840 mg and 1200 mg concentrate for infusion solution
atezolizumab
What Tecentriq is and what it is used for
What Tecentriq is
Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab.
- Atezolizumab belongs to a group of medicines called monoclonal antibodies.
- A monoclonal antibody is a type of protein designed to recognize and bind to specific targets in the body.
- This antibody can help your immune system fight your cancer.
What Tecentriq is used for
Tecentriq is used to treat adults with:
- A type of cancer in the bladder called urothelial carcinoma
- A type of lung cancer, so-called non-small cell lung cancer
- A type of lung cancer, so-called small cell lung cancer
- A type of breast cancer, so-called triple-negative breast cancer
- A type of liver cancer called hepatocellular carcinoma
Patients can receive Tecentriq when cancer has spread to other parts of the body or has come back after previous treatment.
Patients can receive Tecentriq when the lung cancer has not spread to other parts of the body and treatment is then given after surgery and chemotherapy. Treatment after surgery is called adjuvant treatment.
Tecentriq can be given in combination with other cancer medicines. It is important that you also read the package leaflet for the other cancer medicines that you may receive. If you have any questions about these medicines, ask your doctor.
How Tecentriq works
Tecentriq works by binding to a specific protein in your body called programmed-death ligand 1 (PD-L1). This protein suppresses the body’s immune system, thereby protecting cancer cells from being attacked by immune cells. By binding to protein, Tecentriq helps your immune system fight your cancer.
What you need to know before you receive Tecentriq
You cannot receive Tecentriq:
- if you are allergic to mepolizumab 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 receiving Tecentriq if you:
- have an autoimmune disease (a condition where the body attacks its cells)
- have been told that cancer has spread to your brain
- previously had pneumonia ( pneumonitis )
- have or have had a chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C ( HCV )
- have human immunodeficiency virus infection ( HIV ) or have acquired immunodeficiency syndrome ( AIDS )
- have a cardiovascular (heart) disease or blood disorder or damage to organs due to insufficient blood flow
- have had serious side effects from other treatments with antibodies that help your immune system fight cancer
- have received medicines to stimulate your immune system
- have received medicines to suppress your immune system
- have received a live attenuated vaccine
- have been given medicine to treat your infection ( antibiotics ) for the past two weeks
If any of the above apply to you (or if you are not sure), talk to your doctor or nurse before you are given Tecentriq.
Tecentriq can cause some side effects that you must tell your doctor about immediately. They may appear weeks or months after your last dose. Tell your doctor immediately if you experience any of the symptoms below:
- pneumonia ( pneumonitis ): symptoms may include a new or worsening cough, shortness of breath, and chest pain
- inflammation of the liver ( hepatitis ): symptoms may include yellowing of the skin or eyes, nausea, vomiting, bleeding or bruising easily, dark-colored urine, and stomach pain
- inflammation of the intestines ( colitis ): symptoms may include diarrhea (watery, loose or soft stools), blood in the stools, and stomach pain
- inflammation of the thyroid gland ( thyroid ), adrenal glands, or pituitary gland ( hypothyroidism, hyperthyroidism , adrenal insufficiency, or hypophysitis): symptoms may include fatigue, weight loss, weight gain, mood swings, hair loss, constipation, dizziness, headache, increased thirst, need to urinate more often and impaired vision
- type 1 diabetes, including a serious, sometimes life-threatening problem due to acidic blood caused by diabetes (diabetic ketoacidosis): symptoms may include feeling hungrier and thirstier than usual, needing to urinate more often, weight loss and tiredness, tiredness or difficulty thinking, breath that smells sweet or fruity, a sweet or metallic taste in the mouth or a different smell from urine or sweat, nausea or vomiting, stomach pain, and deep or rapid breathing
- inflammation of the brain ( encephalitis ) or inflammation of the membranes around the spine and brain ( meningitis ): symptoms may include neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion, and sleepiness
- inflammation of or problems with the nerves ( neuropathy ): symptoms may include muscle weakness and numbness, tingling in the hands and feet
- inflammation of the pancreas ( pancreatitis ): symptoms may include stomach pain, nausea, and vomiting
- inflammation of the heart muscle ( myocarditis ): symptoms may include shortness of breath, reduced energy on exertion, fatigue, 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 urine color, pelvic pain, and body swelling and may lead to kidney failure
- inflammation of muscles (myositis): symptoms may include muscle weakness, tiredness after walking or standing, tripping or falling, and difficulty swallowing or breathing
- severe reactions linked to infusion one (events that occur during infusion one or within a day of infusion one) may include fever, chills, shortness of breath, and facial flushing.
