Glossary of frequently used terms

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Glossary
    A
    Antibody

    a protein made by the immune system during an immune response. Antibodies attach to specific cells and can affect the immune system’s ability to target and kill cells.

    B
    BRAF V600 mutation

    a specific mutation (change) in the BRAF gene. It can lead to abnormal cell growth, which contributes to the growth of cancer cells.

    BRAF gene

    this gene makes a protein called BRAF, which is involved in sending signals in cells to promote rapid cell growth.

    Biomarker

    a biological molecule that is found in blood, other body fluids, or body tissues. It may be a sign of a normal or abnormal process, or of a condition or disease. Also called molecular marker or signature molecule.

    G
    Gene

    a piece of DNA inside each cell. Most genes contain the information for making a specific protein. For example, the BRAF gene makes the BRAF protein.

    I
    Immune system

    a collection of organs, special cells, and substances that help protect you from infections and diseases.

    Immunotherapy

    a treatment using substances that stimulate or suppress the immune system to help the body fight cancer, infection, and disease. Some types of immunotherapy only target certain cells of the immune system. Others affect the immune system in a general way. Immunotherapy may also affect normal cells.

    In situ

    this term applies to abnormal cells that are found only in the place where they first formed in the body. These abnormal cells may become cancer and spread to nearby normal tissue.

    Infusion

    a method of putting fluids, including medicine, into the bloodstream. Also called intravenous (IV) infusion.

    Infusion reaction

    any sign or symptom you might experience during or soon after the infusion of fluids, including medicine/s, into the bloodstream.

    L
    Lymph node

    a small bean-shaped structure that is part of the body’s immune system. Lymph nodes filter substances that travel through the lymphatic fluid and contain white blood cells (lymphocytes) that help the body fight infection and disease.

    M
    Median

    the middle value, or number, in a set of measurements that have been put in order from lowest to highest.

    Melanocyte

    cells that produce a pigment called melanin, which gives skin its color.

    Melanoma

    a type of skin cancer that develops when the cells that give the skin its color (melanocytes) start to grow out of control. It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines.

    Metastatic

    the spread of cancer from where it originated to other places in the body.

    Mutation

    a change in the DNA of a cell. Mutations may be caused by mistakes during cell division or caused by substances in the environment that damage the DNA. Mutations can be harmful, helpful, or have no effect.

    P
    PD-L1 (programmed death-ligand 1) 

    a protein found on the surface of many cells, including cancer cells. This protein can affect the immune system’s ability to target and attack cells.

    Protein

    a molecule that is the building block of the cells in the body; needed for the body to function properly.

    U
    Unresectable

    unable to be removed with surgery.

Indication

What is TECENTRIQ?

TECENTRIQ is a prescription medicine used to treat adults with:

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-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 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.