For US Healthcare Professionals
Indications

What are TECENTRIQ and TECENTRIQ HYBREZA?

TECENTRIQ (atezolizumab) and TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

  • TECENTRIQ or TECENTRIQ HYBREZA may be used alone as a treatment for your lung cancer:
    • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and
    • you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and
    • your cancer tests positive for “PD-L1”.
  • TECENTRIQ or TECENTRIQ HYBREZA 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 HYBREZA may be used with the medicines bevacizumab, paclitaxel, and carboplatin 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 or TECENTRIQ HYBREZA 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 or TECENTRIQ HYBREZA 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 or TECENTRIQ HYBREZA 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.

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

  • TECENTRIQ or TECENTRIQ HYBREZA may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
  • TECENTRIQ or TECENTRIQ HYBREZA may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
    • has not progressed after first treatment with TECENTRIQ or TECENTRIQ HYBREZA and the chemotherapy medicines carboplatin and etoposide.

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). TECENTRIQ or TECENTRIQ HYBREZA 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.

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. TECENTRIQ or TECENTRIQ HYBREZA may be used alone as a treatment for your bladder cancer:

  • to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
  • small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that TECENTRIQ or TECENTRIQ HYBREZA is right for you.

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

  • in children for the treatment of NSCLC, SCLC, HCC or MIBC.

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

  • in children for the treatment of NSCLC, SCLC, HCC or MIBC.
TECENTRIQ and TECENTRIQ HYBREZA Important Safety Information

Who should not receive TECENTRIQ HYBREZA?
Do not receive TECENTRIQ HYBREZA if you are allergic to hyaluronidase or any of the ingredients in TECENTRIQ HYBREZA

What is the most important information about TECENTRIQ and TECENTRIQ HYBREZA?
TECENTRIQ and TECENTRIQ HYBREZA 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 or TECENTRIQ HYBREZA. 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 or TECENTRIQ HYBREZA. 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 or TECENTRIQ HYBREZA. 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 or TECENTRIQ HYBREZA if you have severe side effects.

Before you receive TECENTRIQ or TECENTRIQ HYBREZA, 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 and TECENTRIQ HYBREZA 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 or TECENTRIQ HYBREZA. Females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ or TECENTRIQ HYBREZA.
    • You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of TECENTRIQ or TECENTRIQ HYBREZA.
  • are breastfeeding or plan to breastfeed. It is not known if TECENTRIQ or TECENTRIQ HYBREZA passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ or TECENTRIQ HYBREZA.

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 HYBREZA when used alone include:

  • feeling tired or weak
  • muscle or bone pain
  • cough
  • shortness of breath
  • decreased appetite

The most common side effects of TECENTRIQ and TECENTRIQ HYBREZA 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 and TECENTRIQ HYBREZA 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 effect of TECENTRIQ and TECENTRIQ HYBREZA when used alone in MIBC is:

  • urinary tract infection

TECENTRIQ and TECENTRIQ HYBREZA 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 and TECENTRIQ HYBREZA. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of TECENTRIQ and TECENTRIQ HYBREZA.

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 TECENTRIQ and TECENTRIQ HYBREZA and the Medication Guides for TECENTRIQ and TECENTRIQ HYBREZA for additional Important Safety Information.

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