420 mg concentrate for solution for infusion
pertuzumab
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:
- Breast cancer has been identified as being of the “HER2-positive” type. Your doctor will test the type of cancer you have.
- Cancer has spread to other parts of the body such as the lungs and liver (metastasized) and has not previously been treated with cancer drugs ( chemotherapy ) or other drugs that bind to HER2, or if cancer has returned to the breast after previous treatment.
- Cancer has not spread to other parts of the body and treatment will be given before surgery (treatment before surgery is called neoadjuvant treatment).
- Cancer has not spread to other parts of the body and treatment will be given after surgery (treatment after surgery is called adjuvant treatment).
At the same time as Perjeta, you will be treated with trastuzumab and medicines called cytotoxic drugs. Information on these medicines can be found in separate package leaflets. Ask your doctor or nurse for information about these medicines.
How Perjeta works
Perjeta belongs to a group of medicines called monoclonal antibodies, which attach to a specific type of receptor on cancer cells.
Perjeta recognizes and binds to a receptor called “human epidermal growth factor receptor 2” ( HER2 ).
HER2 is found in large amounts on the surface of certain cancer cells ( HER2 -positive cancer) and stimulates cell growth there. When Perjeta binds to HER2 on the cancer cells, the growth of the cancer cells can slow down or stop. It can also lead to the death of cancer cells.
What you need to know before you get 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, ask your doctor or nurse.
Warnings and cautions
Treatment with Perjeta may affect the functions of the heart. Talk to a doctor or nurse before receiving Perjeta:
- If you have previously had heart problems (such as heart failure, treatment for severe irregular heartbeat, uncontrolled high blood pressure, recent heart attack), your heart function will be checked before and during treatment with Perjeta and your doctor will check that your heart is functioning properly.
- if you have had heart problems with trastuzumab before.
- if you have previously been treated with cytotoxic drugs from the group of anthracyclines, such as doxorubicin or epirubicin – these medicines can damage the heart muscle and increase the risk of heart problems during treatment with Perjeta.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Perjeta. See section 4 “Serious side effects” for more information on signs of heart problems.
Infusion
reactions Infusion reactions, allergic or anaphylactic (more severe allergic) reactions may occur. Your doctor or nurse will observe you if you get any side effects during infusion one or for 30-60 minutes after the end of the infusion. If you get a severe reaction, your doctor may stop taking Perjeta. In very rare cases, patients have died due to anaphylactic reactions during infusion with Perjeta. See section 4 “Possible side effects” for more information on infusion reactions that may occur during or after the infusion.
Febrile neutropenia (Small number of white blood cells and fever)
When Perjeta is given with other cancer treatments (trastuzumab and chemotherapy ), the number of white blood cells may decrease and fever (increased body temperature) may occur. If you have inflammation of the digestive tract (eg pain and sores in the mouth or diarrhea), you may be more likely to get this side effect.
Diarrhea
Treatment with Perjeta can cause severe diarrhea. Patients over the age of 65 have a higher risk of diarrhea compared with patients younger than the age of 65. Diarrhea is a condition in which your body produces more watery stools than normal. If you experience severe diarrhea during your cancer treatment, your doctor may start treatment for diarrhea and possibly discontinue your treatment with Perjeta until the diarrhea is under control.
Children and young people
Perjeta should not be used in patients under 18 years of age as there is insufficient information for the treatment of this age group.
Use in the elderly
Patients over the age of 65 who are treated with Perjeta more often experience side effects such as decreased appetite, decreased red blood cell count, weight loss, feeling tired, loss or changed taste, weakness, numbness, tingling or tingling sensation mainly in feet and legs and diarrhea, compared to patients younger than 65 years of age.
Other medicines and Perjeta
Tell 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 tell your doctor or nurse if you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby.
Your doctor will advise you on the benefits and disadvantages, for you and your baby, of taking Perjeta during pregnancy.
- Tell your doctor immediately if you become pregnant during treatment with Perjeta or for 6 months after stopping treatment.
- Ask your doctor if you can breastfeed during or after treatment with Perjeta.
Perjeta can harm the fetus. You should use effective contraception during treatment with Perjeta and for at least 6 months after stopping treatment. Talk to your doctor about which contraceptive is best 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 or anaphylactic reactions, do not drive or use machines until these symptoms have disappeared.
Perjeta contains excipients
Sodium :
Perjeta contains less than 1 mmol sodium per dose, ie it is essentially ‘sodium-free’.
How to get Perjeta
Getting this medicine
A doctor or nurse will give you Perjeta in a hospital or clinic.
- The drug is given as an intravenous infusion (“drip”) directly into a blood vessel every 3 weeks.
- Dosage one and the duration of infusion one will vary between the first infusion one and the subsequent infusions.
- The number of infusions you will receive depends on how you respond to the treatment and whether you receive treatment before or after surgery ( neoadjuvant or adjuvant treatment) or for a disease that has spread.
- Perjeta is given with other cancer medicines (trastuzumab and chemotherapy ).
