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Mantle cell lymphoma ibrutinib

Patients with lymphoma should be considered for inclusion into clinical trials. Link to ALLG website, ANZCTR website and Lymphoma Australia website.

The anticancer drug(s) in this protocol may have been included in the ADDIKD guideline. Dose recommendations in kidney dysfunction have yet to be updated to align with the ADDIKD guideline. Recommendations will be updated once the individual protocol has been evaluated by the reference committee. For further information refer to the ADDIKD guideline. To assist with calculations, use the eviQ Estimated Glomerular Filtration Rate (eGFR) calculator.

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The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Continuous treatment
Ibrutinib 560 mg (PO) ONCE a day with or without food. Swallow capsules whole with a glass of water.

Continuous until disease progression or unacceptable toxicity

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Continuous treatment
Ibrutinib 560 mg (PO) ONCE a day with or without food. Swallow capsules whole with a glass of water.

Continuous until disease progression or unacceptable toxicity

  • Mantle cell lymphoma in patients who have received at least one prior therapy
Caution with oral anti-cancer drugs

Select links for information on the safe prescribing, dispensing and administration of orally administered anti-cancer drugs. 

Read more about the COSA guidelines and oral anti-cancer therapy
Emetogenicity minimal or low

No routine prophylaxis required. If patients experience nausea and/or vomiting, consider using the low emetogenic risk regimen.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Cardiac toxicity

Ibrutinib has been associated with atrial fibrillation and flutter, particularly in patients with cardiac risk factors. Patients, especially those with pre-existing cardiovascular disease, should have periodic cardiac assessments and be closely monitored clinically for atrial fibrillation.

Patients who develop arrhythmic symptoms or new onset of dyspnoea should be evaluated clinically and if indicated an electrocardiogram (ECG) should be performed.

Read more about cardiac toxicity associated with anti-cancer drugs
Haemorrhage

Haemorrhagic events have been reported, both with and without thrombocytopenia. These include minor haemorrhagic events (i.e. contusion, epistaxis, petechiae) and major haemorrhagic events (i.e. gastrointestinal bleeding, intracranial haemorrhage, haematuria).

The risk of bleeding may be increased when ibrutinib is administered with anticoagulants (e.g. warfarin) or medications that inhibit platelet function (e.g. fish oil, vitamin E preparations). Avoid concomitant administration.

Ibrutinib should be withheld at least 3 to 7 days pre and post-surgery depending on the risk of bleeding and type of surgery.
Lymphocytosis

A reversible increase in lymphocyte counts has been observed during the first few weeks of ibrutinib therapy (i.e. greater than or equal to 50% increase from baseline and above absolute count 5000/mcL) . Lymphocytosis associated with ibrutinib should not be considered progressive disease in the absence of other clinical findings. It is often associated with reduction of lymphadenopathy.
Hepatotoxicity

Severe hepatotoxicity (including fatal outcomes) has been observed with this treatment.

Monitor for abnormal liver function tests (LFTs), jaundice and tiredness. Refer to blood tests and dose modification sections for specific recommendations.
Progressive multifocal leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) have been reported with certain Tyrosine kinase inhibitors (e.g. ruxolitinib, ibrutinib). Patients should be closely monitored for new or worsening neuropsychiatric symptoms suggestive of PML.

If PML is suspected treatment should be withheld pending appropriate investigation. 

Read more about Therapeutic Goods Administration Medicines Safety update on progressive multifocal leukoencephalopathy from the Australian Government, Department of Health.
Tumour lysis risk

Assess patient for risk of developing tumour lysis syndrome.

Read more about prevention and management of tumour lysis syndrome.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis

PJP prophylaxis is recommended e.g. trimethoprim/sulfamethoxazole 160/800 mg PO one tablet twice daily, twice weekly (e.g. on Mondays and Thursdays) OR one tablet three times weekly (e.g. on Mondays, Wednesdays and Fridays).

Read more about prophylaxis of pneumocystis jiroveci (carinii) in cancer patients
Antiviral prophylaxis

Antiviral prophylaxis is recommended.

Read more about antiviral prophylaxis drugs and doses
Antifungal prophylaxis

Consider antifungal prophylaxis for at-risk patients. 

Clinical vigilance and early intervention is recommended in patients with an increased risk of fungal infections.

Read more about antifungal prophylaxis drugs and doses.
Blood tests

FBC, EUC and LFTs at baseline and repeat monthly during treatment or as clinically indicated.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.

Read more about COVID-19 vaccines and cancer.
Fertility, pregnancy and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. There is a risk of foetal harm in pregnant women. A pregnancy test should be considered prior to initiating treatment in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and adequate contraception timeframe should be discussed with all patients of reproductive potential. Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the effect of cancer treatment on fertility
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.
The dose recommendations in kidney dysfunction (i.e.renal impairment) displayed may not reflect those in the ADDIKD guideline and have been included for historical reference only. Recommendations will be updated once the individual protocol has been evaluated by the reference committee, with this version of the protocol then being archived. Clinicians are expected to refer to the ADDIKD guideline prior to prescribing in kidney dysfunction.
International Consensus Guideline for Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).
Haematological toxicity
ANC x 109/L
Less than 1.0 with infection or fever
OR
Less than 0.5		 Delay treatment until recovery and reinitiate ibrutinib as follows:
1st occurrence: No reduction
2nd occurrence: Reduce ibrutinib to 420 mg daily
3rd occurrence: Reduce ibrutinib to 280 mg daily
4th occurrence: Cease treatment
Platelets x 109/L
Less than 25 Delay treatment until recovery and reinitiate ibrutinib as follows:
1st occurrence: No reduction
2nd occurrence: Reduce ibrutinib to 420 mg daily
3rd occurrence: Reduce ibrutinib to 280 mg daily
4th occurrence: Cease treatment
Renal impairment
Creatinine clearance (mL/min)
30 to 50 No dose adjustments necessary
Less than 30 There is no data in patients with severe renal impairment
Hepatic impairment
Hepatic dysfunction
Mild (Child-Pugh class A) Consider reducing the dose to 280mg daily
Moderate (Child-Pugh class B) Consider reducing the dose to 140mg daily
Severe (Child-Pugh class C) Not recommended
Non-Haematological toxicity
Greater than or equal to grade 3 Delay treatment until recovery and reinitiate ibrutinib for subsequent cycles as follows:
1st occurrence: No reduction
2nd occurrence: Reduce ibrutinib to 420 mg daily
3rd occurrence: Reduce ibrutinib to 280 mg daily
4th occurrence: Cease treatment
Concomitant use with CYP3A4 inhibitor
Moderate CYP3A4 inhibitor Reduce ibrutinib dose to 280 mg for the duration of the inhibitor use.
Voriconazole at any dose OR posaconazole at doses ≤ suspension 200 mg BD Reduce ibrutinib dose to 140 mg for the duration of voriconazole or posaconazole use. 
Strong CYP3A4 inhibitor or posaconazole at higher doses*

If the benefit clearly outweighs the risk and it must be used for:

7 days or less: withhold ibrutinib temporarily.

More than 7 days: reduce ibrutinib dose to 140 mg for the duration of inhibitor use.

* Posaconazole suspension 200 mg three times daily or 400 mg twice daily, posaconazole IV injection 300 mg once daily, posaconazole delayed-release tablets 300 mg once daily.

Drug interactions in eviQ protocols are under review and being updated to align with current literature. Further site-wide updates and changes will occur in due course. References & Disclaimer

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources:  

Ibrutinib
  Interaction Clinical management
CYP3A4 inhibitors (e.g. aprepitant, azole antifungals, clarithromycin, erythromycin, fluvoxamine, grapefruit juice, ritonavir, seville oranges etc.) Increased toxicity of ibrutinib possible due to reduced clearance

Avoid combination or monitor for ibrutinib toxicity. 

If a moderate CYP3A4 inhibitor must be used, reduce ibrutinib dose to 280 mg for the duration of the inhibitor use.

If voriconazole at any dose or posaconazole at doses ≤ suspension 200 mg BD must be used, reduce ibrutinib dose to 140 mg for the duration of voriconazole or posaconazole use. 

If the benefit clearly outweighs the risk and a strong CYP3A4 inhibitor or posaconazole at higher doses* must be used for 7 days or less, withhold ibrutinib temporarily. If it must be used for more than 7 days, reduce ibrutinib dose to 140 mg for the duration of inhibitor use.
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St Johns wort etc.) Reduced efficacy of ibrutinib due to increased clearance Avoid combination with strong CYP3A4 inducers, or consider alternative agents with less CYP3A4 induction. If a CYP3A4 inducer must be used, monitor for decreased effect of ibrutinib.
Drugs metabolised by CYP3A (e.g. ciclosporin, fentanyl, quinidine, ergotamine, pimozide, sirolimus, tacrolimus etc.) with narrow therapeutic indices Increased effects/toxicity of these drugs possible due to inhibition of CYP3A by ibrutinib resulting in reduced clearance Avoid combination
Warfarin or other vitamin K antagonists, fish oil and vitamin E preparations Increased risk of bleeding Avoid combination. Warfarin or vitamin K antagonists should not be administered concomitantly.

* Posaconazole suspension 200 mg three times daily or 400 mg twice daily, posaconazole IV injection 300 mg once daily, posaconazole delayed-release tablets 300 mg once daily.

Note: Ibrutinib solubility is pH dependent. There is a theoretical risk that increasing stomach pH (e.g. proton pump inhibitors) may decrease ibrutinib exposure

General
  Interaction Clinical management
Digoxin Anti-cancer drugs can damage the lining of the intestine; affecting the absorption of digoxin. Monitor digoxin serum levels; adjust digoxin dosage as appropriate.
Antiepileptics Both altered antiepileptic and anti-cancer drug levels may occur, possibly leading to loss of efficacy or toxicity. Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the anti-cancer therapy.
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia. Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding.
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update.
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines. Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA website for further information.

Administration

This is a continuous oral treatment

General patient assessment prior to each day of treatment.

  • urinalysis each visit

Ibrutinib

  • administer orally ONCE daily
  • to be swallowed whole with a glass of water; do not break, crush or chew
  • may be taken with or without food

Note: if a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose.

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Discharge information

Ibrutinib capsules
  • Ibrutinib capsules with written instructions on how to take them.
Antiemetics
  • Antiemetics as prescribed.
Prophylaxis medications
  • Prophylaxis medications (if prescribed) i.e. tumour lysis prophylaxis, PJP prophylaxis, antifungals, antivirals.
Patient information
  • Ensure patient receives patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Headache

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Fatigue

Read more about fatigue
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash
Diarrhoea

Read more about treatment induced diarrhoea
Constipation
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Dizziness

Feeling faint or lightheaded, weak or unsteady. Advise patients to stand up slowly from sitting down or lying down positions and increase fluid intake if dehydrated.
Respiratory tract infection
Cardiotoxicity

Cardiotoxicity may manifest as asymptomatic reduction in left ventricular ejection fraction (LVEF), arrhythmia, cardiomyopathy, hypertension, cardiac ischaemia and congestive heart failure (CHF). The risk of cardiotoxicity is increased by a number of factors, particularly a history of heart disease and electrolyte imbalances.

Read more about cardiotoxicity associated with anti-cancer drugs
Haemorrhage
Visual disturbance

Photopsia, blurred vision, vitreous floaters and visual impairment have been reported with this drug and generally occur after transitioning from a light to dark environment. 
Hypertension associated with angiogenesis inhibitors

High blood pressure can occur with angiogenesis inhibitors and tyrosine kinase inhibitors. 
Atrial fibrillation
Hepatotoxicity

Anti-cancer drugs administered either alone or in combination with other drugs and/or radiation may cause direct or indirect hepatotoxicity. Hepatic dysfunction can alter the metabolism of some drugs resulting in systemic toxicity.
Oral mucositis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following chemotherapy, radiation therapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis

Late (onset weeks to months)
Alopecia - partial

Hair thinning and/or patchy hair loss. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Progressive multifocal leukoencephalopathy (PML)

A rare opportunistic viral infection of the brain, usually leading to death or severe disability, can occur with monoclonal antibodies (e.g. rituximab, obinutuzumab, ofatumumab, brentuximab vedotin) and other targeted therapies (e.g. ibrutinib, ruxolitinib, idelalisib). Onset may occur up to months after the final dose.  

Read more about progressive multifocal leukoencephalopathy (PML)

The evidence for the use of single agent ibrutinib in relapsed/refractory mantle cell lymphoma (MCL) originates in a phase 3 study published in The Lancet in 2016r which advanced on a phase 2 study published in 2013 assessing ibrutinib use in relapsed/refractory mantle cell lymphoma.r Ibrutinib is an oral covalent inhibitor of Bruton’s tyrosine kinase, an essential enzyme in B cell receptor function. This open label, multicenter study, included 280 patients with relapsed or refractory mantle cell lymphoma who were randomized to receive either daily oral ibrutinib 560 mg or intravenous temsirolimus (175 mg on days 1, 8, and 15 of cycle 1; 75 mg on days 1, 8, and 15 of subsequent 21-day cycles). The primary endpoint was progression free survival while secondary endpoints included overall response rate (complete response and partial response), overall survival, 1-year survival rate, duration of response, time to next treatment, safety, pre-specified patient-reported outcomes, biomarkers and pharmacokinetics, and medical resource use rate. Median age was 68 years while median follow up was 20 months.r

