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A - Regimen Name

ATEZ Regimen
Atezolizumab


Disease Site
Lung - Non-Small Cell

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

For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Patients with EGFR or ALK aberrations should have progression on therapy for these aberrations prior to receiving atezolizumab.

 
B - Drug Regimen

atezolizumab
1200 mg IV Day 1
(This drug is not publicly funded. Universal compassionate access program is available. )
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

Pre-medications (prophylaxis for infusion reaction):

  • Consider antipyretic and H1-receptor antagonist.
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. 

Dosage with toxicity

  • Healthcare professionals should also consult the most recent atezolizumab product monograph for additional information.

 

Summary of Principles of Management

  • Immune-related adverse effects (irAEs) are different in their presentation, onset and duration compared to conventional chemotherapy. Patient and provider education is essential.

  • Initial irAE presentation can occur months after completion of treatment and affect multiple organs.

  • Dose escalation or reduction is not recommended.

  • If no other cause can be identified (such as infection), any new symptom should be considered immune-related and prompt treatment initiated.

  • Organ-specific system-based toxicity management is recommended.

  • Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.

 

Management of Infusion-related reactions:

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.

 

Grade Management Re-Challenge
1 or 2
  • Stop or slow the infusion rate.
  • Manage the symptoms.

Restart:

  • No specific recommendations can be made at this time.
  • Re-challenge with close monitoring. Consider pre-medication with antipyretic and H1-receptor antagonists.
3 or 4 
  • Stop treatment.
  • Aggressively manage symptoms.
  • Permanently discontinue (do not re-challenge).

 



Hepatic Impairment

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for management of immune-related hepatic toxicities

Hepatic Impairment Atezolizumab Dose
Mild (bilirubin ≤ 1-1.5 x ULN and any AST OR AST > ULN) No change
Moderate (bilirubin 1.5-3 x ULN and any AST) No data
Severe (bilirubin > 3 x ULN and any AST) No data

 


Renal Impairment

Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for management of immune-related renal toxicities

Renal Impairment Atezolizumab Dose
CrCl ≥ 30 mL/min No change
CrCl < 30 mL/min No data

 


Dosage in the Elderly

No dose adjustment needed.  No differences in safety or efficacy between patients ≥ 65 years of age and younger patients observed.

 


 
F - Adverse Effects

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


Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Fatigue
  • Anorexia
  • Dyspnea
  • Nausea, vomiting
  • Constipation
  • Fever and chills
  • Rash, pruritus (may be severe)
  • Diarrhea (may be severe) 
  • Musculoskeletal pain
  • Myelosuppression ± infection (may be severe)
  • Hypo and hyperthyroidism
  • Type 1 diabetes mellitus
  • Pneumonitis
  • Hypersensitivity; IRRs
  • Adrenal insufficiency
  • Meningo-encephalitis
  • Pancreatitis
  • Hypophysitis
  • Ocular inflammatory disorder
  • Hepatitis
  • Neuropathy, myasthenia gravis, Guillain-Barre syndrome
  • Myocarditis
  • Nephritis
 
G - Interactions

Refer to atezolizumab drug monograph(s) for additional details


  • Atezolizumab is not expected to have pharmacokinetic drug-drug interactions as it is not metabolized by drug metabolizing enzymes. No pharmacokinetic drug interaction studies have been performed.

  • Use of systemic corticosteroids or immunosuppressants should be avoided prior to starting atezolizumab because of potential interference with efficacy. They can be used to treat immune-mediated reactions after starting the drug.

 
H - Drug Administration and Special Precautions

Refer to atezolizumab drug monograph(s) for additional details


Administration

  • Withdraw 20 mL of liquid concentrate from the vial and dilute to the required administration volume with 0.9% sodium chloride solution. Mix by gentle inversion; do not shake.

  • Dilute with 0.9% Sodium Chloride Injection only into a polyvinyl chloride (PVC), polyethylene (PE) or polyolefin (PO) infusion bag. 

  • The initial dose must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes.

  • If a planned dose is missed, it should be administered as soon as possible; do not wait until the next planned dose. The schedule of administration should be adjusted to maintain a 3-week interval between doses. 

  • Store vials at 2-8°; do not freeze. Protect from light.

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.


Contraindications

  • Patients who have a hypersensitivity to this drug or any of its components


Other Warnings/Precautions

  • Atezolizumab may cause serious immune-mediated reactions affecting multiple organ systems, including GI, hepatic, respiratory, endocrine and others. Use with caution and monitor closely in patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders, such as hypo or hyperthyroidism or diabetes mellitus. 

  • Severe infections have been observed in clinical trials.


Pregnancy/Lactation

  • Atezolizumab is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 5 months after the last dose.

  • Breastfeeding is not recommended.

  • Fertility effects: Likely

 

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Blood glucose; Baseline, periodic, and as clinically indicated

  • Liver function tests (AST, ALT, bilirubin); Baseline, prior to each treatment and as clinically indicated; frequent with severe toxicity

  • Renal function tests (including electrolytes); Baseline, prior to each treatment, and as clinically indicated; frequent with severe toxicity

  • Thyroid function tests; Baseline, periodic, and as clinically indicated

  • Clinical toxicity assessment for infection, infusion-related and immune-mediated reactions, ocular, endocrine, skin, GI, cardiac and respiratory toxicity; At each visit

  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
1.5 hrs (1st visit); 1 hr (subsequent visits)
Pharmacy Workload (average time per visit)
18.6 minutes
Nursing Workload (average time per visit)
40.75 minutes
 
K - References

Rittmeyer A, Barlesi F, Waterkamp D et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13.

Atezolizumab Drug Monograph, Cancer Care Ontario

October 2019 Updated infusion reaction information in Premedication and Supportive Measures and Dose Modifications sections.


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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.