In the trial, TECENTRIQ HYBREZA injections and TECENTRIQ infusions were compared by measuring the amount of medicine in the bloodstream after they were given. This is often done to check that the injection works like the infusion.
The trial was done with 371 people who had metastatic non-small cell lung cancer. Trial participants had not previously received immunotherapy, but had received platinum-based chemotherapy that did not work for them.
These were the results:
No major differences were seen in the amount of medicine that went into the bloodstream with TECENTRIQ HYBREZA injections compared to TECENTRIQ infusions. These results showed that no significant differences are expected in how each treatment works.
People experienced similar side effects with TECENTRIQ HYBREZA injections and TECENTRIQ infusions.
TECENTRIQ HYBREZA injections was observed to be similarly effective in fighting cancer as TECENTRIQ infusions.
In another study, most people preferred TECENTRIQ HYBREZA injections over TECENTRIQ infusions
Most participants preferred the 7-minute injection* because it required less time in the clinic. The second most common reason they preferred it was because the injection felt more comfortable.
Participants who preferred TECENTRIQ infusions stated it was because the administration felt more comfortable.
*Depending on other aspects of treatment, including any other medicines you receive, your total treatment time may be longer.
Important Safety Information & Indications
Indications
What is TECENTRIQ HYBREZA?
TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) is a prescription medicine used to treat:
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- 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 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
- is a type called “non-squamous NSCLC”, and
- your tumor does not have an abnormal “EGFR” or “ALK” gene.
- 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 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 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 small cell lung cancer,” which means that it has spread or grown.
Adults with 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.
Adults with 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.
It is not known if TECENTRIQ HYBREZA is safe and effective in children.
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 HYBREZA?
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
- 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 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 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 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.
Before you receive 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 at least 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 at least 5 months after the last dose of 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 HYBREZA when used alone include:
- feeling tired or weak
- muscle or bone pain
- cough
- shortness of breath
- decreased appetite
The most common side effects observed with TECENTRIQ and 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:
- feeling tired or weak
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
- shortness of breath
- muscle or bone pain
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
- nausea
- diarrhea
- constipation
- decreased appetite
- joint pain
- high blood pressure
- rash
- cough
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
- numbness, pain, tingling, or burning in your hands or feet
- hair loss
- shortness of breath
- decreased appetite
- cough
- vomiting
- rash
The most common side effects of TECENTRIQ when used in SCLC with carboplatin and etoposide include:
- feeling tired or weak
- nausea
- hair loss
- decreased appetite
- constipation
- vomiting
The most common side effects of TECENTRIQ when used in HCC with bevacizumab include:
- high blood pressure
- feeling tired or weak
- too much protein in the urine
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 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. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of 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 and Medication Guide for additional Important Safety Information.
TECENTRIQ Indications
What is TECENTRIQ?
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 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 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.
- has spread or grown, and
- 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.
- has spread or grown, and
Adults with a type of lung cancer called small cell lung cancer (SCLC). TECENTRIQ may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
Adults with a type of liver cancer called hepatocellular carcinoma (HCC). TECENTRIQ 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 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 when used:
- In children for the treatment of NSCLC, SCLC, HCC or melanoma.
TECENTRIQ 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 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
The most common side effects of TECENTRIQ 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 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.