0.25 mg / 2 mg film-coated tablets
siponimod

What Mayzent is and what it is used for

What Mayzent is

Mayzent contains the active substance siponimod. Siponimod belongs to a group of medicines called sphingosine 1‑ phosphate (S1P) receptor modulators.

What Mayzent is used for

Mayzent is used to treat adults with secondary progressive multiple sclerosis (SPMS) with active disease. Active disease in SPMS is when there is still relapse or when the results of MRI (magnetic resonance imaging) show signs of inflammation.

How Mayzent works

Mayzent helps protect the central nervous system ( CNS ) from attacks by the body’s immune system. The drug does this by:

  • reduce the ability of certain white blood cells (lymphocytes) to move freely in the body, and
  • prevent these cells from reaching the brain and spinal cord.

This reduces the nerve damage caused by SPMS and Mayzent can thus delay the consequences of the disease (eg aggravated disability, damage to the brain, and relapses ).

What you need to know before taking Mayzent

Do not take Mayzent

  • if you are allergic to siponimod, peanuts or soy or to any of the other ingredients of this medicine (listed in section 6).
  • if you have an immunodeficiency syndrome.
  • if you have ever had progressive multifocal leukoencephalopathy or cryptococcal meningitis .
  • if you have an active cancer.
  • if you have severe liver problems.
  • if you have had a heart attack, unstable angina, stroke or certain types of heart failure in the last 6 months .
  • if you have certain types of irregular or abnormal heartbeat ( arrhythmia ) and you do not have a pacemaker.
  • If blood tests show that your body is unable to break down this medicine sufficiently, do not take it (see “Blood tests before and during treatment” below).
  • if you are pregnant or may become pregnant and do not use an effective method of contraception.

Warnings and cautions

Talk to your doctor before taking Mayzent:

  • if you have an infection or if your immune system is not working properly (for example due to an illness or due to drugs that suppress the immune system, see also “Other medicines and Mayzent”).
  • if you have never had chickenpox and have not been vaccinated against it. You may be at greater risk of complications if you get chickenpox during treatment with Mayzent. Your doctor may want you to be vaccinated against chickenpox before starting treatment.
  • if you are planning to get vaccinated. Your doctor may inform you of this (see “Other medicines and Mayzent”).
  • if you have had, or have vision problems (especially a condition called macular edema) or an infection or inflammation of the eye ( uveitis ). Your doctor may want you to have an examination of your eyes before starting treatment and at regular intervals during treatment. Mayzent can cause swelling in the macula (the area of ​​the eye that allows you to see shapes, colors and other details), so-called macular edema. The risk of getting macular edema is higher if you have had it before or if you have or have had uveitis ( inflammation of the eye).
  • if you have diabetes . The risk of developing macular edema (see above) is higher in patients with diabetes .
  • if you have had any of the following conditions (even if they are being treated): a serious heart disease, irregular or abnormal heart rhythm ( arrhythmia ), stroke or other disease of the blood vessels of the brain, slow heart rhythm, fainting, abnormal heart rhythm (seen on ECG ).
  • if you have severe breathing problems while sleeping ( sleep apnea ).
  • if you have high blood pressure that can not be controlled by medication. Your blood pressure must be checked regularly.
  • if you have had liver problems. Your doctor may want to take blood samples to check your liver function before you receive Mayzent.
  • if you may become pregnant, as siponimod may harm the unborn baby when used during pregnancy. Before starting treatment, your doctor will explain the risk and ask you to take a pregnancy test to make sure you are not pregnant. You must use an effective method of contraception during treatment and up to 10 days after stopping treatment (see “Pregnancy, breast-feeding and fertility”).

If any of the above apply to you, tell your doctor before taking Mayzent.

