Atezolizumab Injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Atezolizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• back, neck, or joint pain
• rash
• itching
• pale skin
• feeling hot or cold
• swelling of arms
• loss of appetite
• constipation
• hair loss
• deepening of voice or hoarseness
• weight gain or loss

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• diarrhea
• stomach pain
• stomach bloating or swelling
• severe nausea or vomiting
• bloody or black tarry stools
• fever
• decreased urination
• frequent, urgent, or painful urination
• difficulty urinating
• pink, red, or dark brown urine
• swelling in your legs, ankles, or feet
• warm, red, swollen, or tender leg
• new or worsening cough
• coughing up blood
• shortness or breath
• chest pain
• yellowing of the skin or eyes
• bleeding or bruising easily
• extreme tiredness or drowsiness
• headaches that won't go away or unusual headaches
• neck stiffness
• sensitivity to light
• numbness or tingling in your hands, feet, arms, or legs
• muscle weakness
• problems with your vision
• eye pain or redness
• dizziness or feeling faint
• feeling more hungry or thirsty than usual
• changes in mood or behavior (decreased sex drive, irritability, confusion, or forgetfulness)
• sore throat, chills, flu like symptoms, or other signs of infection
• breath that smells fruity
• slowed, fast or irregular heartbeat

Atezolizumab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Dosage Forms And Sterngths

Injection: 1200 mg/20 mL (60 mg/mL) colorless to slightly yellow solution in a single-dose vial.

Storage And Handling

TECENTRIQ injection is a sterile, preservative-free, and colorless to slightly yellow solution for intravenous infusion supplied as a carton containing one 1200 mg/20 mL single-dose vial (NDC 50242-917-01).

Store vials under refrigeration at 2°C to 8° 680 C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 USA. Revised: April 2017.

TECENTRIQ®
(te-SEN-trik)
(atezolizumab) Injection

What is the most important information I should know about TECENTRIQ?

TECENTRIQ is a medicine that may treat your bladder cancer or lung cancer by working with your immune system. TECENTRIQ can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Call or see your healthcare provider right away if you get any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include:

• new or worsening cough
• shortness of breath
• chest pain

Liver problems (hepatitis). Signs and symptoms of hepatitis may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• drowsiness
• dark urine (tea colored)
• bleeding or bruising more easily than normal
• feeling less hungry than usual

Intestinal problems (colitis). Signs and symptoms of colitis may include:

• diarrhea (loose stools) or more bowel movements than usual
• blood in your stools or dark, tarry, sticky stools
• severe stomach area (abdomen) pain or tenderness

Hormone gland problems (especially the pituitary, thyroid, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• extreme tiredness
• weight gain or weight loss
• dizziness or fainting
• feeling more hungry or thirsty than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• urinating more often than usual
• nausea or vomiting
• stomach area (abdomen) pain
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Nervous system problems (neuropathy, meningitis, encephalitis). Signs and symptoms of nervous system problems may include:

• severe muscle weakness
• numbness or tingling in hands or feet
• fever
• confusion
• changes in mood or behavior
• extreme sensitivity to light
• neck stiffness

Inflammation of the eyes. Signs and symptoms may include:

• blurry vision, double vision, or other vision problems
• eye pain or redness

Severe infections. Signs and symptoms of infection may include:

• fever
• cough
• frequent urination
• flu-like symptoms
• pain when urinating

Severe infusion reactions. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• swelling of your face or lips
• dizziness
• fever
• feeling like passing out
• back or neck pain

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 delay or completely stop treatment with TECENTRIQ if you have severe side effects.

What is TECENTRIQ?

TECENTRIQ is a prescription medicine used to treat:

a type of bladder and urinary tract cancer called urothelial carcinoma.

• TECENTRIQ may be used when your bladder cancer:
  • has spread or cannot be removed by surgery (advanced urothelial carcinoma), and
  • you are not able to take chemotherapy that contains a medicine called cisplatin, or
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.

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

• TECENTRIQ may be used 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.

It is not known if TECENTRIQ is safe and effective in children.

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 had an organ transplant
• have lung or breathing problems
• have liver problems
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are being treated for an infection
• are pregnant or plan to become pregnant. TECENTRIQ can harm your unborn baby. If you are able to become pregnant, 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.

How will I receive TECENTRIQ?

• Your healthcare provider will give you TECENTRIQ into your vein through an intravenous (IV) line over 30 to 60 minutes.
• TECENTRIQ is usually 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. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of TECENTRIQ?

TECENTRIQ can cause serious side effects, including:

• See “What is the most important information I should know about TECENTRIQ?”

The most common side effects of TECENTRIQ in people with urothelial carcinoma include:

• feeling tired
• decreased appetite
• nausea
• constipation
• urinary tract infection
• diarrhea
• fever

The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:

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

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.

