Mayzent
Mayzent (siponimod) is a disease-modifying treatment option for relapsing multiple sclerosis (MS) in adults. It can lower the chances of worsening MS and lower the number of MS relapses. Mayzent (siponimod) is a tablet that's taken by mouth. Common side effects include headache, high blood pressure, and falls. Mayzent (siponimod) is currently available as a brand-name only.
What is Mayzent (siponimod)?
What is Mayzent (siponimod) used for?
- Relapsing forms of multiple sclerosis (MS)
How Mayzent (siponimod) works
Mayzent (siponimod) is a sphingosine 1-phosphate (S1P) receptor modulator. It attaches to the S1P receptor protein found on your white blood cells. This blocks white blood cells from leaving your lymph nodes and releasing into the body.
The exact way Mayzent (siponimod) works to treat MS is unknown. But it's thought to lower the number of white blood cells that reaches your nervous system where they can cause nerve damage.
Drug facts
Side effects of Mayzent (siponimod)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (15%)
- High blood pressure (13%)
- Higher liver enzyme levels in the blood (11%)
- Falls (11%)
- Swelling of the arms and legs (edema, 8%)
- Nausea (7%)
- Dizziness (7%)
- Diarrhea (6%)
- Low heart rate (6%)
- Pain in arms or legs (6%)
Mayzent (siponimod) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Infection: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills
- Dangerously slow heart rate: dizziness, tiredness, weakness, confusion, feeling faint, trouble breathing, chest pain
- Liver problems: nausea, vomiting, stomach pain, swelling of your stomach, yellowing of your skin or the whites of your eyes, clay-colored stool
- Skin cancer: skin changes, swollen lymph nodes
- Brain problems: severe headaches, visual changes, difficulty staying awake, weakness on one side of the body, dizziness, trouble speaking, seizure
The following Mayzent (siponimod) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Increase in blood pressure
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Shortness of breath
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dizziness
- Headache
- Nausea
- Swelling of the ankles, hands, or feet
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Pros and cons of Mayzent (siponimod)
Pros
- Works well to slow worsening of MS and lower the number of MS relapses
- Taken by mouth once per day
- Doesn't require frequent visits to the clinic or infusion center to receive your dose
Cons
- Requires several tests before starting (e.g., genetic testing, electrocardiogram, blood tests)
- Might not be a good option for people with heart or serious liver problems
- Not safe during pregnancy
Pharmacist tips for Mayzent (siponimod)
- Take Mayzent (siponimod) at the same time every day with or without food. If it's hurting your stomach, try taking it with food. Swallow the tablets whole; don't split, crush, or chew the tablets.
- When you first start taking Mayzent (siponimod), you might experience a temporary drop in your heart rate. You might feel dizzy or tired, which will typically go away within 24 hours. Your heart rate will typically go back to usual within 10 days of treatment.
- Check your blood pressure at home or at your provider's office regularly. Mayzent (siponimod) can raise your blood pressure. If you notice your blood pressure going up, let your provider know.
- If you have certain heart problems, you might need to be observed by a provider for several hours (or even overnight) after your first dose. Mayzent (siponimod) can affect your heart rate and rhythm. So, your provider will check your heart rate and blood pressure often and perform heart rhythm testing (electrocardiogram or EKG) to make sure the medication is safe for you.
- Make sure to tell your provider about all the medications you're taking before starting Mayzent (siponimod). Mayzent (siponimod) can interact with other medications, which can lead to potentially serious problems. For example, taking Mayzent (siponimod) with beta-blockers can lower your heart rate too much. In addition, taking Mayzent (siponimod) with medications that affect your immune system could raise your risk for serious infections.
- Before getting any vaccines, it's important to let your provider or pharmacist know that you're taking Mayzent (siponimod). Most types of vaccines, including the flu shot, are generally safe to get while you're taking Mayzent (siponimod). But, you should avoid live vaccines because we don't know whether they're safe or work well with Mayzent (siponimod) treatment. If you need to get a live vaccine, speak with your provider beforehand about what you should do.
- Don't stop taking Mayzent (siponimod) without talking to your provider first. Stopping the medication can cause your MS symptoms to come back. Sometimes, the symptoms can be worse than they were before you started the medication. Tell your provider if you have worsening symptoms of MS if you stop Mayzent (siponimod) so they can help you manage your symptoms.
