Tecentriq

Tecentriq is used to treat adults with non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (SCLC), hepatocellular carcinoma, melanoma, or muscle invasive bladder cancer (MIBC), and adults and children aged 2 years and older with alveolar soft part sarcoma (ASPS) or stage III mismatch repair deficient (dMMR) colon cancer. It is an immunotherapy treatment given by intravenous infusion and used alone or in combination with other medicines, depending on the cancer type and stage.

Tumors can produce a protein called PD-L1 that suppresses the immune system's ability to attack cancer cells. Tecentriq (atezolizumab) works by binding to PD-L1 and blocking its interaction with the PD-1 and B7.1 receptors on immune cells, which releases this brake on the immune response against the tumor. In studies in mice, blocking PD-L1 reduced tumor growth, and combining PD-L1 blockade with targeted therapy that blocks the MAPK pathway suppressed tumor growth more than the targeted therapy alone. Tecentriq belongs to the drug class called PD-L1 blocking antibodies. It is also called an immune checkpoint inhibitor or monoclonal antibody.

Tecentriq (atezolizumab) first received FDA approval on May 18, 2016. There is no generic.

Tecentriq (atezolizumab) is a PD-L1 inhibitor FDA-approved to treat:

• Non-small cell lung cancer (NSCLC) in adults, as: Adjuvant treatment: After surgery and platinum-based chemotherapy in adults with Stage II–IIIA NSCLC whose tumors express PD-L1 on ≥1% of tumor cells (FDA-authorized test required). First-line monotherapy: For metastatic NSCLC with high PD-L1 expression (TC ≥50% or IC ≥10%), and no EGFR or ALK aberrations (FDA-authorized test required). First-line combination therapy: With bevacizumab, paclitaxel, and carboplatin; or with paclitaxel protein-bound and carboplatin; for metastatic non-squamous NSCLC with no EGFR or ALK aberrations. Previously treated metastatic NSCLC: For adults with disease progression during or after platinum-based chemotherapy. Patients with EGFR or ALK aberrations must have progressed on an FDA-approved targeted therapy before receiving Tecentriq.
• Extensive-stage small cell lung cancer (ES-SCLC) in adults, as: First-line treatment: In combination with carboplatin and etoposide. Maintenance treatment: In combination with lurbinectedin for adults with ES-SCLC whose disease has not progressed following first-line induction therapy with Tecentriq or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
• Hepatocellular carcinoma (HCC) in adults, as: First-line treatment: In combination with bevacizumab for adults with unresectable or metastatic HCC who have not previously received systemic therapy.
• Melanoma in combination with cobimetinib and vemurafenib for adults with unresectable or metastatic melanoma that carries a BRAF V600 mutation.
• Alveolar Soft Part Sarcoma (ASPS) in adults and children 2 years of age and older with unresectable or metastatic ASPS
• Muscle invasive bladder cancer (MIBC) as: Adjuvant treatment: Following cystectomy in adults with confirmed molecular residual disease, indicated by circulating tumor DNA (ctDNA) detected via an FDA-authorized test.
• Mismatch repair deficient (dMMR) colon cancer in adults and children 2 years of age and older, as: Adjuvant treatment: In combination with a fluoropyrimidine and oxaliplatin for stage III dMMR colon cancer. Patients are selected based on dMMR status in tumor specimens. An FDA-authorized test for dMMR tumor status is not currently available.

It is not known if Tecentriq is safe and effective in children younger than 2 years of age for the treatment of ASPS or colon cancer, or in children for the treatment of NSCLC, SCLC, HCC, melanoma, or MIBC.

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 2, 3, or 4 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will test your blood to check for certain side effects.
• For the treatment of melanoma, your healthcare provider will also prescribe you cobimetinib andvemurafenib. 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

Tecentriq is a medicine that may treat certain cancers by working with your immune system. 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 with symptoms such as: cough shortness of breath chest pain.
• Intestinal problems. Symptoms include: 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, with symptoms such as: 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.
• Kidney problems. Symptoms may include: decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite.
• Hormone gland problems. Symptoms may include: 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.
• Skin problems, such as: 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.
• Severe infections. Symptoms may include:fevercoughfrequent urinationflu-like symptomspain when urinating or back pain.

Problems can also happen in other organs. These are not all of the signs and symptoms of the 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 the 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 can occur 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, 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 corticosteroids 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 receiving 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 a corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to the 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
• are breastfeeding or plan to breastfeed.

Pregnancy

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 can 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.

Breastfeeding

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.

Tecentriq can cause serious side effects. See Important Information above.

Most Common Side Effects

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 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 withsores)
• Low thyroid hormone levels
• Sunburn or sun sensitivity.

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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Tecentriq for non-small cell lung cancer (NSCLC)

• Following resection and up to 4 cycles of platinum-based chemotherapy: 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks for up to 1 year.
• In the metastatic setting: 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks.
• When administering with chemotherapy with or without bevacizumab, administer Tecentriq before chemotherapy and bevacizumab when given on the same day

Dose of Tecentriq for extensive-stage small cell lung cancer (ES-SCLC)

• 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks.
• Administer before chemotherapy when given on the same day.

Dose of Tecentriq for hepatocellular carcinoma (HCC)

• 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks.
• Administer before bevacizumab when given on the same day.

Dose of Tecentriq for melanoma

• Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.

Dose of Tecentriq for alveolar soft part sarcoma (ASPS)

• Adults: 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg every 4 weeks.
• Pediatric patients 2 years of age and older: 15 mg/kg (up to a maximum of 1200 mg) intravenously every 3 weeks.

Dose of Tecentriq for muscle invasive bladder cancer (MIBC)

• Administer Tecentriq after cystectomy at 840 mg intravenously every 2 weeks,1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks for up to 1 year.
• Administer in the setting of circulating tumor DNA molecular residual disease (ctDNA MRD) asdetermined by an FDA-authorized test.

Dose of Tecentriq for mismatch repair deficient (dMMR) colon cancer

• Adults: 840 mg intravenously every 2 weeks, 1200 mg intravenously every 3 weeks, or 1680 mg intravenously every 4 weeks.
• Pediatric patients 2 years of age and older: 10 mg/kg (up to a maximum of 840 mg) intravenously every 2 weeks, or 15 mg/kg (up to a maximum of 1200 mg) intravenously every 3 weeks.
• Give Tecentriq in combination with chemotherapy for 6 months, followed by Tecentriq as a single agent for 6 months or until disease recurrence or unacceptable toxicity.
• If chemotherapy is discontinued early, continue Tecentriq as a single agent for a total of 12 months.
• Administer Tecentriq before chemotherapy when given on the same day.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Other drugs may interact with atezolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active ingredient: atezolizumab

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

Tecentriq (atezolizumab) is manufactured by Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 USA.