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A - Regimen Name

IDEL Regimen
Idelalisib


Disease Site
Hematologic - Lymphoma - Non-Hodgkin's Low Grade

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

Monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic therapies and are refractory to both rituximab and an alkylating agent.

 
B - Drug Regimen

idelalisib
150 mg PO BID
(This drug is not currently publicly funded for this regimen and intent)

(available as 150 mg and 100 mg tablets)

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C - Cycle Frequency

CONTINUOUS TREATMENT

Until disease progression or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal – No routine prophylaxis; PRN recommended

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

A supply of loperamide should be provided for diarrhea.

Advise patients to avoid sun exposure or use sufficient sun protection.

Antibiotic prophylaxis for PCP/PJP is required during treatment and for 2 to 6 months after discontinuation of treatment.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

Dosage with toxicity

Dose levels: 150 mg bid, 100 mg bid, discontinue if further dose modification required.

Toxicity

Grade

Action/idelalisib dose

Diarrhea/colitis

 

 

1

Provide supportive care (e.g. loperamide) and continue  at the same dose.

2

Provide supportive care, hold and monitor until resolved to ≤ grade 1.

Restart at the same dose.

3 or 4

Provide supportive care, hold. Consider addition of anti-inflammatory agent (e.g. sulfasalazine, budesonide).

Monitor until resolved to ≤ grade 1. Restart at ↓ 1 dose level

Toxicity Grade Action/idelalisib dose

Neutropenia

Or Thrombocytopenia

 

3

Continue at the same dose and monitor CBC.

4

Hold until ANC ≥ 0.5 x 109/L and ≥ platelets 25 x 109/L. Restart at ↓ 1 dose level

ALT/AST elevation

 

1 or 2

Continue  at the same dose and monitor LFTs.

3 or 4

Hold until ALT/AST ≤ 1 x ULN. Restart at ↓ 1 dose level

Discontinue for recurrent hepatotoxicity.

 

Pneumonitis / organizing pneumnonia

Any grade

Hold and evaluate for respiratory symptoms.

  • If no infectious origin found and pneumonitis is likely drug-related, discontinue idelalisib. Consider steroids especially if severe
  • If infectious origin found, monitor/treat until resolved. Restart at ↓ 1 dose level.
CMV infection/viremia   Discontinuation if evidence of CMV infection or viremia (positive PCR or antigen test)
Signs and symptoms of PML Any

Hold and investigate; refer to neurologist.

Discontinue if confirmed.

Signs and symptoms of PCP/PJP   Discontinue

Rash

 

2

Hold until ≤ grade 1. Restart at the same dose.

3 or 4

Hold until ≤ grade 1. Restart at ↓ 1 dose level.

Discontinue if severe cutaneous reactions (e.g. TEN)

Hypersensitivity

3 or 4

Discontinue, treat appropriately.



Hepatic Impairment

AUC is increased with hepatic impairment, but no dosage adjustment is required in mild to moderate hepatic impairment (monitor closely). Insufficient data for patients with severe hepatic impairment. Patients with baseline ALT/AST > 2.5 x ULN or bilirubin > 1.5 x ULN were excluded from clinical trials.

 


Renal Impairment

No dosage adjustment is required for mild, moderate or severe renal impairment.

 


Dosage in the Elderly

No dosage adjustment is required for elderly patients. The incidence of severe adverse events was higher among patients aged 65 and older compared to younger patients, but age had no clinically relevant effect on drug exposure.

 


 
F - Adverse Effects

Refer to idelalisib drug monograph(s) for additional details of adverse effects

 


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Increased triglycerides
  • Increased LFTs (may be severe)

 

  • Diarrhea (may be severe)
  • Fatigue
  • Cough, dyspnea
  • Nausea, vomiting
  • Fever
  • Abdominal pain
  • Myelosuppression +/- infection (including atypical), bleeding (may be severe)
  • Rash (may be severe) 
  • Anorexia
  • Insomnia
  • Headache
  • Edema
  • Hypersensitivity
  • Pneumonitis (including organizing pneumonia)
  • PML
 
G - Interactions

Refer to idelalisib drug monograph(s) for additional details


  • Idelalisib is a substrate for CYP3A4 and is susceptible to drugs interactions with inducers and inhibitors of this isoenzyme. Avoid strong CYP3A4 inducers and inhibitors where possible.
  • Idelalisib is also a CYP3A4 inhibitor. Caution and monitor with substrates that have a narrow therapeutic index.
  • Idelalisib may reduce the effectiveness of oral contraceptives. Caution and consider an alternative method of contraception.
 
H - Drug Administration and Special Precautions

Refer to idelalisib drug monograph(s) for additional details


Administration

  • May be administered with or without food
  • If a dose is missed, it may be taken within 6 hours of the missed dose. If a dose is missed by more than 6 hours, it should not be taken; the next dose should be taken as scheduled.
  • Dispense only in original container with intact seal
  • Store below 30oC

 

Contraindications

  • in first line CLL and early line indolent NHL outside of a clinical trial
  • patients who have a hypersensitivity to this drug or any of its components

 

Warnings/precautions

  • Idelalisib should not be started in patients with any evidence of ongoing systemic bacterial, fungal or viral infections.
  • not recommended in patients with ongoing inflammatory bowel disease given the risk of severe diarrhea
  • not recommended in patients with active hepatitis or liver disease

 

Pregnancy & lactation

  • Idelalisib is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 1 month after the last dose. Idelalisib may reduce the effectiveness of hormonal contraceptives (refer to drug interactions).  Consider additional alternative methods of contraception.
  • Breastfeeding is not recommended. 
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; Baseline, every 2 weeks for the first 6 months, and at least weekly with grade 3 or 4 myelosuppression.
  • CMV PCR/Antigen; baseline and regular
  • Liver function tests; Baseline, every 2 weeks for the first 3 months, thereafter every 1 to 3 months, and as clinically indicated. Weekly with hepatotoxicity until within ULN.
  • Clinical toxicity assessment for GI, skin, respiratory toxicity, hypersensitivity, bleeding and infection (including opportunistic, CMV); At each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Outpatient prescription for home administration


 
K - References

Gopal AK, Kahl BS, de Vos S, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18.

Idelalisib drug monograph, Cancer Care Ontario.

June 2019 Updated emetic risk category


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.