Tecentriq 1875 mg solucion inyectable

Prescribing Information: Information for the Patient

Tecentriq 1875Injectable Solution

atezolizumab

Read this prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• It is essential that you keep the patient information card during your treatment.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prescribing information. See section 4.

What is Tecentriq

Tecentriq is an anticancer medication that contains the active substance ‘atezolizumab’.

• It is a type of protein that belongs to the group of so-called “monoclonal antibodies”.
• Monoclonal antibodies are a type of protein designed to recognize and bind to a specific target substance in the body.
• This antibody can help your immune system fight cancer.

What is Tecentriq used for

Tecentriq is used in adults to treat:

• Bladder cancer, specifically urothelial carcinoma
• Non-small cell lung cancer
• Small cell lung cancer
• Triple-negative breast cancer
• Hepatocellular carcinoma

Patients may be treated with Tecentriq when their cancers have spread to other parts of the body or after previous treatment.

Patients may be treated with Tecentriq when their non-small cell lung cancer has not spread to other parts of the body, treatment will be given after surgery and chemotherapy. The treatment after surgery is called adjuvant therapy.

Tecentriq may be given in combination with other anticancer medications. It is essential that you also read the prospectus of the other anticancer medications you may be receiving. If you have any doubts about these medications, consult your doctor.

How Tecentriq works

Tecentriq acts by binding to a specific protein that exists in your body and is called the ligand of the programmed death receptor 1 (PD-L1). This protein neutralizes your immune system (defenses), thus protecting cancer cells from attack by immune cells. By binding to this protein, Tecentriq helps your immune system fight cancer.

No use Tecentriq:

• If you are allergic to atezolizumab or any of the other components of this medication (listed in section 6).

If you are unsure, consult your doctor or nurse before starting to use Tecentriq.

Warnings and precautions

Consult your doctor or nurse before starting to use Tecentriq:

• If you have an autoimmune disease (a condition in which the body attacks its own cells)
• If you have been told that your cancer has spread to your brain
• If you have a history of lung inflammation (called pneumonitis)
• If you have a chronic viral liver infection, including hepatitis B (VHB) or hepatitis C (VHC)
• If you have a human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• If you have cardiovascular, blood, or significant organ damage due to inadequate blood pressure
• If you have had severe side effects due to antibody therapies administered to treat your cancer
• If you have been given medications to stimulate your immune system
• If you have been given medications to suppress your immune system
• If you have been given a live attenuated vaccine
• If you have been given antibiotics in the two weeks prior to treatment

Tecentriq acts on your immune system. This can cause inflammation in different parts of your body. The risk of this occurring may be higher if you already have an autoimmune disease (a condition in which the body attacks its own cells). You may also experience frequent exacerbations of your autoimmune disease, which in most cases will be moderate.

If any of the above occur (or you are unsure), consult your doctor or nurse before using Tecentriq.

Tecentriq may cause some side effects that you should report to your doctor immediately. These may occur weeks or months after the last dose. Report to your doctor immediately if you notice any of the following symptoms:

