Tecentriq (atezolizumab)

Generic name: atezolizumab (A te zoe LIZ ue mab)
Brand name: Tecentriq
Drug class: Anti-PD-1 monoclonal antibodies

Tecentriq (atezolizumab) is a monoclonal antibody that affects the actions of the body's immune system. Atezolizumab strengthens your immune system to help your body fight against tumor cells.

Tecentriq is used to treat adults with:

• a type of cancer of the bladder and urinary tract called urothelial carcinoma
• a type of lung cancer called non-small cell lung cancer (NSCLC)
• a type of breast cancer called triple-negative breast cancer (TNBC)
• a type of lung cancer called small cell lung cancer (SCLC)
• a type of liver cancer called hepatocellular carcinoma (HCC)
• a type of skin cancer called melanoma.

Tecentriq is used when the cancer has spread to other parts of the body (metastatic), or cannot be removed by surgery.

Your doctor may perform a biopsy to test your cancer for a protein called "PD-L1," or a specific genetic marker (an abnormal "EGFR" or "ALK" or "BRAF" gene).

Tecentriq is sometimes given after other cancer treatments have not worked or have stopped working. Tecentriq may be given in combination with chemotherapy medicines.

Warnings

Tecentriq affects your immune system and may cause it to attack normal healthy tissues or organs, leading to serious or life-threatening medical problems.

Call your doctor at once if you have new or worsening symptoms such as: chest pain, cough, breathing problems, stomach pain, vomiting, changes in appetite or weight, increased thirst or urination, headaches, neck stiffness, vision problems, tiredness, mood changes, muscle weakness, bleeding or bruising, bloody or tarry stools, dark urine, or yellowing of the skin or eyes.

Before taking this medicine

You should not use Tecentriq if you are allergic to atezolizumab.

To make sure Tecentriq is safe for you, tell your doctor if you have:

• an infection;
• an immune system disorder such as lupus, ulcerative colitis, or Crohn's disease;
• an organ transplant;
• >radiation treatment to your chest area;
• a breathing disorder;
• liver disease; or
• a nervous system disorder such as myasthenia gravis or Guillain Barré syndrome.

Tell your doctor if you plan to receive a stem cell transplant using donor stem cells.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Tecentriq if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your last dose.

Tecentriq may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because atezolizumab can harm an unborn baby.

You should not breastfeed while using atezolizumab and for at least 5 months after your last dose.

How is Tecentriq given?

Tecentriq is given as an infusion into a vein, usually once every 2 or 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take up to 60 minutes to complete.

If you receive Tecentriq to treat a type of skin cancer called melanoma, you will also be given two other medications to take by mouth. Follow your doctor's dosing instructions very carefully.

You may be given other medications to help treat certain serious side effects. Keep using these medicines for as long as your doctor has prescribed.

Tecentriq helps your immune system fight against tumor cells, but your immune system may attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems. You will need frequent medical tests.

Your doctor will determine how long to treat you with this medicine.

Dosing information

Usual Adult Dose for Urothelial Carcinoma:

MONOTHERAPY:
840 mg IV every 2 weeks OR 1200 mg IV every 3 weeks OR 1680 mg IV every 4 weeks until disease progression or unacceptable toxicity
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-Select cisplatin-ineligible patients with previously untreated locally advanced or metastatic UC for therapy with this drug based on the PD-L1 expression on tumor-infiltrating immune cells.

Use: For patients with locally advanced or metastatic urothelial carcinoma (UC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering 5% or greater of the tumor area) OR are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression OR have disease progression during or following any platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy.

Usual Adult Dose for Non-Small Cell Lung Cancer:

MONOTHERAPY:
840 mg IV every 2 weeks OR 1200 mg IV every 3 weeks OR 1680 mg IV every 4 weeks until disease progression or unacceptable toxicity
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY:
1200 mg IV every 3 weeks for 4 or 6 cycles until disease progression or unacceptable toxicity; administer atezolizumab prior to chemotherapy and bevacizumab when given on the same day; following completion of 4 to 6 cycles of chemotherapy, and if bevacizumab is discontinued, the recommended dosage of atezolizumab is:
840 mg IV every 2 weeks OR 1200 mg IV every 3 weeks OR 1680 mg IV every 4 weeks until disease progression or unacceptable toxicity
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-When administering this drug in combination with chemotherapy or other antineoplastic drugs, administer this drug prior to chemotherapy or other antineoplastic drugs when given on the same day.
-Refer to the Prescribing Information for bevacizumab, paclitaxel, and carboplatin for recommended dosing information.

