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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet are: PLGB 00031/0912, PLGB 00031/0919.
Polivy 30 mg and 140 mg powder for concentrate for solution for infusion
Polivy 30 mg powder for concentrate for solution for infusion
Polivy 140 mg powder for concentrate for solution for infusion
polatuzumab vedotin
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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:
“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’.
Polivy is given in combination with other cancer medicines:
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):
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:
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:
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:
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:
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.
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, 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.
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:
Your doctor will check your blood to test your liver function before and regularly during treatment.
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.
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.
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.
The dose of this medicine depends on your body weight.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:
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.
Tell your doctor or nurse if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
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.
Polivy will be stored by the healthcare professionals at the hospital or clinic. The storage details are as follows:
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.
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.
This leaflet was last revised in January 2025
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