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Atezolizumab
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Atezolizumab is an antineoplastic agent belonging to the pharmacological class of Programmed Death-Ligand 1 (PD-L1) inhibitors.
The FDA approves Atezolizumab for treating advanced or metastatic urothelial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, melanoma and small cell lung cancer.
Atezolizumab is widely distributed and efficiently absorbed when administered intravenously. Its steady-state volume of distribution is 6.9 litres. It is broken down into amino acids by metabolism, and the primary mechanism for facilitating its removal is proteolytic breakdown. This leads to an extended elimination half-life of 27 days.
The most common side effects of atezolizumab include fatigue, nausea, decreased appetite, constipation, cough, and shortness of breath.
Atezolizumab is available as an injectable solution.
The molecule is available in India, the United States, Canada, countries within the European Union, Australia, Japan and South Korea.
Atezolizumab is an antineoplastic agent belonging to the pharmacological class of programmed death-ligand 1 (PD-L1) inhibitors.
By binding to PD-L1, atezolizumab, a humanized IgG antibody, inhibits PD-1 and B7-1 from interacting. The suppression of immune responses, including the anti-tumor immune response, is eliminated when PD-L1 and PD-1 interaction is avoided, but antibody-dependent cellular cytotoxicity is left unaffected.
The peak plasma concentration of Atezolizumab increases by 1.91-fold.
The minimum plasma concentration of Atezolizumab increases by 1.46-fold after administration.
The area under the curve (AUC) of Atezolizumab increases by a 2.75-fold rise in the drug's systemic exposure.
Atezolizumab is available as an injectable solution.
Injectable solutions: To be administered parenterally, as applicable.
As prescribed by the physician, take the medication with or without meals.
- Treatment of Small cell lung cancer
- Non-small cell lung cancer
- Melanoma
- Treatment of Hepatocellular carcinoma
- Treatment of Small cell lung cancer (SCLC): Small cell lung cancer has an aggressive action with rapidly proliferating cancer cells similar to oats. There are two main stages that it goes through: the limited stage, which is restricted to one side of the chest, and the extensive stage, which is spread over more than one side. Owing to its aggressive nature, chemotherapy and, occasionally, radiation therapy are used in combination for SCLC treatment. By focusing on the PD-L1 pathway, atezolizumab helps to stimulate the immune system's capacity to identify and eliminate cancer cells.
- Non-small cell lung cancer: By focusing on the PD-L1 pathways, atezolizumab effectively treats non-small cell lung cancer (NSCLC) by boosting the immune system's ability to identify and destroy cancer cells. It is a PD-L1 inhibitor that helps patients with advanced or metastatic NSCLC that is mainly brought on by cigarette smoking by improving overall survival, progression-free survival, and therapeutic outcomes.
- Melanoma: Melanoma is one of the most common type of skin cancer that develops from melanocytes, which produce pigment. Atezolizumab targets the PD-L1 pathway in melanoma, which improves treatment outcomes and overall survival by strengthening the ability of the immune system to combat cancer cells.
- Treatment of Hepatocellular carcinoma: Hepatocellular carcinoma (HCC) is an effective treatment for primary liver cancer produced by hepatocytes treated with atezolizumab. Its effectiveness is due to its ability to interfere with the immune system's PD-L1-mediated suppression, which permits a focused anti-cancer response. With the potential to prolong life and enhance patient quality of life, targeted immunotherapy offers a promising approach to managing HCC.
Atezolizumab is indicated in the following conditions:
- Adjuvant treatment post-resection, platinum-based chemo for NSCLC with PD-L1 expression.
- First-line treatment for metastatic NSCLC with high PD-L1 expression, excluding EGFR or ALK genomic aberrations.
- First-line treatment for metastatic nonsquamous NSCLC without EGFR or ALK aberrations in combination with bevacizumab, paclitaxel, and carboplatin.
- First-line treatment for metastatic nonsquamous NSCLC without EGFR or ALK aberrations in combination with paclitaxel protein-bound and carboplatin.
- As a first-line treatment for an extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
- Combination therapy with bevacizumab for unresectable or metastatic hepatocellular carcinoma (HCC) in treatment-naive patients.
- Combination therapy with cobimetinib and vemurafenib for unresectable or metastatic BRAF V600 mutation-positive melanoma.
- Single-agent treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS).
- when used as a single treatment for adults and pediatric patients older than two years who have unresectable or metastatic alveolar soft part sarcoma (ASPS).
