0.23 mg, 0.46 mg, 0.92 mg hard capsules
ozanimod
What Zeposia is and what it is used for
Zeposia contains the active substance ozanimod, which belongs to a group of medicines that can reduce the number of white blood cells ( lymphocytes ) that circulate freely in the body.
Zeposia is used for the following diseases:
- Multiple sclerosis
- Ulcerative colitis
Multiple sclerosis
Zeposia is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) who have active disease.
- Multiple sclerosis (MS) is a disease in which the immune system (the body’s defenses, including white blood cells ) mistakenly attacks the protective sheath that surrounds the nerves in the brain and spinal cord. This prevents the nerves from working properly and can lead to symptoms such as numbness, difficulty walking, and problems with vision and balance.
- In relapsing multiple sclerosis, the attacks on the nerve cells are followed by periods of recovery. When the relapse is over, the symptoms may disappear completely, but some problems may also remain.
Zeposia helps to protect the nerves against attack by the immune system by preventing certain white blood cells from reaching the brain and spinal cord, where they can cause inflammation and damage the protective covering of the nerves.
Ulcerative colitis
Zeposia is used to treat adult patients with moderately to severely active ulcerative colitis.
- Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given Zeposia to reduce the signs and symptoms of your disease.
Zeposia helps to reduce inflammation in ulcerative colitis by preventing certain white blood cells from reaching the intestine.
What you need to know before you take Zeposia
Do not take Zeposia:
- if you are allergic to ozanimod or any of the other ingredients of this medicine (listed in section 6).
- if you have been told that you have a severely weakened immune system
- if you have had a heart attack, angina pectoris, stroke or mini-stroke ( transient ischemic attack, TIA ), or certain types of severe heart failure in the last 6 months
- if you have certain types of irregular or abnormal heart rhythm ( arrhythmia ) – your doctor will check your heart before starting treatment
- if you have a severe infection, e.g. hepatitis or tuberculosis
- if you have cancer
- if you have severe liver problems
- if you are pregnant or may become pregnant (are fertile ) and are not using an effective contraceptive method.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zeposia:
- if you have a slow heart rate or if you are taking or have recently taken medicines that lower your heart rate (eg beta blockers or calcium channel blockers)
- if you have untreated severe breathing problems during sleep (severe sleep apnea )
- if you have liver problems
- if you have an infection
- if you have low levels of a type of white blood cell called lymphocytes
- if you have never had, or are not sure if you have had, chickenpox
- if you have recently been vaccinated or plan to be vaccinated
- if you or others notice worsening of your MS symptoms and any new or unfamiliar symptoms. This may be due to a rare infection of the brain called progressive multifocal leukoencephalopathy (PML).
- if you have ever had visual disturbances or other signs of fluid accumulation in the central part of the retina, the macula (a condition called macular edema)
- if you have an inflammation of the eye ( uveitis )
- if you have diabetes (which can cause eye problems)
- if you have a severe lung disease ( pulmonary fibrosis or chronic obstructive pulmonary disease, COPD).
Before you start taking Zeposia, the doctor will check your heart with an EKG ( electrocardiogram ). If you have certain heart conditions, your doctor will monitor you for at least 6 hours after the first dose.
As Zeposia can raise blood pressure et, your doctor may want to check your blood pressure regularly.
While you are taking Zeposia (and up to three months after you stop taking the medicine) you may be more likely to get an infection. If you already have an infection, it can get worse. Contact a doctor if you get an infection.
If you develop symptoms of visual disturbances, increasing ( progressive ) weakness, clumsiness, memory loss, or confusion, or if you have MS and you think your disease is gradually getting worse during treatment with Zeposia, contact your doctor immediately. These symptoms may be due to a rare infection of the brain called progressive multifocal leukoencephalopathy (PML) which can lead to severe disability or death.
If you experience symptoms such as severe headache, confusion, convulsions (seizures), or loss of vision during treatment with Zeposia, contact your doctor immediately. These symptoms may be due to a condition called posterior reversible encephalopathy syndrome (PRES).
