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Non-Hodgkin lymphoma idelalisib

 Infection and pneumonitis risk:

Idelalisib can cause serious infections and/or fatal pneumonitis. See 'Pneumocystis jiroveci pneumonia (PJP) prophylaxis' and 'CMV monitoring' in the Clinical information section below for more information.

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

This protocol is based on limited evidence; refer to the evidence section of this protocol for more information.

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
Idelalisib 150 mg (PO) TWICE a day with or without food

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
Idelalisib 150 mg (PO) TWICE a day with or without food

Continuous until disease progression or unacceptable toxicity

  • Follicular lymphoma, as monotherapy where disease is refractory to at least 2 prior systemic therapies including both rituximab and an alkylating agent
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
Pneumonitis

Pneumonitis, including organising pneumonia, some with a fatal outcome have occurred with idelalisib. Treatment may be interrupted in patients presenting with pulmonary symptoms or radiographic appearances. Patient should be assessed for an explanatory etiology, considering infectious causes (e.g. CMV). If pneumonitis is suspected the patient should be treated accordingly.

If moderate-severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib should be permanently discontinued.
Gastrointestinal toxicity

Severe diarrhoea or colitis (grade 3 or higher) and intestinal perforation has been associated with idelalisib treatment in clinical trials. Some fatal outcomes were observed. 

Severe diarrhoea or colitis can be delayed or occur at any time during treatment.

Infectious causes (e.g.Clostridum difficile, CMV) should be excluded when assessing patients with colitis. Interruption of idelalisib and additional treatment (e.g. antidiarrhoeal and anti-inflammatory agents such as enteric budesonide) may be recommended.

Assess hydration status for all patients with diarrhoea, especially in those with increased risk for dehydration (eg. pre-existing renal failure). Monitor patients for any new or worsening abdominal pain, chills, fever, nausea or vomiting and advise them to promptly report symptoms.

Discontinue idelalisib permanently in patients who experience intestinal perforation.
Hepatotoxicity

Hepatotoxicity has been observed with this treatment. Onset of hepatic dysfunction typically occurs within 3 months of starting treatment.

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

Severe or life-threatening (grade ≥ 3) cutaneous reactions have been reported in patients treated with idelalisib.

Fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred when patients were treated with idelalisib administered concomitantly with other medications associated with SJS-TEN.

Idelalisib may be interrupted or discontinued.
Lymphocytosis

A transient increase in lymphocyte counts has been observed with idelalisib therapy. Lymphocytosis associated with idelalisib should not be considered progressive disease in the absence of other clinical findings. 
Progressive multifocal leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) has been reported in one idelalisib study in a CLL patient, who had received rituximab previously.

In any patient receiving idelalisib who reports the new onset of, or changes in pre-existing neurologic signs and symptoms, a diagnosis of PML should be considered.

Read more about progressive multifocal leukoencephalopathy and the Therapeutic Goods Administration Medicines Safety update on progressive multifocal leukoencephalopathy from the Australian Government, Department of Health.
CMV monitoring

All patients should have cytomegalovirus (CMV) status assessed before starting idelalisib.

Monitor closely for laboratory and clinical evidence of CMV infection. If patient is CMV positive or has evidence of a history or CMV infection at baseline, at least monthly clinical and laboratory monitoring for CMV infection is recommended. 

Use of idelalisib may need to be interrupted or stopped.

For patients with asymptomatic CMV viraemia, monitor for evidence of high or rising viral load and if confirmed, consider interrupting idelalisib and commence antiviral therapy to prevent invasive disease. 

For patients with symptomatic CMV viraemia, initiate antiviral therapy and consider interrupting idelalisib until CMV disease has resolved. Pre-emptive CMV therapy should be considered if benefits of resuming idelalisib outweigh the risks. Patients with fever and/or other signs of infection should be evaluated promptly and treated accordingly.
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 in all patients during idelalisib treatment 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).

Post-treatment prophylaxis should continue for 2 to 6 months after the discontinuation of idelalisib and be based on clinical judgement, taking into account the patient's risk factors (e.g. concomitant corticosteroid treatment and prolonged neutropenia).

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
Growth factor support

G-CSF (short or long-acting) is available on the PBS for chemotherapy induced neutropenia depending on clinical indication and/or febrile neutropenia risk.  

Access the PBS website
Blood tests

FBC, EUC, LFTs, LDH at baseline then every 2 weeks for the first 12 weeks, every 4 weeks between weeks 12 and 24, every 6 weeks between weeks 24 and 48, and then every 12 weeks 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
0.5 to less than 1.0  No dose reduction required. Monitor ANC at least weekly and consider adding G-CSF.
less than 0.5

Delay treatment until recovery.

