TECENTRIQ® (atezolizumab) Cancer Immunotherapy

TECENTRIQ may also affect normal cells.

Indications

TECENTRIQ is a prescription medicine used 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, or
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

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 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.”

The approval of TECENTRIQ in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

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 small cell lung cancer,” 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.

It is not known if TECENTRIQ is safe and effective in children.

What is the most important information about TECENTRIQ?
TECENTRIQ can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

Call or see your healthcare provider right away if you get any symptoms of the following problems or these symptoms get worse.

TECENTRIQ can cause serious side effects, including:

Lung problems (pneumonitis)–signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain
Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucus in your stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, your voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of your face or lips, dizziness, fever, feeling like passing out, and back or neck pain

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with TECENTRIQ if you have severe side effects.

Before you receive TECENTRIQ, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects your nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
are pregnant or plan to become pregnant. TECENTRIQ can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TECENTRIQ. Females who are able to become pregnant:
- your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ
- you should use an effective method of birth control during your treatment and for at least 5 months after the last dose of TECENTRIQ
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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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:

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

The most common side effects of TECENTRIQ when used in hepatocellular carcinoma (HCC) 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 may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TECENTRIQ. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of TECENTRIQ.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

TECENTRIQ may work with your immune system to fight cancer

Important Safety Information

Indications