Atezolizumab

TECENTRIQ (ATEZOLIZUMAB) — CLINICIAN SUMMARY

RED FLAG (IMPORTANT) INFORMATION

(Main points to consider before and during treatment)

• Immune-related toxicities are common and can be severe: pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, myocarditis.

• Check liver function before each cycle; high risk of severe hepatitis.

• Monitor for new or worsening cough or shortness of breath — rule out pneumonitis.

• Infusion reactions can occur — supervise infusions, especially the first dose.

• Many indications have PD-L1 requirements or specific combination regimens — verify before prescribing.

• No dose reductions — manage toxicity by withholding treatment and using corticosteroids.

1. BASIC INFORMATION

Generic name: Atezolizumab
Brand name: Tecentriq
Class: Anti–PD-L1 monoclonal antibody (immune checkpoint inhibitor)
Formulation: IV concentrate, 60 mg/mL
Vial strengths: 840 mg, 1200 mg

2. INDICATIONS 

Urothelial Carcinoma

Locally advanced or metastatic urothelial carcinoma (UC):
Tecentriq as monotherapy is indicated in adult patients:

• After platinum-containing chemotherapy, or

• Cisplatin-ineligible patients whose tumours have PD-L1 expression ≥ 5%

Hepatocellular Carcinoma (HCC)

Unresectable hepatocellular carcinoma:

• Tecentriq in combination with bevacizumab

• In patients who have not received prior systemic therapy

Triple-Negative Breast Cancer (TNBC)

Locally advanced or early TNBC:

• Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy

• Used as neoadjuvant treatment

Metastatic disease

Unresectable locally advanced or metastatic TNBC:

• Tecentriq in combination with nab-paclitaxel

• Tumours with PD-L1 expression ≥ 1%

• Patients not previously treated with chemotherapy for metastatic disease

Small Cell Lung Cancer (SCLC)

Extensive-stage small cell lung cancer (ES-SCLC):

• Tecentriq in combination with carboplatin and etoposide as first-line treatment

Non-Small Cell Lung Cancer (NSCLC)

Locally advanced or metastatic NSCLC:

• Tecentriq as monotherapy after prior chemotherapy

First-line treatment – monotherapy

Metastatic NSCLC:

• Tumours with PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC)

• Patients without EGFR or ALK genomic tumour aberrations

First-line treatment – combination therapy

Metastatic non-squamous NSCLC:

• Tecentriq in combination with bevacizumab, paclitaxel, and carboplatin

• Patients with EGFR or ALK genomic tumour aberrations should have received appropriate targeted therapy prior to Tecentriq, if clinically indicated

Metastatic non-squamous NSCLC:

• Tecentriq in combination with carboplatin and nab-paclitaxel

• For patients without EGFR or ALK genomic tumour aberrations

3. DOSING AND ADMINISTRATION

Standard fixed dosing options:

• 840 mg IV every 2 weeks, OR

• 1200 mg IV every 3 weeks, OR

• 1680 mg IV every 4 weeks

Infusion:

• First dose over 60 minutes; if well tolerated, subsequent doses may be given over 30 minutes.

• Do not give as IV push or bolus.

• Do not co-infuse with other drugs in the same line.

Duration:

• Continue until progression or unacceptable toxicity.

4. DOSE MODIFICATIONS / IMMUNE-RELATED MANAGEMENT

• No formal dose reductions.

• Toxicities are managed by holding treatment and giving corticosteroids.

• Resume only after improvement to Grade 1 or baseline and steroid taper.

Examples:

Pneumonitis:

• Grade 2: hold treatment

• Grade 3–4: permanently discontinue

Hepatitis:

• Hold for moderate LFT elevations

• Permanently discontinue for severe or persistent elevation

Colitis:

• Hold for Grade 2 or higher

• Severe cases require IV steroids and possible discontinuation

5. CONTRAINDICATIONS AND PRECAUTIONS

Contraindications:

• Hypersensitivity to atezolizumab or excipients

Precautions:

• Autoimmune conditions

• Interstitial lung disease

• Pregnancy and breastfeeding (avoid)

• Live vaccines should not be used

• Monitor patients with diabetes (contains sucrose)

6. MONITORING REQUIREMENTS

Baseline:

• FBC

• LFTs (ALT, AST, bilirubin)

• Renal function

• Respiratory symptoms

• Thyroid profile if clinically indicated

• Pregnancy test if applicable

During treatment:

• LFTs at each cycle

• Monitor for respiratory symptoms

• Monitor for diarrhoea/abdominal pain

• Thyroid and adrenal function if symptomatic

• Consider FBC regularly, especially with chemo combinations

7. SIDE EFFECTS AND MANAGEMENT

Common immune-related toxicities:

• Pneumonitis

• Hepatitis

• Colitis

• Endocrine disorders (thyroiditis, hypothyroidism, adrenal insufficiency)

• Nephritis

• Skin reactions

• Myocarditis (rare but serious)

Other common effects:

• Fatigue

• Rash

• Nausea, diarrhoea

• Decreased appetite

• Cough

• Fever

Infusion reactions:

• Manage with slowing or stopping infusion and supportive care.

8. DRUG INTERACTIONS AND CO-MEDICATIONS

• No major CYP interactions (monoclonal antibody).

• Avoid live vaccines.

• Immunosuppressants before starting therapy may reduce effectiveness.

• Steroids/immunosuppressants are appropriate for treating immune toxicities once they occur.

• Additive toxicity when combined with chemotherapy (cytopenias, infection risk).

9. SPECIAL POPULATIONS

Elderly: No dose adjustment required.
Renal impairment: No adjustment for mild to moderate impairment.
Hepatic impairment: No adjustment for mild impairment; limited data in moderate/severe impairment.
Paediatrics: Not approved.
Pregnancy: Contraindicated.
Breastfeeding: Avoid.

10. WHEN TO STOP TREATMENT

Stop Tecentriq permanently for:

• Confirmed pneumonitis (Grade 3–4)

• Severe hepatitis

• Severe colitis

• Life-threatening immune-related events

• Severe infusion/hypersensitivity reactions

• Persistent toxicity not improving with steroids

Continue treatment until progression or intolerance.

https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2022/09/Tecentriq-PI_30Aug2022.pdf