Phesgo - Pertuzumab / Trastuzumab uses, dose and side effects

Pertuzumab and trastuzumab are monoclonal antibodies. They are designed to attach to a specific site on the cells, called “human epidermal growth factor receptor 2” ( HER2 ).
HER2 is found in large amounts on the surface of certain cancer cells and stimulates cell growth.
By attaching HER2 to the cancer cells, pertuzumab and trastuzumab can slow or kill their growth.

Physio is available in two different strengths. See section 6 for further information.

Physio is used to treat adult patients with HER2 -positive breast cancer – your doctor will examine you for this. The drug can be used then:

cancer has spread to other parts of the body such as the lungs and liver (metastasized) or cancer has returned to the breast and the area around the breast but cannot be operated on
and no treatment with cancer drugs ( chemotherapy ) or other drugs designed to attach to HER2 has been given.
cancer has not spread to other parts of the body and treatment should be given either before surgery ( neoadjuvant treatment) or after surgery ( adjuvant treatment).

As part of your treatment with Phesgo, you will also receive other medicines called chemotherapy. Information on these medicines can be found in separate package leaflets. Ask your doctor, pharmacist, or nurse for information about these other medicines.

What You Need to Know Before You Get Phesgo

You should not get Phesgo:

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

If you are not sure, talk to your doctor, pharmacist, or nurse before taking Phesgo.

Warnings and cautions

Heart problems

Treatment with Phesgo can affect the heart. Talk to your doctor or nurse before receiving Phesgo about:

you have previously had heart problems (such as heart failure, treatment for severe irregular heartbeat, uncontrolled high blood pressure, recent myocardial infarction). Your doctor will check that your heart is functioning properly before and during treatment with Phesgo.
you have had heart problems with previous treatment with any medicine that contains trastuzumab.
you have previously been treated with chemotherapy from a group of cancer medicines called anthracyclines, such as doxorubicin or epirubicin – these medicines can damage the heart muscle and increase the risk of heart problems when treated with Phesgo.
you have previously received radiation to the chest area, as it may increase the risk of heart problems.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Phesgo. See section 4 “Serious side effects” for more information on signs of heart problems.

Injection reactions

Injection reactions may occur. They are allergic reactions and can be serious.

If you get a severe reaction, your doctor may stop taking Phesgo. See section 4 “Serious side effects” for more information on injection reactions that may occur during or after injection.

Your doctor or nurse will observe you and check if you get any side effects during the injection and:

for another 30 minutes after the first injection one with Phesgo.
for a further 15 minutes after the subsequent injections of Phesgo.

If you get a severe reaction, your doctor may stop taking Phesgo.

Low white blood cell count and fever (Febrile neutropenia )

When Phesgo is given chemotherapy, the number of white blood cells may decrease and fever may occur. If you have any inflammation in the digestive tract (eg sores in the mouth or diarrhea), you may be more likely to get this side effect. If the fever persists for several days, it may be a sign of worsening your condition and you should contact your doctor.

Diarrhea

Treatment with Phesgo can cause severe diarrhea. Patients over the age of 65 have a higher risk of developing diarrhea, compared with patients under the age of 65. If you experience severe diarrhea during your cancer treatment, your doctor may prescribe you medicines for diarrhea. Your doctor may also stop your treatment with Phesgo until the diarrhea is under control.

Children and young people

Pesto should not be used in patients under 18 years of age, as there is no information on the treatment for this age group.

Elderly patients over 65 years

Patients over the age of 65 are more likely to experience side effects such as decreased appetite, decreased red blood cell count, weight loss, fatigue, lost or altered taste, weakness, numbness, stinging or tingling sensation (mainly in the feet and legs) and diarrhea, compared to younger patients. than 65 years.

Other drugs and Phesgo

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

Before starting treatment, you must tell your doctor, pharmacist, 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 talk to you about the benefits and disadvantages, for you and your baby, of taking Phesgo during pregnancy.

Tell your doctor immediately if you become pregnant during treatment with Phesgo or for 7 months after stopping treatment. Phesgo can harm the unborn baby. You should use effective contraception during treatment with Phesgo and for 7 months after stopping treatment.
Discuss with your doctor if you can breastfeed during or after treatment with Phesgo.

Driving and using machines

Phesgo may affect your ability to drive or use machines. If you get symptoms such as dizziness, chills, fever, or any injection reaction or allergic reaction (as described in section 4), do not drive or use machines until these symptoms have disappeared.

Phesgo contains sodium

Phesgo contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

How to get Phesgo

Phesgo will be given to you by a doctor or nurse at a hospital or clinic. Phesgo is given as an injection under the skin ( subcutaneous injection ).

The injection will be given every three weeks.
You will receive an injection first in one thigh than in the other. You will continue to receive the injections alternately between one and the other thigh.
Your doctor or nurse will make sure that each injection is given at a new site (at least 2.5 cm from a previous injection site) and where the skin is not red, bruised, tender, or hard.
Other injection sites should be used for other drugs.

