Calquence 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Calquence 100 mg film-coated tablets acalabrutinib

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

• Keep this leaflet; 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Calquence is and what it is used for
2. What you need to know before taking Calquence
3. How to take Calquence
4. Possible side effects
5. How to store Calquence
6. Contents of the pack and other information

1. What Calquence is and what it is used for

What Calquence is

• Calquence contains the active substance acalabrutinib.
• It belongs to a group of medicines called Bruton's tyrosine kinase (BTK) inhibitors.

What Calquence is used for

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

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

Calquence is used to treat adults with mantle cell lymphoma (MCL).

MCL is a type of blood cancer that affects 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 kill cancer cells and may reduce their number, which can slow the progression of the disease.

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

2. What you need to know before taking Calquence

Do not take Calquence:

• if you are allergic to acalabrutinib or to any of the other ingredients of this medicine (listed in section 6).

If you have any doubts, consult your doctor, pharmacist, or nurse before starting Calquence.

Warnings and precautions

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

• have ever had abnormal bruising or bleeding, or are taking any medicine that increases 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 temporarily stop treatment with Calquence before and after any medical, surgical, or dental procedure.
• have ever had hepatitis B (a liver infection) – because Calquence could reactivate hepatitis B, so your doctor will monitor for signs of this infection returning (see section 4 “Possible side effects”).
• have or have ever had an irregular heartbeat (see section 4 “Possible side effects”).

Talk to your doctor if you develop a new skin lesion or any changes in the appearance of a skin area, as you may be at increased risk of developing skin cancer (see section 4). Use sun protection and perform regular skin examinations.

During treatment, your doctor will perform blood tests as needed to monitor your blood cell counts.

Children and adolescents

Do not give 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

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• antibiotics for bacterial infections – such as clarithromycin
• antifungal medicines – such as posaconazole, itraconazole, or voriconazole
• ketoconazole – a medicine used 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
• cyclosporine – 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 causing uncontrollable movements and sudden utterances of words and sounds)
• St. John’s wort (hypericum) – a herbal medicine used for depression
• theophylline – a medicine used for wheezing, shortness of breath, and chest tightness
• methotrexate – a medicine for conditions such as rheumatoid arthritis, psoriasis, and ulcerative colitis, which occur when the immune system is not working properly.
  • This medicine should be taken at least 6 hours before or after Calquence.

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

• Antiplatelet agents (which prevent clotting) 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 become pregnant, talk to your doctor before using this medicine. This medicine may harm the unborn baby.

Breast-feeding

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

Driving and using machines

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

Calquence contains sodium

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

3. How to take Calquence

Calquence will only be prescribed by a doctor experienced in the use of cancer medicines. Always follow exactly the instructions given by your doctor for taking Calquence. If you are unsure, consult your doctor, pharmacist, or nurse again.

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

What dose to take

• The usual dose is one tablet (100 mg) twice daily. Take the doses approximately 12 hours apart.

How to take Calquence

• Swallow the tablet whole with water, at approximately the same time each day.
• Do not chew, crush, dissolve, or split the tablets.
• You may take Calquence with or without food.
• 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 correct 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, contact a doctor or go immediately to the nearest hospital. Take the tablets and this leaflet with you.

If you forget to take Calquence

• If less than 3 hours have passed since your usual dosing time, take the missed dose immediately. Then take your next dose at the usual time.
• If more than 3 hours have passed since your usual dosing time, skip the missed dose. Take your 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• Bleeding in different parts of the body, including the skin, intestines, and brain. Signs may include black or bloody stools, 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, difficulty breathing [Pneumonia, a very common adverse effect (may affect more than 1 in 10 people) or Aspergillus infections, a less common adverse effect (may affect up to 1 in 100 people)].

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

• Rapid heartbeat, 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 heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. These may be signs of tumor lysis syndrome (TLS) – a condition caused by the rapid breakdown of cancer cells.

Other adverse 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 unwell in the stomach (nausea), vomiting, stomach pain, constipation (infrequent or difficult bowel movements), diarrhea (frequent or loose stools)
• Decreased number of red blood cells in the blood, decreased number of neutrophils (a type of white blood cell), or decreased number of blood-clotting cells (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 sensation when urinating)
• New cancers, including skin cancers, may develop during treatment with Calquence (see section 2, “What you need to know before taking Calquence”)
• Herpes

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

• Elevated liver enzyme levels (aspartate aminotransferase and alanine aminotransferase) in blood tests [when used in combination with certain medicines for the treatment of mantle cell lymphoma (MCL)]
• Bronchitis
• Fever, chills, weakness, confusion, malaise, and yellowing of the skin or eyes (jaundice) – these may be signs of reactivation of hepatitis B (a liver infection)
• Inflammation of the lungs (pneumonitis)

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

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calquence

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

The other components 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).

Nature of the product and contents of the pack

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

Calquence is available in aluminum blisters containing 8 or 10 film-coated tablets. Each blister includes sun/moon symbols to help you take your dose at the correct 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 carton contains 56 or 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB
SE‑151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Gärtunavägen
SE‑152 57 Södertälje
Sweden

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.