Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
atezolizumab (subcut)
Atezolizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds to programmed cell death-ligand 1 (PD-L1) and blocks interactions with the PD-1 and B7.1 receptors on activated T cells. It releases PD-L1/PD-1 pathway-mediated inhibition of the immune response, leading to activation of an anti-tumour immune response.
| Bioavailability |
72% |
| T max |
4.5 days (at Cycle 1); 3.8 days (at steady state) |
| Time to reach steady state |
6 to 9 weeks (2 to 3 cycles) |
Antibodies are primarily cleared by catabolism.
| Half-life |
27 days |
- Non-Small Cell Lung Cancer (NSCLC)
- Small Cell Lung Cancer (SCLC)
- Breast Cancer
- Hepatocellular Carcinoma (HCC)
Refer to the product monograph for a full list and details of approved indications.
Emetogenic Potential:
Extravasation Potential: None
Adverse effects marked with “†” are based on a pooled data set across multiple monotherapy studies.
Adverse effects from studies that used subcutaneous formulation are denoted with “^”.
| ORGAN SITE | SIDE EFFECT* (%) | ONSET** | |||
|---|---|---|---|---|---|
| Cardiovascular | Arrhythmia (1%) | E | |||
| Arterial thromboembolism (<1%) | E | ||||
| Hypotension (5%) | E | ||||
| Myocarditis (rare), pericarditis | E D | ||||
| Venous thromboembolism (4%) | E | ||||
| Dermatological | Rash, pruritus , dry skin (15%) (may be severe) | E D | |||
| Stevens-Johnson syndrome (rare) | E | ||||
| Toxic epidermal necrolysis (rare) | E | ||||
| Gastrointestinal | Anorexia (15%) | E | |||
| Constipation (12%) | E | ||||
| Diarrhea (11%) (may be severe; colitis - 1%)† | E D | ||||
| Nausea, vomiting (14%) | I E | ||||
| General | Fatigue (26%) | E D | |||
| Sarcoidosis (rare) | E | ||||
| Hematological | Aplastic anemia (rare) | E | |||
| Hemolytic anemia (autoimmune - rare) | E | ||||
| Myelosuppression (15%) (including anemia) | E | ||||
| Hepatobiliary | Hepatitis (immune-related) (rare) | E | |||
| ↑ LFTs (5%) (2% immune related hepatitis†) | E D | ||||
| Pancreatitis (rare)† | E D | ||||
| Hypersensitivity | Hypersensitivity (<1%) | I | |||
| Immune | Hemophagocytic lymphohistiocytosis (rare) | E | |||
| Infection | Infection (43%) (11% severe) | E | |||
| Injection site | Injection site reaction (5%) ^ | I | |||
| Metabolic / Endocrine | Abnormal electrolyte(s) (6%) (↓Na, Mg, K, Ca; ↑K, Ca) | E | |||
| Adrenal insufficiency (rare)† | E D | ||||
| Hyperglycemia (4%) (including Type 1 Diabetes - rare†) | E D | ||||
| Hyperthyroidism (5%) | E D | ||||
| Hypophysitis (rare)† | E D | ||||
| Hypothyroidism (9%) (may be severe) | E D | ||||
| Musculoskeletal | Musculoskeletal pain (15%) | E | |||
| Rhabdomyolysis (rare) | E D | ||||
| Nervous System | Encephalitis (Meningo-encephalitis) (rare) | E D | |||
| Guillain-Barre syndrome (rare)† | E D | ||||
| Headache (9%) | E | ||||
| Myasthenia (rare - myasthenia gravis or myasthenic syndrome†) | E D | ||||
| Myelitis (rare) | E | ||||
| Myositis (rare)† | E D | ||||
| Peripheral neuropathy (7%) | E | ||||
| Ophthalmic | Uveitis (and other ocular inflammatory toxicity) (rare)† | E D | |||
| Renal | Creatinine increased (1%) | E | |||
| Nephritis (rare)† | D | ||||
| Respiratory | Cough, dyspnea (14%) | E | |||
| Pneumonitis (3%) † | E D | ||||
| Vascular | Vasculitis (rare) | E | |||
* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare"
may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal
reports.
