Active ingredient
- polatuzumab vedotin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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: EU/1/19/1388/001, EU/1/19/1388/002 .
Polivy 30 mg and 140 mg powder for concentrate for solution for infusion
Package leaflet: Information for the patient
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.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
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
1. What Polivy is and what it is used for
What Polivy is
Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
What Polivy is used for
Polivy is given to treat “diffuse large B-cell lymphoma” that has come back or has not got better with at least one previous therapy and when you cannot receive a stem cell transplant.
Diffuse large B-cell lymphoma is a cancer that develops from B lymphocytes also called B-cells.
These are a type of blood cells.
How Polivy works
The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells. 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 two other cancer medicines called rituximab and bendamustine.
2. What you need to know before you are given Polivy
You must not be given Polivy
If you are not sure, talk to your doctor or nurse before you are given Polivy.
Warnings and precautions
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.
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:
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.
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, in 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.
Children and adolescents
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 Polivy
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.
Contraception (women and men)
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.
Pregnancy
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. You should 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.
Breast-feeding
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.
Fertility
Men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Driving and using machines
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.
Polivy contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How Polivy is given
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.
You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.
Each cycle lasts 21 days.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:
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.
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)
Common (may affect up to 1 in 10 people)
Reporting of side effects
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Polivy
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.
6. Contents of the pack and other information
What Polivy contains
What Polivy looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in December 2020
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
uk-spc-Polivy-clean-201209-30mg-140mg-inf
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