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Mayzent® (Siponimod): 11 FAQs Inc. Side Effects, Usage, and Approval

Pharmacist-checked answers on usage, side effects and approval of Mayzent® (Siponimod)

Mayzent® is the trade name for the MS drug Siponimod. Mayzent® is prescribed for relapsing multiple sclerosis. It is an immunosuppressive drug from the company Novartis. Mayzent® received approval from the European Medicines Agency (EMA) at the beginning of 2020. Read the answers to the ten most frequently asked questions about Mayzent® (Siponimod) here.

  1. What is Mayzent® (Siponimod)?
  2. How does Mayzent® (Siponimod) work?
  3. What should be considered before treatment with Mayzent® (Siponimod)?
  4. How is Mayzent® (Siponimod) taken?
  5. What should I do if I forget a dose of Mayzent® (Siponimod)?
  6. When was Mayzent® (Siponimod) approved by the EMA?
  7. What are the side effects of Mayzent® (Siponimod)?
  8. Is vaccination possible whilst taking Mayzent® (Siponimod)?
  9. Can I drive whilst taking Mayzent® (Siponimod)?
  10. Can I drink alcohol whilst taking with Mayzent® (Siponimod)?
  11. How does Mayzent® (Siponimod) affect pregnancy and breast-feeding?

1. What is Mayzent® (Siponimod)?

The active ingredient of the medicine Mayzent® is called Siponimod. It is prescribed to adult patients with multiple sclerosis (MS) and is available only by edema prescription. Siponimod is used for the treatment of secondary progressive MS (SPMS). This specific form of progression of the chronic disease is characterized by a continuous progression of symptoms and the occurrence of relapses.

*Mayzent® is available in the form of film-coated tablets of 0.25 mg or 2 mg.

2. How does Mayzent® (Siponimod) work?

The active ingredient in Mayzent® - Siponimod - is the "antagonist" of so-called sphingosine-1-phosphate receptors and sphingosine-5-phosphate receptors (S1P and S5P receptors for short). These receptors are located on the surface of lymphocytes (certain white blood cells). Siponimod now has the task of blocking the activity of these receptors. In this way, the drug prevents lymphocytes from leaving the lymph node and entering the bloodstream.

The role of T cells in MS therapy with Siponimod

T cells are a major component of the immune system. MS destroys the myelin sheath, causing inflammation, which activates the T-cell to cross the disrupted blood brain barrier into the CNS. Siponimod prevents T cells from entering the CNS. What is the purpose? T cells have a pro-inflammatory role. They act when foreign bodies or pathogens enter the body - because these must be fought off. Due to the damaged blood-brain barrier, T-cells therefore move into an area where they should not be and mistakenly do their work there. The inflammation-promoting tasks of T-cells, the myelin sheaths, which should protect the nerves, are increasingly damaged. This leads to MS-symptoms. Siponimod is supposed to prevent this.

What distinguishes Siponimod from other MS drugs

Siponimod attaches to the S1P receptor 5 and is therefore able to bind to helper cells called astrocytes and oligodendrocytes in the CNS. These protect and supply neurons. Compared to other MS drugs with a similar mode of action, Mayzent® has a higher receptor specificity.

3. What should be considered before treatment with Mayzent® (Siponimod)?

Before you start treatment with Siponimod, your doctor will determine the rate at which your body breaks down the active substance: This process is called metabolization. Because Siponimod affects your white blood cells, your doctor will need an up-to-date blood count from you before prescribing Siponimod. You will also need to make sure together that you have active protection against chickenpox before starting treatment - either through a past infection or vaccination. If this protection does not exist, the vaccination will be given about one month before the start of therapy with Mayzent®.

Other health factors that could influence treatment with Siponimod: Impaired vision, inflammation of the eyes, heart disease, diabetes or taking other immunosuppressive medicines.

Please note that this medicinal product information is for your personal education only and is not a substitute for medical or pharmaceutical advice. If you have any questions or feel unsure about treatment with Mayzent®, please be sure to consult a doctor or pharmacist.

When not to take Siponimod

  • If you are allergic to Siponimod or other ingredients of Mayzent®.

  • If you have an immune deficiency, an active cancer or liver weakness

  • If you have had a heart attack or stroke in the past six months.

    1. if you have NYHA level III/IV heart failure
    2. during pregnancy or in women of childbearing age who are not using a reliable method of contraception
  • If you have a history of Progressive Multifocal Leukoencephalopathy or Cryptococcal Meningitis.

4. How is Mayzent® (Siponimod) taken?

Treatment with Siponimod starts with a low dose - this is eventually slowly increased. This is called titration. Titration is to help you keep the effects of Mayzent® on your heart rate low.