** I = immediate (onset in hours to days)
E = early (days to weeks)
D = delayed (weeks to months)
L = late (months to years)
The most common side effects for atezolizumab include infection, fatigue, anorexia, musculoskeletal pain, myelosuppression, rash/pruritus, cough/dyspnea, nausea/vomiting, constipation, and diarrhea.
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.
Presentation of immune-mediated reactions may be different compared to other anti-cancer agents and early diagnosis and appropriate management is critical.
Immune-related reactions such as rash, pneumonitis, colitis, hepatitis, pancreatitis, nephritis, endocrinopathies, meningoencephalitis, and neuropathies were reported and may be severe or fatal. Onset may vary from days to many months.
Severe cutaneous adverse reactions (SCARs) (including reports of erythema multiforme, dermatitis bullous, toxic skin eruption, toxic epidermal necrolysis (TEN), exfoliative rash, and dermatitis exfoliative generalized) have occurred in patients who receiving atezolizumab (IV) as monotherapy or in combination with other anti-cancer agents.
Infections, including fatal cases, have been reported with atezolizumab (IV or subcut). Pneumonia was the most common type of grade 3 or higher infection.
Severe bleeding, including fatal events, have been reported in NSCLC and HCC patients treated with the atezolizumab (IV)-bevacizumab combination.
Refer to protocol by which the patient is being treated.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Avoid the use of corticosteroids or immunosuppressants before starting treatment.
Some treatment indications require a validated test to determine PD-L1 tumour status. Refer to the product monograph for details.
Atezolizumab IV and subcutaneous formulations are not interchangeable. The dosing and concentration of these products are different.
Monotherapy - NSCLC
Subcutaneous: 1875 mg Every 3 weeks
Combination therapy
Various schedules are used depending on the indication. Refer to the product monograph or related regimen monographs for details.
Healthcare professionals should also consult the most recent atezolizumab (subcut) 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 administration-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 |
Restart:
|
|
| 3 or 4 |
|
|
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for management of immune-related hepatic toxicities.
| Hepatic Impairment | Atezolizumab Dose |
| Mild (bilirubin ≤ ULN and AST > ULN, OR bilirubin > 1 to 1.5 x ULN and any AST) |
No change |
| Moderate (bilirubin > 1.5 to 3 x ULN and any AST) |
No change |
|
Severe |
No data |
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for management of immune-related hepatic toxicities.
| Creatinine Clearance (mL/min) | Atezolizumab Dose |
| ≥ 30 | No change |
| < 30 | No data |
No dose adjustment is required in patients ≥ 65 years of age. No differences in safety or efficacy were observed between patients ≥ 65 years of age and younger patients observed. Data in patients > 75 years of age are too limited to draw conclusions.
The safety and efficacy in children and adolescents below 18 years of age have not been established.
Atezolizumab IV and subcutaneous formulations are not interchangeable. The dosing and concentration of these products are different.
-
Atezolizuma (subcut) does not require reconstitution or dilution.
-
Administer by subcutaneous injection, over approximately 7 minutes.
-
Allow vials to come to room temperature (15-30°C) before administration.
-
Injection site should be alternated between the left and right thigh only.
-
Use of a subcutaneous infusion set (e.g., winged / butterfly) is recommended. Refer to the product monograph for preparation instructions.
-
DO NOT administer the remaining residual volume in the tubing to the patient.
-
Atezolizumab subcut should be given prior to IV combination therapy if given on the same day.
-
Atezolizumab (subcut) is compatible with polypropylene (PP), polycarbonate (PC), stainless steel (ss), polyvinyl chloride (PVC), and polyurethanes (PU).
-
Inject other subcutaneous medications at separate sites.
-
Do not shake vials.
-
Store vials at 2-8°C. Do not freeze. Protect from light.
- Patients who have a hypersensitivity to this drug or any of its components
- Atezolizumab (subcut) may cause serious immune-mediated reactions affecting multiple organ systems, including GI, hepatic, cardiac, respiratory, endocrine and others. Use with caution and monitor closely in patients with pre-existing autoimmune disease and conditions such as colitis, hepatic impairment, respiratory or endocrine disorders, such as hypo or hyperthyroidism or diabetes mellitus.
- Caution in patients who have previously experienced a severe or life-threatening adverse skin reaction on previous treatment with other immune stimulatory anticancer drugs.
- Do not replace nab-paclitaxel with paclitaxel in combination with atezolizumab (subcut) in unresectable locally advanced or metastatic triple negative breast cancer outside of controlled clinical trials. An increase in the risk of death was reported in PD-L1 positive patients treated with atezolizumab IV and paclitaxel vs placebo and paclitaxel.
- Consider the bleeding risks of atezolizumab (subcut) and bevacizumab combination in HCC and NSCLC before starting treatment. Patients with HCC should be evaluated for the presence of varices and have varices treated within 6 months before starting therapy with the atezolizumab (subcut)-bevacizumab combination. The following patients were excluded from IV atezolizumab clinical trials: NSCLC patients who had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesion (as seen on imaging), or HCC patients with bleeding varices (including recent bleeds), untreated varices or varices at high risk of bleeding.
- Severe infections have been observed in clinical trials.
Other Drug Properties:
-
Carcinogenicity:
Unknown
-
Genotoxicity:
Unknown
-
Fetotoxicity:
Documented in animals
-
Pregnancy:
Atezolizumab (subcut) is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for at least 5 months after the last dose.
-
Breastfeeding:
Breastfeeding is not recommended during treatment and for at least 5 months after the last dose.
-
Fertility effects:
Probable
Documented in studies, in female animals
- Atezolizumab (subcut) 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 (subcut) because of potential interference with efficacy. They can be used to treat immune-mediated reactions after starting the drug. Corticosteroids may be used as premedication (e.g. antiemetic) when given with chemotherapy.
- Acetaminophen may affect the response to immune checkpoint inhibitors. Further clinical studies are needed to determine the exact mechanism and the appropriate clinical management (Bessede et al, 2022).
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
| Monitor Type | Monitor Frequency |
|---|---|
CBC |
Baseline and Q3-6 weeks, or as clinically indicated |
Liver function tests |
Baseline and Q3-6 weeks, or as clinically indicated |
Renal function tests, urine protein |
Baseline and Q3-6 weeks, or as clinically indicated |
Thyroid function tests |
Baseline, and as clinically indicated |
Blood glucose |
Baseline, and as clinically indicated |
Clinical toxicity assessment for infection, fatigue, administration-related reactions, and immune-mediated reactions, such as endocrine, skin, GI, cardiac, neurologic, musculoskeletal, ocular or respiratory toxicity |
At each visit |
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
New Drug Funding Program (NDFP Website )
- Atezolizumab - Advanced or Metastatic Non-Small Cell Lung Cancer
- Atezolizumab - Adjuvant Treatment for Non-Small Cell Lung Cancer
- Atezolizumab - In Combination with Etoposide and Platinum for Extensive-Stage Small Cell Lung Cancer
- Atezolizumab with Bevacizumab (Biosimilar) - Previously Untreated Unresectable or Metastatic Hepatocellular Carcinoma
Atezolizumab drug monograph. Ontario Health (Cancer Care Ontario).
Bessede A, Marabelle A, Guegan JP, et al. Impact of acetaminophen on the efficacy of immunotherapy in cancer patients. Ann Oncol 2022;33(9):909-15.
Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023 Aug;34(8):693-702. Erratum in: Ann Oncol. 2024 May;35(5):482.
Felip E, Burotto M, Zvirbule Z, et al. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155.
Prescribing information: Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use. Genentech, Inc. Sept 2024.
Product monograph: Tecentriq® SC (atezolizumab injection). Hoffmann-La Roche Limited. January 09, 2025.
May 2025 New drug monograph
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.
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