Tecentriq

>10%

All grades unless otherwise stated

Fatigue (52%)

Decreased appetite (26%)

Nausea (25%)

Urinary tract infection (22%)

Constipation (21%)

Pyrexia (21%)

Diarrhea (18%)

Peripheral edema (18%)

Abdominal pain (17%)

Vomiting (17%)

Dyspnea (16%)

Back/neck pain (15%)

Rash (15%)

Arthralgia (14%)

Pruritus (13%)

1-10%

All are grades 3-4

Lymphopenia (10%)

Hyponatremia (10%)

Anemia (8%)

Hyperglycemia (5%)

Increased alkaline phosphatase (4%)

Increased creatinine (3%)

Increased ALT (2%)

Increased AST (2%)

Hypoalbuminemia (1%)

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Tecentriq passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of 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.

Atezolizumab is used to treat a certain type of bladder cancer that has spread to other parts of the body or cannot be removed by surgery.

Atezolizumab is also used to treat non-small cell lung cancer that has spread to other parts of the body.

Atezolizumab is usually given after other cancer medicines have been tried without success.

Atezolizumab may also be used for purposes not listed in this medication guide.

Atezolizumab strengthens your immune system to help your body fight against tumor cells. This may cause the immune system to attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems.

Call your doctor at once if you have new or worsening symptoms such as: cough, breathing problems, changes in appetite or weight, diarrhea, stomach pain, vision problems, increased thirst or urination, yellowing of the skin or eyes, mood or behavior changes, severe muscle weakness, or numbness and tingling.

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

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

• an active infection;
• an immune system disorder such as lupus, ulcerative colitis, or Crohn's disease;
• a history of organ transplant;
• a breathing disorder;
• liver disease; or
• a nervous system disorder such as myasthenia gravis or Guillain Barré syndrome.

Do not use atezolizumab 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.

It is not known whether atezolizumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine or within 5 months after your last dose. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have:

• new or worsening cough, chest pain, feeling short of breath;
• diarrhea, bloody or tarry stools;
• nausea or vomiting;
• severe stomach pain (especially in your upper stomach or spreading to your back);
• a light-headed feeling, like you might pass out;
• blurred vision, double vision, eye pain or redness;
• signs of infection--fever, flu symptoms, cough, painful or frequent urination;
• liver problems--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; or
• signs of a hormonal disorder--frequent or unusual headaches, feeling light-headed or very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, nausea, vomiting, 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 side effects may include:

• nausea, loss of appetite;
• constipation;
• tiredness; or
• urination problems.

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.

Antineoplastic agent; humanized anti-programmed-death ligand-1 (anti-PD-L1) monoclonal antibody.1 2 4 10

Urothelial Carcinoma

Treatment of locally advanced or metastatic urothelial carcinoma that has progressed during or following platinum-containing therapy for advanced disease or within 12 months of platinum-containing therapy in the neoadjuvant or adjuvant setting.1 2

Accelerated approval based on objective response rate and duration of response.1 2 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

Non-small Cell Lung Cancer (NSCLC)

Treatment of metastatic NSCLC that has progressed during or following platinum-based chemotherapy.1 11 12 Patients with epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive tumors also should have documented disease progression during or following an FDA-labeled anti-EGFR or anti-ALK therapy prior to initiating therapy with atezolizumab.1

• Importance of advising patients to read the manufacturer's medication guide.1

• Risk of immune-mediated pneumonitis.1 Importance of informing clinician immediately if new or worsening cough, chest pain, or shortness of breath occurs.1

• Risk of immune-mediated hepatitis.1 Importance of informing clinician immediately if signs and symptoms of liver damage (e.g., jaundice, severe nausea or vomiting, abdominal pain [particularly in right upper quadrant], lethargy, easy bruising or bleeding, lack of appetite, dark urine, drowsiness) occur.1

• Risk of immune-mediated colitis.1 Importance of informing clinician immediately if diarrhea, severe abdominal pain, or changes in stool occur.1

• Risk of immune-mediated endocrine effects.1 Importance of informing clinician immediately if manifestations of hypophysitis, hyperthyroidism, hypothyroidism, adrenal insufficiency, or diabetes mellitus (including ketoacidosis) occur.1

• Risk of immune-mediated meningoencephalitis, myasthenic syndrome/myasthenia gravis, and Guillain-Barré syndrome.1 Importance of informing clinician immediately if manifestations of these conditions occur.1

• Risk of immune-mediated ocular inflammatory toxicity.1 Importance of informing clinician immediately if signs and symptoms of ocular inflammatory toxicity (e.g., ocular pain, redness, blurred or double vision) occur.1

