Polivy ® 30 mg Solution

What Polivy is

Polivy is a cancer medicine that contains the active substance polatuzumab vedotin. It is always used together with other cancer medicines – see below “What other medicines is Polivy given with”.

What is Polivy used for

Polivy is given to treat “diffuse large B - cell lymphoma” that has never been treated before. Polivy is also given to treat “diffuse large B - cell lymphoma” that has come back or has not got better:

• after at least one previous therapy, and
• when you cannot receive a stem cell transplant.

“Diffuse large B - cell lymphoma” is a cancer that comes from “B lymphocytes” also called B - cells. These are a type of blood cells.

How Polivy works

Polivy contains something called a ‘monoclonal antibody’ and a substance that can kill cancer called ‘MMAE’.

• The “monoclonal antibody” part of the medicine attaches to a target on B cells.
• Once attached to B cells, the medicine releases “MMAE” into the B cells and kills them.

What other medicines Polivy is given with

Polivy is given in combination with other cancer medicines:

• rituximab, cyclophosphamide, doxorubicin and prednisone for “diffuse large B - cell lymphoma” that has never been treated before.
• rituximab and bendamustine for “diffuse large B - cell lymphoma” that has come back or has not got better, after at least one previous therapy – and when you cannot receive a stem cell transplant.

You must not be given Polivy

• If you are hypersensitive (allergic) to polatuzumab vedotin or any of other ingredients of Polivy (listed in Section 6).
• if you currently have an active severe infection.

If the above applies to you, you must not be given Polivy. If you are not sure, talk to your medical practitioner or pharmacist before you are given Polivy.

Warnings and precautions

Tell your doctor, health care provider before being given the injection. Special care should be taken with Polivy:

• you have ever had brain or nerve problems such as:
• memory problems
• difficulty moving or sensations in your body such as feeling pins and needles, burning, pain and discomfort even from slight touch
• eyesight problems
• you have ever had liver problems
• you think you have an infection or have had long - lasting or repeated infections such as herpes (see “Infections” in Section 4)
• you are due to have a vaccine or you know you may need to have one in the near future.

If any of the above apply to you (or you are not sure) talk to your doctor or nurse before you are given Polivy.

Pay attention to the following side effects

Polivy can cause some serious side effects that you need to tell your doctor or nurse about straight away. These include:

Do not share medicines prescribed for you with any other person. Polivy is given under the supervision of a doctor experienced in giving such treatments. It is given into a vein, as a drip over 90 minutes.

How much Polivy is given

The dose of this medicine depends on your body weight.

• The usual starting dose is 1,8 mg for each kilogram of your body weight.
• If you have peripheral neuropathy, your doctor may lower your dose.

How often is Polivy given?

• Each cycle lasts 21 days
• You will be given 6 treatment cycles of Polivy in combination with other medicines.

If you miss a dose of Polivy

• If you miss an appointment, make another one straight away.
• For the treatment to be fully effective, it is very important not to miss a dose.

If you stop receiving Polivy

Do not stop treatment with Polivy unless you have discussed this with your doctor. This is because stopping treatment may make your condition worse. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Polivy can have side effects.

Not all side effects reported for Polivy are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Polivy, please consult your healthcare provider for advice.

Serious side effects

Tell your doctor or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment. These may be new symptoms or a change in your current symptoms.

• Infusion - related reactions – your doctor will check for these for 30 - 90 minutes afterwards
• fevers and chills
• rash/hives
• severe infections
• pneumonia (lung infection)
• herpes infection
• viral infections
• upper respiratory tract infection
• skin infection
• urinary tract infection
• unusual bleeding or bruising under the skin
• memory loss, trouble speaking, difficulty walking or problems with your eyesight
• yellowing of skin or whites of your eyes
• breathlessness and difficulty in breathing

Other side effects

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

Very common: may affect more than 1 in 10 people

• pneumonia (lung infection)
• runny nose, sneezing, sore throat and cough (upper respiratory tract infection)
• numbness, tingling, a burning sensation, pain, discomfort or weakness and/or difficulty walking (peripheral neuropathy)
• fever
• cough
• vomiting
• diarrhoea or constipation
• soreness or inflammation of the mouth and/or gut (mucositis)
• feeling sick (nausea)
• abdominal (belly) pain
• feeling tired
• not feeling hungry
• loss of weight
• infusion - related reactions
• common cold
• hair loss
• changes in blood tests:
• low levels of all types of white blood cell (combined)
• low levels of neutrophils (a type of white blood cell) with or without fever
• low level of platelets (a type of blood cell that helps your blood to clot)
• low levels of red blood cells (anaemia)
• low level of potassium in the blood (hypokalaemia)

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

• Store all medicines out of reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.
• Store at or between 2 °C – 8 °C (in a refrigerator)
• Do not freeze.
• Keep the container in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.