IBRUTIX (IBRUTINIB) 140MG CAPSULES 120's

Ibrutix contains ibrutinib, a first-in-class oral BTK inhibitor that covalently and irreversibly binds to BTK — a key enzyme in the B-cell receptor signalling pathway. BTK inhibition blocks proliferation and survival signalling in malignant B-cells, inducing apoptosis and disrupting B-cell homing and adhesion to lymphoid tissue.

Indications in adults:

•       Chronic lymphocytic leukaemia (CLL) / Small lymphocytic lymphoma (SLL) — first-line and relapsed/refractory

•       Mantle cell lymphoma (MCL) — relapsed or refractory

•       Waldenström's macroglobulinaemia (WM) — first-line and relapsed/refractory

•       Marginal zone lymphoma (MZL) — relapsed or refractory after at least one prior anti-CD20 therapy

Dose by indication:

•       CLL/SLL: 420mg (three 140mg capsules) once daily

•       MCL: 560mg (four 140mg capsules) once daily

•       WM: 420mg once daily (or 280mg with rituximab)

Swallow capsules whole with water. May be taken with or without food. Take at the same time each day. Continue until disease progression or unacceptable toxicity.

•       Missed dose: take on the same day if remembered. If the next day, skip the missed dose — do not double up.

•       Dose reductions (Grade 3+ toxicity): reduce by one capsule (140mg) per step. Dose reduction steps: 420mg → 280mg → 140mg (for CLL). For MCL: 560mg → 420mg → 280mg → 140mg.

•       Do not open, crush, or chew capsules.

No absolute contraindications. However, the following require careful assessment:

•       Anticoagulation or dual antiplatelet therapy: significantly increased hemorrhage risk — the combination of ibrutinib with anticoagulants requires careful individualized risk-benefit assessment. Where possible, avoid anticoagulants; if required, discuss with a specialist.

•       Atrial fibrillation or significant cardiovascular disease: monitor ECG; new-onset AF may require cardiology review and possible dose modification

•       Hepatic impairment: Child-Pugh A: reduce dose to 140mg/day. Child-Pugh B: reduce to 140mg/day. Child-Pugh C: avoid use

•       Strong CYP3A4 inhibitors (clarithromycin, voriconazole, ketoconazole, grapefruit): substantially increase ibrutinib exposure — avoid or reduce ibrutinib dose to 140mg/day if co-administration is unavoidable

•       Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John's Wort): markedly reduce ibrutinib — avoid concomitant use

•       Anticoagulants (warfarin, DOACs, LMWH) and NSAIDs: significantly increase bleeding risk — use with extreme caution, if at all

•       Antifungals (azoles): dual concern — CYP3A4 inhibition raises ibrutinib levels, AND immunocompromised patients on ibrutinib are at risk of fungal infection. Use non-azole antifungals where possible.

Q: Why does ibrutinib increase my risk of bruising and bleeding?

Ibrutinib inhibits BTK, which is present not only in B-cells but also in platelets. BTK inhibition impairs platelet activation, reducing the platelets' ability to form a clot. This explains the bruising seen in most patients and the increased risk of more significant bleeding, particularly when combined with other blood-thinning medicines.

Q: I have been told ibrutinib can affect my heart — what should I watch for?

Atrial fibrillation (irregular heartbeat) occurs in some patients on ibrutinib. Symptoms include palpitations, a racing or fluttering sensation in the chest, breathlessness, or light-headedness. Report these to your haematologist promptly. Regular ECG monitoring is part of your follow-up care.

Q: When should I stop ibrutinib before surgery?

Ibrutinib should be withheld for 3–7 days before and after any surgical or invasive procedure. This includes dental extractions and biopsies. Your haematologist and surgical team will coordinate the timing together.