Prospecto: Information for the User

Perjeta 420mg Concentrate for Infusion Solution

pertuzumab

Read the entire prospect carefully before starting to use this medication, because it contains important information for you.

?Keep this prospect, as you may need to read it again.

?If you have any doubts, consult your doctor or nurse.

?If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect.See section 4.

1.What Perjeta is and for what it is used

2.What you need to know before starting to use Perjeta

3.How to use Perjeta

4.Possible adverse effects

5.Storage of Perjeta

6.Contents of the package and additional information

Perjeta contains the active ingredient pertuzumab and is used to treat adult patients with breast cancer when:

?It has been identified that the cancer is of the "HER2-positive" type–your doctor will perform tests to determine if this is the case.

?The cancer has spread to other parts of the body (has metastasized) such as the lungs or liver and has not been previously treated with cancer medications (chemotherapy) or other medications designed to bind to HER2, or if the cancer has recurred in the breast after previous treatment.

?The cancer has not spread to other parts of the body and treatment is to be carried out before surgery (pre-surgical treatment is called neoadjuvant therapy).

?The cancer has not spread to other parts of the body and treatment is to be carried out after surgery (post-surgical treatment is called adjuvant therapy).

In addition to Perjeta, you will also receive trastuzumab and other medications called chemotherapeutics. The information about these medications is described in separate prospectuses. Ask your doctor or nurse for information about these other medications.

How Perjeta works

Perjeta is a type of medication called a "monoclonal antibody" that binds to specific targets within the body and cancer cells.

Perjeta recognizes and binds to a target called the "human epidermal growth factor receptor 2" (HER2). HER2 is found in large quantities on the surface of some cancer cells, where it stimulates their growth. When Perjeta binds to HER2-positive cancer cells, it may slow down or stop the growth of cancer cells, or destroy them.

No use Perjeta:

If you are allergic to pertuzumab or any of the other components of this medicine (listed in section 6).

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

Warnings and precautions

Treatment with Perjeta may affect the heart. Consult your doctor or nurse before Perjeta 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 heart function will be checked before and during treatment with Perjeta, and your doctor will perform tests to check if your heart is working properly.

If you have ever had heart problems during previous treatment with trastuzumab.

If you have ever received a chemotherapy medicine called an anthracycline, such as doxorubicin or epirubicin; these medicines can damage the heart muscle and increase the risk of heart problems with Perjeta.

If any of the above has happened to you (or you are unsure), consult your doctor or nurse before Perjeta is administered to you. See section 4 for more details on the signs of heart problems to watch for.

Infusion reactions

Infusion reactions, allergic reactions, or anaphylactic reactions (more severe than allergic reactions) may occur. Your doctor or nurse will check for any adverse effects during the infusion and in the 30 to 60 minutes following it. If you experience any severe reaction, your doctor will stop treatment with Perjeta. Rarely, patients have died due to anaphylactic reactions during infusion with Perjeta. See section 4 for more details on infusion reactions to watch for during and after infusion.

Fever and low white blood cell count (neutropenia)

When Perjeta is administered with other cancer treatments (trastuzumab and chemotherapy), 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 adverse effect.

Dys diarrhea

Treatment with Perjeta may cause severe diarrhea. Patients over 65 years old have a higher risk of diarrhea compared to patients under 65 years old. Diarrhea is a condition in which the body produces more liquid stools than normal. If you experience severe diarrhea while receiving cancer treatment, your doctor may start an anti-diarrheal treatment and may stop treatment with Perjeta until diarrhea is under control.

Children and adolescents

Perjeta is not recommended for patients under 18 years old because there is no information on its efficacy in this age group.

Older patients

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

Other medicines and Perjeta

Use of Perjeta with other medicines: Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medicine.

Pregnancy and breastfeeding

Before starting treatment, you must inform your doctor or nurse if you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant. You will be informed of the benefits and risks for you and your child of administering Perjeta during pregnancy.

If you become pregnant during treatment with Perjeta or in the 6 months following treatment interruption, inform your doctor immediately.

Ask your doctor if you can breastfeed during or after treatment with Perjeta.

Perjeta may harm the fetus. You must use an effective contraceptive method during treatment with Perjeta and in the 6 months following treatment interruption. Consult your doctor about the best contraceptive method for you.

Driving and operating machinery

Perjeta may have a low effect on your ability to drive or operate machinery. However, if you experience dizziness, infusion reactions, allergic reactions, or anaphylactic reactions, wait until these symptoms disappear before driving or operating machinery.

Sodium

Perjeta contains less than 1 mmol of sodium per dose; it is essentially "sodium-free".

Administration of this medication

A doctor or nurse will administer Perjeta in a hospital or clinic.

?It is administered through a drip in a vein (intravenous infusion) once every three weeks.

?The amount of medication administered and the duration of the infusion will be different during the first dose and subsequent doses.

?The number of infusions administered will depend on how you respond to treatment and whether you are receiving treatment before or after surgery (neoadjuvant or adjuvant therapy) or if your disease has spread.

?Perjeta is administered with other cancer treatments (trastuzumab and chemotherapy).

During the first infusion:

?You will be administered 840 mg of Perjeta over 60 minutes. Your doctor or nurse will check for side effects during the infusion and in the 60 minutes following it.

?You will also be administered trastuzumab and chemotherapy.

During all subsequent infusions, if the first infusion was well tolerated:

?You will be administered 420 mg of Perjeta over 30 to 60 minutes. Your doctor or nurse will check for side effects during the infusion and in the 30 to 60 minutes following it.

?You will also be administered trastuzumab and chemotherapy.

For more information on the administration of trastuzumab and chemotherapy (which may also cause side effects), see the package insert for these products. If you have any questions about these medications, consult your doctor or nurse.

If you forget to use Perjeta

If you forget or miss your appointment to receive Perjeta, schedule another appointment as soon as possible. If it has been 6 weeks or more since your last visit, you will be administered a higher dose of Perjeta, 840 mg.

If you interrupt treatment with Perjeta

Do not stop using this medication without first speaking with your doctor. It is essential that you receive all the recommended doses.

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.

Severe side effects

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

?Severe or persistent diarrhea (7 or more bowel movements per day).

?Decreased number or low count of white blood cells (shown in a blood test), with or without fever, which may increase the risk of infection.

?Reactions to infusion with symptoms that may be mild or more severe and may include nausea, fever, chills, fatigue, headache, loss of appetite, muscle and joint pain, and hot flashes.

?Allergic and anaphylactic reactions (more severe than allergic) with symptoms that may include swelling of the face and throat, with difficulty breathing. Rarely, patients have died due to anaphylactic reactions during Perjeta infusion.

?Cardiac problems (heart failure) with symptoms that may include cough, difficulty breathing, and swelling (fluid retention) in legs or arms.

?Tumor lysis syndrome (a condition that may occur when cancer cells die rapidly, causing changes in blood levels of minerals and metabolites, shown in a blood test). Symptoms may include kidney problems (weakness, difficulty breathing, fatigue, and confusion), cardiac problems (heart palpitations with a faster or slower heart rate), seizures, vomiting or diarrhea, and tingling in the mouth, hands, and feet.

Inform a 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):

?Diarhea

?Hair loss

?Feeling unwell or nauseous

?Feeling tired

?Rash

?Inflammation of the digestive tract (e.g., mouth pain)

?Decreased red blood cell count, shown in a blood test

?Muscle or joint pain, muscle weakness

?Constipation

?Loss of appetite

?Changes in taste

?Fever

?Swelling of ankles or other parts of the body due to excessive water retention

?Insomnia

?Hot flashes

?Feeling of weakness, numbness, tingling, or pins and needles, mainly affecting the feet and legs

?Nosebleeds

?Cough

?Acid reflux

?Dryness, itching, or acne on the skin

?Nail problems

?Sore throat, redness, pain, or nasal discharge, flu-like symptoms, and fever

?Increased tear production

?Fever associated with low levels, which may be hazardous, of a type of white blood cell (neutrophils)

?Pain in the body, arms, legs, and waist

?Difficulty breathing

?Feeling of dizziness

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

?Feeling of numbness, itching, or tingling in the feet or hands; sharp, stabbing pain, with a feeling of cold or heat; feeling pain with something that should not be painful, such as a light touch; reduced ability to feel changes in temperature; loss of balance or coordination

?Inflammation of the nail bed at its junction with the skin

?Infection of the ear, nose, or throat

?A condition in which the left ventricle of the heart is functionally altered with or without symptoms

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 causing damage to the tissues around the air sacs in the lungs)

?Fluid around the lungs causing difficulty breathing

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

Some of the side effects you experience may be due to your breast cancer. If you are administered Perjeta with trastuzumab and chemotherapy 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 or nurse, even if it is a possible side effect not listed in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Perjeta 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 after CAD. The expiration date is the last day of the month indicated.

?Store in refrigerator (2°C - 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 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. This will help protect the environment.

Perjeta Composition

?The active ingredient is pertuzumab. Each vial contains a total of 420mg of pertuzumab at a concentration of 30mg/ml.

?The other components are glacial acetic acid, L-histidine, sucrose, polisorbate 20, and water for injection.

Appearance of Perjeta and packaging contents

Perjeta is a concentrate for solution for infusion. It is a transparent to slightly opalescent (pearly) liquid, colorless to pale yellow. It is supplied in a glass vial containing 14ml of concentrate.

Each package contains one vial.

Marketing Authorization 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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of thisleaflet:

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