Patient leaflet - Tecentriq 1 200 mg concentrate for solution for infusion
1. What Tecentriq is and what it is used for
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.
This antibody can help your immune system fight
your cancer.
What Tecentriq is used for
Tecentriq is used in adults to treat:
- A kind of bladder cancer, called urothelial carcinoma
- A kind of lung cancer, called non-small cell lung cancer
- A kind of lung cancer, called small cell lung cancer
- A kind of breast cancer, called triple negative breast cancer
- A kind of liver cancer, called hepatocellular carcinoma
Patients may get Tecentriq when their cancer has spread to other parts of the body or has come back after previous treatment.
Patients may get Tecentriq when their lung cancer has not spread to other parts of the body and treatment will be given after surgery and chemotherapy. Treatment after surgery is called adjuvant therapy.
Tecentriq may be given in combination with other anticancer medicines. It is important that you also read the package leaflets for the other anticancer medicines you may be receiving. If you have any questions about these medicines, ask your doctor.
How Tecentriq works
Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1). This protein suppresses the body’s immune (defence) system, thereby protecting cancer cells from being attacked by the immune cells. By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
2. What you need to know before you are given Tecentriq
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 an auto-immune disease
(a condition where the body attacks its own cells)
- have been told that your cancer has spread to your brain
have any history of inflammation of your lungs
(called pneumonitis)
have or have had chronic viral infection of the liver,
including hepatitis B (HBV) or hepatitis C (HCV)
have human immunodeficiency virus (HIV) infection
or acquired immune deficiency syndrome (AIDS)
have a significant cardiovascular (heart) disease or blood
disorders or organ damage due to inadequate blood flow
have had serious side effects because of other antibody
therapies that help your immune system to fight cancer
- have been given medicines to stimulate your immune system
- have been given medicines to suppress your immune system
- have been given a live, attenuated vaccine
have been given medicines to treat infections (antibiotics)
in the past two weeks
Tecentriq acts on your immune system. It may cause inflammation in parts of your body. Your risk of these side effects may be higher if you already have an autoimmune disease (a condition where the body attacks its own cells). You may also experience frequent flares of your autoimmune disease, which in the majority of cases are mild.
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 may cause some side effects that you must tell your doctor about straight away. They may happen weeks or months after your last dose. Tell your doctor straight away if you notice any of the symptoms below:
inflammation of the lung (pneumonitis): symptoms may
include new or worsening cough, shortness of breath, and chest pain
inflammation of the liver (hepatitis): symptoms may include
yellowing of skin or eyes, nausea, vomiting, bleeding or bruising, dark urine, and stomach pain
inflammation of the intestines (colitis): symptoms may
include diarrhoea (watery, loose or soft stools), blood in stools, and stomach pain
inflammation of the thyroid, adrenal glands and the
pituitary gland (hypothyroidism, hyperthyroidism, adrenal insufficiency or hypophysitis): symptoms may include tiredness, weight loss, weight gain, change in mood, hair loss, constipation, dizziness, headaches, increased thirst, increased urination and changes in vision
type 1 diabetes, including a serious, sometimes
life-threatening problem due to acid in the blood produced from diabetes (diabetic ketoacidosis): symptoms may include feeling more hungry or thirsty than usual, need to urinate more often, weight loss, feeling tired or having difficulty thinking clearly, breath that smells sweet or fruity, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, nausea or vomiting, stomach pain, and deep or fast breathing
inflammation of the brain (encephalitis) or inflammation of
the membrane around the spinal cord and brain (meningitis): symptoms may include neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness
inflammation or problems of the nerves (neuropathy):
symptoms may include weakness in the arm and leg muscles, or face muscles, double vision, difficulties with speech and chewing, numbness, and tingling in hands and feet
inflammation of the spinal cord (myelitis): symptoms may
include pain, abnormal sensations such as numbness, tingling, coldness or burning, weakness in the arms or legs, and bladder and bowel problems
inflammation of the pancreas (pancreatitis): symptoms may
include abdominal pain, nausea and vomiting
inflammation of the heart muscle (myocarditis): symptoms
may include shortness of breath, decreased exercise tolerance, feeling tired, chest pain, swelling of the ankles or legs, irregular heartbeat, and fainting
inflammation of the kidneys (nephritis); symptoms may
include changes in urine output and colour, pain in pelvis, and swelling of the body and may lead to failure of the kidneys
inflammation of the muscles (myositis); symptoms may
include muscle weakness, fatigue after walking or standing, tripping or falling, and trouble swallowing or breathing
severe reactions associated with infusion, including serious
allergic reactions (events occurring during the infusion or within one day of the infusion): may include fever, chills, shortness of breath and flushing
severe skin reactions (SCARs); which may include rash,
itching, skin blistering, peeling or sores, and/or ulcers in the mouth or in lining of the nose, throat or genital area
inflammation of the heart sac with build-up of fluid in the
sac (in some cases) (pericardial disorders): symptoms are similar to those of myocarditis and may include chest pain (usually over the front of the chest, sharp, and worsened by deep breathing and better when you sit up and lean forward in case of inflammation of the heart sac), cough, irregular heartbeat, swelling of the ankles, legs or abdomen, shortness of breath, fatigue, and fainting
a condition where the immune system makes too many
infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (haemophagocytic lymphohistiocytosis): symptoms may include enlarged liver and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and heart problems
inflammation of the middle layer of the eye (uveitis):
symptoms may include painful red eye, changes in eyesight or sensitivity to light
If you notice any of the symptoms above, tell your doctor straight away.