At first infusion one
- You will receive 840 mg Perjeta for 60 minutes. Your doctor or nurse will observe whether you experience any side effects during infusion one or within 60 minutes after the end of the infusion.
- You will also receive trastuzumab and chemotherapy.
For all of the following infusions, if the first infusion was well tolerated:
- You will receive 420 mg Perjeta as an infusion over 30-60 minutes. Your doctor or nurse will observe you if you get any side effects during infusion one or within 30 to 60 minutes after the end of the infusion.
- You will also receive trastuzumab and chemotherapy.
For more information on trastuzumab dosage and cytotoxic drugs (which may also cause side effects ), see the Package Leaflet for these products. Ask your doctor or nurse if you have any questions about these medicines.
If you forget to use Perjeta
If you have forgotten or missed a treatment visit to get Perjeta, make an appointment as soon as possible. If more than 6 weeks have passed since your last visit, you will receive a higher dose of Perjeta of 840 mg.
If you stop using Perjeta
Do not stop treatment without consulting your doctor first. You must get all the infusions that have been recommended.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell your doctor or nurse immediately if you notice any of the following side effects:
- Very severe or persistent diarrhea (stools 7 or more times a day).
- Decreased number of white blood cells (shown in a blood test), together with or without fever, may increase the risk of infection.
- Infusion reactions with symptoms that can be either mild or more severe and may include nausea, fever, chills, fatigue, headache, loss of appetite, joint, and muscle aches, and hot flashes.
- Allergic and anaphylactic (more severe allergic) reactions with symptoms that may include swelling of the face and respiratory tract, with difficulty breathing. In very rare cases, patients have died due to anaphylactic reactions during infusion with Perjeta.
- Heart problems ( heart failure ) with symptoms that may include coughing, shortness of breath, and swelling (fluid accumulation) in the arms or legs.
- Tumor light syndrome (a condition that can occur when cancer cells die quickly, causing changes in the levels of minerals and residues in the blood, which can be seen with blood tests). Symptoms may include kidney problems (weakness, shortness of breath, fatigue, and confusion), heart problems (heart flutter with a faster or slower heartbeat), cramps, vomiting or diarrhea, and tingling in the mouth, hands, or feet.
Tell your doctor or nurse immediately if you notice any of the above side effects:
Other side effects:
Very common (more than 1 in 10 patients):
- Diarrhea
- Hair loss
- Nausea or fatigue
- Rash
- Inflammation of the digestive tract (eg sore mouth)
- Reduced number of red blood cells – detected by blood tests
- Joint or muscle pain, muscle weakness
- Constipation
- Decreased appetite
- Altered or loss of taste
- Fever
- Swollen ankles or other parts of the body due to water accumulation in the body
- Insomnia
- Pastures
- The feeling of weakness, numbness, tingling, or stinging sensation, especially in the feet and legs
- Nasal blood
- Cough
- Heartburn
- Dry, itchy, or acne-like skin
- Nail problems
- Sore throat, red, sore or runny nose, flu-like symptoms, and fever
- Increased tear production
- Fever is associated with dangerously low levels of a type of white blood cell ( neutrophils )
- Pain in the body, arms, legs, and abdomen
- Respiratory distress
- Dizziness
Common side effects (up to 1 in 10 patients)
- Feeling of numbness, tingling, or tingling in feet or hands; sharp stabbing, throbbing, icy, or burning pain; feelings of pain for something that should not be painful such as light touch; decreased ability to feel changes in heat or cold; impaired balance or coordination.
- Inflammation of the cuticles
- Infection of the ears, nose, or throat
- Decreased function of the left ventricle of the heart, with or without symptoms
Uncommon (up to 1 in 100 patients)
- Chest symptoms such as dry cough or shortness of breath (possible symptoms of interstitial lung disease, a condition with tissue damage around the air sacs in the lungs)
- Fluid around the lungs that causes difficulty breathing
If you experience any of the above symptoms after stopping treatment with Perjeta, contact your doctor immediately and tell them that you have been treated with Perjeta before.
Some of the side effects may be due to your breast cancer. If you are taking Perjeta at the same time as trastuzumab and chemotherapy, some of the side effects may be caused by the other medicines.
How to store Perjeta
Perjeta will be stored by medical staff at the hospital or clinic. The medicinal product must be stored 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. day. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C).
- Do not freeze.
- Keep the vial in the outer carton. Sensitive to light.
- Do not use this medicine if you notice particles in the solution or if the color is incorrect (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. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is pertuzumab. Each vial contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
- The other ingredients are concentrated acetic acid, L-Histidine, sucrose, polysorbate, and water for injections.
What the medicine looks like and the contents of the pack
Perjeta is a concentrated solution for infusion. It is a clear to slightly opalescent, colorless to pale yellow solution. Perjeta is supplied as a glass vial containing 14 ml of concentrate.
Each pack contains one vial.
Marketing Authorization Holder and Manufacturer
Roche Registration GmbH
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Whylen
Germany
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