Package leaflet: Information for the patient
Zeposia 0.23 mg hard capsules
Zeposia 0.46 mg hard capsules
Zeposia 0.92 mg hard capsules
ozanimod
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
1. What Zeposia is and what it is used for
2. What you need to know before you take Zeposia
3. How to take Zeposia
4. Possible side effects
5. How to store Zeposia
6. Contents of the pack and other information
1. What Zeposia is and what it is used for
What Zeposia is
Zeposia contains the active substance ozanimod that belongs to a group of medicines which can reduce the number of white blood cells (lymphocytes) circulating freely round the body.
What Zeposia is used for
Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease.
What multiple sclerosis is
How Zeposia works
Zeposia helps to protect against attacks on the nerves by stopping lymphocytes reaching the brain and spine where they could cause inflammation and damage the nerves protective coating.
2. What you need to know before you take Zeposia
Do not take Zeposia:
Warnings and precautions
Talk to your doctor or pharmacist before taking Zeposia if:
Before you start taking Zeposia, your doctor will check your heart using an electrocardiogram (ECG).
If you have certain heart conditions your doctor will monitor you for at least the first 6 hours after your first dose.
As Zeposia can increase your blood pressure, your doctor may want to check your blood pressure regularly.
While you are taking Zeposia (and for up to 3 months after you stop taking it), you may get infections more easily. Any infection that you already have may get worse. Talk to your doctor if you develop an infection.
During treatment with Zeposia, if you develop disturbance of vision, progressive weakness, clumsiness, memory loss or confusion, or if you think your MS is getting progressively worse, speak to your doctor straight away. These symptoms may be due to PML, a rare brain infection that may lead to severe disability or death.
During treatment with Zeposia, if you develop a severe headache, feel confused, or have seizures (fits) and loss of vision, speak to your doctor straight away. These symptoms may be due to a syndrome called posterior reversible encephalopathy syndrome (PRES).
As Zeposia may increase the risk of skin cancer, you should limit your exposure to sun light and UV (ultraviolet) light, by wearing protective clothing and applying regular sunscreen (with high sun protection factor).
Women of childbearing potential
If used during pregnancy, Zeposia can harm the unborn baby. Before you start treatment with Zeposia, your doctor will explain the risk to you and ask you to do a pregnancy test in order to ensure that you are not pregnant. Your doctor will give you a card which explains why you should not become pregnant while taking Zeposia. It also explains what you should do to avoid becoming pregnant while you are taking Zeposia. You must use effective contraception during treatment and for 3 months after stopping treatment (see section “Pregnancy and breastfeeding”).
If any of these apply to you, tell your doctor or pharmacist before taking Zeposia.
Worsening of MS after stopping Zeposia treatment
Tell your doctor straight away if you think your MS worsens after you have stopped treatment with Zeposia (see “If you stop taking Zeposia” in section 3).
Children and adolescents
Do not give this medicine to children and adolescents aged under 18 years. This is because Zeposia has not been studied in children and adolescents.
Other medicines and Zeposia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Zeposia can affect the way some other medicines work. Also some other medicines can affect the way Zeposia works.
In particular, before taking Zeposia, tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Do not use Zeposia during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception. If Zeposia is used during pregnancy, there is a risk of harm to the unborn baby. If you are a woman who could become pregnant, your doctor will inform you about this risk before you start treatment with Zeposia and will ask you to do a pregnancy test in order to ensure that you are not pregnant. You must use effective contraception while taking Zeposia and for at least 3 months after you stop taking it. Ask your doctor about reliable methods of contraception.
Your doctor will give you a card which explains why you should not become pregnant while taking Zeposia.
If you do become pregnant while taking Zeposia, tell your doctor straight away. Your doctor will decide to stop treatment (see “If you stop taking Zeposia” in section 3). Specialised pre‑natal monitoring will be performed.
Breast-feeding
You should not breast-feed while you are taking Zeposia. Zeposia can pass into breast milk and there is a risk of serious side effects for the baby.
Driving and using machines
Zeposia has no or negligible influence on your ability to drive and use machines.
3. How to take Zeposia
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
When you first start taking Zeposia, you need to take at a low dose and gradually build up, to reduce any effect in slowing your heart rate.
How to take Zeposia
If you take more Zeposia than you should
If you take more Zeposia than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take Zeposia
If you stop taking Zeposia
You will need to start the ‘treatment initiation pack’ again.
Zeposia will stay in your body for up to 3 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur (see “Possible side effects” in section 4).
Tell your doctor straight away if you think your MS worsens after you have stopped treatment with Zeposia.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor or pharmacist immediately if you notice any of the serious side effects listed below:
Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
5. How to store Zeposia
6. Contents of the pack and other information
What Zeposia contains
What Zeposia looks like and contents of the pack
Pack sizes
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol‑Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Celgene Distribution B.V.
Winthontlaan 6 N
3526 KV Utrecht
Netherlands
This leaflet was last revised in September 2021
Other sources of information
Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone. The same information is also available on the following URL : www.zeposia-eu-pil.com.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.