Perjeta

Package leaflet: Information for the user

Perjeta 420 mg concentrate for solution for infusion

pertuzumab
Please read all of this leaflet carefully before you are given this medicine because it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Perjeta is and what it is used for
2. What you need to know before you are given Perjeta
3. How Perjeta is given
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:

• The breast cancer has been identified as "HER-2 positive." Your doctor will perform a test to determine this.
• The cancer has spread to other parts of the body such as the lungs or liver (metastatic) and has not been previously treated with anticancer medicines (chemotherapy) or other medicines designed to target HER2, or 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 given before surgery is known as neoadjuvant therapy).
• The cancer has not spread to other parts of the body and treatment will be given after surgery (treatment given after surgery is known as adjuvant therapy).

In addition to Perjeta, you will also be given chemotherapy medicines. Information about
these medicines is described in separate 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 on cancer cells.
Perjeta recognizes and binds to a target called "human epidermal growth factor receptor 2"
(HER2). HER2 is present in large amounts on the surface of certain cancer cells and stimulates
their growth. When Perjeta binds to HER2-positive cancer cells, it may slow down or stop their
growth or may kill them.

2. What you should know before being given Perjeta

You must not be given Perjeta

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

If you have any doubts, consult your doctor or nurse before being given Perjeta.
Warnings and precautions
Treatment with Perjeta may have effects on the heart. Before you are given Perjeta, speak to your doctor or nurse:

• if you have had heart problems in the past (for example, heart failure, treatment for serious irregularities in heart rhythm, uncontrolled high blood pressure, or recent heart attack). Your heart function will be assessed before and during treatment with Perjeta, and your doctor will perform certain tests to check that your heart is working properly;
• if you have had heart problems in the past during previous treatment with trastuzumab;
• if you have previously been given a chemotherapy medicine from the anthracycline class, such as doxorubicin or epirubicin; these medicines can damage the heart muscle and increase the risk of heart problems with Perjeta.

If any of these conditions apply to you (or if you have any doubts), discuss them with your doctor or
nurse before being given Perjeta. For further details on signs of heart problems to watch for, see section 4 “Serious unwanted effects”.
Infusion reactions
Infusion reactions, allergic reactions, or anaphylactic reactions (a more severe type of allergic reaction) may occur. Your doctor or nurse will monitor you for any adverse effects during the infusion and for 30–60 minutes afterwards. If you experience any serious reaction, your doctor may stop your treatment with Perjeta. Very rarely, patients have died due to anaphylactic reactions during infusion with Perjeta. See section 4 “Serious unwanted effects” for further information on infusion reactions to monitor during and after the infusion.
Febrile neutropenia (low levels of white blood cells with fever)
Administration of Perjeta together with other anticancer treatments (trastuzumab and chemotherapy) may cause a decrease in the number of white blood cells and lead to fever (elevated body temperature). If you have inflammation of the gastrointestinal tract (e.g., mouth sores or diarrhea), you may be more likely to develop 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 stools that are more watery than normal. If you develop severe diarrhea while receiving anticancer treatment, your doctor may start you on antidiarrheal treatment and may temporarily interrupt treatment with Perjeta until the diarrhea is under control.
Use in children and adolescents
Perjeta must not be given to patients under 18 years of age, as there is no information available on its efficacy in this age group.
Use in the elderly
Compared to patients under 65 years of age, patients over 65 years of age treated with Perjeta are more likely to experience adverse effects such as decreased appetite, reduced number of red blood cells, weight loss, feeling of fatigue, loss or change in taste, feeling of weakness, numbness, tingling, or prickling sensations mainly in the feet and legs, and diarrhea.
Other medicines and Perjeta
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Before starting treatment, you must inform your doctor or nurse if you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast milk. Your doctor or nurse will inform you about the benefits and risks to you and your baby associated with treatment with 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 cause harm to the unborn baby. You must use effective contraception during treatment with Perjeta and for 6 months after stopping treatment. Ask your doctor for advice on the most suitable contraceptive method for you.
Driving and using machines
Perjeta may have minor effects on your ability to drive or use machinery. However, if you experience dizziness, any infusion reaction, allergic or anaphylactic reactions, wait until these symptoms have completely resolved before driving or using machinery.
Perjeta contains Sodium
Perjeta contains less than 1 mmol of sodium per dose, i.e., it is essentially sodium-free.
Perjeta contains Polysorbate
Perjeta contains polysorbate 20. This medicine contains 2.8 mg of polysorbate 20 per 14 mL vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Perjeta is administered

Administration of the medicine
Perjeta will be administered to you by a doctor or nurse at a hospital or clinic.

• The medicine is given as an intravenous infusion (a drip into a vein) once every three weeks.
• The dose and duration of infusion will differ for the first dose compared to subsequent doses.
• The number of infusions you will receive depends on your response to treatment and whether you are receiving treatment before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy), or due to advanced disease.
• Perjeta is given in combination with other anticancer treatments (trastuzumab and chemotherapy).