Uses:
Non-small cell lung cancer (NSCLC):
-As a single agent for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of tumor cells [TC greater than or equal to 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 10% of the tumor area [IC greater than or equal to 10%]), as determined by an approved test, with no EGFR or ALK genomic tumor aberrations
-In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
-In combination with paclitaxel protein-bound and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
-As a single-agent, for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for NSCLC harboring these aberrations prior to receiving this drug

Usual Adult Dose for Breast Cancer:

840 mg IV on Days 1 and 15 followed by paclitaxel protein-bound 100 mg/m2 IV on Days 1, 8, and 15 for each 28-day cycle until disease progression or unacceptable toxicity
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-Atezolizumab and paclitaxel protein-bound may be discontinued for toxicity independently of each other.
-Refer to the Prescribing Information for paclitaxel protein-bound for recommended dosing information.

Use:
Triple-Negative Breast Cancer (TNBC): In combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering 1% or greater of the tumor area), as determined by an approved test

Usual Adult Dose for Small Cell Lung Cancer:

1200 mg IV every 3 weeks in combination with carboplatin and etoposide until disease progression or unacceptable toxicity; following completion of 4 cycles of carboplatin and etoposide, the recommended dosage of atezolizumab is:
840 mg IV every 2 weeks OR 1200 mg IV every 3 weeks OR 1680 mg IV every 4 weeks until disease progression or unacceptable toxicity
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-When administering atezolizumab in combination with chemotherapy, administer it prior to chemotherapy when given on the same day.
-Refer to the prescribing information for the chemotherapy agents administered in combination with this drug for recommended dosing information.

Use: In combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)

Usual Adult Dose for Hepatocellular Carcinoma:

1200 mg IV over 60 minutes, followed by 15 mg/kg of bevacizumab on the same day, every 3 weeks until disease progression or unacceptable toxicity; if bevacizumab is discontinued for toxicity, the recommended dosage of atezolizumab is:
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-Refer to the Prescribing Information for bevacizumab prior to initiation.

Use: In combination with bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy

Usual Adult Dose for Melanoma -- Metastatic:

Prior to initiating atezolizumab, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once a day (21 days on and 7 days off) and vemurafenib 960 mg orally 2 times a day on Days 1 through 21, and vemurafenib 720 mg orally 2 times a day on Days 22 through 28 followed by atezolizumab 840 mg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity, when administered with cobimetinib 60 mg orally once a day (21 days on and 7 days off) and vemurafenib 720 mg orally 2 times a day
NOTE: Administer the first infusion over 60 minutes; if well tolerated, administer subsequent infusions over 30 minutes

Comments:
-Refer to the Prescribing Information for cobimetinib and vemurafenib prior to initiation.

Use: In combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Tecentriq injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Tecentriq?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tecentriq side effects

Get emergency medical help if you have signs of an allergic reaction to Tecentriq (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, chilled or feverish, itchy, tingly, or have neck or back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

• new or worsening cough, shortness of breath;
• chest pain, irregular heartbeats;
• swelling in your ankles;
• severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;
• liver problems - right-sided upper stomach pain, loss of appetite, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
• nervous system problems - neck stiffness, increased sensitivity to light, confusion, severe muscle weakness, numbness or tingling in your hands or feet, vision problems, eye pain or redness;
• signs of infection - fever, flu symptoms, cough, back pain, painful or frequent urination; or
• signs of a hormonal disorder - frequent or unusual headaches, dizziness, feeling very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Tecentriq side effects may include:

• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• anemia, fever, infections;
• cough, feeling short of breath;
• liver problems;
• mouth sores or swelling;
• high blood pressure, abnormal blood or urine tests;
• headache, tiredness, weakness
• joint, muscle, or bone pain;
• numbness or tingling in your hands or feet;
• swelling in your legs or arms;
• rash, itching, sunburn or being more sensitive to sunlight; or
• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tecentriq?

Other drugs may interact with atezolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.