Atezolizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of atezolizumab.
Drugs List
Therapeutic Indications
Uses
Advanced or metastatic non-small cell lung cancer after chemotherapy failed
Advanced/metastatic transitional cell carcinoma of the urothelial tract
Breast cancer
Hepatocellular carcinoma
Small cell lung cancer
Locally advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy or who are considered cisplatin ineligible with PD-L1 expression above or equal to 5%.
Locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab.
First-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) when used in combination. In patients with EGFR mutant or ALK-positive NSCLC, atezolizumab, when used in combination is indicated only after failure of appropriate targeted therapies.
First-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with Carboplatin and Etoposide.
Treatment of advanced or unresectable hepatocellular carcinoma (HCC) in combination with Bevacizumab in patients with no prior treatment.
In combination with nab-paclitaxel for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) with PD-L1 expression above or equal to 1% without prior chemotherapy.
Dosage
Adults
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
840 mg every two weeks, or 1200 mg every three weeks, or 1680 mg every four weeks.
Additional Dosage Information
Missed dose
If a planned dose is missed, the dose should be administered as soon as possible, and the dosing schedule should be adjusted to maintain the appropriate interval between doses.
Dose modifications
Immune-related reactions may warrant interruption of treatment and corticosteroid initiation, based on severity.
All toxicities
Grade 4 toxicity, except endocrinopathies controlled by replacement hormones: Permanently discontinue.
Any toxicity that does not resolve to grade 0 or grade 1 within 12 weeks: Permanently discontinue.
Any toxicity that requires more than 10mg prednisolone (or equivalent) daily for over 12 weeks: Permanently discontinue.
All adverse events
Any recurring event, grade 3 or higher: Permanently discontinue.
Pneumonitis
Grade 2: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Hepatitis without HCC
Grade 2, ALT or AST between 3 and 5 times upper limit of normal (ULN) or blood bilirubin between 1.5 and 3 times ULN: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Hepatitis with HCC
If ALT or AST is within normal limits at baseline and increases to between 3 and 10 times upper limit of normal (ULN) or
If ALT or AST is between 1 and 3 ULN at baseline and increases to between 5 and 10 times ULN or If ALT or AST is between 3 and 5 ULN at baseline and increases to between 8 and 10 times ULN: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Diarrhoea and colitis
Grade 2 or 3 diarrhoea, or symptomatic colitis: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Hypothyroidism or hyperthyroidism
Symptomatic hypothyroidism: Withhold atezolizumab until symptoms are controlled by thyroid replacement therapy and thyroid stimulating hormone levels decrease.
Symptomatic hyperthyroidism: Withhold atezolizumab until symptoms are controlled by antithyroid therapy and thyroid function improves.
Adrenal insufficiency
Symptomatic adrenal insufficiency: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, patient is stable on replacement therapy, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Hypophysitis
Grade 2 or 3: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, patient is stable on replacement therapy, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Type 1 diabetes mellitus
Grade 3 or 4 (fasting glucose greater than 13.9 millimoles per litre): Withhold atezolizumab until insulin replacement therapy returns normal metabolic control.
Rash
Grade 3: Withhold atezolizumab until rash resolves, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Pancreatitis
Grade 2 or 3 pancreatitis, grade 3 or 4 serum amylase, or lipase levels greater than 2 times ULN: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Myocarditis
Grade 2 myocarditis: Withhold atezolizumab until symptoms improve to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to equal to or less than 10mg prednisone (or equivalent) per day.
Nephritis
Grade 2 (creatinine level greater than 1.5 to 3 times baseline or 1.5 to 3 times ULN): Withhold atezolizumab until symptoms improve to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Grade 3 or 4 (creatinine level greater than 3 times baseline or 3 times ULN): Permanently discontinue.
Myositis
Grade 2 or 3: Withhold atezolizumab until return to grade 0 or grade 1 within 12 weeks, and corticosteroids are reduced to equal to or below 10mg per day (prednisolone or equivalent).
Grade 4 or recurrent grade 3: Permanently discontinue.
Other immune-related adverse reactions
Grade 2 or 3: Withhold atezolizumab until symptoms improve to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to equal to or less than 10mg prednisone (or equivalent) per day.
Administration
Administer initial dose over 60 minutes. If this first infusion is well tolerated, reduce subsequent infusion times to 30 minutes.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Asian ancestry
History of autoimmune disorder
Major organ dysfunction
Within 4 weeks of other live vaccines
Cerebral metastases
Haematological disorder
Hepatitis B
Hepatitis C
History of pneumonitis
Positive HIV status
Severe cardiovascular disorder
Severe hepatic impairment
Severe renal impairment
Thyroid dysfunction
Advise patient that dizziness/fatigue may initially affect ability to drive
Consider use of corticosteroids if adverse reactions occur
Not all available strengths are licensed for all indications
TNBC: Confirm PD-L1 expression of tumour prior to treatment
Treatment to be initiated and supervised by a specialist
UC: Confirm PD-L1 expression of tumour prior to treatment
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Suspend treatment or reduce rate until infusion reactions resolve
Monitor hepatic function before treatment and regularly during treatment
Monitor thyroid function prior to and periodically during treatment
Monitor for signs and symptoms of colitis
Monitor for signs and symptoms of myositis
Monitor for signs and symptoms of pancreatitis
Monitor for signs and symptoms of pneumonitis
Monitor patient for signs and symptoms of meningitis or encephalitis
Monitor patients for endocrinopathies
Monitor patients for signs and symptoms of myocarditis
Monitor patients for symptoms of neuropathy
Monitor renal function
Discontinue if myasthenia gravis or myasthenic syndrome occurs
Suspend treatment if grade 2 adrenal insufficiency occurs
Suspend treatment if grade 3 or worse skin reaction occurs
Discontinue if grade 3 myocarditis occurs
Discontinue if grade 3 or greater adverse reaction that recurs/persists
Discontinue if grade 3 or higher infusion reaction occurs
Discontinue if grade 4 immune related reactions occur
Discontinue if grade 4 skin reaction occurs
Discontinue if meningitis or encephalitis occurs
Discontinue permanently if grade 4 colitis occurs
Discontinue permanently if grade 4 diarrhoea occurs
Discontinue permanently if grade 4 or recurrent grade 3 myositis occurs
Discontinue treatment if AST/ALT >5 times upper limit of normal
Discontinue treatment if grade 3 or greater nephritis occurs
Discontinue treatment if grade 3 or greater pneumonitis occurs
Discontinue treatment if grade 4 hypophysitis occurs
Discontinue treatment if grade 4 pancreatitis occurs
Discontinue treatment if total bilirubin >3 times upper limit of normal
Suspend treatment if AST/ALT is 3-5 times upper limit of normal
Suspend treatment if grade 2 diarrhoea occurs
Suspend treatment if grade 2 myocarditis occurs
Suspend treatment if grade 2 nephritis occurs
Suspend treatment if grade 2 or 3 colitis occurs
Suspend treatment if grade 2 or 3 hypophysitis occurs
Suspend treatment if grade 2 or 3 immune related reactions occur
Suspend treatment if grade 2 or 3 myositis occurs
Suspend treatment if grade 2 pneumonitis occurs
Suspend treatment if grade 3 or greater elevations in lipase or amylase
Suspend treatment if grade 3 or greater hyperglycaemia occurs
Suspend treatment if total bilirubin between 1.5 and 3 times ULN
Female: Contraception required during & for at least 5 months after therapy
Remind patient of importance of carrying Alert Card with them at all times
Pregnancy and Lactation
Pregnancy
Atezolizumab is contraindicated during pregnancy.
The manufacturer does not recommend using atezolizumab during pregnancy unless clinically necessary. Animal studies have shown teratogenic effects. Human data is limited and as such potential risks are unknown, however atezolizumab is expected to cross the placenta.
Lactation
Atezolizumab is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking atezolizumab. The presence of atezolizumab in human breast milk is unknown but due to its large molecular weight, transfer is not expected. A decision must be made to discontinue breastfeeding or discontinue treatment.
Side Effects
Abdominal pain
Acne
Acute adrenal insufficiency
Anaemia
Arthralgia
Asthenia
Back pain
Chills
Colitis
Constipation
Cough
Cytokine release syndrome
Decreased appetite
Dermatitis
Diabetes mellitus
Diarrhoea
Dry skin
Dysphagia
Dysphonia
Dyspnoea
Elevated amylase levels
Elevated serum lipase
Encephalitis
Erythema
Fatigue
Guillain-Barre syndrome
Headache
Hepatitis
Hepatotoxicity
Herpes zoster
Hyperglycaemia
Hypersensitivity reactions
Hyperthyroidism
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Hypophysitis
Hypotension
Hypothyroidism
Hypoxia
Increase in serum ALT/AST
Influenza-like symptoms
Infusion related reaction
Interstitial lung disease
Ketoacidosis
Meningitis
Musculoskeletal pain
Myasthenic syndrome (transient)
Myocarditis
Myositis
Nasal congestion
Nasopharyngitis
Nausea
Nephritis
Neutropenia
Oropharyngeal pain
Pancreatitis
Peripheral motor neuropathy
Peripheral neuropathy
Peripheral sensory neuropathy
Pneumonitis
Proteinuria
Pruritus
Psoriasis
Pyelonephritis
Pyrexia
Rash
Serum creatinine increased
Stomatitis
Thrombocytopenia
Urinary tract infections
Uveitis
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2021
Reference Sources
Summary of Product Characteristics: Tecentriq 1,200mg concentrate for solution for infusion. Roche Products Ltd. Revised June 2022.
Summary of Product Characteristics: Tecentriq 840mg concentrate for solution for infusion. Roche Products Ltd. Revised June 2022.
National Center for Biotechnology Information (NCBI). Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK500809/
Atezolizumab Last revised: 20 July 2020
Last accessed: 21 January 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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