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.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about TECENTRIQ, talk with your healthcare provider. You can ask your healthcare provider for information about TECENTRIQ that is written for health professionals.

What are the ingredients in TECENTRIQ?

Active ingredient: atezolizumab

Inactive ingredients: glacial acetic acid, L-histidine, sucrose, polysorbate 20

The following adverse reactions are discussed in greater detail in other sections of the label:

• Immune-Related Pneumonitis [see WARNINGS AND PRECAUTIONS]
• Immune-Related Hepatitis [see WARNINGS AND PRECAUTIONS]
• Immune-Related Colitis [see WARNINGS AND PRECAUTIONS]
• Immune-Related Endocrinopathies [see WARNINGS AND PRECAUTIONS]
• Other Immune-Related Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Infection [see WARNINGS AND PRECAUTIONS]
• Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma

The safety of TECENTRIQ was evaluated in Study 4, a multicenter, open-label, single-arm trial that included 119 patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy and were either previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy [see Clinical Studies]. Patients received 1200 mg of TECENTRIQ intravenously every 3 weeks until either unacceptable toxicity or disease progression. The median duration of exposure was 15.0 weeks (range 0, 87 weeks).

The most common adverse reactions (≥ 20%) were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%). The most common Grade 3–4 adverse reactions (≥ 2%) were fatigue, urinary tract infection, anemia, diarrhea, blood creatinine increase, intestinal obstruction, ALT increase, hyponatremia, decreased appetite, sepsis, back/neck pain, renal failure, and hypotension.

Five patients (4.2%) who were treated with TECENTRIQ experienced one of the following events which led to death: sepsis, cardiac arrest, myocardial infarction, respiratory failure, or respiratory distress. One additional patient (0.8%) was experiencing herpetic meningoencephalitis and disease progression at the time of death. TECENTRIQ was discontinued for adverse reactions in 4.2% (5/119) of patients. The adverse reactions leading to discontinuation were diarrhea/colitis (1.7%), fatigue (0.8%), hypersensitivity (0.8%), and dyspnea (0.8%). Adverse reactions leading to interruption of TECENTRIQ occurred in 35% of patients, the most common (≥ 1%) were intestinal obstruction, fatigue, diarrhea, urinary tract infection, infusion related reaction, cough, abdominal pain, peripheral edema, pyrexia, respiratory tract infection, upper respiratory tract infection, creatinine increase, decreased appetite, hyponatremia, back pain, pruritus, and venous thromboembolism. Serious adverse reactions occurred in 37% of patients. The most frequent serious adverse reactions (≥ 2%) were diarrhea, intestinal obstruction, sepsis, acute kidney injury, and renal failure.

Immune-related adverse reactions requiring systemic corticosteroids or hormone replacement therapy occurred in 19.3% (23/119) patients, including 12.6% (15/119) patients who required systemic corticosteroid therapy and 6.7% (8/119) patients who required only hormone replacement therapy.

Six patients (5.0%) received an oral prednisone dose equivalent to ≥40 mg daily for an immune335 mediated adverse reaction [see WARNINGS AND PRECAUTIONS].

Table 1 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 2 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in Study 4.

Table 1: All 339 Grade Adverse Reactions in 340 ≥ 10% of Patients with Urothelial Carcinoma in Study 4

Table 2: Grade 342 3–4 Laboratory Abnormalities in 343 Patients with Urothelial Carcinoma in Study 4 in ≥ 1% of Patients

Previously Treated Patients with Locally Advanced or Metastatic Urothelial Carcinoma

The safety of TECENTRIQ was evaluated in Study 1, a multicenter, open-label, single-arm trial that included 310 patients in a single arm trial with locally advanced or metastatic urothelial carcinoma who had disease progression during or following at least one platinum-containing chemotherapy regimen or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen [see Clinical Studies]. Patients received 1200 mg of TECENTRIQ intravenously every 3 weeks until unacceptable toxicity or either radiographic or clinical progression. The median duration of exposure was 12.3 weeks (range: 0.1, 46 weeks).

The most common adverse reactions (≥ 20%) were fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%). The most common Grade 3–4 adverse reactions (≥ 2%) were urinary tract infection, anemia, fatigue, dehydration, intestinal obstruction, urinary obstruction, hematuria, dyspnea, acute kidney injury, abdominal pain, venous thromboembolism, sepsis, and pneumonia.