Parenterally: Administer atezolizumab only by intravenous (IV) infusion; do not give atezolizumab as an IV bolus or IV push. Use an IV line with or without an in-line filter (pore size of 0.2-0.22 micron) that is sterile, nonpyrogenic, and low-protein binding. Give the first IV infusion for sixty minutes. If the first infusion goes well, doses for subsequent infusions can be spread out over a half-hour. When taking chemotherapy and atezolizumab together, give the medication earlier, if possible, on the same day. Avoid co administering other medicines through the same IV line to ensure proper administration.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Atezolizumab is available as an injectable solution.
Dose Adjustment in Adult Patients:
Give atezolizumab intravenously for 60 minutes. All subsequent infusions may be administered over 30 minutes if the initial injection is tolerated.
Urothelial Cancer
Give 840 mg, 1200 mg, or 1680 mg of atezolizumab every two, three, or four weeks as a single dose.
NSCLC
Give atezolizumab in the adjuvant setting after resection and during up to four cycles of platinum-based chemotherapy (840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks for a maximum of one year).
Administer atezolizumab as 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks in the metastatic setting.
Give atezolizumab before chemotherapy and bevacizumab on the same day when administering chemotherapy and bevacizumab together.
Small Cell Lung Cancer
Give 840 mg, 1200 mg, or 1680 mg of atezolizumab every two, three, or four weeks. If atezolizumab is administered on the same day as carboplatin and etoposide, it should be given before chemotherapy.
Hepatocellular Carcinoma
Give 840 mg, 1200 mg, or 1680 mg of atezolizumab every two, three, or four weeks. When administered on the same day, give atezolizumab before bevacizumab. Every three weeks, bevacizumab is given at a dosage of 15 mg/kg.
Melanoma
Give Atezolizumab 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks after completing a 28-day cycle of cobimetinib and vemurafenib. The regimen includes 60 mg of cobimetinib taken once daily (21 days on, seven days off) and 720 mg of vemurafenib taken twice daily.
While undergoing Atezolizumab treatment, it is crucial to refrain from consuming antioxidant-rich foods like berries and spinach for added health benefits. Integrate fibre-rich options into your diet, including beans, peas, lentils, nuts, whole grains,and seeds, as they contribute to improved digestion.
The dietary restriction should be individualized as per patient requirements.
- Severe immune-mediated adverse reactions affecting various organs may occur, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, nephritis, and transplant rejection. Monitor for early detection, regularly assessing liver enzymes, creatinine, and thyroid function. Adjust treatment based on reaction severity.
- Manage infusion-related reactions by interrupting, slowing infusion, or discontinuing based on severity.
- Allogeneic hematopoietic stem cell transplant (HSCT) recipients may experience fatal complications; caution is warranted.
- Potential embryo-fetal toxicity exists; advise reproductive-age females on fetal risk and ensure effective contraception.
Alcohol Warning
Breast Feeding Warning
Pregnancy Warning
Food Warning
The adverse reactions related to atezolizumab can be categorized as:
- Common Adverse Effects: Fatigue, decreased appetite, and dyspnea.
- Less Common Adverse Effects: Liver enzyme elevation, hypothyroidism, and rash.
- Rare Adverse Effects: Pneumonitis, colitis, hepatotoxicity, dermatologic reactions, nephritis, or transplant rejection.
Reports on Postmarketing
The Heart: myocarditis, pericarditis, effusion around the Heart, and tamponade of the Heart
Dermatologic: Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pemphigoid, erythema multiforme
Gastrointestinal: Amylase or lipase elevations in serum, as well as pancreatitis
In general, histiocytic necrotizing lymphadenitis and systemic inflammatory response syndrome
Haematological conditions include immune thrombocytopenic purpura and autoimmune hemolytic anaemia.
Musculoskeletal: myolysis and rhabdomyolysis
Neurological: polymyalgia rheumatic, autoimmune neuropathy, Vogt-Koyanagi-Harada syndrome, immune-related meningoencephalitis, aseptic meningitis, encephalitis, facial and abducens nerve paresis, and Guillain-Barre syndrome
Uveitis and iritis in ophthalmology
Reproductive: Nephrotic syndrome and nephritis
Vascular: Inflammation of the Vasculature
Hyperthyroidism
Elevated alkaline phosphate or transaminases
Reactions related to infusion
The clinically relevant drug interactions of Atezolizumab are briefly summarized here.
Systemic corticosteroids and immunosuppressants should not be used with atezolizumab as they may interfere with its pharmacodynamic activity and efficacy. Nonetheless, additional immunosuppressants or systemic corticosteroids may be used to treat adverse effects caused by the immune system after starting atezolizumab.