Monitor ANC at least weekly until ANC ≥ 0.5, then resume idelalisib at 100 mg TWICE a day. Consider adding G-CSF.
Platelets x 109/L
25 to less than 50 No dose reduction required. Monitor platelet counts at least weekly.
less than 25

Delay treatment until recovery. 

Monitor platelet count at least weekly. May resume idelalisib at 100 mg TWICE a day when platelets ≥ 25.
Renal impairment
No dose adjustments are necessary.
Hepatic impairment
Hepatic dysfunction (ALT/AST)

> 3-5 x ULN

 No dose reduction required. Monitor as least weekly until ≤ 1 x ULN.
> 5-20 x ULN 

Delay treatment and monitor at least weekly until ≤ 1 x ULN, then resume idelalisib at 100 mg TWICE a day.

If no recurrence, the dose can be re-escalated to 150 mg TWICE a day at the discretion of the treating clinician.

If there is recurrence, delay treatment until return to grade 1 or below. Consider resuming idelalisib at the discretion of the treating clinician.
> 20 x ULN Discontinue idelalisib permanently. 
Bilirubin

> 1.5-3 x ULN

No dose reduction required. Monitor as least weekly until ≤ 1 x ULN.
>  3-10 x ULN 

Delay treatment and monitor at least weekly until ≤ 1 x ULN, then resume idelalisib at 100 mg TWICE a day.
> 10 x ULN Discontinue idelalisib permanently. 
Diarrhoea

Grade 2

No dose reduction required. Monitor as least weekly until recovery.
Grade 3

Delay treatment and monitor at least weekly until recovery, then resume idelalisib at 100 mg TWICE a day.

If no recurrence, the dose can be re-escalated to 150 mg TWICE a day at the discretion of the treating clinician.
Grade 4 Discontinue idelalisib permanently. 
Rash
Grade 1 or 2 No dose reduction required. Monitor until resolved.
Grade 3 or 4

Delay treatment until recovery to ≤ grade 1 and resume idelalisib at 100 mg TWICE a day at the discretion of the treating clinician. 

If no recurrence, the dose can be re-escalated to 150 mg TWICE a day at the discretion of the treating clinician.

If SJS or TEN is suspected interrupt idelalisib immediately. 

Permanently discontinue idelalisib if there is a severe cutaneous reaction.
CMV infection
Patients with positive baseline CMV serology

Monitor patients with CMV viraemia (positive polymerase (PCR) or antigen test).

Consider delaying idelalisib until the infection has resolved. Provide treatment according to established clinical guidelines.
Patients with CMV viraemia without associated clinical signs of CMV infections

Careful monitoring is recommended.
If the benefits of resuming idelalisib outweigh the risks, consider pre-emptive CMV therapy.
Pneumonitis
Symptomatic pneumonitis (any grade)

Discontinue idelalisib. 

However, if re-treatment is appropriate once pneumonitis has resolved, consider resuming idelalisib at 100 mg TWICE a day, at the discretion of the treating physician.
Organising pneumonia Permanently discontinue idelalisib
Pneumocystis jiroveci pneumonia (PJP)

Delay treatment for suspected PCP infection of any grade; permanently discontinue idelalisib if PJP infection is confirmed. 
Intestinal perforation

Permanently discontinue idelalisib.

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:  

Idelalisib
  Interaction Clinical management
CYP3A inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of idelalisib possible due to reduced clearance Avoid combination or monitor for idelalisib toxicity
CYP3A inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort, dexamethasone etc.)  Reduced efficacy of idelalisib possible due to increased clearance Avoid combination or monitor for decreased clinical response to idelalisib
CYP3A substrates (e.g. atorvastatin, benzodiazepines, calcineurin inhibitors, clarithromycin, dihydroergotamine, simvastatin, etc.) Increased toxicity of these drugs possible due to inhibition of CYP3A by idelalisib resulting in reduced clearance Avoid combination or monitor for increased toxicity of the interacting drugs. 
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

General patient assessment prior to each day of treatment.

Any toxicity grade 2 or greater may require delay of treatment and review by medical officer before commencing treatment.

