CALQUENCE 100 mg FILM-COATED TABLETS

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, consult your doctor, pharmacist, or nurse before taking Calquence.

Warnings and precautions

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

• have ever had any unusual or unexplained bleeding, or are taking any medicines that may increase the risk of bleeding (see section 4 "Possible side effects").
• have an infection (see section 4 "Possible side effects").
• have recently had or are about to have surgery. 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, so your doctor will look for signs of the infection coming back (see section 4 "Possible side effects").
• have or have ever had an irregular heartbeat (see section 4 "Possible side effects").

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

During treatment, your doctor will do blood tests to check your blood cell count when necessary.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years old. 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, have recently taken, or might take any other medicines, especially:

• 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)
• ergotamine - a medicine for migraines
• conivaptan - a medicine for low sodium levels in the blood
• metformin - a medicine for high blood sugar levels
• ciclosporin - a medicine to prevent organ rejection
• medicines for seizures or epilepsy - such as carbamazepine or phenytoin
• pimozide - a medicine used for Tourette's syndrome (a condition that causes uncontrolled movements and sudden outbursts of words or 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 when there are problems with the immune system.
• • This medicine should be taken at least 6 hours before or after Calquence.

You can take medicines that reduce stomach acid, 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. Tell your doctor, pharmacist, or nurse if you take other medicines that increase the risk of bleeding:

• Antiplatelet medicines (which prevent blood clots) such as acetylsalicylic acid and clopidogrel
• Anticoagulants (blood thinners) such as warfarin or enoxaparin

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. This is because this medicine may harm your unborn baby.

Breast-feeding

Do not breast-feed during treatment with Calquence and for 2 days after receiving the last dose of Calquence. It is not known whether Calquence passes into breast milk.

Driving and using machines

Calquence is unlikely to affect your ability to drive or use machines. However, if you feel dizzy, weak, or tired while taking Calquence, do not drive or use machines.

Calquence contains sodium

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

3. How to take Calquence

Calquence will only be prescribed by a doctor with experience in using medicines for cancer. Follow your doctor's instructions for taking Calquence exactly. If you are unsure, ask your doctor, pharmacist, or nurse again.

Depending on the type of cancer you have, Calquence may be given in combination with other cancer medicines.

How much to take

• The usual dose is one tablet (100 mg) twice a day. Take the doses about 12 hours apart.

How to take Calquence

• Swallow the tablet whole with water, at about the same time every day.
• Do not chew, crush, dissolve, or divide the tablets.
• You can take Calquence with or without food.
• You can check when you last took a Calquence tablet by looking at the blister pack. The pictures 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 evening dose.

If you take more Calquence than you should

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

If you forget to take Calquence

• If it has been less than 3 hours since your usual dose time, take the missed dose as soon as you remember. Take the next dose at the usual time.
• If it has been more than 3 hours since your usual dose time, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of Calquence to make up for a missed dose.

If you have any other questions about using 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 your doctor or go to hospital immediately if you notice any of the following side effects:

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

• Bleeding in different places, including the skin, intestine, and brain. The signs may be black or bloody stools, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion.
• Infections: The signs may include fever, chills, feeling weak or confused, cough, difficulty breathing [Pneumonia, a very common side effect(may affect more than 1 in 10 people) or Aspergillus infections, a rare 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 heartbeats, weak or irregular pulse, dizziness, feeling faint, chest discomfort or difficulty breathing (signs of heart rhythm problems, known as atrial fibrillation or atrial flutter).
• Fever, chills, nausea, vomiting, confusion, difficulty breathing, seizures, irregular heartbeats, dark or cloudy urine, unusual tiredness or muscle or joint pain. This may be a sign of a condition called tumour 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
• Rash
• Feeling tired (fatigue), weak or lacking energy
• Feeling sick (nausea), vomiting, stomach pain, constipation (infrequent or difficult bowel movements), diarrhoea (frequent or loose bowel movements)
• Decrease in the number of red blood cells, decrease in the number of neutrophils (a type of white blood cell), or decrease in the number of cells that help the blood to clot (platelets)
• High blood pressure
• Dizziness
• 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 when urinating)
• New cancers, including skin cancers, may appear 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):

• High levels of liver enzymes (aspartate aminotransferase and alanine aminotransferase) in the blood [when used in combination with certain medicines to treat mantle cell lymphoma (MCL)]
• Bronchitis
• 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
• Lung inflammation (pneumonitis)

Uncommon side effects(may affect up to 1 in 100 people):

• Memory loss, problems thinking, difficulty walking, or loss of vision - these may be signs of a serious brain infection (Progressive Multifocal Leukoencephalopathy or PML)
• Lymphocytosis (an increase in the normal level of lymphocytes, a type of white blood cell)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 hydroxypropylcellulose (E463), and sodium stearyl fumarate (see section 2 "Calquence contains sodium").
• Tablet coating: hypromellose (E464), copovidone, titanium dioxide (E171), macrogol, medium-chain triglycerides, yellow iron oxide (E172), and red iron oxide (E172)

Appearance and packaging of Calquence

Calquence is an orange, 7.5 x 13 mm, oval, biconvex, film-coated tablet engraved with "ACA 100" on one side and plain on the reverse.

Calquence is available 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 sun and moon blisters contain the same medicine. Each carton contains 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can get more information about this medicine from your local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.