Three patients (1.0%) who were treated with TECENTRIQ experienced one of the following events which led to death: sepsis, pneumonitis, or intestinal obstruction. TECENTRIQ was discontinued for adverse reactions in 3.2% (10/310) of the 310 patients. Sepsis led to discontinuation in 0.6% (2/310) of patients. Adverse reactions leading to interruption of TECENTRIQ occurred in 27% of patients; the most common (> 1%) were liver enzyme increase, urinary tract infection, diarrhea, fatigue, confusional state, urinary obstruction, pyrexia, dyspnea, venous thromboembolism, and pneumonitis. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions (> 2%) were urinary tract infection, hematuria, acute kidney injury, intestinal obstruction, pyrexia, venous thromboembolism, urinary obstruction, pneumonia, dyspnea, abdominal pain, sepsis, and confusional state.

Immune-related adverse reactions requiring systemic corticosteroids or hormone replacement therapy occurred in 11.0% (34/310) patients, including 8.4% (26/310) patients who required systemic corticosteroid therapy and 2.6% (8/310) patients who required only hormone replacement therapy.

Eighteen patients (5.8%) received an oral prednisone dose equivalent to ≥40 mg daily for an immune-mediated adverse reaction [see WARNINGS AND PRECAUTIONS].

Table 3 summarizes the adverse reactions that occurred in ≥ 375 10% of patients while Table 4 summarizes Grade 3–4 selected laboratory abnormalities that occurred in ≥ 1% of patients treated with TECENTRIQ in Study 1.

Table 3: All Grade Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinoma in Study 1

Table 4: Grade 3–4 Laboratory Abnormalities 380 in Patients with Urothelial Carcinoma in Study 1 in > 1% of Patients

The safety of TECENTRIQ was evaluated in Study 3, a multicenter, international, randomized, open-label trial in patients with metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression [see Clinical Studies]. Patients received 1200 mg of TECENTRIQ (n=142) administered intravenously every 3 weeks until unacceptable toxicity or either radiographic or clinical progression or docetaxel (n=135) administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The median duration of exposure was 3.7 months (range: 0–19 months) in TECENTRIQ-treated patients and 2.1 months (range: 0–17 months) in docetaxel-treated patients.

The most common adverse reactions (≥ 20%) in patients receiving TECENTRIQ were fatigue (46%), decreased appetite (35%), dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain (22%), and constipation (20%). The most common Grade 3-4 adverse reactions (≥2%) were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia.

Nine patients (6.3%) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (2), pneumothorax, ulcer hemorrhage, cachexia secondary to dysphagia, myocardial infarction, or large intestinal perforation which led to death. TECENTRIQ was discontinued due to adverse reactions in 4% (6/142) of patients. Adverse reactions leading to interruption of TECENTRIQ occurred in 24% of patients; the most common (>1%) were pneumonia, liver function test abnormality, upper respiratory tract infection, pneumonitis, acute kidney injury, hypoxia, hypothyroidism, dyspnea, anemia, and fatigue. Serious adverse reactions occurred in 37% of patients. The most frequent serious adverse reactions (> 2%) were pneumonia, dyspnea, pleural effusion, pyrexia, and venous thromboembolism.

Table 5 summarizes adverse reactions that occurred in at least 10% of TECENTRIQ-treated patients and at a higher incidence than in the docetaxel arm. Table 6 summarizes selected laboratory abnormalities worsening from baseline that occurred in ≥10% of TECENTRIQ409 treated patients and at a higher incidence than in the docetaxel arm.

Table 5: Adverse Reactions Occurring in ≥410 10% of TECENTRIQ-Treated Patients with NSCLC and at a Higher Incidence than in the Docetaxel Arm (Between Arm Difference of ≥5% [All Grades] or ≥2% [Grades 3–4]) (Study 3)

Table 6: Selected Laboratory Abnormalities Worsening from Baseline Occurring in ≥10% of TECENTRIQ-Treated Patients with NSCLC and at a Higher Incidence than in the Docetaxel Arm (Between Arm Difference of ≥5% [All Grades] or ≥2% [Grades 3–4]) (Study 3)

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. Among 275 patients in Study 1, 114 patients (41.5%) tested positive for treatment-emergent (treatment-induced or treatment-enhanced) anti-therapeutic antibodies (ATA) at one or more post-dose time points. Among 135 patients in Study 3, 73 patients (54.1%) tested positive for treatment-emergent ATAs at one or more post-dose time points. Among 111 patients in Study 4, 53 patients (47.7%) tested positive for treatment-emergent ATAs at one or more post-423 dose time points. In Study 1, Study 3, and Study 4, the presence of ATAs did not appear to have a clinically significant impact on pharmacokinetics, safety or efficacy.

Immunogenicity assay results are highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of incidence of ATAs to TECENTRIQ with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Tecentriq (Atezolizumab Injection)

• Cysview
• Gemzar
• Mutamycin
• Platinol

• Platinol-AQ
• Sancuso
• Theracys
• Valstar

© Tecentriq Patient Information is supplied by Cerner Multum, Inc. and Tecentriq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.