As Zeposia can increase the risk of skin cancer, you should limit exposure to sunlight and UV light (ultraviolet light) by wearing protective clothing and regularly applying sunscreen (with a high sun protection factor).
Fertile women
Zeposia can harm the unborn baby if used during pregnancy. Before you start treatment with Zeposia, your doctor will explain the risk to you and ask you to take a pregnancy test to make sure you are not pregnant. The doctor will give you a card explaining why you should not get pregnant while taking Zeposia. The card also explains what to do to avoid becoming pregnant while taking Zeposia. You must use an effective method of contraception during treatment and for 3 months after the end of treatment (see section “Pregnancy and breast-feeding” ).
If any of these apply to you, talk to your doctor or pharmacist before taking Zeposia.
Exacerbated MS after stopping treatment with Zeposia
Tell your doctor straight away if you think your MS is getting worse after you stop taking Zeposia (see “If you stop taking Zeposia” in section 3).
Children and young people
Do not give this medicine to children or adolescents under 18 years of age. This is because the drug has not been studied in this age group.
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 how other medicines work. Some medicines can also affect how 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:
- medicines that inhibit or alter the immune system (eg ciclosporin)
- medicines used to treat MS such as alemtuzumab, beta interferon, dimethyl fumarate, glatiramer acetate, mitoxantrone, natalizumab, or teriflunomide
- medicines used to treat ulcerative colitis such as azathioprine and 6-mercaptopurine
- gemfibrozil to lower the levels of fats or cholesterol in the blood
- clopidogrel, a medicine used to prevent the blood from clotting (clotting)
- rifampicin, an antibiotic used to treat tuberculosis and other serious infections
- medicines called monoamine oxidase inhibitors to treat depression (eg phenelzine) or Parkinson’s disease (eg selegiline )
- medicines that lower the heart rate (such as beta-blockers or calcium channel blockers)
- certain types of vaccines. Live attenuated vaccines should be avoided during treatment and for 3 months after treatment with Zeposia.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
Do not use Zeposia during pregnancy, if you are planning to have a baby or if you may become pregnant and are not using an effective method of contraception. If Zeposia is used during pregnancy, there is a risk of harm to the unborn child. If you can become pregnant, your doctor will inform you of this risk before you start treatment with Zeposia. You will also be given a pregnancy test to make sure you are not pregnant. You must use an effective method of contraception while taking Zeposia and for at least 3 months after you stop taking it. Consult your doctor about reliable birth control methods.
Your doctor will give you a card explaining why you should not become pregnant while taking Zeposia.
Inform your doctor immediately if you become pregnant during treatment with Zeposia. The doctor will decide to stop treatment (see “If you stop taking Zeposia” in section 3). Special maternity care monitoring will be carried out.
Breast-feeding
- You should not breastfeed while taking Zeposia. Zeposia can pass into breast milk and there is a risk of serious side effects in the baby.
Driving ability and use of machinery
Zeposia has no or negligible effect on the ability to drive and use machines.
Zeposia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost ‘sodium-free’.
How to take Zeposia
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to take
When you start taking Zeposia, you should take a low dose and gradually increase the dose to reduce any reduction in heart rate.
- You will receive a step-up pack to help you start treatment in this way. It contains:
- 4 light gray capsules, containing 0.23 mg ozanimod. You take one of these on days 1 to 4 of treatment.
- 3 light gray and orange colored capsules, containing 0.46 mg ozanimod. You take one of these on days 5, 6, and 7.
- On day 8 and beyond, when you have finished the step-up pack, you will switch to a regular pack of orange capsules containing the recommended dose one of 0.92 mg ozanimod. You will continue regular treatment with one capsule of 0.92 mg daily.
How to take Zeposia
- Zeposia is intended for oral use (taken by mouth).
- Swallow the capsules whole.
- You can take them with or without food.
If you have taken too much Zeposia
If you have taken too much Zeposia, contact a doctor or go to the hospital immediately. Take the medicine package and this leaflet with you.
If you forget to take Zeposia
- If you have forgotten a dose, take it as soon as you remember. If you forget to take a dose throughout the day, skip the missed dose and take the next dose as usual at the time you would normally have taken it.