• Lung inflammation (pneumonitis), symptoms may include recent or worsening cough, difficulty breathing, and chest pain
• Liver inflammation (hepatitis): symptoms may include yellowing of the skin or eyes, nausea, vomiting, bleeding or bruising, dark urine, and abdominal pain
• Intestinal inflammation (colitis), symptoms may include diarrhea (watery, loose, or soft stools), blood in the stool, and abdominal pain
• Thyroid and adrenal gland inflammation and pituitary gland inflammation (hypothyroidism, hyperthyroidism, or adrenal insufficiency or hypophysitis), symptoms may include fatigue, weight loss, weight gain, mood changes, hair loss, constipation, dizziness, headache, increased thirst, increased need to urinate, and vision changes
• Type 1 diabetes, including severe cases, in some cases life-threatening, due to the blood becoming acidic produced by diabetes (diabetic ketoacidosis), symptoms may include increased hunger or thirst, increased need to urinate, weight loss, feeling tired or having difficulty thinking clearly, breath that smells sweet or fruity, a sweet or metallic taste in the mouth, or a different odor in the urine or sweat, nausea or vomiting, abdominal pain, and deep or rapid breathing
• Brain inflammation (encephalitis) or inflammation of the membrane surrounding the spinal cord and brain (meningitis), symptoms may include neck stiffness, headache, fever, chills, vomiting, sensitivity to light, confusion, and drowsiness
• Nerve inflammation or problems (neuropathy), symptoms may include weakness in the muscles of the arms and legs, or in the muscles of the face, double vision, difficulty speaking and swallowing, numbness, and tingling in the hands and feet
• Spinal cord inflammation (myelitis), symptoms may include pain, abnormal sensations such as numbness, tingling, coldness, or burning, weakness in the arms or legs, and problems with urination and bowel movements
• Pancreas inflammation (pancreatitis), symptoms may include abdominal pain, nausea, and vomiting
• Heart muscle inflammation (myocarditis), symptoms may include difficulty breathing, decreased exercise tolerance, feeling tired, chest pain, swelling of the ankles or legs, irregular heartbeat, and fainting
• Kidney inflammation (nephritis); symptoms may include changes in the amount and color of urine, pelvic pain, and inflammation of the body, and may lead to kidney failure
• Muscle inflammation (myositis); symptoms may include muscle weakness, fatigue after walking or standing, stumbling or falling, and difficulty swallowing or breathing
• Severe reactions related to injection (events that occur during or within the first day after injection), may include fever, chills, difficulty breathing, and redness
• Severe skin reactions (SCARs); which may include rash, itching, blistering, peeling, or ulcers on the skin, and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area
• Pericardial disorders (inflammation of the sac surrounding the heart with accumulation of fluid in the sac in some cases), symptoms are similar to myocarditis and may include chest pain (usually in the front of the chest, sharp and worsens with deep breathing and improves when sitting and leaning forward in case of pericardial inflammation), cough, irregular heartbeat, swelling of the ankles, legs, or abdomen, difficulty breathing, fatigue, and fainting
• A condition in which the immune system produces too many cells that fight infections, called histiocytes and lymphocytes, which can cause various symptoms (hemophagocytic lymphohistiocytosis). These symptoms may include liver and/or spleen enlargement, skin rash, lymph node enlargement, respiratory problems, easy bruising, renal abnormalities, and cardiac problems

Report to your doctor immediately if you experience any of the symptoms described above.

Do not attempt to treat your symptoms with other medications on your own.Your doctor may:

• Administer other medications to prevent complications and reduce your symptoms.
• Wait longer for your next dose of Tecentriq.
• Interrupt your treatment with Tecentriq.

Tests and monitoring

Before your treatment, your doctor will check your overall health status. They will also perform blood tests during your treatment.

Children and adolescents

This medication 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 for this age group.

Other medications and Tecentriq

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications, including herbal remedies.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.
• Do not take Tecentriq if you are pregnant unless your doctor has told you to do so. This is because the effect of Tecentriq on pregnant women is unknown - it may cause harm to the baby.
• If you may become pregnant, you must use an effective contraceptive method:

• While you are being treated with Tecentriq and
• For 5 months after the last dose.

• If you become pregnant while being treated with Tecentriq, inform your doctor.

Breastfeeding

The safety of Tecentriq during breastfeeding is unknown. It is not possible to rule out the risk to the infant. Ask your doctor if you should stop breastfeeding or if you should stop treatment with Tecentriq.

Driving and operating machinery

Tecentriq may have a minor effect on your ability to drive and operate machinery. If you feel tired, do not drive or operate machinery until you feel better.

Tecentriq contains polysorbate

Tecentriq 1875 mg contains 9 mg of polysorbate 20 in each 15 ml dose, which is equivalent to 0.6 mg/ml.

Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Patient information leaflet

The important information in this leaflet can be found in the Patient Information Leaflet that your doctor has given you. It is essential that you keep this leaflet and show it to your partner or caregiver.

You will receive treatment with Tecentriq from an experienced cancer doctor

There are two different formulations for Tecentriq:

• one is administered as an intravenous infusion
• the other is administered as a subcutaneous injection.

Your doctor may consider switching your Tecentriq intravenous treatment to Tecentriq subcutaneous (or vice versa) if it is appropriate for you.

How much Tecentriq subcutaneous is administered

The recommended dose of Tecentriq injectable solution is 1,875 mg every three weeks

How to administer Tecentriq subcutaneous

Tecentriq is administered as a subcutaneous injection by a doctor or nurse.

• Injections will be administered in the thigh in about 7 minutes
• The injection site will be alternated between the left and right thigh
• Your doctor or nurse will ensure that each injection is administered in a new location (at least 2.5 cm away from any previous injection site), and where the skin is not red, bruised, sensitive, or hard
• Different injection sites should be used for other medications

Treatment duration

Your doctor will continue to administer Tecentriq as long as you benefit from it. However, treatment will be stopped if adverse effects are not tolerated.

What to do if you forget to take Tecentriq

If you forget an appointment with your doctor, ask for another one immediately. To make treatment as effective as possible, it is very important to continue receiving the injections.

What to do if you interrupt treatment with Tecentriq

Do not stop treatment with Tecentriq unless you have discussed it with your doctor. Stopping treatment may stop the medication's effect.