Common questions about Mayzent (siponimod)
A clinical study showed that people who took Mayzent (siponimod) had a 21% lower chance of their MS worsening in 3 months than those who took placebo. Mayzent (siponimod) also lowered the number of MS relapses per year by 55%. Keep in mind that some people took Mayzent (siponimod) for almost 2 years in this study. Also be aware that everyone responds differently to medications and you might not necessarily have these same results. Make sure to follow up with your provider regularly to discuss how well Mayzent (siponimod) is working for you.
Your genetic makeup determines how well Mayzent (siponimod) gets broken down (metabolized) in your body. In people who aren't able to metabolize Mayzent (siponimod) as well, the medication can build up in your body and raise your risk of side effects. For this reason, the target dose of Mayzent (siponimod) is lower to help prevent these side effects from happening. Certain people who have even more trouble metabolizing Mayzent (siponimod) can't take this medication because of the risk of serious side effects from high levels of Mayzent (siponimod). Before starting this medication, it's important that you do genetic testing so your provider can find the right dose for you.
Let your provider or pharmacist know right away if you miss a dose. Mayzent (siponimod) can lower your heart rate, which can be more notable if you take the medication after missing doses. If you miss 1 or more doses of Mayzent (siponimod) during the initial ramp-up period, you'll need to restart the medication at the lowest dose. If you're at your target daily dose and miss a dose, take it as soon as you remember. However, if you miss 4 or more target doses in a row, you’ll need to go back to the starting dose and slowly increase your dose again. This will help your body adjust to the medication again so that it doesn't drop your heart rate too much.
Yes, Mayzent (siponimod) is considered an immunosuppressant. It can lower the number of white blood cells in your body, which can weaken your immune system. This can raise your risk of infections. Look out for symptoms of an infection, such as fever, cough, difficulty breathing, diarrhea, or chills, while you're taking Mayzent (siponimod). Let your provider know if you have an infection.
Mayzent (siponimod) and fingolimod (Gilenya) are both disease-modifying therapies used for relapsing forms of MS and are taken by mouth. People who took Mayzent (siponimod) had 55% fewer MS relapses in a year than those who took placebo. And people who took fingolimod (Gilenya) for 2 years had 54% fewer relapses in a year than those who took placebo. Keep in mind that there haven't been any studies so far making direct comparisons about how well the two medications work. As for side effects, Mayzent (siponimod) might have fewer side effects than fingolimod (Gilenya) because it works on fewer types of S1P receptors. Compare the similarities and differences between the two medications. Then, speak with your provider about which medication is right for you.
No. There haven't been enough human studies about how Mayzent (siponimod) affects pregnancy, but animal studies showed that it caused harm to unborn babies. While what happens in animal studies doesn't always happen in humans, it means that there's a potential risk in humans. If you become pregnant during treatment or within 10 days after stopping Mayzent (siponimod), let your provider know. It's also recommended that you enroll in the MotherToBaby Pregnancy Study in Multiple Sclerosis. This program keeps track of your and your baby's health outcomes. Enroll by visiting their website, calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu.
Mayzent (siponimod) has the potential to harm an unborn baby when it's taken during pregnancy. It's recommended to use birth control to avoid pregnancy during treatment and for at least 10 days after the last dose of Mayzent (siponimod). Talk to your provider about forms of birth control that you can use to prevent pregnancy while taking this medication. Let your provider know if you become pregnant during treatment or within 10 days after stopping Mayzent (siponimod).
Talk to your provider about the risks and benefits of taking Mayzent (siponimod) if you're breastfeeding or planning to breastfeed. It's not known whether Mayzent (siponimod) can get into human breast milk and what effects the medication might have on breastfed babies if it does. Because it's not clear how safe it is, your provider can discuss ways to feed your baby as safely as possible while you're taking Mayzent (siponimod).
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Risks and warnings for Mayzent (siponimod)
Mayzent (siponimod) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
- Risk factors: Active, chronic (long term), or recurrent infection | Having other conditions that raise your risk of infection | Taking medications that weaken your immune system
Mayzent (siponimod) lowers your white blood cell count, which affects your body's ability to fight off infections. This can raise your risk of bacterial, viral, and fungal infections that can sometimes be serious. Make sure you're up-to-date on all of your vaccinations before starting Mayzent (siponimod). If you develop an infection during treatment, your provider will probably ask you to stop taking Mayzent (siponimod) so your body can fight the infection first. Let your provider know if you develop symptoms of an infection, such as fever, cough, difficulty breathing, diarrhea, or chills.
Be aware that you might still be at risk for infections for a few weeks after stopping Mayzent (siponimod). This is because it takes some time for your white blood cell counts to go back to normal after stopping the medication. Continue to look out for symptoms of infection and avoid or limit your time around others who are sick for at least 1 month about stopping Mayzent (siponimod).
Eye problems
- Risk factors: Diabetes | History of eye inflammation (uveitis)
Some people developed an eye condition called macular edema while they were taking Mayzent (siponimod). In studies, this eye problem happened within the first 4 months of treatment. Your provider will examine your eyes before and during treatment. Make sure you let them know if you start to have blurry or worsening vision at any time while you're taking Mayzent (siponimod).
Slow heart rate
- Risk factors: Taking other medications that affect heart rate | History of heart problems | Starting or restarting Mayzent (siponimod)
Mayzent (siponimod) can temporarily cause your heart rate to slow down when you first start treatment. This can happen within 24 hours after each dose of Mayzent (siponimod) during the initial ramp-up period. In studies, heart rate went back up after the sixth day of treatment. You'll typically go back to your usual heart rate within 10 days of starting Mayzent (siponimod). Let your provider know if you have any heart-related conditions or if you're taking medications that also affect heart rate. In certain situations, your provider will monitor your heart for at least 6 hours after your first dose of Mayzent (siponimod). Get medical help if you have symptoms of low heart rate, such as dizziness, tiredness, weakness, feeling faint, trouble breathing, and chest pain, while you're taking Mayzent (siponimod),
Breathing problems
Mayzent (siponimod) can cause breathing problems. This can sometimes happen as early as 3 months after you start the medication. Let your provider know if you have trouble breathing while you're taking Mayzent (siponimod). You might need to do routine breathing tests to check how well your lungs are working.
Liver damage
Mayzent (siponimod) can sometimes cause liver injury. This can happen to anyone, but be sure to tell your provider if you have liver problems before starting treatment. You'll need to do blood work to check your liver health before you start and during Mayzent (siponimod) treatment. If your liver lab results are outside of the normal range, your provider might ask you to stop taking this medication. Typically, your liver health should return to normal after you stop Mayzent (siponimod). Get medical attention right away if you notice symptoms of liver damage, such as loss of appetite, dark urine, stomach pain, or yellowing of the eyes or skin.
Risk of skin cancer
Although rare, Mayzent (siponimod) can raise your risk of getting certain types of skin cancer. You'll probably need regular skin exams while you take Mayzent (siponimod). This helps your provider check for your cancer risk. Make sure to wear protective clothing and sunscreen when you're outside, even on cloudy days. Watch out for new moles or skin damage, and report them to your provider if any appear.
Harm to unborn babies
Based on animal studies, it's possible that Mayzent (siponimod) can harm a unborn baby when it's taken during pregnancy. Women who can have a child should use birth control to avoid pregnancy during treatment and for at least 10 days after the last dose of Mayzent (siponimod). Let your provider know right away if you become pregnant or think you might be pregnant while you're taking Mayzent (siponimod).
Brain problem called posterior reversible encephalopathy syndrome (PRES)
Although rare, there have been reports of a brain problem called posterior reversible encephalopathy syndrome (PRES) in people taking medications like Mayzent (siponimod). So far, there haven’t been reports of PRES in people taking Mayzent (siponimod). But, it's important to be aware of this risk because it can lead to serious complications, such as stroke. Contact your provider right away if you notice a sudden headache, seizures, loss of consciousness, or changes in vision.
Mayzent (siponimod) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.25mg | 12 tablets | $1,032.15 | $86.01 |
| 2mg | 30 tablets | $10,265.34 | $342.18 |
| 1mg | 30 tablets | $10,265.34 | $342.18 |
Typical dosage for Mayzent (siponimod)
Your dose will depend on your genetic makeup, which can affect how well your body can break down the medication. For this reason, you'll need to do genetic testing before starting Mayzent (siponimod) so your provider can choose the appropriate dose for you.
In general, the typical starting dose is 0.25 mg by mouth once daily. Then, your provider will slowly raise your dose over 4 or 5 days to reach the target maintenance dose of 1 mg or 2 mg once daily.
How much does Mayzent (siponimod) cost?
$1,032.15
Mayzent (siponimod) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Mayzent (siponimod) will not be safe for you to take.
- Genetic makeup that prevents Mayzent (siponimod) from being broken down in the body
- Recent heart attack, chest pain, stroke, "mini-stroke", or heart failure within the last 6 months
- Certain heart rate or rhythm problems (e.g., AV block, sick sinus syndrome), unless you have a functioning pacemaker
What are alternatives to Mayzent (siponimod)?
