Helpful information and terms

What is immunotherapy?

Researchers have found that some cancer cells can go undetected by your immune system. This can allow the cancer to grow and spread. Cancer immunotherapy can help to reactivate the immune system so that it can recognize cancer in the body. It is also important to know that each person can respond differently to such treatment. You should have a discussion with your doctor if you are considering immunotherapy treatment.

What is ALK?

ALK is a gene that makes a protein called anaplastic lymphoma kinase (ALK), which may be involved in cell growth.

What is an antibody?

An antibody is a protein made by the immune system during an immune response that attaches to specific cells and can affect the immune system's ability to target and kill cells.

What is EGFR (epidermal growth factor receptor)?

EGFR is the protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor.

What is the immune system?

The immune system is a collection of organs, special cells, and substances that help protect you from infections and other diseases.

What is an infusion?

An infusion is a method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.

What is an infusion reaction?

An infusion reaction is any sign or symptom you might experience during or soon after the infusion of fluids, including drugs, into the bloodstream.

What does median mean?

Median is a statistics term. The middle value, or number, in a set of measurements, which have been put in order from lowest to highest.

What is metastatic?

Metastatic is a stage in cancer where it has spread from the place where it started to other distant parts of the body.

What is NSCLC (non-small cell lung cancer)?

NSCLC is a cancer that grows from inside your lungs or the lining of the airways.

What is non-squamous lung cancer?

Non-squamous lung cancer is a type of lung cancer that does not start in early versions of squamous cells, which are flat cells that line the inside of the airways in the lungs.

What is PD-L1 (programmed death-ligand 1)?

PD-L1 is a protein found on the surface of many cells, including cancer cells, that can affect the immune system's ability to target and attack cells.

What is a protein?

A molecule that is the building block of the cells in the body. Proteins are needed for the body to function properly.

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Indication

TECENTRIQ is a prescription medicine used to treat adults with:

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.

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-Barré 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
decreased appetite
nausea
cough
shortness of breath

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

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.