ACABRUNAT (ACALABRUTINIB) 100MG Caps 30`S

ACABRUNAT contains acalabrutinib, a targeted cancer medicine that belongs to a class of drugs called BTK inhibitors (Bruton's Tyrosine Kinase inhibitors). It works by blocking a specific protein (BTK) that cancer cells need to grow and survive, effectively slowing or stopping the growth of certain blood cancers.

Acalabrutinib 100 mg is indicated for the treatment of adults with: Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) — as a first-line treatment or after at least one prior therapy; and Mantle Cell Lymphoma (MCL) — in patients who have received at least one prior therapy.

Unlike traditional chemotherapy, acalabrutinib is a precision medicine that specifically targets cancer cells. It is taken orally and has been shown in clinical trials to significantly improve progression-free survival in patients with CLL/SLL and MCL.

The recommended dose of acalabrutinib is 100 mg taken twice daily (approximately every 12 hours), with or without food. Capsules should be swallowed whole with water — do not open, crush, or chew the capsules.

Dosing Schedule

•       Take one 100 mg capsule in the morning and one 100 mg capsule in the evening.

•       Take at roughly the same times every day to maintain steady levels in your blood.

•       If you miss a dose, take it as soon as you remember — unless the next dose is within 3 hours. Never double up.

Acid-Reducing Medicines

Proton pump inhibitors (PPIs) such as omeprazole can reduce acalabrutinib absorption. If you take antacids (e.g., aluminium/magnesium hydroxide), take acalabrutinib at least 2 hours before or after. If you use H2-receptor antagonists (e.g., ranitidine), take acalabrutinib at least 2 hours before taking the H2 blocker. PPIs should ideally be avoided — discuss alternatives with your doctor.

Common Side Effects (may affect more than 1 in 10 patients)

•       Headache — often mild and occurs early in treatment.

•       Diarrhoea — usually mild; stay hydrated.

•       Bruising easily and petechiae (small red/purple spots on skin).

•       Fatigue and muscle aches (myalgia).

•       Upper respiratory tract infections (coughs, colds).

•       Nausea.

Serious Side Effects — Tell Your Doctor Immediately

•       Unusual bleeding (blood in urine/stool, prolonged bleeding from cuts).

•       Signs of infection: fever, chills, persistent sore throat.

•       Irregular heartbeat or palpitations (atrial fibrillation).

•       Severe skin rash or allergic reaction.

•       Progressive Multifocal Leukoencephalopathy (PML) — rare brain infection: confusion, memory loss, vision or speech changes.

Bleeding Risk

Acalabrutinib increases the risk of bleeding. Tell your doctor before starting this medicine if you take blood thinners (warfarin, heparin, aspirin, NSAIDs like ibuprofen). You may need to stop acalabrutinib 3–7 days before any surgical procedure.

Infections

Patients taking acalabrutinib are more prone to infections, including serious bacterial, viral, and fungal infections. Report any signs of infection to your doctor promptly.

Cardiac Effects

Atrial fibrillation (irregular heartbeat) has been reported. Tell your doctor if you have existing heart problems or experience palpitations, shortness of breath, or chest discomfort.

Pregnancy and Breastfeeding

Acalabrutinib can harm an unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose. Breastfeeding is not recommended during treatment.

Tell your doctor and pharmacist about all medicines you are taking, as acalabrutinib is metabolised by CYP3A4 enzymes and interacts with several drugs:

•       Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) — increase acalabrutinib levels; avoid combination.

•       Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St John's Wort) — decrease acalabrutinib levels; avoid combination.

•       Anticoagulants and antiplatelet drugs (warfarin, aspirin, clopidogrel) — increased bleeding risk.

•       Proton pump inhibitors (omeprazole, lansoprazole) — reduce absorption; use antacids or H2 blockers with timing separation instead.

•       Store below 30°C in a dry place, away from direct sunlight.

•       Keep in the original packaging.

•       Keep out of reach of children.

•       Do not use after the expiry date printed on the pack.

ACABRUNAT (acalabrutinib) is a prescription-only medicine (POM) in Kenya. It must only be dispensed on the prescription of a registered oncologist or physician. This is a specialist medicine and patients should not share it with others.

•       Dose: 100 mg twice daily (200 mg/day total). No dose adjustment for mild-moderate hepatic impairment; avoid in severe hepatic impairment.

•       CrCl ≥15 mL/min: no dose adjustment needed. Not adequately studied in severe renal impairment — monitor.

•       Monitor full blood count (FBC), liver function tests (LFTs), and signs of bleeding/infection regularly.

•       Hold treatment at least 3–7 days prior to elective surgery.

•       No food effect on absorption — capsules may be taken with or without food.

•       Counsel patient on PML risk (rare) — reinforce reporting of any neurological symptoms.

What is ACABRUNAT used for?

ACABRUNAT contains acalabrutinib, a targeted cancer medicine used to treat chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) in adults.

Can I eat normally while taking ACABRUNAT?

Yes, acalabrutinib can be taken with or without food. However, avoid grapefruit and Seville oranges as they can affect how the drug is processed in your body.

What should I do if I miss a dose?

Take the missed dose as soon as you remember, unless your next scheduled dose is within 3 hours — in that case, skip the missed dose and continue with your normal schedule. Never take two doses at once.

Is it safe to take ACABRUNAT with blood thinners?

This combination increases bleeding risk significantly. If you take warfarin, aspirin, or other anticoagulants, your doctor needs to know and will monitor you carefully.

Can I have surgery while taking ACABRUNAT?

You should stop acalabrutinib 3–7 days before any planned surgery or invasive procedure to reduce bleeding risk. Always inform your surgeon and anaesthetist you are on this medicine.

How long will I need to take this medicine?

Acalabrutinib is usually a long-term treatment taken until disease progression or until side effects become unacceptable. Your oncologist will review this regularly.

Can I take heartburn medicines with ACABRUNAT?

Proton pump inhibitors (like omeprazole) reduce the absorption of acalabrutinib and should ideally be avoided. If you need antacids, take them at least 2 hours before or after your dose. Discuss alternatives with your doctor.

Will ACABRUNAT affect my immune system?

Yes. Acalabrutinib can lower your ability to fight infections. Avoid close contact with people who are ill, and contact your doctor promptly if you develop fever, chills, or any signs of infection.

Is ACABRUNAT safe during pregnancy?

No. Acalabrutinib can harm an unborn baby. Effective contraception must be used by women of childbearing potential during treatment and for at least 1 week after the last dose.

Can I store ACABRUNAT in the refrigerator?

There is no need to refrigerate ACABRUNAT. Store it at room temperature (below 30°C) in its original packaging, away from moisture and sunlight.