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Mayzent (siponimod)

Mayzent®, manufactured by Novartis AG, is an approved oral medication indicated for relapsing forms of multiple sclerosis (MS). Its approvals include the treatment of clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults. It comes in tablet form in strengths of 0.25 mg and 2 mg and is taken by mouth.1,2

What are the ingredients in Mayzent?

The active ingredient in Mayzent is siponimod.2

How does Mayzent work?

Mayzent is a sphingosine-1-phosphate receptor modulator. It is thought that Mayzent works by reducing lymphocyte migration into the central nervous system (CNS). The active ingredient siponimod, is a sphingosine-1-phosphate (S1P) receptor modulator. It binds to S1P receptors 1 and 5 and blocks the ability of lymphocytes to leave the lymph nodes, lowering the number of lymphocytes in peripheral blood. This produces the anti-inflammatory and re-myelination effects of Mayzent. Lymphocyte counts generally return to the normal range in 90% of patients within a few weeks after stopping treatment.1

What are possible side effects of Mayzent?

Many clinical trials evaluated the safety and efficacy of Mayzent. The most common side effects experienced by those taking Mayzent include:2

  • Headache
  • High blood pressure
  • Increase in liver function test values

This is not an exhaustive list of all potential side effects of Mayzent. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Mayzent, contact your doctor or healthcare provider promptly.

Things to note about Mayzent

Mayzent treatment requires titration. Patients begin with a starting dose and then increase on a predetermined schedule until they reach a prescribed maintenance level dose of medication.

Mayzent may cause macular edema, put you at increased risk for infections, and/or cause a decrease in heart rate.

Before starting Mayzent, your doctor should assess the appropriateness of the treatment and consider any other conditions you may have, and medications you may take. This includes genotype determination, a complete blood count, liver function tests, identification of any active infections, an eye exam, and cardiac evaluation.1

Be sure to discuss with your doctor if you:1,2

  • Have experienced a heart attack, unstable angina, or Class III/IV heart failure in the 6 months prior to initiating treatment
  • Have had a stroke or TIA in the 6 months prior to initiating treatment
  • Have Mobitz type II second-degree or third-degree atrioventricular block, or sick sinus syndrome, unless you have a functioning pacemaker
  • Have an active infection
  • Are pregnant or planning to get pregnant, as Mayzent may cause fetal harm. Contraception should be used during and until 10 days after the last dose
  • Have a history of hypersensitivity to siponimod
  • Take certain medications including anti-neoplastic, immunosuppressive, or immunomodulatory drugs, because use of Mayzent at the same time can have unintended additive effects.

Individuals with the above conditions should be monitored closely while taking Mayzent. It is not recommended for use in patients with a CYP2C9*3/*3 genotype.1

The presence of varicella zoster antibodies should be tested before starting Mayzent. If not present, the varicella zoster (VZV) vaccine should be given prior to treatment. Live attenuated vaccines should be avoided while taking Mayzent and for 4 additional weeks after stopping treatment.1

Mayzent tablets are taken orally with water and can be taken with or without food.

Dosing information

Mayzent comes in two strengths. The 0.25 mg tablet is pale red, and the 2 mg tablet is pale yellow. The recommended cumulative dosage will be either 1 mg or 2 mg per day upon reaching the maintenance level dose.1

Patients with CYP2C9 genotypes *1/*1, *1/*2, or *2/*2

There is a 5-day titration period where dosages are increased until reaching the maintenance dose of 2 mg is reached on Day 6. A starter pack is available for people who will be titrated to the 2 mg maintenance dosage.

Titration for the 2 mg/day maintenance dose

  • Day 1: 0.25 mg (1 x 0.25 mg)
  • Day 2: 0.25 mg (1 x 0.25 mg)
  • Day 3: 0.50 mg (2 x 0.25 mg)
  • Day 4: 0.75 mg (3 x 0.25 mg)
  • Day 5: 1.25 mg (5 x 0.25 mg)
  • Day 6 and thereafter: 2 mg (1 x 2 mg)

Patients with CYP2C9 genotypes *1/*3 or *2/*3

There is a 4-day titration period where dosages are increased until reaching a maintenance dose of 1 mg on Day 5.

Titration for 1mg/day maintenance dose

  • Day 1: 0.25 mg (1 x 0.25 mg)
  • Day 2: 0.25 mg (1 x 0.25 mg)
  • Day 3 0.50 mg (2 x 0.25 mg)
  • Day 4: 0.75 mg (3 x 0.25 mg)
  • Day 5 and thereafter: 1 mg (4 x 0.25 mg)

After completing initial titration, if a maintenance treatment dose is missed for 4 or more consecutive days, restart treatment with Day 1 of the titration plan. Some people may require first-dose monitoring if they have certain pre-existing cardiac conditions. Your doctor will let you know if monitoring is indicated.1

For additional details, read the full prescribing information of Mayzent. Prescribing information is available here.

  1. Mayzent Prescribing Information. Available at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/mayzent.pdf. Accessed 4.9.19.
  2. FDA Approves New Oral Treatment for MS. Available at: https://multiplesclerosis.net/news/fda-approves-mayzent/. Accessed 4.10.19.