PERJETA 420 mg CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Perjeta 420mg concentrate for solution for infusion

pertuzumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

? If you have any further questions, ask your doctor or nurse.

? If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Perjeta and what is it used for
2. What you need to know before you use Perjeta
3. How to use Perjeta
4. Possible side effects
5. Storage of Perjeta
6. Contents of the pack and other information

1. What is Perjeta and what is it used for

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

? The cancer has been identified as being of the "HER2-positive" type – your doctor will do tests to find out 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 medicines (chemotherapy) or other medicines designed to bind to HER2, or if the cancer has come back in the breast after previous treatment.

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

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

In addition to Perjeta, you will also receive trastuzumab and other medicines called chemotherapeutics. Information about these medicines is described in separate package leaflets. Ask your doctor or nurse to give you information about these other medicines.

How Perjeta works

Perjeta is a type of medicine called a "monoclonal antibody" that binds to specific targets in the body and to 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 cancer cells, it can slow down or stop the growth of the cancer cells, or destroy them.

2. What you need to know before you use Perjeta

Do not use Perjeta:

? If you are allergic to pertuzumab 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 Perjeta.

Warnings and precautions

Treatment with Perjeta may affect the heart. Talk to your doctor or nurse before you are given Perjeta:

? If you have ever had heart problems (such as heart failure, treatment for 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 do 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 from a group called anthracyclines, 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 not sure), talk to your doctor or nurse before you are given Perjeta. See section 4 for more details on the signs of heart problems to look out for.

Infusion reactions

Infusion reactions, allergic reactions or anaphylactic reactions (more severe than allergic reactions) can occur. Your doctor or nurse will check for side effects during and for 30 to 60 minutes after the infusion. If you have a severe reaction, your doctor will stop treatment with Perjeta. Very rarely, patients have died due to anaphylactic reactions during infusion with Perjeta. See section 4 for more details on the infusion reactions to look out for during and after the infusion.

Neutropenic fever (low white blood cell count and fever)

When Perjeta is given with other cancer treatments (trastuzumab and chemotherapy), the number of white blood cells in the blood may decrease and fever (increase in temperature) 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.

Diarrhea

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

Children and adolescents

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

Elderly patients

Patients over 65 years of age who are treated with Perjeta are more likely to experience side effects such as decreased appetite, decrease in 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 of age.

Other medicines and Perjeta

Using Perjeta with other medicines: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or plan to become pregnant. You will be informed of the benefits and risks to you and your baby of Perjeta administration during pregnancy.

? Tell your doctor immediately if you become pregnant during treatment with Perjeta or in the 6 months following the end of treatment.

? Ask your doctor if you can breast-feed during or after treatment with Perjeta.

Perjeta may harm the fetus. You must use an effective method of contraception during treatment with Perjeta and for 6 months after the end of treatment. Consult your doctor about the best contraceptive method for you.

Driving and using machines

Perjeta may have a minor effect on your ability to drive or use machines. However, if you experience dizziness, infusion reactions, allergic reactions or anaphylactic reactions, wait until they have resolved before driving or using machines.

Sodium

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

3. How to use Perjeta

Administration of this medicine

A doctor or nurse will give you Perjeta in a hospital or clinic.

? It is given by drip into a vein (intravenous infusion) once every three weeks.

? The amount of medicine you are given and the duration of the infusion will be different during the first dose and subsequent doses.

? The number of infusions you are given 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 given with other cancer treatments (trastuzumab and chemotherapy).

For the first infusion:

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

? You will also be given trastuzumab and chemotherapy.

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

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

? You will also be given trastuzumab and chemotherapy.

For more information on the administration of trastuzumab and chemotherapy (which can also cause side effects), see the package leaflet for these products. If you have questions about these medicines, ask your doctor or nurse.

If you miss a dose of Perjeta

If you miss or do not attend a scheduled dose of Perjeta, make another appointment as soon as possible. If it has been 6 weeks or more since your last visit, you will be given a higher dose of Perjeta of 840 mg.

If you stop treatment with Perjeta

Do not stop using this medicine without talking to your doctor first. It is important that you are given all the doses that are recommended.

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.

Serious side effects

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

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

? Decrease in white blood cell count or low white blood cell count (shown in a blood test), with or without fever, which can increase the risk of infection.

? Infusion reactions with symptoms that can be mild or more severe and can include feeling unwell (nausea), fever, chills, fatigue, headache, loss of appetite, muscle and joint pain, and flushing.

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

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

? Tumor lysis syndrome (a condition that can occur when cancer cells die quickly, causing changes in blood mineral and metabolite levels, shown in a blood test). Symptoms can include kidney problems (weakness, difficulty breathing, fatigue, and confusion), heart problems (rapid or slow heartbeat), seizures, vomiting or diarrhea, and tingling in the mouth, hands, and feet.

Tell a doctor or nurse immediately if you notice any of the above side effects.

Other side effects

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

? Diarrhea

? Hair loss

? Feeling unwell or sick

? Feeling tired

? Rash

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

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

? Joint or muscle pain, muscle weakness

? Constipation

? Decreased appetite

? Loss or alteration of taste

? Fever

? Swelling of ankles or other parts of the body due to excess fluid retention

? Difficulty sleeping

? Flushing

? Feeling weak, numbness, tingling or itching, mainly in the feet and legs

? Nosebleeds

? Cough

? Indigestion

? Dryness, itching or acne of the skin

? Nail problems

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

? Increased tear production

? Fever associated with low levels, which can be life-threatening, of a type of white blood cell (neutrophils)

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

? Difficulty breathing

? Feeling dizzy

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

? Feeling numb, itchy or tingling in the feet or hands; sharp, stabbing, cold or hot pain; feeling pain from something that should not be painful, such as light touch; decreased ability to feel changes in temperature; loss of balance or coordination

? Inflammation of the nail bed where the nail meets the skin

? Ear, nose or throat infection

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

Uncommon (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 tissue around the air sacs in the lungs)

? Fluid around the lungs that causes difficulty breathing

If you experience any of the above symptoms after your treatment with Perjeta has been stopped, you should contact your doctor immediately and inform them that you have been previously treated with Perjeta.

Some of the side effects you experience may be due to your breast cancer. If you are given Perjeta with trastuzumab and chemotherapy at the same time, some side effects may also be due to these other medicines.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Perjeta

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

? Keep this medicine out of the sight and reach of children.

? Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

? Store in a refrigerator (2°C - 8°C).

? Do not freeze.

? Keep the vial in the outer carton to protect it from light.

? Do not use this medicine if you notice particles in the liquid or it has an unusual color (see section 6).

? Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Perjeta composition

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

The other components are glacial acetic acid, L-histidine, sucrose, polysorbate 20, and water for injectable preparations.

Appearance of Perjeta and container contents

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

Each container 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:

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