If you have any other questions about using this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the side effects listed below or they worsen,inform your doctor immediately. They can occur weeks or months after your last dose.Do not administer with other medications on your own.

Tecentriq used alone

The following side effects have been reported in clinical trials with Tecentriq used alone:

Very common:can affect more than 1 in 10 patients

• fever
• nausea
• vomiting
• feeling very tired, without energy (fatigue)
• lack of energy
• itching of the skin
• diarrhea
• joint pain
• eruption
• loss of appetite
• difficulty breathing
• urinary tract infection
• back pain
• cough
• headache

Common:can affect up to 1 in 10 patients

• inflammation of the lungs (pneumonitis)
• low oxygen levels that can cause difficulty breathing due to lung inflammation (hypoxia)
• stomach pain
• muscle and bone pain
• inflammation of the liver
• elevation of liver enzymes (shown in tests) that may be a sign of liver inflammation
• difficulty swallowing
• low levels of potassium (hypokalemia) or sodium (hyponatremia) in the blood, as shown in blood tests
• low blood pressure (hypotension)
• underactive thyroid gland (hypothyroidism)
• allergic reaction (reaction related to infusion, hypersensitivity, or anaphylaxis)
• flu-like illness
• chills
• inflammation of the intestines
• low platelet count, which may make you more prone to bruising or bleeding
• elevated blood sugar
• common cold (rhinopharyngitis)
• mouth and throat pain or dry mouth
• dry skin
• altered kidney function parameters (possible kidney damage)
• overactive thyroid gland (hyperthyroidism)
• inflammation of the pericardium with accumulation of fluid in the sac (in some cases) (pericardial disorders)
• reaction at the injection site

Rare:can affect up to 1 in 1,000 patients

• inflammation of the heart muscle
• myasthenia gravis, a disease that can cause muscle weakness
• inflammation of the eyes (uveitis)
• hemophagocytic lymphohistiocytosis, a disorder in which the immune system produces too many cells that fight infections, called histiocytes and lymphocytes, which can cause various symptoms
• inflammation of the spinal cord (myelitis)
• weakness of the facial nerves and muscles (facial paralysis)
• celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods containing gluten)

Other side effects that have been reported with unknown frequency(cannot be estimated from available data):

• Inflammation of the bladder. Symptoms may include frequent and/or painful urination, urgent need to urinate, blood in the urine, pain or pressure in the lower abdomen.
• Absence or reduction of pancreatic enzymes produced by the pancreas (exocrine pancreatic insufficiency)

Tecentriq used in combination with cancer medications

The following side effects have been reported in clinical trials when Tecentriq is administered in combination with cancer medications.

Very common:can affect more than 1 in 10 patients

• low red blood cell count, which can cause fatigue and difficulty breathing
• low white blood cell count with or without fever, which can increase the risk of infection (neutropenia, leucopenia)
• low platelet count, which may make you more prone to bruising or bleeding (thrombocytopenia)
• constipation
• nervous system damage, which can cause numbness, pain, or loss of motor function (peripheral neuropathy)
• underactive thyroid gland (hypothyroidism)
• loss of appetite
• difficulty breathing
• diarrhea
• nausea
• itching of the skin
• eruption
• joint pain
• feeling tired (fatigue)
• fever
• headache
• cough
• muscle and bone pain
• vomiting
• back pain
• lack of energy
• lung infection
• common cold (rhinopharyngitis)
• hair loss
• high blood pressure (hypertension)
• swelling in arms or legs

Common:can affect up to 1 in 10 patients

• blood tests showing low levels of potassium (hypokalemia) or sodium (hyponatremia)
• inflammation of the mouth or lips
• hoarse voice (dysphonia)
• low levels of magnesium (hypomagnesemia), which can cause weakness and muscle cramps, numbness, and pain in arms and legs
• protein in the urine (proteinuria)
• syncope
• elevated liver enzymes (detected in tests), which may be a sign of liver inflammation
• change in sense of taste (dysgeusia)
• decrease in lymphocyte count (a type of white blood cell), which is associated with an increased risk of infection
• abnormal kidney function test (possible kidney damage)
• overactive thyroid gland (hyperthyroidism)
• dizziness
• reactions related to infusion
• severe blood infection (sepsis)

Rare:can affect up to 1 in 1,000 patients

• psoriasis
• itching, blistering, peeling, or ulceration of the skin, and/or ulcers in the mouth or mucous membranes of the nose, throat, or genital area, which can be severe (severe skin reactions)
• inflammation of the pericardium with accumulation of fluid in the sac (in some cases) (pericardial disorders)
• inflammation of the pituitary gland located at the base of the brain

Unknown frequency:(cannot be estimated from available data)

• Absence or reduction of pancreatic enzymes produced by the pancreas (exocrine pancreatic insufficiency)

If you notice any of the side effects listed above or they worsen, inform your doctor immediately.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

• Do not use this medication after the expiration date that appears on the packaging and on the vial label after EXP. The expiration date is the last day of the month indicated.
• Store in refrigerator (between 2 °C and 8 °C). Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Do not use this medication if you observe that it is cloudy, discolored, or contains particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Tecentriq

• The active ingredient is atezolizumab. Each ml contains 125 mg of atezolizumab.

