Product Information for the User

Phesgo 600mg/600mg Injectable Solution

Phesgo 1.200mg/600mg Injectable Solution

pertuzumab/trastuzumab

This product is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1.What is Phesgo and what it is used for

2.What you need to know before starting to usePhesgo

3.How to use Phesgo

4.Possible adverse effects

5.Storage of Phesgo

6.Contents of the package and additional information

Phesgo is a cancer medication that contains two active principles: pertuzumab and trastuzumab.

• Pertuzumab and trastuzumab are “monoclonal antibodies”. They are designed to bind to specific targets in cellsknown as “human epidermal growth factor receptor 2”, (HER2).
• HER2 is found in large quantities on the surface of some cancer cells, and stimulates their growth.
• By binding to HER2 on cancer cells, pertuzumab and trastuzumab slow down their growth or destroy them.

Phesgo is available in two different doses. For more information, see section 6.

Phesgo is a medication used to treat adult patients with breast cancer thatis of the type “HER2-positive”–your doctor will perform tests to determine if this is the case. It can be used when:

• the cancer has spread to other parts of the body (has made metastasis) such as the lungs or liver, or the cancer has recurred in the breast and the surrounding area, but cannot be operated on and has not been treated with cancer medications (chemotherapy) or other medications designed to bind to HER2.
• the cancer has not spread to other parts of the body and treatment is to be carried out before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy).

In addition to Phesgo, you will receiveother medications called chemotherapeutics. Information about these medications is described in separate prospectuses. Ask your doctor, pharmacist, or nurse for information about these other medications.

No use Phesgo

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

If you are unsure, speak with your doctor, pharmacist, or nurse before Phesgo is administered to you.

Warnings and precautions

Heart problems

Treatment with Phesgomay affect the heart. Consult your doctor, pharmacist, or nurse before Phesgo is administered to you if:

• You have ever had heart problems(such as heart failure, severe irregular heartbeats, uncontrolled high blood pressure, recent heart attack).Your doctor will perform tests to check if your heart is working properlybefore and during treatment withPhesgo.
• You have ever had heart problems during previous treatment with a medication containingtrastuzumab.
• You have ever received a chemotherapy medication from the group of cancer medications called anthracyclines, such as doxorubicin or epirubicin; these medications can damage the heart muscle and increase the risk of heart problems with Phesgo.
• You have ever received radiation therapy in the chest area, as it may increase the risk of heart problems.

If any of the above has occurred (or you are unsure), consult your doctor or nurse before Phesgo is administered to you. See the "Severe side effects" section in section 4 for more details on the signs of heart problems to monitor.

Injection reactions

Injection reactionsmay occur. They are allergic reactions and can be severe.

If you experience any severe reaction, your doctor may interrupt treatment with Phesgo. See section 4, “Severe side effects”, for more details on injection-related reactions to monitor during and after injection.

Your doctor or nurse will check for side effects during the injection and during:

• 30minutes afterthe first Phesgo injection.
• 15minutes after subsequent Phesgo injections.

If you experience any severe reaction, your doctor will interrupt treatment with Phesgo.

Low white blood cell count in the blood and fever (Neutropenia febril)

When Phesgo is administered with chemotherapy medications,the number of white blood cells in the blood may decrease and fever may occur. If you have inflammation of the digestive tract (e.g., mouth pain or diarrhea), you may be more likely to experience this side effect. If fever persists for several days, it may be a sign of worsening condition and you should contact your doctor.

Dysentery

Treatment with Phesgo may cause severe diarrhea. Patients over 65years old have a higher risk of experiencing diarrhea compared to patients under 65years old.If you experience severe diarrhea while receiving cancer treatment, your doctor may give you medications to control the diarrhea. Your doctor may also interrupt your treatment with Phesgo until diarrhea is under control.

Children and adolescents

Phesgo should not be administered to patients under 18 years old because there is no information available on its efficacy in this age group.

Patients over 65 years old

Patients over 65 years old are more likely to experience side effects such as reduced appetite, decreased red blood cell count, weight loss, fatigue, loss or alteration of taste, weakness,numbness, tingling sensation, or itching, mainly in the feet and legs, and diarrhea, compared to patients under 65years old.

Other medications and Phesgo

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

Before starting treatment, inform your doctor, pharmacist, or nurse if you are pregnant orbreastfeeding, or if you think you may be pregnant or plan to become pregnant. You will be informed of the benefits and risks for you and your child of administering Phesgoduring pregnancy.

• Inform your doctor immediately if you become pregnant during treatment with Phesgoor in the 7months following treatment interruption. Phesgo may harm the fetus. You must use an effective contraceptive method during treatment with Phesgo and in the 7 months following treatment interruption.
• Ask your doctor if you can breastfeed during or after treatment with Phesgo.

Driving and operating machinery

Phesgomay affect your ability to drive or operate machinery. If during treatment you experience symptoms, such as dizziness, chills, fever, injection reactions, or allergic reactions as described in section 4, do not drive or operate machinery until these symptoms disappear.

Phesgo contains Sodium

Phesgo contains less than 1 mmol of sodium (23mg) per dose; this is essentially “sodium-free”.

A healthcare professional will administer Phesgo to you in a hospital or clinic via injection under your skin (subcutaneous injection).They will administer the injections every three weeks.

• The injections will be administered first in one thigh and then in the other. You will continue to receive the injection in one thigh and then in the other.
• Your healthcare professional will ensure that each injection is administered in a new location (at a minimum distance of 2.5 cm from the previous injection site), and where the skin is not red, bruised, sensitive, or hard.
• You should use different injection sites for other medications.

Initial treatment (initial dose)

• You will receive 1,200 mg / 600 mg of Phesgo under the skin for 8 minutes. Your healthcare professional will monitor side effects during your injection and for 30 minutes afterwards.
• You will also receive chemotherapy.

Subsequent injections (maintenance dose), which will be administered if the first injection did not cause severe adverse reactions

• You will receive 600 mg / 600 mg of Phesgo under the skin for 5 minutes.Your healthcare professional will monitor side effects during your injection and for 15 minutes afterwards.
• According to the doctor's prescription, you will also receive chemotherapy.
• The number of injections you will receive depends on:

• how you respond to the treatment
• whether you are receiving treatment before surgery or after surgery, or if the disease has spread.

For more information on the initial and maintenance doses, see section 6.

For more information on the chemotherapy dose (which can also cause side effects), read the prospectus for those medications. If you have questions about these medications, consult your doctor, pharmacist, or nurse.

If you forgot to use Phesgo

If you miss your appointment to receive Phesgo, please schedule another appointment as soon as possible.Depending on how long it has been since your last visit, your doctor will decide what dose of Phesgo to give you.

If you interrupt treatment with Phesgo

Do not stop your treatment with this medication without first speaking with your doctor.It is essential that you receive all the injection cycle at the right time every three weeks. This helps your medication work as effectively as possible.

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

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

Severe side effects

Inform your doctor or nurse immediately if you notice any of the following severe side effects:

• Heart problems:abnormal heart rhythm or palpitations and symptoms that may include cough, shortness of breath, and swelling (fluid retention) in your legs or arms.
• Injection reactions:these can be mild or more severe and may include feeling unwell, fever, chills, fatigue, headache, loss of appetite, muscle and joint pain, and hot flashes.
• Diarrhea:it can be mild or moderate but may be severe or persistent, with 7 or more bowel movements per day.
• Low white blood cell countshown in a blood test. With or without fever.
• Allergic reactions:swelling of the face and throat, with difficulty breathing, this may be a sign of a severe allergic reaction.

Inform your doctor or nurse immediately if you notice any of the above severe side effects.

Other side effects

Very common (may affect more than 1 in 10 people):

• Hair loss
• Rash
• Inflammation of the digestive tract (e.g. mouth pain)
• Decreased red and white blood cell count, shown in a blood test
• Muscle weakness
• Constipation
• Loss or alteration of taste
• Insomnia
• Sensation of weakness, numbness, tingling, or pins and needles, mainly affecting the feet, legs, and hands
• Runny nose
• Acid reflux
• Dryness, itching, or acne on the skin
• Pain at the injection site, redness (erythema) and hematomas at the injection site
• Nail problems, such as discoloration with white or dark streaks or change in nail color
• Sore throat, redness, pain, or nasal discharge,flu-like symptomsand fever that may lead to ear, nose, or throat infections.
• Increased tear production
• Pain in the body, arms, legs, and abdomen.
• Sharp, stabbing pain, with a sensation of cold or heat.
• Feeling pain from something that should not be painful, such as a light touch
• Loss of balance or coordination.

Common (may affect up to 1 in 10 people):

• Shortness of breath
• Reduced ability to feel changes in temperature or cold
• Loss of balance or coordination.
• Inflammation of the nail bed at its junction with the skin
• A process in which the left side of the heart does not function properly with or without symptoms
• A process in which the heart muscle becomes weaker, which can lead to difficulty breathing
• Allergic reaction that causes a variety of symptoms from mild to severe, such as fever, chills, headache, and difficulty breathing.

Rare (may affect up to 1 in 100 people):

• Chest symptoms such as dry cough or difficulty breathing (possible signs of interstitial lung disease, a disease that damages the tissues around the air sacs in the lungs).
• Fluid around the lungs that causes difficulty breathing

Severe side effects have been observed with intravenous pertuzumab but not with Phesgo, including tumor lysis syndrome (where cancer cells die rapidly). Tumor lysis syndrome may include kidney problems (signs include weakness, shortness of breath, fatigue, and confusion), heart problems (signs include palpitations, a faster or slower heart rate, seizures, vomiting, or diarrhea, and tingling in the mouth, hands, or feet).

If you experience any of the above side effects, talk to your doctor, nurse, or pharmacist.

If you experience any of the symptoms above after stopping treatment with Phesgo, you should consult your doctor immediately and inform them that you have previously been treated with Phesgo..

Some of the side effects you experience may be due to your breast cancer.If you are administered Phesgowithchemotherapy at the same time, some side effects may also be due to these other medications.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse.This includes otherpossible side effects that do not appear in this leaflet.You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and on the vial after CAD. The expiration date is the last day of the month indicated.
• Store in a refrigerator(2°C-8°C).
• Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Once the vial is opened, administer the solution immediately.Do not use this medication if you observe particles in the liquid or have a rare color (see section 6).
• 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 ofPhesgo

The active principles arepertuzumab and trastuzumab.

• Maintenance dose:One vial of 10ml of solution contains 600mg of pertuzumab and 600mg of trastuzumab. Eachml contains 60mg of pertuzumab and 60mg of trastuzumab
• Initial dose:One vial of 15ml of solution contains 1.200mg of pertuzumab and 600mg of trastuzumab. Eachml contains 80mg of pertuzumab and 40mg of trastuzumab.

The other components are:vorhialuronidasa alfa, L-histidina, L-histidina hidrocloruro monohidrato, α,α-trehalosa dihidrato, sacarosa, L-metionina, polisorbato20 and water forinjectable preparations(see section 2 “Phesgo contains sodium”).

Appearance of Phesgo and contents of the packe

Phesgo is an injectablesolution.It is a transparent to slightly opalescent, colourless to pale brown solution contained in a glass vial. Each pack contains a vial with a solution of 10ml or 15ml.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse1

79639Grenzach-Wyhlen

Germany

Responsible for manufacturing

Roche Pharma AG

Emil-Barell-Strasse1

79639Grenzach-Wyhlen

Germany

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

Last update of the 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 summary of product characteristics is available on the website of the European Medicines Agency in all EU/EEA languages.