Please note the following when taking Mayzent

If you get any of the following while taking Mayzent, tell your doctor straight away. It can be serious:

  • if you get an infection . Mayzent reduces the number of white blood cells . White blood cells fight infection and therefore you can get infection more easily when you are treated with Mayzent (and for 3 to 4 weeks after stopping treatment). These can be serious and even life-threatening.
  • if you think your MS is getting worse or if you get any new or unusual symptoms. A very rare infection in the brain, called multifocal leukoencephalopathy (PML), can cause symptoms similar to secondary progressive MS (SPMS). It can occur in patients taking medicines such as Mayzent and other medicines for MS.
  • if you get a fever, feel like you have the flu , or get a headache at the same time as a stiff neck, photosensitivity, nausea or confusion. This may be a symptom of a type of meningitis ( meningitis ) caused by a fungal infection ( cryptococcal meningitis ).
  • if you experience vision changes, e.g. if you see blurred or shadows in the middle of the field of view , if a blind spot develops in the middle of the field of view , or if you have difficulty seeing colors or small details. This may be a symptom of macular edema. In the earlier stages of macular edema, you may not have any symptoms. It can cause partly the same visual symptoms as an MS ( optic neuritis ) attack . Your doctor may want your eyes examined 3 to 4 months after you start treatment and maybe even later. If macular edema is confirmed, your doctor may advise you to stop treatment with Mayzent.
  • if you get symptoms such as sudden headache, confusion, seizures and changes in vision. This may be a symptom of a condition called posterior reversible encephalopathy syndrome (PRES).
  • if you get symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, yellow skin and whites of the eyes or abnormally dark urine. This can be a symptom of liver problems.
  • if you notice any lumps of skin (eg shiny, pearly lumps), spots or open wounds that do not heal within a few weeks.

Slow heart rate ( bradycardia ) and irregular heartbeat

During the first days of treatment, Mayzent can make the heartbeat slower ( bradycardia ). You may not notice anything, or you may become dizzy or tired. The drug can also cause the heart rhythm to become irregular at the beginning of treatment. If there is any indication that you may be at greater risk of having such consequences from your treatment, your doctor may decide that you need to be monitored more closely at the beginning of treatment, first refer you to a cardiologist or choose not to prescribe Mayzent to you.

Sampling before and during treatment

How quickly this drug is broken down (metabolized) in the body varies from patient to patient. Different people, therefore, need different doses. Your doctor will take blood or saliva samples before you start treatment to see which dose is right for you. In rare cases, blood tests may show that you should not take Mayzent at all.

You may also need to submit blood samples before treatment and at regular intervals during treatment to check the number of white blood cells. The doctor may need to stop taking Mayzent or a lower dose of one of the numbers of white blood cells is too low.

Before the treatment starts, blood samples are also taken to check your liver function.

Skin cancer

Skin cancer has been reported in MS patients treated with Mayzent. Talk to your doctor immediately if you notice any lumps of skin (eg shiny, pearly lumps), spots, or open wounds that do not heal within a few weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (eg unusual liver spots) with changes in color, shape, or size over time. Before you start taking Mayzent, a skin examination is required to check if you have any skin lumps. Your doctor will also perform regular skin examinations during your treatment with Mayzent. If you develop problems with your skin, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be examined regularly.

Exposure to the sun and protection from the sun

Mayzent weakens your immune system. This can increase your risk of skin cancer. You should limit your exposure to sunlight and UV rays by

  • wear appropriate protective clothing
  • use sunscreen with a high UV protection factor regularly.

Exacerbation of MS after discontinuation of treatment with Mayzent

Do not stop taking Mayzent or change your dose without talking to your doctor first.

Tell your doctor straight away if you think your MS is getting worse after stopping treatment with Mayzent (see “If you stop taking Mayzent” in section 3).

Elderly patients (65 years or older)

There is no experience with Mayzent in elderly patients. Talk to your doctor if you have any problems.

Children and young people

This medicine should not be given to children and adolescents under 18 years of age as it has not been studied in this age group.