Do not try to treat yourself with other medicines. Your doctor may:
Give you other medicines to prevent complications and
reduce symptoms.
- Delay giving your next dose of Tecentriq.
- Stop your treatment with Tecentriq.
Tests and checks
Before your treatment, your doctor will check your general health. You will also have blood tests during your treatment.
Children and adolescents
This medicine should not be given to children or adolescents below 18 years of age. This is because the safety and efficacy of Tecentriq have not been established in this age group.
Other medicines and Tecentriq
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Pregnancy and contraception
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You will not be given Tecentriq if you are pregnant unless
your doctor considers it necessary. This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
If you could become pregnant, you must use
effective contraception:
- while you are being treated with Tecentriq and – for 5 months after the last dose.
If you become pregnant while you are being treated
with Tecentriq tell your doctor.
Breast-feeding
It is not known if Tecentriq gets into breast milk. Ask your doctor if you should stop breast-feeding or if you should stop treatment with 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.
Tecentriq contains Polysorbate (E 432)
Tecentriq 840 mg contains 5.6 mg of polysorbate 20 in each 14 ml dose, which is equivalent to 0.4 mg/mL.
Tecentriq 1,200 mg contains 8.0 mg of polysorbate 20 in each 20 ml dose, which is equivalent to 0.4 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Patient Card
Important information from this package leaflet can be found in the Patient Card you have been given by your doctor. It is important that you keep this Patient Card and show it to your partner or caregivers.
3. How Tecentriq is given
You will be given Tecentriq by a doctor experienced in cancer treatment in a hospital or clinic.
Two different types (formulations) of Tecentriq exist:
- one is given as an infusion into a vein (intravenous infusion)
the other is given as an injection under the skin
(subcutaneous injection).
Your doctor may consider switching your intravenous Tecentriq treatment to subcutaneous Tecentriq treatment (and vice versa) if considered appropriate for you.
How much intravenous Tecentriq is given
The recommended dose is either:
- 840 milligrams (mg) every two weeks, or
- 1,200 milligrams (mg) every three weeks, or
- 1,680 milligrams (mg) every four weeks.
How intravenous Tecentriq is given
Tecentriq is given as a drip into a vein (an intravenous infusion).
Your first infusion will be given over 60 minutes.
- Your doctor will monitor you carefully during the first infusion.
- If you do not have an infusion reaction during the first infusion, the next infusions will be given to you over a period of 30 minutes.
How long treatment lasts
Your doctor will keep giving you Tecentriq until you no longer benefit from it. However, it may be stopped if the side effects become too much of a problem.
If you miss a dose of Tecentriq
If you miss an appointment, make another one straight away. For the treatment to be fully effective, it is very important to keep having the infusions.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the side effects below or if they get worse. They may happen weeks or months after your last dose. Do not try to treat yourself with other medicines.
Tecentriq used alone
The following side effects have been reported in clinical trials with Tecentriq used alone:
Very common: may affect more than 1 in 10 people
- fever
- nausea
- vomiting
- feeling very tired with no energy (fatigue)
- lack of energy
- itching of the skin
- diarrhoea
- joint pain
- rash
- loss of appetite
- shortness of breath
- urinary tract infection
- back pain
- cough
- headache
Common: may affect up to 1 in 10 people
- inflammation of the lungs (pneumonitis)
- low oxygen levels, which may cause shortness of breath as a consequence of inflamed lungs (hypoxia)
- stomach pain
- pain in the muscles and bones
- inflammation of the liver
- elevated liver enzymes (shown in tests), which may be a sign of an inflamed liver
- difficulty swallowing
blood tests showing low levels of potassium
(hypokalaemia) or sodium (hyponatremia)
- low blood pressure (hypotension)
- underactive thyroid gland (hypothyroidism)
reactions related to the infusion of the medicine
(infusion-related reaction, hypersensitivity, cytokine release syndrome or anaphylaxis)
- flu-like illness
- chills
- inflammation of the intestines
- low platelet count, which may make you more likely to bruise or bleed (thrombocytopenia)
- high blood sugar
- common cold (nasopharyngitis)
Package leaflet: Information for the patient
Tecentriq® 1200 mg concentrate for solution for infusion
(atezolizumab) UK610870P99-A6.1
- mouth and throat pain, or dry mouth
- dry skin
- abnormal kidney test (possible kidney damage)
- overactive thyroid gland (hyperthyroidism)
inflammation of the heart sac with build-up of fluid in the sac
(in some cases) (pericardial disorders)
nerve damage resulting in possible numbness, pain, and/or
loss of motor function (peripheral neuropathy)
- inflammation of the joints (arthritis)
Uncommon: may affect up to 1 in 100 people
- inflammation of the pancreas
numbness or paralysis, which may be signs of
Guillain-Barré syndrome
inflammation of the membrane around the spinal
cord and brain
- low levels of adrenal hormones
- type 1 diabetes (including diabetic ketoacidosis)
- inflammation of muscles (myositis)
- red, dry, scaly patches of thickened skin (psoriasis)
- inflammation of the kidneys
itching, skin blistering, peeling or sores, and/or ulcers in the
mouth or in lining of nose, throat, or genital area which can be severe (severe skin reactions)
inflammation of the pituitary gland situated at the base
of the brain
elevated creatine phosphokinase in the blood (shown in test),
which may be a sign of muscle or heart inflammation
changes in any area of the skin and/or genital area that are
associated with drying out, thinning, itching and pain (lichen disorders)
- inflammation of the eye (uveitis)
- inflammation around tendons (tenosynovitis)
Rare: may affect up to 1 in 1,000 people
- inflammation of the heart muscle
myasthenia gravis, an illness that can cause
muscle weakness
- inflammation of the spinal cord (myelitis)
- weakness of facial nerves and muscles (facial paresis)
haemophagocytic lymphohistiocytosis, a condition where
the immune system makes too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms
coeliac disease (characterised by symptoms such as
stomach pain, diarrhoea, and bloating after consuming gluten-containing foods)
- a type of herpes virus infection (cytomegalovirus infection)
inflammatory disease mainly affecting the skin, lung and
eye (sarcoidosis)
Other side effects that have been reported with frequency not known (cannot be estimated from the available data):
inflammation of the bladder; signs and symptoms may
include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen.
lack or reduction of digestive enzymes made by the
pancreas (pancreatic exocrine insufficiency)
Tecentriq used in combination with anticancer medicines
The following side effects have been reported in clinical trials when Tecentriq is given in combination with anticancer medicines:
Very common: may affect more than 1 in 10 people
low number of red blood cells, which can cause tiredness
and shortness of breath
low white blood cell count with and without fever,
which can increase the risk of infection
(neutropenia, leukopenia)
low platelet count, which may make you more likely
to bruise or bleed (thrombocytopenia)
- constipation
nerve damage resulting in possible numbness, pain,
and/or loss of motor function (peripheral neuropathy)
- underactive thyroid gland (hypothyroidism)
- loss of appetite
- shortness of breath
- diarrhoea
- nausea
- itching of the skin
- rash
- joint pain
- feeling very tired (fatigue)
- fever
- headache
- cough
- pain in the muscles and bones
- vomiting
- back pain
- lack of energy
- infection of the lung
- common cold (nasopharyngitis)
- hair loss
- high blood pressure (hypertension)
- swelling in arms or legs
Common: may affect up to 1 in 10 people
blood tests showing low levels of potassium
(hypokalaemia) or sodium (hyponatremia)
- inflammation of the mouth or lips
- hoarse voice (dysphonia)
low levels of magnesium (hypomagnesaemia),
which can cause weakness and muscle cramping, numbness and pain in the arms and legs
- protein in urine (proteinuria)
- inflammation of the intestines
- fainting
elevated liver enzymes (shown in tests),
which may be a sign of an inflamed liver
