100 mg hard capsules 
akalabrutinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours. 
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
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 packaging and other information 

1. What Calquence is and what it is used for

What Calquence is

Calquence is a drug used to treat cancer.

  • 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 the white blood cells called B lymphocytes (or B cells ). These cells are part of the immune system (the body’s defenses).

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 further questions on the use of Calquence or why you have been prescribed this medicine, ask your doctor, pharmacist, or nurse.

2. What you need to know before taking Calquence

Do not take Calquence:

  • if you are allergic to akalabrutinib 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 cautions

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

  • have ever had unusual bruising or bleeding or are taking any medicines that increase the risk of bleeding (see section 4 “Possible side effects”).
  • have an infection (see section 4 “Possible side effects”).
  • recently or soon to be operated on. Your doctor may want to take a break from Calquence before and after a medical, surgical, or dental procedure.
  • have ever had hepatitis B (an infection of the liver). The reason for this is that Calquence can cause your hepatitis B to become active again. Your doctor will therefore be aware of any signs that an infection has returned (see section 4 “Possible side effects”).
  • have or have had an irregular heartbeat (see section 4 “Possible side effects”).

Talk to your doctor if you develop a new skin change or see any change in the appearance of your skin because you have an increased risk of developing skin cancer, see section 4. Use sunscreen and examine your skin regularly.

Your doctor will check your blood levels as needed during treatment.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age. The reason is that it has not been studied in this age group.

Other drugs and Calquence

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

  • Antibiotics for bacterial infections – such as clarithromycin
  • medicines for fungal infections – such as posaconazole, itraconazole, voriconazole
  • ketoconazole – a drug for Cushing’s syndrome (a condition in which the body produces too much of the hormone et cortisol )
  • medicines for HIV – infections – such as indinavir and ritonavir
  • medicines for hepatitis C – such as telaprevir
  • rifampicin – an antibiotic for bacterial infection ( tuberculosis )
  • medicines for migraines – ergotamine
  • drug for low sodium in the blood – conivaptan
  • drug for high blood sugar – metformin
  • drug to prevent organ rejection – cyclosporine
  • medicines for seizures (seizures) or epilepsy – such as carbamazepine and phenytoin
  • pimozide – a drug used in Tourette’s (a condition that causes uncontrolled movements and outbursts of words and sounds)
  • (traditional) herbal medicines containing St. John’s wort – for mild depression
  • Theophylline – a drug used for wheezing, shortness of breath, and pressure over the chest
  • medicines to reduce stomach acid:
  • antacids – such as calcium carbonate
    • take Calquence 2 hours before or 2 hours after taking these medicines
  • histamine -2 receptor blockers – such as ranitidine and famotidine
    • take Calquence 2 hours before or 10 hours after taking these medicines
  • proton pump inhibitors – such as omeprazole
    • Avoid taking these medicines while taking Calquence
  • methotrexate – a drug for diseases such as rheumatoid arthritis, psoriasis, and ulcerative colitis caused by the immune system not working properly.
    • This medicine should be taken at least 6 hours before or after taking Calquence

Drugs that increase the risk of bleeding

Calquence can make you bleed easier. Tell your doctor, pharmacist, or nurse if you are taking other medicines that increase your risk of bleeding.

  • Platelet inhibitors (prevents blood clots from forming) e.g. acetylsalicylic acid and clopidogrel
  • Anticoagulants (blood thinners) e.g. 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 using Calquence. This is because Calquence can 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 unknown if Calquence passes into breast milk.

Driving and using machines

Calquence is not expected to affect the ability to drive or use machines. However, you must not drive or use machines if you feel dizzy, weak or tired while taking Calquence.

Calquence contains sodium

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

3. How to take Calquence

Calquence will only be prescribed by doctors with experience in the use of anti-cancer drugs. Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How much to take

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

How to take it

  • Swallow the capsule whole with water at about the same time each day.
  • Do not chew, dissolve, or open the capsule as this may change how quickly the medicine is absorbed into your body.
  • You can take Calquence with food or between meals.
  • You can check when you last took a capsule of Calquence by looking at the blister. Pictures of the blister 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, consult a doctor, or see your nearest hospital immediately. Take the capsules and this leaflet with you.

If you forget to take Calquence

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

If you have any further questions on the use of this product, 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 the nearest emergency room immediately if you experience any of the following side effects:

  • Bleeding. Symptoms may include black stools or blood in the stools, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion.
  • Infection is. Signs may include fever, chills, weakness or confusion, cough, shortness of breath [pneumonia, a very common side effect (may affect more than 1 in 10 people) or aspergillus infection, a less common side effect (may affect up to 1 in 100 people) user)].

Common serious side effects are (may affect up to 1 in 10):

  • rapid heartbeat, missed heartbeat, weak or irregular heartbeat, dizziness, fainting, chest discomfort, or shortness of breath (signs of heart rhythm problems called atrial fibrillation and atrial flutter ).

Common serious side effect is (may affect up to 1 in 100):

  • fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, and muscle or joint pain. These can be symptoms of tumor lysis syndrome (TLS) – a condition caused by a rapid breakdown of cancer cells.

Other side effects:

Very common (may affect more than 1 user in 10)

  • muscle or joint pain
  • headache
  • rash
  • fatigue, weakness, or lack of energy
  • nausea, vomiting, abdominal pain, constipation (irregular periods), diarrhea (recurrent)
  • decreased number of red blood cells, decreased number of neutrophils (a type of white blood cell), or decreased number of cells that help the blood to clot ( platelets ).
  • dizziness
  • headache, pressure in the eye, nose, or cheeks (sinusitis)
  • sore throat and runny nose ( nasopharyngitis )
  • upper respiratory tract infection
  • urinary tract infection (pain or burning sensation when urinating).
  • new cancers, including skin cancer, may occur during treatment with Calquence (see section 2 “What you need to know before you take Calquence”)

Common (may affect up to 1 in 10 people)

  • tracheal catarrh (does not require immediate action)
  • herpes

Less common side effects are (may affect up to 1 in 100)

  • memory loss, difficulty thinking, difficulty walking, or loss of vision – these may be signs of serious brain infection ( progressive multifocal leukoencephalopathy or PML)
  • fever, chills, weakness, confusion, nausea, and yellowing of the skin or whites of the eyes (jaundice) – these may be signs that hepatitis B (a liver infection) has become active again.
  • lymphocytosis (the number of lymphocytes is higher than normal, a type of white blood cell in the blood).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 and the carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is akalabrutinib. Each hard capsule contains 100 mg of akalabrutinib.

Other ingredients are:

  • Capsule contents: microcrystalline cellulose, colloidal anhydrous silica, partially pregelatinized maize starch, magnesium stearate (E470b), and sodium starch glycolate (see section 2 “Calquence contains sodium”).
  • Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and indigo carmine (E132).
  • Ink: shellac, black iron oxide (E172), propylene glycol (E1520), and ammonium hydroxide.

What the medicine looks like and the contents of the pack

Calquence is a hard gelatin capsule with a yellow base, blue top, 20 mm hard capsule, marked with “ACA 100 mg” in black.

Calquence is supplied in aluminum blisters with 6 or 8 hard capsules. Each carton contains either 56 or 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 24455000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080 The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 210 6871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 PolandAstraZeneca Pharma Poland Sp. z ooTel: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000 RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
ΚύπροςAlexander the Great:Ηλ: +357 22490305
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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