TECENTRIQ 1200 MG / 20 ML ( ATEZOLIZUMAB ) VIAL FOR IV INFUSION

Important Safety Information

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.

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.

TECENTRIQ is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in TNBC when your breast cancer has spread or cannot be removed by surgery.

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 in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough

shortness of breath

chest pain

Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual

stools that are black, tarry, sticky, or have blood or mucus

severe stomach-area (abdomen) pain or tenderness

Liver problems

yellowing of your skin or the whites of your eyes

severe nausea or vomiting

pain on the right side of your stomach area (abdomen)

dark urine (tea colored)

bleeding or bruising more easily than normal

Hormone gland problems

headaches that will not go away or unusual headaches?

eye sensitivity to light?

eye problems?

rapid heartbeat?

increased sweating?

extreme tiredness?

weight gain or weight loss?

feeling more hungry or thirsty than usual

urinating more often than usual?

hair loss?

feeling cold?

constipation?

your voice gets deeper?

dizziness or fainting?

changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

decrease in your amount of urine?

blood in your urine

swelling of your ankles?

loss of appetite

Skin problems

rash?

itching?

skin blistering or peeling

painful sores or ulcers in mouth or nose, throat, or genital area?

fever or flu-like symptoms?

swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with TECENTRIQ. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles

Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs

Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight

Persistent or severe muscle pain or weakness, muscle cramps

Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking?

itching or rash?

flushing?

shortness of breath or wheezing

dizziness?

feeling like passing out?

fever?

back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with TECENTRIQ. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with TECENTRIQ. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to 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 received an organ transplant

have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)

have received radiation treatment to your chest area

have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barr? syndrome

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:

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 (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 and Medication Guide for additional Important Safety Information.