- Do not take a double dose to make up for a missed dose.
- If you miss one or more doses during the first 14 days after starting treatment with Zeposia, talk to your doctor about how to resume treatment.
If you stop taking Zeposia
- Do not stop taking Zeposia without first talking to your doctor.
- Talk to your doctor about how to resume treatment, if you have stopped taking Zeposia:
- for 1 day or more during the first 14 days of treatment
- for more than seven consecutive days between day 15 and day 28 of treatment
- for more than 14 consecutive days after day 28 of treatment.
You will need to start with the “step-up pack” again.
Zeposia will remain in your body for up to 3 months after you stop taking the medicine. The number of white blood cells ( 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 is getting worse after you stop taking Zeposia.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Contact your doctor or pharmacist immediately if you experience any of the following side effects:
- Common: may affect up to 1 in 10 users
- slow heart rate
- urinary tract infection
- elevated blood pressure
- Uncommon: may affect up to 1 in 100 users
- allergic reaction – signs of this can e.g. skin rash.
- Rare: may affect up to 1 in 1,000 users
- infection of the brain called progressive multifocal leukoencephalopathy (PML) (see section 2).
Other side effects ar
Talk to your doctor or pharmacist if you notice any of the following side effects:
- Very common: may affect more than 1 in 10 users
- infection in the nose or nostrils, nasal cavity, mouth, throat ( pharynx ), or larynx ( larynx ) caused by viruses
- low levels of a type of white blood cell called lymphocytes
- Common: may affect up to 1 in 10 users
- inflammation of the throat ( pharyngitis )
- respiratory infection (signs of infection in the lungs)
- herpes zoster ( shingles )
- herpes simplex or cold sores (oral herpes)
- headache
- blood pressure drop
- swelling, especially of the ankles and feet, due to fluid retention (peripheral edema)
- increased liver enzyme levels in blood tests (a sign of liver problems) or yellow pigmentation of the skin, mucous membranes, or eyes (jaundice)
- affected lung function which can lead to shortness of breath
- Uncommon: may affect up to 1 in 100 users
- blurred vision (macular edema)
How to store Zeposia
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the blister and carton after “EXP”. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
- Do not use this medicine if the packaging is damaged or appears to have been tampered with.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ozanimod.
- Zeposia 0.23 mg hard capsules
- Each hard capsule contains 0.23 mg ozanimod (as hydrochloride).
- Zeposia 0.46 mg hard capsules
- Each hard capsule contains 0.46 mg ozanimod (as hydrochloride).
- Zeposia 0.92 mg hard capsules
- Each hard capsule contains 0.92 mg ozanimod (as hydrochloride).
- Other ingredients are
- Capsule contents:
- Microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, and magnesium stearate.
- Capsule shell:
- Each 0.23 mg capsule contains gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), and red iron oxide (E172).
- Each 0.46 mg capsule contains gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), and red iron oxide (E172).
- Each 0.92 mg capsule contains gelatin, titanium dioxide (E171), iron oxide yellow (E172), and iron oxide red (E172).
- Marking ink: black iron oxide (E172), shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527) and potassium hydroxide (E525)
Appearance and package sizes of the medicine
- Zeposia 0.23 mg hard capsule, 14.3 mm long, has a light gray, opaque (opaque) cap and cap, marked with “OZA” on the cap and “0.23 mg” on the cap in black ink.
- Zeposia 0.46 mg hard capsule, 14.3 mm long, has an orange, opaque cap, and light gray cap, marked with “OZA” on the cap and “0.46 mg” on the cap in black ink.
- Zeposia 0.92 mg hard capsule, 14.3 mm long, has an orange, opaque cap and body, marked with “OZA” on the cap and “0.92 mg” on the cap in black ink.
Package sizes
- “Step-up pack” is a wallet pack containing 7 hard capsules: 4 x 0.23 mg hard capsules and 3 x 0.46 mg hard capsules.
- Packages containing 28 x 0.92 mg hard capsules or 98 x 0.92 mg hard capsules.
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 BV
Orteliuslaan 1000
3528 BD Utrecht
Netherlands