Each vial of 15 ml contains 1,875 mg of atezolizumab.

The other components are: L-histidine, L-methionine, acetic acid, sucrose, polisorbate 20 (see section 2 "Tecentriq contains polisorbate"), rHuPH20, water for injection

Appearance of the product and contents of the pack

Tecentriq is an injectable solution. It is a clear, colourless to pale yellow liquid.

Tecentriq is available in packs containing 1 vial of glass.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsible for manufacturing

Roche Pharma AG

Emil-Barell-Strasse 1

79639

Grenzach-Wyhlen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

--------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals:

To prevent errors, it is essential to check the labels on the vials to ensure the correct use of the formulation (intravenous or subcutaneous) as prescribed for the patient.

Tecentriq injectable solution should be visually inspected to ensure that there are no particles or discoloration before administration.

Tecentriq injectable solution is a prepared solution for use that MUST NOT be diluted or mixed with other medicinal products.

Tecentriq injectable solution is for single use only and should only be prepared by a healthcare professional.

No incompatibilities have been observed between Tecentriq and polypropylene (PP), polycarbonate, stainless steel (SS), chlorinated polyvinyl chloride (PVC), and polyurethane (PU).

Preparation of the syringe

• From a microbiological point of view, the medicinal product should be used immediately, once it has been transferred from the vial to the syringe, as it does not contain any antimicrobial preservative or bacteriostatic agent.

• Remove the vial from the refrigerator and let the solution reach room temperature.
• Extract all the content of the injectable solution from the Tecentriq vial with a sterile syringe and a transfer needle (recommended 18G).
• Remove the transfer needle and attach a transfer set (e.g. winged/butterfly) containing a stainless steel 23-25G injection needle. Use a subcutaneous infusion set with a residual volume/retention not exceeding 0.5 ml for administration.
• Prime the subcutaneous infusion set with the medicinal product solution to eliminate air from the infusion set and stop before the liquid reaches the needle.
• Ensure that the syringe contains exactly 15 ml of the solution after priming and expelling any excess volume from the syringe.
• Administer immediately to prevent clogging of the needle. DO NOT conserve the prepared syringe attached to the subcutaneous infusion set.

If the dose is not administered immediately, see "conservation of the syringe" below.

Conservation of the syringe

• If not used immediately, the storage time until use and the storage conditions before use are the responsibility of the user and, in general, should not exceed 24 hours between 2°C and 8°C, unless the preparation of the syringe has been performed in controlled and validated aseptic conditions.
• If the dose is not going to be administered immediately, use an aseptic technique to extract all the content of Tecentriq injectable solution from the vial to the syringe to take into account the dose volume (15 ml) and the infusion set volume. Replace the transfer needle with a syringe stopper. DO NOT place a subcutaneous infusion set for conservation.
• The prepared syringe can be stored for a maximum of 30 days at 2-8°C and for a maximum of 8 hours at ≤30°C with diffuse natural light from the moment of preparation.
• If the syringe has been stored in a refrigerator, it should be allowed to reach room temperature before administration.

Administration

The Tecentriq SC formulation cannot be used for intravenous administration and should only be used as a subcutaneous injection.

Before administration, remove the Tecentriq subcutaneous solution from the refrigerator and let it reach room temperature. For instructions on use and handling of the Tecentriq injectable formulation before administration, see section 6.6 of the SmPC.

Administer 15 ml of Tecentriq injectable solution subcutaneously in the thigh for approximately 7 minutes. It is recommended to use a subcutaneous infusion set (e.g. winged/butterfly). DO NOT administer the residual volume remaining in the tube to the patient.

The injection site should be alternated between the right and left thighs. New injections should be administered at least 2.5 cm from the previous site and never in areas where the skin is red, has haematomas, is sensitive, or is hard. During treatment with the Tecentriq subcutaneous formulation, it is preferable that other subcutaneous products are administered in different areas.

Elimination

The unused medicinal product and all materials that have been in contact with it will be disposed of in accordance with local regulations.