Polivy 140 mg powder for concentrate for solution for infusion

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

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

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”.

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.

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.

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.

• if you are allergic to polatuzumab vedotin or any of the other ingredients of this medicine (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 doctor or nurse before you are given Polivy.

Talk to your doctor or nurse before you are given Polivy if any of the following apply to you (or you are not sure):

• 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.

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

Myelosuppression

Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets. Your doctor will do blood tests to check your blood cell count.

Tell your doctor or nurse straight away if you:

• develop chills or shivering
• have a fever
• have headaches
• feel tired
• feel dizzy
• look pale
• have unusual bleeding, bruising under the skin, bleeding longer than usual after your blood has been drawn, or bleeding from your gums.

Peripheral neuropathy

Tell your doctor or nurse straight away if you have any problems with a change in the sensitivity of your skin, especially in your hands or feet, such as:

• numbness
• tingling
• a burning sensation
• pain
• discomfort or weakness
• difficulty walking.

If you had any of these symptoms before treatment with Polivy, tell your doctor straight away if you notice any changes in them.

If you have symptoms of peripheral neuropathy, your doctor may lower your dose.

Infections

Signs and symptoms of infections vary between individuals, tell your doctor or nurse straight away if you develop symptoms of an infection such as:

• fever
• cough
• chest pain
• tiredness
• painful rash
• sore throat
• burning pain when passing urine
• feeling weak or generally unwell.

Progressive multifocal leukoencephalopathy (PML)

PML is a very rare and life threatening infection in the brain, that has occured in one patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.

Tell your doctor or nurse straight away if you have:

• memory loss
• trouble speaking
• difficulty walking
• problems with your eyesight.

If you had any of these symptoms before treatment with Polivy, tell your doctor straight away if you notice any changes in them. You may need medical treatment.

Tumour lysis syndrome

Some people may develop unusual levels of some substances (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment. This is called “tumour lysis syndrome”. Your doctor, pharmacist or nurse will do blood tests to check for the condition.

Infusion-related reactions

Infusion-related reactions, allergic or anaphylactic (more severe allergic) reactions can happen. Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards. If you get any serious reaction, your doctor may stop treatment with Polivy.

Liver damage

This medicine can cause inflammation or damage to cells in the liver that affect the normal function of the liver. Injured liver cells may leak high amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, which can be detected by blood tests.

In most cases you will not have any symptoms but tell your doctor or nurse straight away if you get:

• yellowing of your skin and of the whites of your eyes (jaundice).

Your doctor will check your blood to test your liver function before and regularly during treatment.

Skin and tissue damage due to extravasation

Extravasation means that Polivy has leaked out of your vein into the tissues around the infusion site. Tell your doctor or nurse immediately if you feel a burning sensation, pain or tenderness at or surrounding the infusion site during the infusion. If Polivy has leaked outside the blood vessel, skin redness, pain, discolouration, swelling, blistering, peeling, or infection of deeper layers of your skin (cellulitis) at or surrounding the infusion site can occur within hours or weeks after the infusion.

This medicine should not be used in children or young people under the age of 18. This is because there is no information about its use in this age group.

Other medicines and vaccines

Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Also tell your doctor or nurse if you are due to have a vaccine or you know you may need to have one in the near future.

If you are a woman of childbearing age, you must use effective contraception during treatment – and for 9 months after the last dose of Polivy.

Men must use contraception during treatment – and for 6 months after the last dose of Polivy.

It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. This is because Polivy can affect your baby’s health.

Do not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs possible risk to the unborn baby.

Do not breast-feed while receiving Polivy – and for at least 3 months after the last dose, because small amount of Polivy may pass into your breast milk.

Men are advised to have sperm samples preserved and stored before treatment with this medicine.

Polivy has a minor influence on your ability to drive, cycle or use any tools or machines.

• If you get infusion-related reactions or nerve damage, or if you feel tired, weak or dizzy (see section 4) do not drive, cycle or use tools or machines until the reaction stops.

See section 4 for more information about side effects.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Polivy 30 mg contains 1.8 mg of polysorbate 20 in each vial. Polivy 140 mg contains 8.4 mg of polysorbate 20 in each vial, equivalent to 1.2 mg/ml. Polysorbate may cause allergic reactions. Tell your doctor if you have any known allergies.

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.

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

• rituximab, cyclophosphamide, doxorubicin and prednisone for “diffuse large B-cell lymphoma” that has never been treated before or,
• 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.

• 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.

Do not stop treatment with Polivy unless you have discussed this with your doctor. This is because stopping treatment may make your condition worse.

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.
• leaking of Polivy out of the vein into surrounding tissues (also called extravasation, see section 2. Skin and tissue damage due to extravasation) (frequency uncommon).

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)

Common: may affect up to 1 in 10 people

• severe infection (sepsis)
• urinary tract infection
• viral infections
• herpes infection
• skin infections
• inflammation of the lungs
• breathlessness and difficulty in breathing
• dizziness
• fluid retention causing swelling in the lower legs or hands (oedema peripheral)
• high level of transaminases in the blood
• joint pain
• itchiness
• chills
• rash
• dry skin
• muscle pain
• changes shown in blood tests:
  • decreased number of all blood cells (pancytopenia)
  • low levels of lymphocytes (a type of white blood cells)
  • low level of phosphate in the blood (hypophosphataemia)
  • low level of calcium in the blood (hypocalcaemia)
  • low level of albumin in the blood (hypoalbuminemia)
  • high level of lipase enzyme in the blood

Uncommon: may affect up to 1 in 100 people

• blurred vision

Tell your doctor or nurse straight away if you notice any of the side effects listed above.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is polatuzumab vedotin.
• Polivy 30 mg: Each vial contains 30 milligrams (mg) polatuzumab vedotin.
• Polivy 140 mg: Each vial contains 140 milligrams (mg) polatuzumab vedotin.
• After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
• The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20. See section “Polivy contains sodium”.

Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.

Each pack of Polivy consists of one vial.