Patient Information Leaflet

Calquence100Film-Coated Tablets
acalabrutinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, ask your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Calquence and what it is used for

2.What you need to know before you start taking Calquence

3.How to take Calquence

4.Possible side effects

5.Storage of Calquence

6.Contents of the pack and additional information

What is Calquence

Calquence is a medication used to treat cancer.

• Calquence contains the active ingredient acalabrutinib.
• It belongs to a group of medications known as Bruton's tyrosine kinase (BTK) inhibitors.

How is Calquence used

Calquence is used to treat adults with chronic lymphocytic leukemia (CLL).

CLL is a cancer of the white blood cells in the blood called B lymphocytes (or B cells). These cells are part of the immune system (the body's defenses).

How Calquence works

Calquence acts by blocking BTK, a protein in the body that helps these cancerous cells grow and survive. By blocking BTK, Calquence helps kill and may reduce the number of cancer cells, which can slow the progression of the disease.

If you have any questions about how Calquence works or why you have been prescribed this medication, consult your doctor, pharmacist, or nurse.

Do not take Calquence:

• if you are allergic to acalabrutinib or any of the other ingredients of this medicine (listed in section6).

If you are unsure, consult your doctor, pharmacist or nurse before starting to take Calquence.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Calquence if you:

• have ever had any bleeding or bruising problems or are taking any medicine or supplement that increases the risk of bleeding, (see section 4 “Possibleside effects”).
• have an infection (see section4 “Possible side effects”).
• have recently undergone surgery or are about to have one. Your doctor may interrupt your treatment with Calquence before or after a medical, surgical or dental procedure.
• have ever had hepatitis B (a liver infection) - this is because Calquence could reactivate hepatitis B, so your doctor will look for signs of reactivation of this infection (see section 4 “Possible side effects”).
• have or have had any irregular heartbeat (see section 4 “Possible side effects”).

Consult your doctor if you develop a new injury or any change in the appearance of an area of skin, as you have a high risk of developing skin cancer, see section 4. Use sun protection and have regular skin checks.

Your doctor will make blood tests during treatment to check your blood cell count when necessary.

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age. This is because it has not been studied in this age group.

Other medicines and Calquence

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medicine, especially if you are taking any of the following:

• antibiotics for bacterial infections, such as clarithromycin.
• medicines for fungal infections, such as posaconazole, itraconazole or voriconazole
• ketoconazole, a medicine for when the body produces too much cortisol (Cushing's syndrome).
• medicines for HIV infection - such as indinavir and ritonavir
• medicines for hepatitis C - such as telaprevir
• rifampicin - an antibiotic for bacterial infections (tuberculosis).
• medicine for migraines – ergotamine
• medicine for low sodium levels in the blood – conivaptan
• medicine for high blood sugar levels – metformin
• medicine to prevent organ rejection – ciclosporin
• medicines for seizures or epilepsy - such as carbamazepine or phenytoin.
• pimozide - a medicine used for Tourette's syndrome (a condition that causes involuntary movements and sudden emissions of words and sounds)
• St. John's Wort - a herbal medicine used for depression.
• theophylline - a medicine used for wheezing, difficulty breathing and chest tightness.
• methotrexate – a medicine for diseases such as rheumatoid arthritis, psoriasis and ulcerative colitis, which are caused by problems in the immune system.
• • This medicine should be taken at least 6 hours before or after Calquence.

You can take acid-reducing medicines such as antacids (calcium carbonate), histamine-2 receptor antagonists (ranitidine and famotidine) and proton pump inhibitors (omeprazole) with Calquence tablets.

Medicines that increase the risk of bleeding

Calquence may make you bleed more easily. Inform your doctor, pharmacist or nurse if you are taking other medicines that increase the risk of bleeding:

• antiplatelet medicines (that prevent clot formation) such as aspirin and clopidogrel
• anticoagulants (blood thinners) such as warfarin or enoxaparin

Pregnancy

If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine. This is because this medicine may harm the fetus.

Breastfeeding

Do not breastfeed during treatment with Calquence and for 2 days after you have received the last dose of Calquence. It is not known if Calquence is excreted in breast milk

Driving and using machines

It is unlikely that Calquence will affect your ability to drive and use machines. However, if you feel dizzy, weak or tired while taking Calquence, you should not drive or use machines.

Calquence contains sodium

This medicine contains less than 1mmol of sodium (23mg) per dose, which is essentially “sodium-free”.

Calquence will only be prescribed by an experienced doctor in the use of cancer medications. Follow exactly the administration instructions for Calquence indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

What dose to take

• The usual dose is one tablet (100mg) twice a day. Take the doses with a 12-hour interval.

How to take Calquence

• Swallow the tablet whole with water, approximately at the same time every 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 Calquence tablet by looking at the blister pack. The images on the blister pack will help you take your dose at the right time - the sun for the morning dose and the moon for the night dose.

If you take more Calquence than you should

If you have taken more Calquence than you should, consult a doctor or go immediately to the nearest hospital. Bring the tablets and this leaflet with you.

If you forgot to take Calquence

• If less than 3 hours have passed since the usual time of taking, take the missed dose immediately. Take the next dose at the usual time.
• If more than 3 hours have passed since the usual time of taking, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Calquence to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Calquence and contact your doctor or go to the emergency room immediately if you notice any of the following side effects:

• Bleeding. Signs may include black or bloody stools, pink or brown urine, nasal bleeding, bruises, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion.
• Infections: Signs may include fever, chills, feeling weak or confused, cough, difficulty breathing[Pneumonia, avery common side effect(may affect more than 1 in 10 people) or Aspergillus infections, aless common side effect(may affect up to 1 in 100 people)].

Frequent severe side effects(may affect up to 1 in 10 people)

• Fast heart rate, lost heartbeats, weak or irregular pulse, dizziness, feeling of fainting, chest pain or difficulty breathing (signs of heart rhythm problems, known as atrial fibrillation or flutter).

Less frequent severe side effects(may affect up to 1 in 100 people)

• Fever, chills, nausea, vomiting, confusion, difficulty breathing, convulsions, irregular heartbeats, dark or cloudy urine, unusual fatigue or muscle or joint pain. This may be a sign of a tumor lysis syndrome (TLS) - a condition caused by the rapid breakdown of cancer cells.

Other side effects

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

• Muscle or joint pain
• Headache
• Skin rash
• Sensation of fatigue (fatigue), weakness or lack of energy
• Sensation of stomach discomfort (nausea), vomiting, stomach pain, constipation (infrequent or difficult bowel movements), diarrhea (frequent or loose bowel movements)
• Decreased number of red blood cells in the blood, decreased number of neutrophils (a type of white blood cell) or decreased number of platelets (cells that help blood to clot)
• High blood pressure
• Dizziness
• Headache, pressure in the eyes, nose or face (sinusitis)
• Throat pain and nasal discharge (nasopharyngitis)
• Upper respiratory tract infection
• Urinary tract infection (pain or sensation of burning while urinating)
• New cancers, including skin cancers, may appear during treatment with Calquence (see section 2. “What you need to know before starting to take Calquence”).

Frequent(may affect up to1 in 10 people):

• Bronchitis (no immediate action required)
• Herpes

Less frequent side effects(may affect up to 1 in 100 people)

• Memory loss, difficulty thinking, difficulty walking or loss of vision - these may be signs of a rare and serious brain infection, (Progressive Multifocal Leukoencephalopathy or PML)
• Fever, chills, weakness, confusion, discomfort and yellowing of the skin or eyes (jaundice) - these may be signs that hepatitis B (a liver infection) has become active again
• Lymphocytosis (an increase in the normal level of lymphocytes, a type of white blood cell).

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Calquence

The active ingredient is acalabrutinib. Each film-coated tablet contains 100mg of acalabrutinib (as acalabrutinib maleate).

The other components are:

• Core of the tablet: mannitol (E421), microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463) and sodium stearate fumarate (see section 2 “Calquence contains sodium”).
• Coating of the tablet: hypromellose (E464), copovidone, titanium dioxide (E171), macrogol, medium-chain triglycerides, yellow iron oxide (E172) and red iron oxide (E172)

Appearance of the product and contents of the pack

Calquence is an orange, oval, biconvex tablet, 7.5 x 13 mm, engraved with “ACA 100” on one side and smooth on the reverse.

Calquence is presented in aluminium blisters containing 8 or 10 film-coated tablets. Each blister has sun/moon symbols to help you take your dose at the right time – the sun for the morning dose and the moon for the evening dose. Both the sun and moon blisters contain the same medicine. Each box contains 56 or 60 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

AstraZeneca AB

SE‑151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

For more information about this medicine, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.