Other drugs and Mayzent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor if you are taking or receiving any of the following medicines or treatments:

  • drugs for irregular heartbeat e.g. amiodarone , procainamide , quinidine or sotalol. Your doctor may decide not to prescribe Mayzent as it may aggravate an already irregular heartbeat.
  • drugs that cause slower heartbeats, e.g. diltiazem or verapamil (these belong to a group of medicines called calcium channel blockers), digoxin or ivabradine . Your doctor may refer you to a cardiologist as your treatment may need to be changed so that Mayzent can reduce your heart rate during the first few days of treatment. If you are taking a beta blocker , e.g. atenolol or propranolol, you may need to pause the beta blocker until you reach your full daily dose of Mayzent.
  • drugs that affect the immune system, e.g. chemotherapy , drugs that suppress the immune system or other drugs for the treatment of MS. Your doctor may ask you to stop taking these medicines to avoid an increased effect on the immune system.
  • vaccines. If you need to be vaccinated, talk to your doctor first. During treatment and for up to 4 weeks after treatment with Mayzent, you should not receive certain types of vaccines (so-called live attenuated vaccines) as they may trigger the infection they are intended to prevent (see section 2).
  • Fluconazole and certain other medicines may increase the concentration of Mayzent in the blood and are not recommended in combination with Mayzent. Your doctor will advise you on this.
  • carbamazepine and certain other medicines may reduce the concentration of Mayzent in the blood and thus impair the effect of the medicine. Your doctor will inform you about this.
  • modafinil and certain other medicines may reduce the concentration of Mayzent in the blood of some patients and thus impair the effect of the medicine. Your doctor will inform you of this if it is relevant to you.
  • phototherapy (light therapy) with UV rays or photochemotherapy, PUVA. UV therapy during treatment with Mayzent may increase your risk of developing skin cancer.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Mayzent during pregnancy, if you are trying to conceive or if you are a woman who may become pregnant and you are not using an effective contraceptive. If Mayzent is used during pregnancy, there is a risk of harm to the unborn baby. If you are a woman who may become pregnant, your doctor will inform you of this risk before starting treatment with Mayzent and ask you to take a pregnancy test to determine that you are not pregnant. You must use an effective method of contraception while taking Mayzent and for at least 10 days after the last dose to avoid becoming pregnant. Ask your doctor about reliable contraceptive methods that you can use during this time.

If you become pregnant while taking Mayzent, tell your doctor immediately. Your doctor will decide to stop your treatment (see “If you stop taking Mayzent” in section 3). Specialized monitoring of your and your baby’s health will take place during pregnancy.

You should not breastfeed while taking Mayzent. Mayzent can pass into breast milk and there is a risk of serious side effects in the baby.

Driving and using machines

Your doctor will tell you if you can drive any vehicles and use machines safely with your illness. Mayzent is not expected to affect your ability to drive or use machines once you have started taking a regular dose. At the beginning of the treatment, however, you may sometimes feel dizzy. Therefore, on the first day of treatment with Mayzent, do not drive or use machines.

Mayzent contains lactose and soy lecithin

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

If you are allergic to peanuts or soy, do not use this medicine.

How to take Mayzent

Treatment with Mayzent is performed under the supervision of a physician experienced in the treatment of MS.

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

How much Mayzent should you take?

When you start treatment

You will receive an escalation pack of the medicine with a gradually increasing dose for 5 days. Follow the instructions on the packaging (see also the table “Escalation packaging”).

The escalator pack is to reduce the risk of side effects on the heart at the beginning of treatment. If there is a risk that your heart may start beating more slowly or irregularly, your doctor may want to monitor you more closely at the beginning of treatment.

Escalator packaging

Day Dose Number of tablets Mayzent 0.25 mg
Day 1 0.25 mg 1 tablet
Day 2 0.25 mg 1 tablet
Day 3 0.5 mg 2 tablets
Day 4 0.75 mg 3 tablets
Day 5 1.25 mg 5 tablets

On day 6 you switch to your usual treatment dose.

For the first 6 days of treatment, it is best to take the tablets in the morning with or without food.

Treatment dose

The recommended dose is 2 mg once daily (one Mayzent 2 mg tablet) with or without food.

Your doctor may instruct you to take only 1 mg once daily (four 0.25 mg tablets) if the blood samples taken before treatment showed that your body breaks down Mayzent slowly (see “Sampling before and during treatment”). If this applies to you, please note that it is still safe for you to take five 0.25 mg tablets on day 5 of the escalation period as indicated above.

