For US Healthcare Professionals
    A
    Adjuvant treatment

    Additional treatment given after surgery to help prevent the cancer from coming back.

    Antibody

    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.

    B
    Biomarker

    A biological molecule found in blood, other body fluids, or tissues. It is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may show how likely the body responds to a treatment for a disease or condition.

    C
    Chemotherapy

    Traditional chemotherapy works throughout the body to destroy fast-growing cells, including both cancer cells and certain healthy cells.

    Colectomy

    A surgical procedure to remove all or part of the colon.

    Colostomy

    A surgical procedure that creates an opening (stoma) in the belly to allow stool to pass from your body.

    D
    DNA

    The molecule inside cells that contains the genetic information needed for a person and most other organisms to develop and grow.

    dMMR

    A biomarker that can be found in your tumor through a biomarker test. Cancers positive for dMMR stand out to your immune system, making them susceptible to immunotherapy. Your biomarker results help your doctor create a personalized treatment plan.

    I
    Immunotherapy

    Treatment that uses a person's own immune system to fight cancer. Immunotherapy boosts the immune system to make it easier for immune cells to find and attack cancer cells.

    Infusion

    A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.

    L
    Lymph node

    A small structure that is part of the immune system. Lymph nodes contain substances that help the body fight infection and disease.

    P
    PD-L1 programmed death-ligand 1

    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.

    S
    Stoma

    An opening created after surgery to allow stool to pass from your body.

    Subcutaneous injection

    A method of putting medicine into the body using an injection that goes under the skin.

Important Safety Information and Indication

Indication

What is TECENTRIQ?
TECENTRIQ is a prescription medicine used to treat:
Adults and children 2 years of age and older with a type of colon cancer. TECENTRIQ may be used with a fluoropyrimidine and oxaliplatin medicine:

  • to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and
  • you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR).

It is not known if TECENTRIQ is safe and effective when used in children:

  • younger than 2 years of age for the treatment of colon cancer.

Important Safety Information

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 worsening 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 your mouth or your 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 worsening 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

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

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 or tissue transplant, including corneal 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 colon cancer with a fluoropyrimidine and oxaliplatin include:

  • nausea
  • diarrhea
  • numbness, tingling, or pain in the hands or feet
  • decreased appetite
  • stomach-area (abdominal) pain
  • constipation
  • cough
  • shortness of breath
  • mouth swelling (sometimes with sores)
  • vomiting
  • fever

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.

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