  • weigh patient on each visit 

This is a continuous oral treatment

Idelalisib

  • administer orally TWICE a day
  • 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 and it is less than 6 hours late, it should be taken as soon as the patient remembers. If it is more than 6 hours late, 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

Idelalisib tablets
  • Idelalisib tablets with written instructions on how to take them.
Antiemetics
  • Antiemetics as prescribed.
Antidiarrhoeals
  • Antidiarrhoeals as prescribed.
Growth factor support
  • Arrangements for administration if 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
Abdominal pain

Dull ache, cramping or sharp pains are common with some anti-cancer drugs. These are caused by either increased or decreased gastrointestinal motility and can be associated with diarrhoea or constipation.
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
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
Constipation
Gastrointestinal perforation

A rupture of the wall of the stomach, small intestine or large bowel. Symptoms include acute abdominal pain, tenderness and signs of sepsis. 
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
Respiratory tract infection
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.
Dyspnoea
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.
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Electrolyte imbalance

Hypokalaemia, hypercalcaemia, hyponatraemia and hyperuricaemia may occur with idelalisib.
Hyperlipidaemia and hypercholesterolaemia

Abnormally elevated levels of lipids and cholesterol in the blood.
Hypoalbuminaemia

Abnormally low levels of albumin in the blood.

Late (onset weeks to months)
Anaemia

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

Read more about anaemia
Diarrhoea

Read more about treatment induced diarrhoea
Pulmonary toxicity

Pulmonary toxicity may include damage to the lungs, airways, pleura and pulmonary circulation. 

Read more about pulmonary toxicity associated with anti-cancer drugs

Between April 2011 and October 2012, 41 sites in USA and Europe conducted an open labelled single arm phase 2 multicentre study to assess the efficacy of idelalisib as a single agent. This study recruited 125 patients with relapsed or refractory indolent non-Hodgkin Lymphoma (iNHL), and treated them with idelalisib 150 mg twice daily until disease progressed, unacceptable toxicity or death.r

Disease characteristics at study entry

© ZYDELIG Product Information v5.0 2017

All patients had at least 2 prior systemic therapies, however the median number of prior treatments were 4. All patients had either primary refractory disease, or relapsed within 6 months of rituximab and alkylating chemotherapy.r

The primary end point was the overall rate of response (ORR); secondary end points included the duration of response, progression free survival and safety.r

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments

Phase II trials

Gopal et al. 2014r

Yes

Yes

 

Phase II trials

Salles et al. 2017r

Yes

Yes

-

Guidelines

Date published/revised

Supports Use

Is the dose and regimen consistent with the protocol?

Comments

NCCN

B-Cell Lymphomas 2019 V.4.2019

Yes

Yes

-

BCCA

Revised December 2018

Yes

Yes

-
CCO N/A N/A - -

Efficacy

The ORR of for all iNHL was 57%, with a complete remission (CR) rate of 6%. The ORR by subtype were similar however it was noted that numbers were small for some categories. Specifically the ORR by subtype were: FL 54%, SLL 61%, MZL 47%, LPL/WM 80%.r

The median time to response was 1.9 months, median duration of response 12.5 months and median progression free survival (PFS) was 11 months.r

The median duration of treatment was 6.6 months, with a range of 0.6 to 23.9 months. Progressive disease accounted for 33% of all discontinuations, while adverse events 20% of discontinuation.r

In a post hoc sub group study analysing only the follicular lymphoma cohort from the phase 2 study, the authors described a median duration of treatment by idelalisib of 8.2 months, during which 59% of all patients experienced a greater than 50% decrease in disease related sum of the product of diameters (SPD). ORR in this sub-analysis was 55.6% with a 13% CR rate. The median time to first response was 2.6 months and the median duration of response was 10.8 months.r

© N Engl J Med 2014

Toxicity

©  N Engl J Med 2014

It was noted that Grade 1-2 transaminase derangements all returned to normal without any dose modifications.r

Drug discontinuation due to adverse events accounted for 20%. Dose modification were required in 34%, mostly due to transaminase derangement, diarrhoea and neutropenia.r

28 deaths were reported (22%), with 11 deaths occurring during active treatment or within 30 days of treatment cessation; these were largely due to progressive disease (27%) and pneumonia (27%). Deaths occurring in the long term follow up were largely secondary to progressive disease. There was no evidence of cumulative toxic effects documented.r

In the subgroup analysis,rr the authors reported that within the a total of 51% of patients experienced serious adverse events, mostly pyrexia (19%), diarrhoea (11%) and pneumonia (11%). CMV infection was reported in one pneumonia event, and two colitis events. No cases of pneumocystis jirovecii pneumonia were reported, and prophylaxis was not mandated in this study. Pneumonitis was reported in 3 patients – resulting in 1 drug interruption, 1 drug discontinuation and 1 death.r

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Version 1

Date Summary of changes
25/05/2018 New Protocol discussed at Haematology Reference Committee meeting.
25/07/2018 Approved and published on eviQ.
13/09/2019 Reviewed by Haematology Reference Committee with no significant changes, review in 5 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.

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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https://www.eviq.org.au/p/3411

31 Mar 2023