Mayzent should be taken by mouth. Take the tablet with water.

If you take more Mayzent than you should

If you have taken too many Mayzent tablets, or if you have accidentally taken your first tablet from the treatment pack instead of the escalator pack, contact your doctor immediately. Your doctor may want to keep you under observation.

If you forget to take Mayzent

If you have missed your dose for one day during the first 6 days of treatment, consult your doctor before taking the next dose. The doctor must prescribe a new escalator package. You must start again on day 1.

If you miss a dose while taking the usual treatment dose (day 7 and onwards), take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. If you forget to take Mayzent 4 days in a row or more, contact your doctor before taking the next dose. Your doctor will need to prescribe a new escalator pack and you will need to start treatment on day 1.

If you stop taking Mayzent

Do not stop taking Mayzent and do not change the dose without talking to your doctor first.

Mayzent remains in the body for up to 10 days after stopping treatment. The number of white blood cells ( lymphocytes ) can remain at a low level for up to 3-4 weeks after you stop taking Mayzent. The side effects described in this leaflet may still occur during this period (see “Possible side effects” in section 4).

If you have to start Mayzent again more than 4 days after stopping the medicine, your doctor will prescribe a new escalator pack and you will have to start again on day 1.

Tell your doctor immediately if you think your MS is getting worse after stopping Mayzent treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Common (may affect up to 1 in 10 people)

  • rash with small fluid-filled blisters, which appear on reddened skin (symptoms of a viral infection called herpes zoster, which can become severe)
  • a type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly lump but can also take other forms
  • fever, sore throat and / or cold sores due to infection (lymphopenia)
  • convulsions, seizures
  • vision changes such as a shadow or blind spot in the middle of the visual field , blurred vision, difficulty seeing colors or details (symptoms of macular edema, a swelling in the yellow spot in the retina at the back of the eye)
  • irregular heartbeat (atrioventricular block)
  • slow heartbeat ( bradycardia ).

If you get any of these symptoms, tell your doctor immediately.

Has been reported (occurs in an unknown number of users)

  • cryptococcal infection (a type of fungal infection), such as cryptococcal meningitis with symptoms such as headache along with neck stiffness, photosensitivity, nausea or confusion.

Another possible side effect is

Other side effects that may occur are listed below. If any of these side effects get worse, tell your doctor or pharmacist.

Very common (may affect more than 1 user in 10)

  • headache
  • high blood pressure ( hypertension ), sometimes with symptoms such as headache and / or dizziness
  • blood tests show elevated liver enzymes.

Common (may affect up to 1 in 10 people)

  • new birthmarks
  • dizziness
  • involuntary tremors in the body ( tremor )
  • diarrhea
  • nausea
  • pain in hands or feet
  • swollen hands, ankles, legs or feet (peripheral edema )
  • weakness ( asthenia )
  • liver function tests show impaired function.

How to store Mayzent

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton/blister after “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is siponimod.

Mayzent 0.25 mg film-coated tablets

  • Each tablet contains 0.25 mg siponimod (as siponimod fumarate)
  • Other ingredients are:Tablet core: Lactose monohydrate (see “Mayzent contains lactose”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), talc, soy lecithin, xanthan gum.

Mayzent 2 mg film-coated tablets

  • Each tablet contains 2 mg of siponimod (as siponimod fumarate),
  • Other ingredients are:Tablet core: Lactose monohydrate (see “Mayzent contains lactose”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soy lecithin, xanthan gum.

What the medicine looks like and contents of the pack

Mayzent 0.25 mg film-coated tablets are light red, round film-coated tablets marked with the company logo on one side and “T” on the other.

Mayzent 2 mg film-coated tablets are light yellow, round film-coated tablets marked with the company logo on one side and “II” on the other.

Mayzent 0.25 mg film-coated tablets are available in the following pack sizes:

  • Escalator packaging in wallet format with 12 tablets, and
  • Packs of 84 or 120 tablets.

Mayzent 2 mg film-coated tablets are supplied in packs of 14, 28, or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharmacéutica, SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
.ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070 United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370

Muhammad Nadeem

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