The common side effects of atezolizumab include
Fatigue
Weakness
Upper respiratory tract infections
Injection site reactions
Decreased appetite
Nausea
Cough
Breathlessness
Constipation
Vomiting
Diarrhoea
Headache
Fever
Back pain
- Pregnancy
When used during pregnancy, it may be harmful to the fetus due to its mode of action.
There is no information on use in expectant mothers.
Animal data
Studies on animals have shown that inhibition of the PD-L1/PD-1 pathway can raise the risk of immune-related fetal rejection, which can be fatal.
Contraception
Encourage women who are fertile to use birth control during their treatment and for a minimum of five months after the last dosage.
Infertility
Research on animals suggests that atezolizumab treatment may reduce the fertility of females capable of having children.
- Nursing Mothers
If distributed in human breast milk is still unknown
The possibility of human IgG absorption and harm to the newborn is unknown because it is excreted in human milk.
Advise nursing mothers to stop nursing for at least five months following the last dosage and not to do so during treatment.
- Pediatric Use
The safety and effectiveness of Atezolizumab in pediatric patients have not been established.
Dose Adjustment
Alveolar Soft Part Sarcoma
15 mg/kg, up to 1,200 mg maximum III q3Weeks
Continue until the disease worsens or the level of toxicity is unacceptable.
Dose Adjustment in Kidney Impairment Patients:
For mild or moderate patients (eGFR 30-89 mL/min/1.73 m2): No need to change the dosage.
Severe (eGFR <20 mL/min/1.73 m2): Unstudied
Dose Adjustment in Hepatic Impairment Patients:
Mild: It is not advised to change the dosage.
Moderate to severe: Unstudied
There is no information available regarding atezolizumab overdose.
In the event of an Atezolizumab overdose, patients should start receiving the proper symptomatic treatment and be continuously observed for indications of adverse reactions.
Pharmacodynamic
A humanized monoclonal antibody called atezolizumab is used to stop PD-L1 and PD-1 from interacting, thereby eliminating the immune response inhibition that some cancers have. Since this medication is typically taken every three to four weeks, its duration of action is prolonged. Patients with colitis, hepatitis, immune-mediated pneumonitis, and certain endocrinopathies shouldn't take atezolizumab.
Pharmacokinetics
- Absorption: The body efficiently and broadly absorbs atezolizumab when it is given intravenously. Atezolizumab takes about 6 to 9 weeks to stabilize in the blood.
- Distribution: It is observed that the drug is distributed throughout the body to the extent that its volume of distribution at a steady state is 6.9 litres.
- Metabolism: Monoclonal antibodies, such as atezolizumab, are broken down metabolically into amino acids and smaller polypeptides.
- Excretion: The body eliminates atezolizumab via several processes, but primarily via proteolytic breakdown and not renally excreted. Atezolizumab exhibits an elimination half-life of 27 days.
- Krishnamurthy A, Jimeno A. Atezolizumab: A novel PD-L1 inhibitor in cancer therapy with a focus in bladder and non-small cell lung cancers. Drugs Today (Barc). 2017 Apr;53(4):217-237. doi: 10.1358/dot.2017.53.4.2589163. PMID: 28492290.
- Das M, Ogale S, Jovanoski N, Johnson A, Nguyen C, Bhagwakar J, Lee JS. Cost-effectiveness of adjuvant atezolizumab for patients with stage II-IIIA PD-L1+ non-small-cell lung cancer. Immunotherapy. 2023 Jun;15(8):573-581. doi: 10.2217/imt-2022-0311. Epub 2023 Apr 6. PMID: 37021770; PMCID: PMC10334222.
- Tie Y, Yang H, Zhao R, Zheng H, Yang D, Zhao J, Liu M. Safety and efficacy of atezolizumab in the treatment of cancers: a systematic review and pooled-analysis. Drug Des Devel Ther. 2019 Feb 4;13:523-538. doi: 10.2147/DDDT.S188893. PMID: 30787594; PMCID: PMC6366347.
- Rattanapisit K, Bulaon CJI, Strasser R, Sun H, Phoolcharoen W. In vitro and in vivo studies of plant-produced Atezolizumab as a potential immunotherapeutic antibody. Sci Rep. 2023 Aug 29;13(1):14146. doi: 10.1038/s41598-023-41510-w. PMID: 37644118; PMCID: PMC10465495.
- https://www.ncbi.nlm.nih.gov/books/NBK567758/
- US Food and Drug Administration (FDA) [Internet]. Maryland. USA; Package leaflet information for the user; Tecentriq® (atezolizumab)
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf
- https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf