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Ibrutinib oral


Oral formulations of ibrutinib.

Drugs List

  • ibrutinib 140mg film coated tablets
  • ibrutinib 280mg film coated tablets
  • ibrutinib 420mg film coated tablets
  • ibrutinib 560mg film coated tablets
  • IMBRUVICA 140mg film coated tablets
  • IMBRUVICA 280mg film coated tablets
  • IMBRUVICA 420mg film coated tablets
  • IMBRUVICA 560mg film coated tablets
  • Therapeutic Indications


    Leukaemia - chronic lymphocytic
    Mantle cell lymphoma (MCL)
    Waldenstrom's macroglobulinaemia

    Treatment of relapsed or refractory mantle cell lymphoma (MCL) as a single agent.

    Treatment of chronic lymphocytic leukaemia (CLL) in adult patients as a single agent or in combination with rituximab or obinutuzumab.

    Treatment of CLL in patients who have received at least one prior treatment, as a single agent or in combination with bendamustine and rituximab.

    Treatment of Waldenstrom's macroglobulinaemia (WM) as a single agent in patients who have received one prior therapy, or first line treatment in patients unsuitable for chemo-immunotherapy, or in combination with rituximab.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Mantle cell lymphoma
    560mg once daily.

    Chronic lymphocytic leukaemia
    420mg once daily either as a single agent or in combination therapy.

    Waldenstrom's macroglobulinaemia
    420mg once daily either as a single agent or in combination therapy.

    Patients with Hepatic Impairment

    Child-Pugh Class A: 280mg once daily.
    Child-Pugh Class B: 140mg once daily.
    Child-Pugh Class C: Not recommended.

    Additional Dosage Information

    Concurrent use of CYP3A4 inhibitors
    Moderate inhibitor: Reduce dose of ibrutinib to 280mg once daily.
    Strong inhibitor: Concomitant use of strong CYP3A4 inhibitors with ibrutinib should be avoided where possible. If treatment is deemed necessary after thorough risk/benefit analysis, reduce ibrutinib dose to 140mg once daily and monitor patient for signs of toxicity.

    Suspend treatment in the following conditions:
    New onset or worsening grade 3 or greater non-haematological toxicity.
    Grade 3 or greater neutropenia with infection or fever.
    Grade 4 or greater haematological toxicity.
    Once symptoms have resolved to grade 1 or baseline (recovery), therapy may be reinitiated at the starting dose. If toxicity reoccurs reduce dose as follows.
    Mantle cell lymphoma
    First toxicity occurrence: 560mg once daily.
    Second toxicity occurrence: 420mg once daily.
    Third toxicity occurrence: 280mg once daily.
    Forth toxicity occurrence: Discontinue treatment.
    Chronic lymphocytic leukaemia or Waldenstrom's macroglobulinaemia
    First toxicity occurrence: 420mg once daily.
    Second toxicity occurrence: 280mg once daily.
    Third toxicity occurrence: 140mg once daily.
    Forth toxicity occurrence: Discontinue treatment.

    Combination with anti-CD20 therapies
    Administer ibrutinib prior to rituximab or obinutuzumab when given on the same day.

    Missed doses
    Advise patients to take missed dose as soon as remembered if on the same day and return to the normal dose schedule the following day. Patients should not take extra tablets to make up for the missed dose.


    Children under 18 years
    Severe hepatic impairment

    Precautions and Warnings

    Acute infection
    Predisposition to haemorrhage
    Risk factors for cardiovascular disorder
    Atrial fibrillation
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Mild hepatic impairment
    Renal impairment

    Consider anti-infective prophylaxis in immunocompromised patients
    Consider withholding for 3 to 7 days pre and post surgery
    Reduce dose in patients with hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating screen all patients for hepatitis B infection
    Hepatitis B: Refer prior to initiation to liver disease specialist
    Maintain adequate hydration of patient prior / during treatment
    Monitor patients for non-melanoma skin cancer prior to and during treatment
    Treatment to be initiated and supervised by a specialist
    Some formulations contain lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Perform blood counts before and at monthly intervals during treatment
    Perform liver function tests before commencing therapy and during therapy
    Consider immunosuppressant adjustment in the event of PML
    Consider splenic rupture if patient has abdominal or shoulder pain
    If atrial fibrillation occurs, assess risk for thromboembolic disease
    Monitor blood pressure
    Monitor for signs and symptoms of interstitial lung disease
    Monitor patients for arrhythmias
    Monitor patients for signs and symptoms of cardiac failure
    Monitor patients for signs of tumour lysis syndrome
    Monitor patients receiving concurrent anticoagulants
    Monitor serum creatinine in patients with renal impairment
    Monitor spleen size
    Perform ECG for new onset dyspnoea
    Perform ECG if arrhythmic symptoms develop
    Risk of developing hyperleukocytosis
    Advise patient to report any signs of cardiac arrhythmias
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Advise patient to report signs of haemophagocytic lymphohistiocytosis (HLH)
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Potential for increased risk of bleeding
    Suspend treatment if ventricular tachyarrhythmia is suspected
    Consider suspending therapy if lymphocyte count > 400 x 10 to the power 9/L
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Suspend and/or reduce dose in grade 3 neutropenia with fever/infection
    Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
    Suspend treatment and/or reduce dose in grade 4 haematological toxicity
    Suspend treatment if interstitial lung disease is suspected
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid supplements containing fish oil
    Advise patient to avoid supplements containing vitamin E
    Advise patient grapefruit products may increase plasma level
    Advise patient Seville (sour) orange products may increase plasma level
    Female:Barrier contraception required during & for 3 months after treatment

    Patients who develop atrial fibrillation during treatment should be assessed for the risk of thromboembolic disease. Other treatment options should be considered in high risk patients. If the use of ibrutinib is necessary, consider treatment with anticoagulants.

    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

    Pregnancy and Lactation


    Ibrutinib is contraindicated during pregnancy.

    The manufacturer states that ibrutinib should not be used during pregnancy.

    There is no data available on the use of ibrutinib in pregnant women. Animal studies have shown reproductive toxicity.


    Ibrutinib is contraindicated during breastfeeding.

    The manufacturer states that breastfeeding should be discontinued during treatment with ibrutinib.

    It is not known whether ibrutinib is excreted into human breast milk. A risk to neonates cannot be excluded.

    Side Effects

    Atrial fibrillation
    Atrial flutter
    Basal cell carcinoma
    Blurred vision
    Febrile neutropenia
    Gastro-intestinal haemorrhage
    Haemophagocytic lymphohistiocytosis
    Hepatic failure
    Interstitial lung disease
    Intracranial bleeding
    Muscle spasm
    Musculoskeletal pain
    Non melanoma skin cancer
    Peripheral neuropathy
    Peripheral oedema
    Progressive multifocal leukoencephalopathy (PML)
    Reactivation of hepatitis B
    Serum creatinine increased
    Skin infection
    Splenic rupture
    Squamous cell carcinoma
    Stevens-Johnson syndrome
    Subdural haematoma
    Tumour lysis syndrome
    Upper respiratory tract infection
    Urinary tract infections
    Ventricular tachycardia


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    NICE Evidence Services Available at: Last accessed: 01 August 2019

    Summary of Product Characteristics: Imbruvica 140mg hard capsules. Janssen-Cilag Ltd. Revised August 2019.

    Summary of Product Characteristics: Imbruvica 140mg, 280mg, 420mg, 560mg film-coated tablets. Janssen-Cilag Ltd. Revised January 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.