What Tecentriq is

Tecentriq is an anti‑cancer medicine that contains the active substance atezolizumab. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body.

What Tecentriq is used for

TECENTRIQ is a prescription medicine used to treat adults with:

·         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, and if you have any one of the following conditions:

§  you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or

§  you are not able to take chemotherapy that contains any platinum regardless of “PD-L1” status.

·         A type of lung cancer called non-small cell lung cancer (NSCLC):

o    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.

o    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.

o    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.

o    TECENTRIQ 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.

·         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 SCLC,” which means that it has spread or grown.

·         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.

You must not be given Tecentriq if:

·           You are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before you are given Tecentriq.

Warnings and precautions

Talk to your doctor or nurse before you are given Tecentriq 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.

If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Tecentriq.

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 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 get any symptoms of the following problems or these symptoms get worse:

· Lung problems:

·       Cough

·       shortness of breath

·       chest pain

· Intestinal problems:

·       diarrhea (loose stools) or more 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 heart beat

·       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

· 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 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 eye sight

·       persistent or severe muscle pain or weakness, muscle cramps

·       low red blood cells, bruising

· Severe infections. Signs and symptoms of infection may include:

·       fever

·       cough

·       flu-like symptoms

·       pain when urinating, frequent urination or back pain

· Severe infusion reactions. 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 delay or completely stop treatment with TECENTRIQ if you have severe side effects.

Children and adolescents

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

Other medicines and Tecentriq

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Pregnancy and contraception

·         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:

o    Your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ.

o    You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of TECENTRIQ.

Breast‑feeding

 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.

Driving and using machines

Tecentriq has minor influence on your ability to drive and use machines. If you feel tired, do not drive or use machines until you feel better.

·         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 you for certain side effects.

If you miss a dose of Tecentriq

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

If you stop receiving Tecentriq

Do not stop treatment with Tecentriq unless you have discussed this with your doctor. This is because stopping treatment may stop the effect of the medicine.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

TECENTRIQ can cause serious side effects, including:

· See “Warning and Precaution?”

· 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

If you notice any of the side effects above or if they get worse, tell your doctor straight away.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

Tecentriq will be stored by the healthcare professionals at the hospital or clinic. The storage details are as follows:

·           Keep this medicine out of the sight and reach of children.

·           Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month. 

·           Store in a refrigerator (2 °C ‑ 8 °C). Do not freeze.

·           Keep the vial in the outer carton in order to protect from light.

·           The diluted solution should not be kept more than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature.

·           Do not use if this medicine is cloudy, discoloured or contains particles

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help to protect the environment.