Acalabrutinib Cipla 100 mg Capsules

What ACALABRUTINIB CIPLA is

ACALABRUTINIB CIPLA is a medicine used to treat cancer.

• ACALABRUTINIB CIPLA contains the active substance: acalabrutinib
• ACALABRUTINIB CIPLA belongs to a class of anti-cancer medicines called Bruton tyrosine kinase (BTK) inhibitors.

What ACALABRUTINIB CIPLA is used for

ACALABRUTINIB CIPLA is used to treat adults with a type of cancer called:

• Mantle cell lymphoma (MCL), who have received at least one prior treatment for their cancer
• Chronic lymphocytic leukaemia (CLL), which 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)

ACALABRUTINIB CIPLA works by blocking BTK, a protein in the body that helps these cancer cells grow and survive. By blocking BTK, ACALABRUTINIB CIPLA helps to kill and can reduce the number of cancer cells which can slow down the worsening of the disease.

Do not take ACALABRUTINIB CIPLA:

• if you are allergic (hypersensitive) to acalabrutinib or any of the other ingredients of ACALABRUTINIB CIPLA listed in section 6. If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Tell your doctor or health care provider before taking ACALABRUTINIB CIPLA if:

• you have an infection, see section 4 ‘Possible side effects’
• you have ever had unusual bruising or bleeding problems or are on any medicines that increase your risk of bleeding (see section 4)
• you have had recent operation or are planning to have operation. Your healthcare provider may stop ACALABRUTINIB CIPLA before and after a medical, surgical, or dental procedure
• you are pregnant or plan to become pregnant. ACALABRUTINIB CIPLA may harm your unborn baby and problems during childbirth
• you are breastfeeding or plan to breastfeed. It is not known if ACALABRUTINIB CIPLA passes into your breast milk. Do not breastfeed during treatment with ACALABRUTINIB CIPLA and for at least 2 days after your final dose
• you have ever had hepatitis B (a liver infection) – this is because ACALABRUTINIB CIPLA 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)
• you have or ever had irregular heartbeat (see section 4)

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.

Do not share medicines prescribed for you with any other person. Always take your ACALABRUTINIB CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The usual dose is one 100 mg capsule twice a day (to be taken in 12 hours apart)
• Swallow the capsule whole with water at approximately the same time each day
• Do not open, dissolve, or chew the capsules
• You can take ACALABRUTINIB CIPLA with or without food
• If you take medicine called antacids (e.g. calcium carbonate), take the antacid medicine 2 hours before or 2 hours after you take
• If you take medicines called histamine-2 receptor blockers (e.g. ranitidine or famotidine), take ACALABRUTINIB CIPLA, 2 hours before the histamine-2 receptor blocker.

Your doctor will tell you how long your treatment with ACALABRUTINIB CIPLA will last. Do not stop treatment early because you feel better. If you have the impression that the effect of ACALABRUTINIB CIPLA is too strong or too weak, tell your doctor or pharmacist.

If you take more ACALABRUTINIB CIPLA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ACALABRUTINIB CIPLA

• 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 ACALABRUTINIB CIPLA to make up for a forgotten dose.

ACALABRUTINIB CIPLA can have side effects. Not all side effects reported for ACALABRUTINIB CIPLA are included in this leaflet. Should your general health worsens or if you experience any untoward effects while taking ACALABRUTINIB CIPLA, please consult your health care provider for advice.

If any of the following happens, stop taking ACALABRUTINIB CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Bleeding: 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.

These are all very serious side effects. If you have them, you may have had a serious reaction to ACALABRUTINIB CIPLA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent 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).

These are all serious side effects. You may need urgent medical attention.

Other side effects

Tell your doctor if you notice any of the following:

Frequent side effects:

• 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)
• dizziness
• nose bleeds
• bleeding
• new cancers, including cancers of the skin, may happen during treatment with ACALABRUTINIB CIPLA (see section 2)
• non-melanoma skin cancer
• bruising

Frequent side effects in blood tests:

• decreased number of white blood cells
• decreased number of red blood cells
• decreased number of cells that help blood clot (platelets)

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

• 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or [email protected]. By reporting side effects, you can help provide more information on the safety of ACALABRUTINIB CIPLA.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Store in the original package / container
• Do not use after the expiry date stated on the bottle
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).