib. Each film-coated tablet contains 100 mg of acalabrutinib (as acalabrutinib maleate). The other ingredients are:

• Tablet core: mannitol (E421), microcrystalline cellulose (E460), low-substituted hydroxypropyl cellulose (E463) and sodium stearyl fumarate (see section 2 ‘Calquence contains sodium’). • Tablet coating: hypromellose (E464), copovidone, titanium dioxide (E171), macrogol, medium-chain triglycerides, iron oxide yellow (E172) and iron oxide red (E172).

What Calquence looks like and contents of the pack

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.

Marketing Authorisation Holder

AstraZeneca UK Limited,

1 Francis Crick Avenue,

Cambridge,

CB2 0AA,

UK

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

This leaflet was last revised in June 2026.

© AstraZeneca 2026

Calquence is a registered trademark of the AstraZeneca group of companies.

ONC 26 0027

Other sources of information

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Product name Reference number

Calquence^® 100 mg PLGB 17901/0369 film-coated tablets

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