For the first infusion:

• You will receive 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.

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

• You will receive 420 mg of Perjeta over 30–60 minutes. Your doctor or nurse will monitor you for adverse reactions during the infusion and for 30–60 minutes afterwards.
• You will also receive trastuzumab and chemotherapy.

For further information on the administration of trastuzumab and chemotherapy (which may also cause adverse reactions), please read the package leaflet for these medicines. If you have any questions about these medicines, consult your doctor or nurse.

If you forget to take Perjeta
If you miss or skip an appointment for Perjeta administration, schedule another appointment as soon as possible. If six weeks or more have passed since your last visit, you will be given a higher dose of Perjeta (840 mg).

If you stop treatment with Perjeta
Do not stop taking this medicine without first talking to your doctor. It is important that you receive all the infusions prescribed for you.

If you have any questions about the use of this medicine, consult 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
If you notice any of the following side effects, tell your doctor or nurse immediately.

• Severe or persistent diarrhoea (7 or more bowel movements per day).
• A 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 can range from mild to more severe, and may include feeling unwell (nausea), fever, chills, feeling tired, headache, loss of appetite, joint and muscle pain, hot flushes.
• Allergic and anaphylactic reactions (more severe 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 infusion with Perjeta.
• Heart problems (heart failure) with symptoms that may include cough, shortness of breath, and oedema (fluid retention) in the legs or arms.
• Tumour lysis syndrome (a condition that may occur when tumour cells die rapidly, causing changes in blood levels of minerals and metabolites detected by blood tests). Symptoms may include kidney problems (weakness, shortness of breath, fatigue, confusion), heart problems (heart rhythm disturbances with increased or decreased heart rate), seizures, vomiting or diarrhoea, and tingling of the mouth, hands or feet.

If you notice any of the above side effects, tell your doctor or nurse immediately.
Other side effects include:
Very common (affects more than 1 in 10 people):

• Diarrhoea
• Hair loss
• Feeling unwell or nausea
• Feeling tired
• Skin rash
• Inflammation of the digestive tract (mouth inflammation)
• Decrease in red blood cells, detectable by blood test
• Joint or muscle pain, muscle weakness
• Constipation
• Reduced appetite
• Loss or change in taste
• Fever
• Swelling of the ankles or other parts of the body due to excessive fluid retention
• Difficulty sleeping
• Hot flushes
• Feeling of weakness, numbness, tingling or prickling, mainly in the feet and legs
• Nosebleeds
• Cough
• Heartburn
• Dry skin, itching or acne-like rash
• Nail problems
• Sore throat, nasal redness, nasal pain or excessive nasal secretion, flu-like symptoms and fever
• Increased tear production
• Fever associated with dangerously low levels of neutrophils (a type of white blood cell)
• Body, arm, leg and stomach pain
• Shortness of breath
• Dizziness

Common (affects up to 1 in 10 people):

• Sensation of numbness, prickling or tingling in the feet or hands; sharp, shooting or burning pain, or pain triggered by something that should not be painful, such as light touch; reduced ability to perceive changes in temperature (hot or cold); loss of balance or coordination
• Inflammation of the nail bed at the point where the nail and skin meet
• Ear, nose or throat infection
• Condition associated with impaired function of the left ventricle of the heart, with or without symptoms.

Uncommon (affects less than 1 in 100 people):

• Chest symptoms such as dry cough or shortness of breath (possible signs of interstitial lung disease, a condition involving damage to the tissues around the lung alveoli).
• Fluid around the lungs, causing difficulty breathing.

If you experience any of the above symptoms after stopping treatment with Perjeta, consult your doctor immediately and inform them that you have previously been treated with Perjeta.
Some of the side effects listed may be due to breast cancer. If Perjeta is administered together with trastuzumab and chemotherapy, some side effects may also be due to these other medicines.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perjeta

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

• Keep the medicine out of the sight and reach of children.
• Do not use the medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
• Store in the refrigerator (2°C - 8°C).
• Do not freeze.
• Keep the vial in the outer carton to protect the medicine from light.
• Do not use the medicine if you notice particles in the solution or if the colour has changed (see section 6).
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Perjeta contains

• 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”).

Description of the appearance of Perjeta and contents of the pack
Perjeta is a concentrate for solution for infusion. It is a liquid ranging from clear 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 Authorisation 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg UAB “Roche Lietuva”
N.V. Roche S.A. Tel: +370 5 2546799
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11
България
Рош България ЕООД
Тел: +359 2 474 5444
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500
Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99
Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050
Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00
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Roche (Hellas) A.E. Roche Austria GmbH
Ελλάδα Tel: +43 (0) 1 27739
Τηλ: +30 210 61 66 100
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Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88
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Roche Roche Farmacêutica Química, Lda
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Ireland/L-Irlanda Tel: +386 - 1 360 26 00
Tel: +353 (0) 1 469 0700
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Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000
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Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500
Sverige
Roche AB
Tel: +46 (0) 8 726 1200
Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu .