MEDICATION GUIDE
TECENTRIQ HYBREZA™ (te-SEN-trik hye-BREEZE-uh)
(atezolizumab and hyaluronidase-tqjs)
injection, for subcutaneous use |
| What is the most important information I should know about TECENTRIQ HYBREZA? |
TECENTRIQ HYBREZA is a medicine that may treat certain cancers by working with your immune system.
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 worse signs or symptoms, including: |
| Lung problems. |
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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
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| 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)
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- dark urine (tea colored)
- bleeding or bruising more easily than normal
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| 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
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- 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
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| Kidney problems. |
- decrease in your amount of urine
- blood in your urine
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- swelling of your ankles
- loss of appetite
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| Skin problems. |
- rash
- itching
- skin blistering or peeling
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- painful sores or ulcers in mouth or nose, throat, or genital area
- fever or flu-like symptoms
- swollen lymph nodes
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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 HYBREZA. 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 eye sight
- persistent or severe muscle pain or weakness, muscle cramps
- low red blood cells, bruising
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| 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
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- dizziness
- feeling like passing out
- fever
- back or neck pain
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| 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 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 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 HYBREZA if you have severe side effects. |
| What is TECENTRIQ HYBREZA? |
TECENTRIQ HYBREZA is a prescription medicine used to treat adults with:
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a type of lung cancer called non-small cell lung cancer (NSCLC).
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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."
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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.
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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.
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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.
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TECENTRIQ HYBREZA may also 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.
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a type of lung cancer called small cell lung cancer (SCLC). TECENTRIQ HYBREZA may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer is a type called "extensive-stage SCLC," which means that it has spread or grown.
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a type of liver cancer called hepatocellular carcinoma (HCC). 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.
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a type of skin cancer called melanoma. TECENTRIQ HYBREZA 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 HYBREZA combination is right for you.
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a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). TECENTRIQ HYBREZA may be used alone when your sarcoma has spread to other parts of the body or cannot be removed by surgery.
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| It is not known if TECENTRIQ HYBREZA is safe and effective in children. |
| Do not receive TECENTRIQ HYBREZA if you are allergic to hyaluronidase or any of the ingredients in TECENTRIQ HYBREZA. See the end of this Medication Guide for a complete list of ingredients in TECENTRIQ HYBREZA. |
Before receiving 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 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 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 HYBREZA.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ HYBREZA.
- You should use an effective method of birth control during your treatment and for 5 months after the last dose of TECENTRIQ HYBREZA.
- are breastfeeding or plan to breastfeed. It is not known if TECENTRIQ HYBREZA passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose of TECENTRIQ HYBREZA.
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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How will I receive TECENTRIQ HYBREZA?
- Your healthcare provider will give you TECENTRIQ HYBREZA as an injection under the skin in the thigh over about 7 minutes.
- TECENTRIQ HYBREZA is given every 3 weeks.
- Your healthcare provider will decide how many treatments you need.
- Your healthcare provider will test your blood to check you for certain side effects.
- For treatment of a type of skin cancer called melanoma, your healthcare provider will also prescribe you cobimetinib and vemurafenib. Take cobimetinib and vemurafenib exactly as your healthcare provider tells you.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
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| What are the possible side effects of TECENTRIQ HYBREZA? |
| TECENTRIQ HYBREZA can cause serious side effects, including:
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| The most common side effects of TECENTRIQ HYBREZA when used alone in NSCLC include: |
- feeling tired or weak
- muscle or bone pain
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- cough
- shortness of breath
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The most common side effects observed with intravenous TECENTRIQ, which may be experienced with TECENTRIQ HYBREZA are shown below.
The most common side effects of TECENTRIQ when used alone as the first treatment for NSCLC include:
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| The most common side effects of TECENTRIQ when used alone in NSCLC that has spread or grown include: |
- feeling tired or weak
- cough
- decreased appetite
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- shortness of breath
- muscle or bone pain
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| The most common side effects of TECENTRIQ when used alone in ASPS include: |
- muscle or bone pain
- feeling tired
- rash
- cough
- headache
- nausea
- high blood pressure
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- vomiting
- constipation
- shortness of breath
- dizziness
- bleeding
- diarrhea
- trouble sleeping
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- stomach-area (abdominal) pain
- low thyroid hormone levels
- fever
- anxiety
- irregular heartbeat (arrhythmia)
- decreased appetite
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| The most common side effects of TECENTRIQ when used in NSCLC with bevacizumab, paclitaxel, and carboplatin include: |
- numbness, pain, tingling, or burning in your hands or feet
- feeling tired or weak
- hair loss
- muscle or bone pain
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- nausea
- diarrhea
- constipation
- decreased appetite
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- joint pain
- high blood pressure
- rash
- cough
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| The most common side effects of TECENTRIQ when used in non-squamous NSCLC with paclitaxel protein-bound and carboplatin include: |
- feeling tired or weak
- nausea
- diarrhea
- muscle or bone pain
- constipation
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- numbness, pain, tingling, or burning in your hands or feet
- hair loss
- shortness of breath
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- decreased appetite
- cough
- vomiting
- rash
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| The most common side effects of TECENTRIQ when used in SCLC with carboplatin and etoposide include: |
- feeling tired or weak
- nausea
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- hair loss
- decreased appetite
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| The most common side effects of TECENTRIQ when used in HCC with bevacizumab include: |
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- too much protein in the urine
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| 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
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- fever
- nausea
- itching
- swelling of legs or arms
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- mouth swelling (sometimes with sores)
- low thyroid hormone levels
- sunburn or sun sensitivity
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| 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 HYBREZA. |
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| General information about the safe and effective use of TECENTRIQ HYBREZA. |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about TECENTRIQ HYBREZA that is written for health professionals. |
| What are the ingredients in TECENTRIQ HYBREZA? |
| Active ingredients: atezolizumab and hyaluronidase-tqjs |
Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, water for injection.
Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 USA
U.S. License No.: 1048 TECENTRIQ HYBREZA is a trademark of Genentech, Inc.
For more information, call 1-877-436-3683 or go to www.TECENTRIQHYBREZA.com. |