  • Day 1: 1 tablet a day (0.25 mg)
  • Day 2: 1 tablet a day (0.25 mg)
  • Day 3: 2 tablets a day (0.25 mg)
  • Day 4: 3 tablets a day (0.25 mg)
  • Day 5: 5 tablets a day (0.25 mg)

  • From day 6: Either 8 tablets (0.25 mg) or 1 tablet (2 mg) a day, in patients with a certain genotype the maintenance dose may be 1 mg a day.

Ultimately, however, your doctor will determine which treatment amount is best for you. Take your daily dose of Mayzent® once a day. Set a fixed, consistent time to take your medicine. You can combine it with a meal and take the tablets before or after eating.

5. What should I do if I forget a dose of Mayzent® (Siponimod)?

Do not take the regular dose of Siponimod (2 mg) within the first six days of treatment if you have forgotten to take it - the titration phase should be followed through without errors so that your body can get used to the new therapy.

If you miss 1 or more doses of Mayzent during the initial dose titration, you need to restart the medication, a missed dose after the initial dose-titration, take Mayzent as soon as you remember.

If you have not taken Mayzent® for four days during the treatment phase, do not start again with the regular dose. After four days of missed doses, you should start the titration again - in this case, consult your doctor.

6. When was Mayzent® (Siponimod) approved by the EMA?

The drug was approved by the European Medicines Agency (EMA) in early 2020 for the treatment of SPMS.

7. What are the side effects of Mayzent® (Siponimod)?

Please note that this list is not exhaustive and this medication information does not replace medical advice. The following side effects have been reported during treatment with Mayzent®. If you feel unwell during therapy with Siponimod or if you feel that the course of your MS is getting worse despite treatment, contact your doctor immediately.

Skin

Therapy with Mayzent® increases your risk of skin cancer. Therefore, avoid direct sunlight and UV light and take protective measures such as applying sunscreen (high sun protection factor!).

Sight

If you suffer from visual disturbances during or one month after treatment with Mayzent®, please seek medical help immediately. Macular oedema (swelling of the center of the retina due to accumulation of fluid) may develop during therapy with Siponimod. If macular edema is detected early, it can be treated well and heal. Signs are:

  • Blurred or distorted vision
  • Loss of vision
  • Faded or altered color perception

Infections

Therapy with Mayzent® increases your risk of infection. You should therefore look out for the following signs:

  • Fever and flu-like sensation
  • Headache and a stiff neck
  • Nausea and / or confusion

Liver

Your liver function may be affected by therapy with Mayzent®. If you notice any of the following signs, call a doctor:

  • Rash
  • Unusual tiredness
  • Abdominal pain
  • Dark discolored urine
  • Yellowing of the eyes or skin
  • Vomiting
  • Unexplained nausea

Neurological/Psychiatric

If you notice any neurological or psychiatric abnormalities, contact your doctor. For example: Seizures, headache, confusion, change in vision.

Other side effects

  • High blood pressure (hypertension)
  • Results of lung function tests show reduced function
  • Swollen hands, ankles, legs or feet
  • Headaches
  • Lack of strength
  • New moles
  • Pain in hands or feet
  • Dizziness
  • Nausea, diarrhea
  • Involuntary shaking (tremor)

8. Is vaccination possible whilst taking Mayzent® (Siponimod)?

Patients are to avoid live attenuated vaccines during and up to 4 weeks after treatment with Mayzent. Examples of live attenuated vaccines include MMR, Chicken pox and yellow fever. Vaccinations may be ineffective if administered during treatment, best to take vaccine 1 week prior to treatment or wait 4 weeks after.

9. Can I drive whilst taking Mayzent® (Siponimod)?

During treatment with Mayzent® , headaches and dizziness may occur, especially at the beginning, as the body needs time to adjust to the drug. Therefore, it is not recommended to operate heavy machinery or a vehicle during the titration phase - especially not on the first day.

10. Can I drink alcohol whilst taking with Mayzent® (Siponimod)?

There are no reports on the connection between therapy with Mayzent® and the consumption of alcohol. In general, however, it is recommended to limit alcohol consumption in patients with multiple sclerosis.

11. How does Mayzent® (Siponimod) affect pregnancy and breast-feeding?

Treatment with Mayzent® also affects the fetus. Therefore, women of childbearing age must be made aware of the risks that therapy with Siponimod entails for pregnancy. During pregnancy, treatment with Mayzent® must be suspended. As Siponimod is still detectable in your body for up to ten days after stopping the drug, reliable contraceptives should be used throughout treatment and for up to ten days after stopping.

It is unknown if Siponimod passes into breastmilk. Discuss your breast feeding options with your healthcare provider.


The content on this page is provided for informational purposes only. If you have any questions or concerns about your treatment, you should talk to your doctor, pharmacist, or healthcare professional. This is particularly important if you are taking multiple medications or have any existing medical conditions.

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