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Mayzent

Last reviewed on RxList: 2/3/2021
Mayzent Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Mayzent?

Mayzent (siponimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

What Are Side Effects of Mayzent?

Common side effects of Mayzent include:

  • headache,
  • high blood pressure (hypertension),
  • increased transaminase,
  • falls,
  • swelling of extremities,
  • nausea,
  • dizziness,
  • diarrhea,
  • slow heart rate, and
  • pain in extremities

Dosage for Mayzent

Initiate Mayzent with a 5-day titration. The recommended maintenance dosage of Mayzent is 2 mg.

What Drugs, Substances, or Supplements Interact with Mayzent?

Mayzent may interact with:

  • "live" vaccines,
  • cancer medications,
  • immune-modulating drugs,
  • immunosuppressive therapies,
  • anti-arrhythmics,
  • QT prolonging drugs,
  • calcium channel blockers,
  • other drugs that may decrease heart rate,
  • beta-blockers,
  • fluconazole,
  • rifampin,
  • carbamazepine,
  • modafinil, or
  • efavirenz.

Mayzent During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Mayzent is not recommended for use during pregnancy; it may harm a fetus. Women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping Mayzent treatment. It is unknown if Mayzent passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Mayzent (siponimod) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What kind of disease is multiple sclerosis? See Answer
Mayzent Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow or irregular heartbeats;
  • vision problems, blurred vision, eye pain, or having a blind spot or shadows in the center of your vision (vision problems may occur 1 to 4 months after you start taking siponimod);
  • headache, confusion, change in mental status;
  • a seizure;
  • sores in your mouth and throat, cold sores, sores on your genital or anal area;
  • skin changes, unusual moles that change in color or size;
  • shortness of breath;
  • liver problems--nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
  • symptoms of meningitis--fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.

Common side effects may include:

  • headache;
  • increased blood pressure; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mayzent (Siponimod Tablets)

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow
Mayzent Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

  • Infections [see WARNINGS AND PRECAUTIONS]
  • Macular Edema [see WARNINGS AND PRECAUTIONS]
  • Bradyarrhythmia and Atrioventricular Conduction Delays [see WARNINGS AND PRECAUTIONS]
  • Respiratory Effects [see WARNINGS AND PRECAUTIONS]
  • Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Increased Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Fetal Risk [see WARNINGS AND PRECAUTIONS]
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see WARNINGS AND PRECAUTIONS]
  • Severe Increase in Disability After Stopping MAYZENT [see WARNINGS AND PRECAUTIONS]
  • Immune System Effects After Stopping MAYZENT [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 1737 MS patients have received MAYZENT at doses of at least 2 mg daily. These patients were included in Study 1 [see Clinical Studies] and in a Phase 2 placebo-controlled study in patients with MS. In Study 1, 67% of MAYZENT-treated patients completed the double-blind part of the study, compared to 59.0% of patients receiving placebo. Adverse events led to discontinuation of treatment in 8.5% of MAYZENT-treated patients, compared to 5.1% of patients receiving placebo. The most common adverse reactions (incidence at least 10%) in MAYZENT-treated patients in Study 1 were headache, hypertension, and transaminase increases.

Table 3 lists adverse reactions that occurred in at least 5% of MAYZENT-treated patients and at a rate at least 1% higher than in patients receiving placebo.

Table 3 Adverse Reactions Reported in Study 1 (Occurring in at Least 5% of MAYZENT-Treated Patients and at a Rate at Least 1% Higher Than in Patients Receiving Placebo)

Adverse ReactionMAYZENT 2 mg
(N = 1099)
%
Placebo
(N = 546)
%
Headachea1514
Hypertensionb139
Transaminase increasedc113
Falls1110
Edema peripherald84
Nausea74
Dizziness75
Diarrhea64
Bradycardiae63
Pain in extremityf64
Terms were combined as follows:
aheadache, tension headache, sinus headache, cervicogenic headache, drug withdrawal headache, and procedural headache.
bhypertension, blood pressure increased, blood pressure systolic increased, essential hypertension, blood pressure diastolic increased.
calanine aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, liver function test increased, hepatic function abnormal, liver function test abnormal, transaminases increased.
dedema peripheral, joint swelling, fluid retention, swelling face.
ebradycardia, sinus bradycardia, heart rate decreased.
fpain in extremity and limb discomfort.

The following adverse reactions have occurred in less than 5% of MAYZENT-treated patients but at a rate at least 1% higher than in patients receiving placebo: herpes zoster, lymphopenia, seizure, tremor, macular edema, AV block (1st and 2nd degree), asthenia, and pulmonary function test decreased [see WARNINGS AND PRECAUTIONS].

Seizures

In Study 1, cases of seizures were reported in 1.7% of MAYZENT-treated patients, compared to 0.4% in patients receiving placebo. It is not known whether these events were related to the effects of MS, to MAYZENT, or to a combination of both.

Respiratory Effects

Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) were observed in patients treated with MAYZENT [see WARNINGS AND PRECAUTIONS].

Vascular Events

Vascular events, including ischemic strokes, pulmonary embolisms, and myocardial infarctions, were reported in 3.0% of MAYZENT-treated patients compared to 2.6% of patients receiving placebo. Some of these events were fatal. Physicians and patients should remain alert for the development of vascular events throughout treatment, even in the absence of previous vascular symptoms. Patients should be informed about the symptoms of cardiac or cerebral ischemia caused by vascular events and the steps to take if they occur.

Malignancies

Malignancies such as malignant melanoma in situ and seminoma were reported in MAYZENT-treated patients in Study 1. An increased risk of cutaneous malignancies has been reported in association with another S1P modulator.

Read the entire FDA prescribing information for Mayzent (Siponimod Tablets)

Related Resources for Mayzent

© Mayzent Patient Information is supplied by Cerner Multum, Inc. and Mayzent Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

What kind of disease is multiple sclerosis? See Answer

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