- changes to sense of taste (dysgeusia)
decreased number of lymphocyte
(a type of white blood cells), which is associated with an increased risk of infection
- abnormal kidney test (possible kidney damage)
- overactive thyroid gland (hyperthyroidism)
- dizziness
reactions related to the infusion of the medicine
(infusion-related reaction, hypersensitivity, cytokine release syndrome or anaphylaxis)
- severe infection in the blood (sepsis)
inflammation of the joints (arthritis)
Uncommon: may affect up to 1 in 100 people
- red, dry, scaly patches of thickened skin (psoriasis)
itching, skin blistering, peeling or sores, and/or ulcers in the
mouth or in lining of nose, throat, or genital area which can be severe (severe skin reactions)
inflammation of the heart sac with build-up of fluid in the sac
(in some cases) (pericardial disorders)
inflammation of the pituitary gland situated at the base
of the brain
- inflammation around tendons (tenosynovitis)
Rare: may affect up to 1 in 1,000 people
- weakness of facial nerves and muscles (facial paresis)
haemophagocytic lymphohistiocytosis, a condition where
the immune system makes too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms
coeliac disease (characterised by symptoms such as
stomach pain, diarrhoea, and bloating after consuming gluten-containing foods)
changes in any area of the skin and/or genital area that
are associated with drying out, thinning, itching and pain (lichen disorders)
- inflammation of the eye (uveitis)
- a type of herpes virus infection (cytomegalovirus infection)
Other side effects that have been reported with frequency not known (cannot be estimated from the available data):
lack or reduction of digestive enzymes made by the
pancreas (pancreatic exocrine insufficiency)
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tecentriq
Tecentriq will be stored by the healthcare professionals at the hospital or clinic. The storage details are as follows:
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 (≤ 25 °C), unless dilution has taken place
in controlled and validated aseptic conditions.
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.
If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Tecentriq contains
The active substance is atezolizumab.
Each mL contains 60 mg of atezolizumab. Each 14 mL vial contains 840 mg of atezolizumab. Each 20 mL vial contains 1,200 mg of atezolizumab.
After dilution, the final concentration of the diluted solution
should be between 3.2 and 16.8 mg/mL.
The other ingredients are L-histidine, glacial acetic acid,
sucrose, polysorbate 20 (E 432) (see section 2 “Tecentriq contains Polysorbate”) and water for injections.
What Tecentriq looks like and contents of the pack
Tecentriq is a concentrate for solution for infusion. It is a clear, colourless to slightly yellowish liquid.
Tecentriq is available in a pack containing 1 glass vial.
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639
Grenzach-Wyhlen
Germany
Procured from within the EU and repackaged for the PL Holder:
Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom
Tecentriq 1200 mg concentrate for solution for infusion 1 vial PL 45763/0870
POM
Tecentriq® is a registered trademark of F. Hoffmann-La Roche AG
For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd.
tel: +44(0)2036301244,
email: MedInfo@abacusmedicine.co.uk or
drugsafetyuk@abacusmedicine.co.uk
This leaflet was last revised on 02.03.2026.
Blind or partially sighted? Is this leaflet hard to see or read? Call 02036301310 or write to info@abacusmedicine.com to obtain the leaflet in a format suitable for you.
The following information is intended for healthcare professionals only:
Instructions for dilution
For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
For the recommended dose of 1,200 mg: twenty mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
For the recommended dose of 1,680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
After dilution, the final concentration of the diluted solution should be between 3.2 and 16.8 mg/mL. The bag should be gently inverted to mix the solution in order to avoid foaming. Once the infusion is prepared it should be administered immediately.
Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration. If particulates or discoloration are observed, the solution should not be used.
No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of PVC, PO, PE, or PP. In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane. The use of in-line filter membranes is optional.
Diluted solution
Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤ 30 °C and for up to
30 days at 2 °C to 8 °C from the time of preparation.
From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Method of administration
Tecentriq is for intravenous use. The infusions must not be administered as an intravenous push or bolus.
The initial dose of Tecentriq must be administered over 60 minutes. If the first infusion is well tolerated all subsequent infusions may be administered over 30 minutes.
Do not co-administer other medicinal products through the same infusion line.
Disposal
The release of Tecentriq in the environment should be minimised. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.