Ibrutinib

• Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
• Treatment of adult patients with chronic lymphocytic leukaemia (CLL), including those with a 17p chromosome deletion, who have received at least one prior therapy.
• Treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
• Treatment of adult patients with chronic graft-versus-host disease (cGVHD) who have received at least one prior line of systemic therapy.

When should one not use Ibrutinib

• If you have a known hypersensitivity to ibrutinib or any ingredient of this medicine.
• If you are taking preparations containing St. John's Wort, as this is contraindicated with ibrutinib.

Common side effects of this drug are:

• Very common side effects:
• Diarrhoea
• Low neutrophil count (neutropenia)
• Musculoskeletal pain
• Bleeding or bruising
• Rash
• Nausea
• Low platelet count
• Joint pain (arthralgia)
• Upper respiratory tract infection
• Common side effects:
• Pneumonia (lung infection)
• Heart failure
• Irregular heart rhythm (atrial fibrillation)
• High blood pressure
• Serious but less common side effects:
• Serious bleeding, including in the digestive tract or brain
• Severe infections, including invasive fungal infections
• Heart rhythm disturbances, heart failure, and sudden cardiac death
• Stroke or other clot-related brain events
• A rare brain infection called progressive multifocal leukoencephalopathy
• Severe allergic reactions
• Reactivation of hepatitis B infection
• Rupture of the spleen, particularly after stopping treatment
• Lung inflammation (interstitial lung disease)
• Liver injury, including severe or fatal cases
• Tumour lysis syndrome, particularly in patients with a high tumour burden
• Non-melanoma skin cancers

Other General Warnings

• You have a bleeding disorder or are taking blood thinners.
• You have heart problems or a history of irregular heart rhythms.
• You have liver problems or a history of hepatitis B infection.
• You are due for surgery or an invasive procedure.
• You develop new or worsening breathlessness or cough.
• You notice unusual bruising, bleeding, or blood in your stool or urine.
• You develop yellowing of the skin or eyes, dark urine, or other symptoms of liver problems.
• You have a high tumour burden and are at risk of tumour lysis syndrome.
• You are planning to have children.
• Avoid grapefruit and Seville oranges throughout treatment.
• Report any unusual bleeding or bruising to your doctor immediately.
• Report chest pain, palpitations, or an irregular heartbeat promptly.
• Tell your medical team you are taking this medicine before any surgery or dental procedure, as treatment may need to be paused.
• Report any fever, chills, or signs of infection to your medical team immediately.
• Attend regular blood tests and monitoring appointments as advised by your doctor.
• Keep out of the reach of children and pets.
• This is a hazardous cytotoxic medicine; return any unused or expired capsules to your pharmacy for safe disposal.

How Does It Work?

Interactions with other medicines

• St. John's Wort: do not take this medicine with St. John's Wort, as it substantially reduces ibrutinib levels and effectiveness.
• Strong CYP3A4 inhibitors (certain antifungal and antibiotic medicines): can significantly increase the amount of ibrutinib in your body; your doctor may need to adjust your dose or avoid the combination.
• Strong CYP3A4 inducers can reduce the effectiveness of ibrutinib.
• Do not use warfarin or other vitamin K antagonists with ibrutinib. Anticoagulants and antiplatelet medicines can increase the risk of major bleeding.
• Tell your doctor about all other prescription medicines, over-the-counter medicines, and herbal supplements you are taking.

Interactions with food items

Overdose

Missed a Dose