• Risk of immune-mediated pancreatitis.1 Importance of informing clinician immediately if manifestations of pancreatitis occur.1

• Risk of infections.1 Importance of informing clinician if fever, flu-like symptoms, cough, or painful or frequent urination occurs.1

• Risk of infusion-related reactions.1 Importance of informing clinician if signs and symptoms of such reactions, including dizziness, chills, fever, breathing difficulty (i.e., shortness of breath, wheezing), pruritus, flushing, feeling of faintness, back or neck pain, or angioedema, occur.1

• Risk of rash.1 Importance of informing clinician if rash occurs.1

• Risk of fetal harm.1 Necessity of advising women of childbearing potential that they should use an effective method of contraception while receiving atezolizumab and for ≥5 months after discontinuance of therapy.1 Importance of women informing clinicians if they are or plan to become pregnant.1 If pregnancy occurs, advise pregnant women of potential risk to the fetus.1

• Importance of advising women to avoid breast-feeding while receiving atezolizumab and for ≥5 months after discontinuance of therapy.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

• It is used to treat bladder cancer.
• It is used to treat lung cancer.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Recommended Dosing

The recommended dose of Tecentriq is 1200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. Do not administer Tecentriq as an intravenous push or bolus.

Dose Modifications

No dose reductions of Tecentriq are recommended.

Withhold Tecentriq for any of the following:

• Grade 2 pneumonitis [see Warnings and Precautions (5.1)]
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN [see Warnings and Precautions (5.2)]
• Grade 2 or 3 diarrhea or colitis [see Warnings and Precautions (5.3)]
• Symptomatic hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, or Grade 3 or 4 hyperglycemia [see Warnings and Precautions (5.4)]
• Grade 2 ocular inflammatory toxicity [see Warnings and Precautions (5.5)]
• Grade 2 or 3 pancreatitis, or Grade 3 or 4 increases in amylase or lipase levels (greater than 2.0 times ULN) [see Warnings and Precautions (5.5)]
• Grade 3 or 4 infection [see Warnings and Precautions (5.6)]
• Grade 2 infusion-related reactions [see Warnings and Precautions (5.7)]
• Grade 3 rash

Tecentriq may be resumed in patients whose adverse reactions recover to Grade 0–1.

Permanently discontinue Tecentriq for any of the following:

• Grade 3 or 4 pneumonitis [see Warnings and Precautions (5.1)]
• AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN [see Warnings and Precautions (5.2)]
• Grade 4 diarrhea or colitis [see Warnings and Precautions (5.3)]
• Grade 4 hypophysitis [see Warnings and Precautions (5.4)]
• Myasthenic syndrome/myasthenia gravis, Guillain-Barré or meningoencephalitis (all grades) [see Warnings and Precautions (5.5)]
• Grade 3 or 4 ocular inflammatory toxicity [see Warnings and Precautions (5.5)]
• Grade 4 or any grade of recurrent pancreatitis [see Warnings and Precautions (5.5)]
• Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.7)]
• Grade 4 rash

Preparation and Administration

Preparation

Visually inspect drug product for particulate matter and discoloration prior to administration whenever solution and container permit. Tecentriq is a colorless to slightly yellow solution. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial.

Prepare the solution for infusion as follows:

• Withdraw 20 mL of Tecentriq from the vial.
• Dilute into a 250 mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride Injection, USP.
• Dilute with 0.9% Sodium Chloride Injection only.
• Mix diluted solution by gentle inversion. Do not shake.
• Discard used or empty vials of Tecentriq.

Storage of Infusion Solution

This product does not contain a preservative.

Administer immediately once prepared. If diluted Tecentriq infusion solution is not used immediately, it can be stored either:

• At room temperature for no more than 6 hours from the time of preparation. This includes room temperature storage of the infusion in the infusion bag and time for administration for infusion.
• Under refrigeration at 2°C–8°C (36°F–46°F) for no more than 24 hours.

Do not freeze.

Do not shake.

Administration

Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Do not co-administer other drugs through the same intravenous line.

There is no information on overdose with Tecentriq.

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

Get emergency medical help if you have signs of an allergic reaction to Tecentriq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have:

• new or worsening cough, chest pain, feeling short of breath;

• diarrhea, bloody or tarry stools;

• nausea or vomiting;

• severe stomach pain (especially in your upper stomach or spreading to your back);

• a light-headed feeling, like you might pass out;

• blurred vision, double vision, eye pain or redness;

• signs of infection--fever, flu symptoms, cough, painful or frequent urination;

• liver problems - 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; or

• signs of a hormonal disorder - frequent or unusual headaches, feeling light-headed or very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, nausea, vomiting, 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, loss of appetite;

• constipation;

• tiredness; or

• urination problems.

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.