Atezolizumab

What is Atezolizumab?

• Atezolizumab (Tecentriq) is a programmed death-ligand 1 (PD-L1) blocking antibody used to treat urothelial carcinoma, non-smal cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC).

What are the uses of this medicine?

Atezolizumab (Tecentriq) medicine is to treat adults with:

a type of bladder and urinary tract cancer called urothelial carcinoma. Tecentriq may be used when your bladder cancer has spread or cannot be removed by surgery, and if you have any one of the following conditions:

• you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for "PD-L1", or
• you are not able to take chemotherapy that contains any platinum regardless of "PD-L1" status

a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq may be used alone as your first treatment when your lung cancer:

• has spread or grown, and
• your cancer tests positive for "high PD-L1", and
• your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer:

• has spread or grown, and
• is a type called "non-squamous NSCLC", and
• your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer:

• has spread or grown, and
• is a type called "non-squamous NSCLC", and
• your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq may also be used alone when your lung cancer:

• has spread or grown, and
• you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• if your tumor has an abnormal "EGFR" or "ALK" gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

a type of breast cancer called triple-negative breast cancer (TNBC). Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:

• has spread or cannot be removed by surgery, and
• your cancer tests positive for "PD-L1".

a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer

• is a type called "extensive-stage SCLC," which means that it has spread or grown.

a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when your liver cancer:

• has spread or cannot be removed by surgery, and
• you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer.

a type of skin cancer called melanoma. Tecentriq may be used with the medicines cobimetinib and vemurafenib when your melanoma:

• has spread to other parts of the body or cannot be removed by surgery, and
• has a certain type of abnormal "BRAF" gene. Your healthcare provider will perform a test to make sure this Tecentriq combination is right for you.

How does this medicine work?

• Atezolizumab (a" te zoe liz' ue mab) is a humanized monoclonal immunoglobulin G1 antibody to the programmed cell death ligand 1 (PD-L1) that is used in cancer immunotherapy.
• Inhibition of PD-L1 overcomes the usual block ("check point") in immune surveillance of tumor cell neoantigens and can induce remissions in several forms of advanced, metastatic cancer including urothelial (bladder and urethral) carcinoma and non-small cell lung cancer (NSCLC).
• In clinical trials, atezolizumab led to prolongation of recurrence free survival as well as overall survival in patients with bladder cancer and NSCLC. Response rates to atezolizumab were somewhat higher in patients who expressed high levels of PD-L1 in tumor-infiltrating immune cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed with Tecentriq .

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage:

Urothelial Carcinoma

• Administer Tecentriq as a single agent as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
• NSCLC
• Administer Tecentriq as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
• When administering with chemotherapy with or without bevacizumab, administer Tecentriq prior to chemotherapy and bevacizumab when given on the same day.

Metastatic Treatment of TNBC

• Administer Tecentriq 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
• Administer Tecentriq prior to paclitaxel protein-bound when given on the same day.
• For each 28 day cycle, paclitaxel protein-bound is administered at 100 mg/m2 on days 1, 8, and 15.

Small Cell Lung Cancer Administer Tecentriq as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. When administering with carboplatin and etoposide, administer Tecentriq prior to chemotherapy when given on the same day.

Hepatocellular Carcinoma

• Administer Tecentriq as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.
• Administer Tecentriq prior to bevacizumab when given on the same day.
• Bevacizumab is administered at 15 mg/kg every 3 weeks.

Melanoma Following completion of a 28 day cycle of cobimetinib and vemurafenib, administer Tecentriq 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.

Administration

• Your healthcare provider will give you Tecentriq into your vein through an intravenous (IV) line over 30 to 60 minutes.
• Tecentriq is usually given every 2, 3, or 4 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will test your blood to check you for certain side effects.
• For treatment of a type of skin cancer called melanoma, your healthcare provider will also prescribe you cobimetinib and vemurafenib. Take cobimetinib and vemurafenib exactly as your healthcare provider tells you.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 840 mg/14 mL (60 mg/mL) and 1200 mg/20 mL (60 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Tecentriq

What side effects can this medication cause?

The most common side effects of Tecentriq when used alone include:

• feeling tired or weak
• nausea
• cough
• shortness of breath
• decreased appetite

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:

• decrease in hemoglobin (anemia)
• decreased white blood cells
• hair loss
• tingling or numbness in hands or feet
• feeling tired
• nausea
• diarrhea
• constipation
• cough
• headache
• vomiting
• decreased appetite

The most common side effects of Tecentriq when used in hepatocellular carcinoma with bevacizumab include:

• high blood pressure
• feeling tired or weak
• too much protein in the urine

The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

• skin rash
• joint, muscle, or bone pain
• feeling tired or weak
• liver injury
• fever
• nausea
• itching
• swelling of legs or arms
• mouth swelling (sometimes with sores)
• low thyroid hormone levels
• sunburn or sun sensitivity

Tecentriq can cause serious side effects, including:

• Lung problems
• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
• Withhold or permanently discontinue based on severity and type of reaction.
• Tecentriq can cause immune-mediated pneumonitis. Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions.
• Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
• Tecentriq Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Tecentriq can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Tecentriq in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Tecentriq have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: atezolizumab
• Inactive ingredients: glacial acetic acid, L-histidine, polysorbate 20 and sucrose

Who manufactures and distributes this medicine?

• Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco

What should I know about storage and disposal of this medication?

• Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Atezolizumab
• FDA Atezolizumab

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