Perjeta 420 mg concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Perjeta 420 mg concentrate for solution for infusion

pertuzumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Perjeta is and what it is used for

Perjeta contains the active substance 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 this.
• 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 anticancer medicines (chemotherapy) or other medicines designed to bind to HER2, or if the cancer has recurred in the breast after prior treatment.
• The cancer has not spread to other parts of the body and treatment will be given before surgery (treatment before surgery is called neoadjuvant therapy).
• The cancer has not spread to other parts of the body and treatment will be given after surgery (treatment after surgery is called adjuvant therapy).

In addition to Perjeta, you will also receive trastuzumab and other medicines called chemotherapeutic agents. Information about these medicines is described in separate patient information leaflets. Ask your doctor or nurse to provide you with 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 cancer cells.

Perjeta recognizes and binds to a target called “human epidermal growth factor receptor 2” (HER2). HER2 is found in large amounts on the surface of certain 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 may destroy them.

2. What you need to know before using Perjeta

Do not use Perjeta:

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

If you are unsure, speak with your doctor or nurse before being given Perjeta.

Warnings and precautions

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

• If you have ever had heart problems (such as heart failure, treatment for serious irregular heartbeats, uncontrolled high blood pressure, or a recent heart attack); your heart function will be checked before and during treatment with Perjeta, and your doctor will perform tests to assess whether 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 the 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 apply to you (or if you are unsure), consult your doctor or nurse before receiving Perjeta. See the section "Serious side effects" in section 4 for more details about 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 monitor you for adverse effects during the infusion and for 30 to 60 minutes afterward. If you have a serious reaction, your doctor will stop treatment with Perjeta. Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion. See the section "Serious side effects" in section 4 for more details about infusion reactions to monitor during and after the infusion.

Febrile neutropenia (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 (elevated 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 adverse effect.

Diarrhea

Treatment with Perjeta may 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 condition in which the body produces more liquid stools than normal. If you experience severe diarrhea while receiving your cancer treatment, your doctor may start anti-diarrheal treatment and may temporarily discontinue Perjeta until the diarrhea is under control.

Children and adolescents

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

Elderly patients

Patients over 65 years of age receiving Perjeta are more likely to experience adverse effects such as decreased appetite, reduced number of red blood cells, weight loss, feeling tired, loss or change in 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: Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Before starting treatment, 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 about the benefits and risks to you and your baby of receiving Perjeta during pregnancy.

• Inform your doctor immediately if you become pregnant during treatment with Perjeta or within 6 months after stopping treatment.
• Ask your doctor whether you can breastfeed during or after treatment with Perjeta.

Perjeta may harm the unborn baby. You must use an effective method of contraception during treatment with Perjeta and for 6 months after stopping treatment. Discuss with your doctor the most suitable contraceptive method for you.

Driving and using machines

Perjeta may have a minor 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 have resolved before driving or operating machinery.

Perjeta contains sodium

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

Perjeta contains polysorbate

Perjeta contains polysorbate 20. Each 14 ml vial contains 2.8 mg of polysorbate 20. Polysorbate 20 may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Perjeta

Administration of this medicine

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

• It is given as an intravenous infusion (drip into a vein) once every three weeks.
• The amount of medicine given and the duration of the infusion will differ between the first dose and subsequent doses.
• The number of infusions you receive 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 together with other cancer treatments (trastuzumab and chemotherapy).

During the first infusion:

• You will be given 840 mg of Perjeta over 60 minutes. Your doctor or nurse will monitor you for adverse reactions during the infusion and for 60 minutes afterwards.
• You will also receive trastuzumab and chemotherapy.

During 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 monitor you for adverse reactions during the infusion and for 30 to 60 minutes afterwards.
• You will also receive trastuzumab and chemotherapy.

For more information about the administration of trastuzumab and chemotherapy (which may also cause adverse effects), refer to the package leaflets for these products. If you have any questions about these medicines, consult your doctor or nurse.

If you forget to use Perjeta

If you miss or do not attend 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 given a higher dose of Perjeta (840 mg).

If you interrupt treatment with Perjeta

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

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

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

Serious adverse effects

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

• Severe or persistent diarrhoea (7 or more bowel movements per day).
• Decrease in the number or low levels of white blood cells (shown in a blood test), with or without fever, which may increase the risk of infection.
• Infusion reactions with symptoms that may be mild or more severe and may include feeling unwell (nausea), fever, chills, fatigue, headache, loss of appetite, muscle and joint pain, and hot flushes.
• Allergic and anaphylactic reactions (more severe than allergic reactions) with symptoms that may include swelling of the face and throat, with difficulty breathing. Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion.
• Heart problems (heart failure) with symptoms that may include cough, shortness of breath, and swelling (fluid retention) in arms or legs.
• Tumour 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), heart problems (fluttering of the heart or faster or slower heartbeat), seizures, vomiting or diarrhoea, and tingling around the mouth, hands, and feet.

Tell a doctor or nurse immediately if you experience any of the above adverse effects.

Other adverse effects

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

• Diarrhoea
• 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
• Loss of appetite
• Loss or change in taste
• Fever
• Swelling of ankles or other body parts due to excessive fluid retention
• Inability to sleep
• Hot flushes
• Sensation of weakness, numbness, tingling, or prickling, mainly affecting feet and legs
• Nosebleeds
• Cough
• Heartburn
• Dry, itchy skin or acne
• Nail problems
• Sore throat, redness, pain or runny nose, flu-like symptoms and fever
• Increased tear production
• Fever associated with low levels, which may be dangerous, of a type of white blood cells (neutrophils)
• Body, arm, leg, and back pain
• Difficulty breathing
• Dizziness

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

• Sensation of numbness, itching, or tingling in feet or hands; sharp, shooting pain; feeling cold or heat; pain from stimuli that should not be painful, such as 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
• 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 condition involving 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 Perjeta treatment has been stopped, you must consult your doctor immediately and inform them that you have previously been treated with Perjeta.

Some of the adverse effects you experience may be due to your breast cancer. If Perjeta is administered together with trastuzumab and chemotherapy, some adverse effects may also be due to these other medicines.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perjeta

Perjeta will be stored by healthcare professionals at 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 stated on the container after EXP. The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (2ºC - 8ºC).
• Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Do not use this medicine if you notice particles in the liquid or if it has an unusual colour (see section 6).
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Perjeta

• 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 injections (see section 2 “Perjeta contains polysorbate”).

Appearance of Perjeta and contents of the container

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

Each pack 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

More information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this package leaflet:

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