- severe skin reactions (SCARs): which may include rash, itching, blistering of the skin, peeling or sores, and/or sores in the mouth, or the mucous membranes of the nose, throat, or genitals
If you experience any of the above symptoms, tell your doctor immediately.
Do not try to treat yourself with other medicines. Your doctor may:
- give you other medicines to prevent complications and reduce symptoms
- delay the time until the next dose of Tecentriq
- stop your treatment with Tecentriq.
Sampling and controls
Before the treatment, your doctor will check your general state of health. You will also be allowed to give a blood sample during the treatment.
Children and young people
This medicine should not be given to children or adolescents under 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 the doctor or nurse if you are taking, have recently taken, or might take other medicines. This also applies to medicines that you can buy without a prescription, including herbal medicines.
Pregnancy and contraception
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
- You will not be treated with Tecentriq if you are pregnant unless your doctor considers it necessary. This is because the effects of Tecentriq in pregnant women are not known – it is possible that it could harm your unborn baby.
- If it is possible for you to become pregnant, you must use effective contraception;
- while being treated with Tecentriq and
- for 5 months after the last dose a.
- If you become pregnant while being treated with Tecentriq, tell your doctor.
Breast-feeding
It is not known whether Tecentriq passes into breast milk. Ask your doctor if you should stop breastfeeding or if you should stop taking Tecentriq.
Driving ability and use of machinery
Tecentriq has a slight influence on your ability to drive or use machines. If you feel tired, do not drive or use machines until you feel better.
How Tecentriq is given
You will be given Tecentriq by a doctor who is experienced in cancer treatment in a hospital or clinic.
How much Tecentriq will be given
The recommended dose is either:
- 840 milligrams (mg) every two weeks or
- 1200 milligrams (mg) every three weeks or
- 1680 milligrams (mg) every four weeks.
How 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 closely during the first infusion.
- If you do not have an infusion reaction during the first infusion, the next infusion will be given over 30 minutes.
How long does the treatment lasts
Your doctor will continue to give you Tecentriq until you no longer benefit from it. However, the treatment can be interrupted if the side effects become too severe.
If you miss a dose of Tecentriq
If you miss a scheduled treatment, book a new one immediately. For the treatment to have a full effect, you must continue to receive the infusions.
If you stop receiving Tecentriq
Do not stop treatment with Tecentriq without discussing this with your doctor. If you stop treatment, the effect of the drug may cease.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the side effects below or if they get worse. They may appear 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 studies with Tecentriq when used alone:
Very common: may affect more than 1 in 10 users
- fever
- nausea
- vomiting
- feeling extremely tired or having no energy
- lack of energy
- itchy skin
- diarrhea
- joint pain
- rash
- loss of appetite
- respiratory distress
- urinary tract infection
- back pain
- cough
- headache
Common: may affect up to 1 in 10 users
- pneumonia ( pneumonitis )
- low oxygen levels, which can cause shortness of breath as a consequence of pneumonia ( hypoxia )
- stomach pains
- pain in muscles and bones
- liver inflammation
- elevated liver enzymes (shown on sampling), which may be a sign of liver inflammation
- difficulty swallowing
- blood tests showing low levels of potassium ( hypokalemia ) or sodium ( hyponatremia )
- low blood pressure ( hypotension )
- underactive thyroid ( hypothyroidism )
- allergic reaction (infusion-related reaction, hypersensitivity, or anaphylactic shock )
- flu-like illness
- pain in muscles and bones
- overindulge
- inflammation of the intestines
- low levels of platelets which can make you bruise or bleed more easily
- high blood sugar
- common cold ( nasopharyngitis )
- pain in the mouth and throat
- dry skin
- abnormal kidney test (possible damage to the kidneys)
- overactive thyroid gland ( hyperthyroidism )
Uncommon: may affect up to 1 in 100 users
- 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 )
- kidney inflammation
- itching, blistering of the skin, peeling or sores, and/or sores in the mouth, or in the mucous membranes of the nose, throat, or genitals which may become severe (severe skin reactions)
Rare: may affect up to 1 in 1,000 users
- inflammation of the heart muscle
- myasthenia gravis, a disease that can cause muscle weakness
- inflammation of the pituitary gland, which is located in the lower part of the brain
- inflammation of the eye ( uveitis )
Other side effects that have been reported (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 urinate, blood in the urine, and pain or pressure in the lower abdomen.