Start of treatment ( loading dose )

Phesgo 1200 mg / 600 mg will be given under your skin for 8 minutes. Your doctor or nurse will check if you get any side effects during the injection and for 30 minutes afterward.
You will also receive chemotherapy.

Subsequent injections (maintenance doses), which will be given if the first injection did not cause any serious side effects:

Phesgo 600 mg / 600 mg will be given under your skin for 5 minutes. Your doctor or nurse will check if you get any side effects during the injection and for 15 minutes afterward.
You will also receive chemotherapy depending on your doctor’s prescription.
The number of injections you will receive depends on:
- how to respond to treatment
- if you are receiving treatment before or after surgery or if the disease has spread.

For further information on charge dose and maintenance dose, see section 6.

For more information on chemotherapy dosage ( which may also cause side effects ), read the package leaflet for these medicines. If you have any further questions, ask your doctor, pharmacist, or nurse.

If you forget to use Phesgo

If you miss your booked time to get Phesgo, a new appointment should be booked as soon as possible. Depending on the length of time between two visits, your doctor will decide which strength of Phesgo to give you.

If you stop using Phesgo

Do not stop your treatment with this medicine without talking to your doctor first. You must get all your injections in the treatment regimen at the right time every three weeks. This helps the drug to work as well as possible.

If you have any further questions on the use of this product, ask your doctor, pharmacist, 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:

Heart problems: slower or faster heartbeat than usual, or heart palpitations and symptoms such as cough, shortness of breath, and swelling (fluid accumulation) in the arms or legs.
Injection-related reactions: may be mild or more severe and may include nausea, fever, chills, fatigue, headache, loss of appetite, joint, and muscle aches, and hot flashes.
Diarrhea: may be mild or moderate, but may also be very severe (watery stools 7 or more times a day) or persistent.
Decreased white blood cell count ( detected by a blood test): may occur with or without fever.
Allergic reactions: swelling of the face and throat/airways, difficulty breathing; maybe a sign of a severe allergic reaction.
Tumor light syndrome (a condition that can occur when cancer cells die quickly). Symptoms may include:
- kidney problems (signs include weakness, shortness of breath, fatigue, and confusion)
- heart problems (signs include palpitations with a faster or slower heartbeat)
- cramps, vomiting, or diarrhea as well as 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 ar

Very common (more than 1 in 10 patients):

Hair loss
Rash
Inflammation of the digestive tract (eg sore mouth)
Reduced number of red blood cells (detected by a blood test)
Muscle weakness
Constipation
Altered or loss of taste
Insomnia
Feeling of weakness, numbness, tingling, or stinging sensation, especially in the feet and legs
Nasal blood
Heartburn
Dry, itchy, or acne-like skin
Injection site pain, reddening of the skin, and bruising at the injection site
Nail problems, such as discoloration similar to white or dark streaks or altered nail color
Sore throat, red, sore or runny nose, flu-like symptoms, and fever, which can lead to infection in the ears, nose, or throat
Increased tear production
Pain in the body, arms, legs, and abdomen

Common side effects (up to 1 in 10 patients) :

The feeling of numbness, tingling, or tingling in the 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 temperature changes
Impaired balance or coordination
Inflammation of the nail bed where the nail and skin meet
Conditions where the left part of the heart does not work properly, 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 get any of the side effects listed above, talk to your doctor, nurse, or pharmacist.

If you get any of the above symptoms after stopping treatment with Phesgo, contact your doctor immediately. Tell them you’ve been treated to Phesgo before.

Some of the side effects may be due to your breast cancer. If you are receiving Phesgo at the same time as chemotherapy, some of the side effects may be caused by the other medicines.

How to store Phesgo

Phesgo will be stored by healthcare professionals 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. data and on the vial after EXP. 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.
When the vial is opened, the solution should be used immediately. The drug should not be used if the solution contains visible particles 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 package and other information

What Phesgo contains

The active substances are pertuzumab and trastuzumab.

Maintenance dose: One vial of 10 ml solution contains 600 mg pertuzumab and 600 mg trastuzumab. Each ml contains 60 mg pertuzumab and 60 mg trastuzumab.
Charge dose: One 15 ml solution for injection contains 1200 mg pertuzumab and 600 mg trastuzumab. Each ml contains 80 mg of pertuzumab and 40 mg of trastuzumab.

The other ingredients are hyaluronidase alfa, L-histidine, L ‑ histidine hydrochloride monohydrate, α, α-trehalose dihydrate, sucrose, L-methionine, polysorbate 20, and water for injections (see section 2 “Phesgo contains sodium”).

Phesgo appearance and pack size

Phesgo is a solution for injection. It is clear to slightly opalescent, colorless to the slightly brown solution provided in glass vials. Each pack contains a vial of either 10 ml or 15 ml solution.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG