Acalabrutinib (Acalabrutinib 100 mg) is a prescription cancer medicine taken by mouth. It is used to treat some blood cancers that start in B cells, a type of white blood cell. In adults, it is used for chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL). Acalabrutinib (Acalabrutinib 100 mg) belongs to a group of medicines called Bruton tyrosine kinase (BTK) inhibitors. It blocks a signal that cancerous B cells need to grow and survive. Doctors may prescribe it alone or with other cancer medicines. It is usually taken twice a day and needs regular check-ups and blood tests.

Acalabrutinib (Acalabrutinib 100 mg) is a targeted cancer medicine. Standard chemotherapy damages many fast-growing cells in the body, but Acalabrutinib (Acalabrutinib 100 mg) works differently. It targets one protein called Bruton tyrosine kinase (BTK). B cells use BTK to pass on growth signals. In CLL, SLL and mantle cell lymphoma, cancerous B cells depend on these signals to multiply, move around the body and stay alive. When BTK is blocked, the cancer cells lose this support.

In adults, Acalabrutinib (Acalabrutinib 100 mg) is used for:

• Chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL): It is used alone or with other cancer medicines, such as obinutuzumab or venetoclax, to treat these B-cell cancers of the blood, bone marrow and lymph nodes.
• Previously treated mantle cell lymphoma (MCL): It is used in adults whose mantle cell lymphoma has already been treated with at least one other therapy.
• Newly diagnosed mantle cell lymphoma (MCL): It is used together with bendamustine and rituximab in adults who cannot have a stem cell transplant. A stem cell transplant is a procedure that replaces damaged bone marrow with healthy blood-forming cells.

Acalabrutinib (Acalabrutinib 100 mg) is a tablet or capsule taken at home. How long you take Acalabrutinib (Acalabrutinib 100 mg) depends on your treatment plan. When it is used alone, or after combination treatment for mantle cell lymphoma, it is usually continued for as long as it keeps working and side effects stay manageable. When it is combined with venetoclax for CLL/SLL, treatment usually stops after a set number of 28-day cycles (up to 14 cycles). Your doctor will tell you how long to take it. When taken regularly twice a day, Acalabrutinib (Acalabrutinib 100 mg) keeps BTK almost fully blocked across each 12-hour dosing period.

Acalabrutinib (Acalabrutinib 100 mg) needs close medical supervision. It can cause serious infections, serious bleeding, low blood counts, heart rhythm problems and liver injury. Some of these can be life-threatening. People taking it have also developed new cancers, most often skin cancers. Your doctor will order regular blood tests and liver tests, check your skin, and ask about your symptoms at each visit.

Acalabrutinib (Acalabrutinib 100 mg) also interacts with many common medicines. Some of these can change how much of it stays in your blood. Always tell every doctor, dentist and pharmacist you see that you take Acalabrutinib (Acalabrutinib 100 mg). Your doctor may need to pause it before an operation or dental procedure because it raises the risk of bleeding.

1. Targeted action against cancerous B cells - Acalabrutinib (Acalabrutinib 100 mg) blocks BTK, a signal that cancerous B cells need to grow, move and survive.
2. Treats more than one blood cancer - It is used for CLL, SLL and mantle cell lymphoma in adults.
3. Can be used alone or in combination - Doctors may give it on its own or with other cancer medicines, depending on the type and stage of the illness.
4. Taken by mouth at home - It is a tablet or capsule you take at home. If it is combined with other cancer medicines, those may still be given as a drip in hospital.
5. Steady effect between doses - In people with B-cell cancers, a twice-daily dose kept BTK almost fully blocked across each 12-hour period.
6. Flexible with meals - You can take it with or without food, which makes it easier to fit into a daily routine.

Common Side Effects (Usually Mild)

• Upper respiratory infections, such as a cold, sore throat or blocked nose
• Diarrhoea
• Headache
• Muscle and joint pain
• Tiredness
• Bruising
• Lower white blood cell, red blood cell (anaemia) and platelet counts on blood tests

Serious Side Effects (Seek Urgent Medical Attention)

• Serious infections: Signs include fever, chills, cough, breathlessness or flu-like symptoms. These infections can be fatal. They include opportunistic infections, which are infections that mostly affect people with a weak immune system. Examples include fungal pneumonia (a lung infection caused by a fungus) and Pneumocystis pneumonia (a serious lung infection caused by a fungus that mostly affects people with weak immunity). Another example is hepatitis B reactivation, which means an old hepatitis B infection becomes active again. A rare and serious brain infection called progressive multifocal leukoencephalopathy (PML) has also been reported. Warning signs of PML include new confusion, weakness or problems with speech or vision.
• Serious bleeding (haemorrhage): Warning signs include black or tarry stools, blood in stools, and pink or brown urine. Others are vomiting blood or vomit that looks like coffee grounds, coughing up blood, and bleeding you cannot stop. Bleeding inside the head can cause a long-lasting headache, confusion, dizziness, weakness or changes in speech. The risk is higher if you also take blood thinners.
• Low blood counts (cytopenias): The number of white blood cells, red blood cells or platelets can drop sharply. This raises the risk of infection, tiredness and bleeding.
• Heart rhythm problems (cardiac arrhythmias), including atrial fibrillation: Atrial fibrillation means the upper chambers of the heart beat fast and out of rhythm. Watch for a fast or irregular heartbeat, dizziness, fainting, chest discomfort or shortness of breath. These problems can be serious or fatal.
• Liver damage (drug-induced liver injury): This can be severe or life-threatening. Signs include stomach pain, dark urine and yellowing of the skin or eyes.
• New cancers (second primary cancers): Some people have developed new cancers during treatment, most often skin cancers. Other organs can also be affected.

• Take Acalabrutinib (Acalabrutinib 100 mg) exactly as your doctor prescribes. It is usually taken about every 12 hours, for example once in the morning and once in the evening.
• Try to take it at the same times each day. This keeps a steady level of medicine in your body.
• Swallow the tablet whole with a glass of water. Do not chew, crush, dissolve or cut it.
• If you have the capsule form, swallow it whole with water. Do not open, break or chew the capsule.
• You can take Acalabrutinib (Acalabrutinib 100 mg) with or without food.
• If you take antacids or other acid-reducing medicines, follow your doctor's advice on timing. This matters most for the capsule form (see the drug interactions section).
• Keep taking Acalabrutinib (Acalabrutinib 100 mg) for as long as your doctor tells you. Do not stop or change the dose on your own, even if you feel well.
• Keep all appointments for blood tests and liver tests. Your doctor uses these results to decide whether the dose needs to change.

B cells are white blood cells that help fight infection. Each B cell has a receptor on its surface that works like an "on" switch. When the switch is turned on, a chain of signals passes into the cell. One key link in that chain is an enzyme called Bruton tyrosine kinase (BTK). An enzyme is a protein that speeds up a chemical step inside the body.

In CLL, SLL and mantle cell lymphoma, cancerous B cells rely on BTK signals to multiply, travel through the body, and stick in places like the lymph nodes and bone marrow, where they are protected.

Acalabrutinib (Acalabrutinib 100 mg) fits into the working pocket of BTK. There it forms a strong, lasting chemical bond, called a covalent bond, with one part of the enzyme. Once this bond forms, that BTK molecule stops working. The liver also turns Acalabrutinib (Acalabrutinib 100 mg) into an active breakdown product, and this product blocks BTK in the same way.

With BTK switched off, growth and survival signals no longer reach the cancerous B cells properly. In laboratory studies, this stopped cancerous B cells from multiplying and slowed tumour growth.

The liver mainly breaks down Acalabrutinib (Acalabrutinib 100 mg) using an enzyme system called CYP3A. This is why medicines that speed up or slow down CYP3A can change how much Acalabrutinib (Acalabrutinib 100 mg) is in your blood.

• Take your doses about 12 hours apart, at the same times each day.
• Swallow the tablet whole with water. Never chew, crush, dissolve or cut it. If you have capsules, do not open, break or chew them.
• Keep a list of all your medicines, vitamins and herbal products, and show it to every doctor and pharmacist you see.
• Tell your doctor right away if you have a fever, chills or flu-like symptoms.
• Report any unusual bruising, black stools, blood in your urine, or bleeding that will not stop.
• Report a racing or irregular heartbeat, fainting or chest discomfort straight away.
• Use sunscreen and protective clothing outdoors, and point out any new or changing skin spots at your check-ups.
• Tell your surgeon or dentist that you take Acalabrutinib (Acalabrutinib 100 mg) before any procedure.
• Never take extra doses to make up for a missed one.

• Store at room temperature between 20°C and 25°C (68°F to 77°F). Short periods between 15°C and 30°C (59°F to 86°F) are acceptable.
• Keep the medicine in its original container with the lid tightly closed.
• The bottle has a child-resistant cap. Keep it closed and store it where children and pets cannot see or reach it.
• Do not use the medicine after its expiry date. Ask your pharmacist how to dispose of unused medicine safely.

• Meals: You can take Acalabrutinib (Acalabrutinib 100 mg) with or without food. A high-fat meal slows how fast the medicine is absorbed and lowers its peak level. However, it does not change the total amount absorbed.
• Herbal products and supplements: Some herbal products can speed up or slow down the liver enzymes that break down Acalabrutinib (Acalabrutinib 100 mg). For example, St John's wort can lower the level of Acalabrutinib (Acalabrutinib 100 mg) and make it less effective. Check with your doctor or pharmacist before taking any herbal remedy or supplement.
• Grapefruit and grapefruit juice: Grapefruit can slow down CYP3A, the liver enzyme that breaks down Acalabrutinib (Acalabrutinib 100 mg), which may raise its level in your blood. Ask your doctor whether you should avoid grapefruit while taking Acalabrutinib (Acalabrutinib 100 mg).
• Alcohol: Discuss alcohol use with your doctor, since Acalabrutinib (Acalabrutinib 100 mg) can affect the liver.

• Strong CYP3A blockers (for example, itraconazole): These medicines sharply raise the level of Acalabrutinib (Acalabrutinib 100 mg) in the blood and increase the risk of side effects. Doctors usually avoid using them together. If the other medicine is needed only for a short time, your doctor may pause Acalabrutinib (Acalabrutinib 100 mg).
• Moderate CYP3A blockers (for example, erythromycin, fluconazole and diltiazem): These can raise the level of Acalabrutinib (Acalabrutinib 100 mg). Your doctor may lower your dose of Acalabrutinib (Acalabrutinib 100 mg) while you take them.
• Strong CYP3A speeders (for example, rifampicin): These lower the level of Acalabrutinib (Acalabrutinib 100 mg), which may make it less effective. Doctors usually avoid this combination. If it cannot be avoided, your doctor may change your dose.
• Blood thinners and antiplatelet medicines (for example, warfarin, aspirin and clopidogrel): Taking these with Acalabrutinib (Acalabrutinib 100 mg) may further raise the risk of bleeding. Your doctor will weigh the risks and benefits.
• Acid-reducing medicines (capsule form only): Avoid proton pump inhibitors (strong stomach-acid-reducing medicines), such as omeprazole and pantoprazole, with Acalabrutinib (Acalabrutinib 100 mg) capsules. If you take H2 blockers (another type of acid-reducing medicine), such as famotidine, take the capsule 2 hours before them. Keep antacids at least 2 hours apart from the capsule. The tablet form was not affected by a proton pump inhibitor in studies. Check with your pharmacist which form you have.
• Other medicines, vitamins and herbal products: Acalabrutinib (Acalabrutinib 100 mg) interacts with many medicines. Tell your doctor about everything you take, including medicines bought without a prescription.

• Active or recent infection: Acalabrutinib (Acalabrutinib 100 mg) lowers the body's ability to fight infection. Tell your doctor if you have any infection before you start.
• Hepatitis B, past or present: An old hepatitis B infection can become active again. Your doctor may test you and watch you closely.
• Liver disease: Avoid Acalabrutinib (Acalabrutinib 100 mg) if you have severe liver disease. Liver tests are needed throughout treatment.
• Bleeding disorders or recent or planned surgery: The risk of bleeding is higher. Your doctor may stop the medicine for about 3 to 7 days before and after surgery, depending on the type of procedure and your bleeding risk.
• Heart rhythm problems, high blood pressure or other heart risk factors: These raise the risk of irregular heartbeats such as atrial fibrillation while taking Acalabrutinib (Acalabrutinib 100 mg).
• Low blood counts: Acalabrutinib (Acalabrutinib 100 mg) can lower blood counts further, so regular blood tests are needed.
• History of skin cancer: New skin cancers have been reported, so regular skin checks and sun protection are advised.

• The usual adult dose of Acalabrutinib (Acalabrutinib 100 mg) is 100 mg taken by mouth about every 12 hours. This is two doses in 24 hours.
• Your doctor may lower the dose or how often you take it if you have certain side effects or take certain other medicines.
• Take only the dose your doctor prescribes. Do not change the dose, skip doses or stop treatment without first talking to your doctor.

If you or someone else has taken more Acalabrutinib (Acalabrutinib 100 mg) than prescribed, contact a doctor or go to the nearest emergency department straight away. Take the medicine pack with you. An overdose may raise the risk of the medicine's known serious effects, such as bleeding, heart rhythm problems and liver injury. Watch for unusual bleeding or bruising, a fast or irregular heartbeat, dizziness, fainting, or yellowing of the skin. Hospital staff will monitor the person and treat any symptoms.

• If you remember within 3 hours of your usual time, take the missed dose straight away.
• If more than 3 hours have passed, skip the missed dose. Take your next dose at the usual time.
• Never take an extra dose to make up for a missed one.

Seek medical help right away if you notice:

• Fever, chills, cough, breathlessness or flu-like symptoms
• Black or tarry stools, blood in your stools, or pink or brown urine
• Vomiting blood or vomit that looks like coffee grounds, or coughing up blood
• Bleeding that is heavy or will not stop, or bruising or red or purple skin marks without a clear cause
• A long-lasting headache, new confusion, weakness, or changes in your speech or vision
• A fast or irregular heartbeat, chest discomfort, dizziness or fainting
• Stomach pain, dark urine, or yellowing of your skin or eyes
• A new or changing spot, sore or growth on your skin
• Signs that you may be pregnant