A second study, published in NEJM in 2013 then updated in Blood in 2015 was a multicentre trial where ibrutinib was administered as a single agent to 111 patients with relapsed or refractory MCL.rr The primary endpoint was response rate with secondary endpoints of duration of response, progression free survival (PFS), overall survival (OS) and safety. The median age of the patients was 68 years and 86% had intermediate or high risk MCL based on clinical scores (simplified MIPI). The patients had received a median of 3 prior treatments (including bortezomib).r

Efficacy

Ibrutinib treatment resulted in a 57% reduction in the risk of disease progression or death compared with temsirolimus (HR 0·43 [95% CI 0·32–0·58]; p<0·0001, figure 1). The median progression-free survival was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group. At 2 years, the progression-free survival rate is 41% in the ibrutinib group versus 7% in the temsirolimus group. Overall response rate was significantly higher in the ibrutinib group compared with the temsirolimus group (72% vs 40%, p <0.0001). Significantly, there was no benefit shown between the two arms in patients with the blastoid subtype, it should be noted however, that the sample size in this subgroup was small.r

The overall response rate in the phase 2 study by Wang et al. was 68% with 21% complete responses (CR) and 47% partial responses (PR) (see figure 2).r Prior treatment with bortezomib had no effect on response rate. A transient increase in the absolute lymphocyte count was observed in 34% of patients and typically resolved within a median of 8.0 weeks.r The median follow up in the initial paper was 15.3 monthsr and was extended to 26.7 months in the second publication.3 At the later follow up, the median treatment duration was reported as 8.3 months with 46% treated for >12 months and 22% for >24 months. The median PFS was 13 months and median OS was 22.5 months. The 2 year PFS was 31% and OS was 47% (see figure 3).r

Figure 1.

© The Lancet 2016

Figure 2.

© New England Journal of Medicine 2013

Figure 3.

© Blood 2015

Toxicity

The commonest non-haematological adverse events (AEs) seen in patients with MCL treated with ibrutinib were diarrhoea (56%), fatigue (50%), nausea (33%) and dyspnoea (32%) (see figure 4).r The majority of these events were of grade 1 or 2 only. Grade =3 haemorrhage did occur, with 2% of patients suffering subdural haematomas (all associated with trauma) and 2% experiencing haematuria. Atrial fibrillation (AF) occurred in 12 patients (11%) with grade 3 reported in 7 (6%), however treatment was not discontinued in any patient as a result of AF.r Haematological AEs included thrombocytopenia (22%), neutropenia (19%) and anaemia (18%) (see figure 4).r

The phase 3 study by Dreyling et al. showed a similar adverse effect profile though they did identify an increased number of secondary malignancies in the ibrutinib arm (figure 5).r These were predominantly non melanomatous skin cancers. It should be noted however, that when adjusted for length of exposure the risk of secondary malignancy was similar in both groups.r

Figure 4.

© Blood 2015

Figure 5.

© The Lancet 2016

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Version 3

Date Summary of changes
11/09/2015 New protocol discussed at Haematology Reference Committee meeting.
16/11/2015 Approved and published on eviQ.
01/03/2016 Cardiac function monitoring section updated.
24/06/2016 Hepatotoxicity clinical information block and side effect added as per April 2016 TGA medicines safety update.
21/09/2016 Emetogenicity clinical information block changed from 'minimal' to 'low'.
31/05/2017 Transferred to new eviQ website. Version number change to v.2.
25/05/2018

Protocol reviewed at Haematology Reference Committee meeting:

  • Treatment schedule: drug status updated.
  • Interactions for CYP 3A4 inhibitors updated.
  • Dose modifications updated to include dose reductions for concomitant use with CYP 3A4 inhibitors.
  • Evidence reviewed and updated.
  • Version number changed to v.3.
13/09/2019 Reviewed by Haematology Reference Committee, no major changes. Clinical information block added for the consideration of antifungal prophylaxis. Review in 5 years.
27/03/2020 Reviewed by Haematology Reference Committee with no significant changes, review in 4 years.
21/12/2021 Changed antiemetic clinical information block to minimal or low, to align with new categories. See ID 7 Prevention of anti-cancer therapy induced nausea and vomiting (AINV) v5.
19/05/2022 Clinical information - antifungal prophylaxis block updated.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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31 Mar 2023