Tecentriq used in combination with cancer drugs
The following side effects have been reported in clinical studies where Tecentriq was given in combination with cancer drugs:
Very common: may affect more than 1 in 10 users
- low red blood cell count, which can cause tiredness and shortness of breath
- the low number of white blood cells with or without fever, – which can increase the risk of infection ( neutropenia, leukopenia )
- the low number of platelets, which can make you bruise or bleed more easily ( thrombocytopenia )
- constipation
- nerve damage resulting in possible numbness, pain, and/or loss of motor function ( peripheral neuropathy )
- underactive thyroid ( hypothyroidism )
- loss of appetite
- respiratory distress
- diarrhea
- nausea
- itching of the skin
- rash
- joint pain
- feeling extremely tired
- fever
- headache
- cough
- pain in muscles and bones
- vomiting
- back pain
- lack of energy
- lung infection
- common cold ( nasopharyngitis )
- hair loss
- high blood pressure ( hypertension )
- swelling of arms or legs
Common: may affect up to 1 in 10 users
- blood tests showing low levels of potassium ( hypokalemia ) or sodium ( hyponatremia )
- inflammation of the mouth or lips
- hoarseness ( dysphonia )
- low levels of magnesium ( hypomagnesemia ), which can cause weakness and muscle cramps, numbness, and pain in the arms and legs
- protein in the urine ( proteinuria )
- fainting
- increased levels of liver enzymes (seen in tests) which may be a sign of inflamed liver
- changes in taste (taste disturbance)
- decreased levels of lymphocytes (a type of white blood cell ) which is associated with an increased risk of infection
- abnormal kidney function values (possible kidney damage)
- overactive thyroid gland ( hyperthyroidism )
- dizziness
- infusion-related reactions
- serious infection in the blood ( sepsis )
Uncommon: may affect up to 1 in 100 users
- red, dry, scaly patches of thickened skin ( psoriasis )
- itching, blistering of the skin, peeling or sores, and/or sores in the mouth, or in the mucous membranes of the nose, throat, or genitals which may become severe (severe skin reactions)
If you experience any of the side effects above or if they get worse, tell your doctor immediately.
How to store Tecentriq
Tecentriq will be stored by the healthcare staff at the hospital or clinic. The storage conditions are as follows:
- Use before the expiry date which is stated on the label on the carton after “Exp.” and on the vial after “EXP”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2°C – 8°C). Do not freeze.
- Store the vial in the outer carton. Light sensitive.
- The diluted solution should not be stored for more than 24 hours at 2°C – 8°C or 8 hours at room temperature (≤ 25°C), unless dilution has been performed under controlled and validated aseptic conditions.
- Do not use this medicine if it is cloudy, discolored, or contains particles.
Medicines must not be thrown into the drain or among the household waste. Healthcare staff will dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- 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 1200 mg of atezolizumab.
- After dilution, the final concentration of the diluted solution should be between 3.2 and 16.8 mg/ml.
- Other ingredients are L-histidine, concentrated acetic acid, sucrose, polysorbate 20, and water for injections.
Appearance and package sizes of the medicine
Tecentriq is a concentrate for infusion solution, solution. It is a clear, colorless to slightly yellowish liquid.
Tecentriq is available in a pack size of 1 glass vial.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639
Grenzach-Wyhlen
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| Finland/FinlandRoche Oy Tel: +358 (0) 10 554 500 |
| SwedenRoche phone: +46 (0) 8 726 1200 |