TM Owner Novartis
Mayzent 2mg Tablet
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Indications & Clinical Uses
- Mayzent 2 mg film-coated tablets contain siponimod, formulated as a siponimod fumaric acid co-crystal, a sphingosine 1-phosphate (S1P) receptor modulator used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- In the European Union, Mayzent's approved use is narrower: it is authorised only for adults with secondary progressive MS who have active disease shown by relapses or inflammatory imaging findings.
- Before starting Mayzent, everyone needs a CYP2C9 genotype test, since the dose depends on the result and Mayzent is not given at all to people with the CYP2C9*3/*3 genotype.
- The usual maintenance dose is 2 mg once daily, reached after a short titration on lower-strength (0.25 mg and 1 mg) tablets.
- Mayzent is manufactured by Novartis Pharmaceuticals.
Side Effects
- Mayzent has no boxed warning on its current US or EU label.
- The most common side effects, reported in 10% or more of patients, are headache, high blood pressure, and abnormal liver blood tests.
- Other reactions include swelling of the macula at the back of the eye (macular oedema), particularly in people with diabetes or a history of eye inflammation, and a slowed heart rate that can occur after the first dose, which is why first-dose heart monitoring is required in some patients.
- Mayzent can also increase the risk of infections, including shingles and other herpes viral infections, and there is a small risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
- Report vision changes, a very slow or irregular heartbeat, fever, or new neurological symptoms to your healthcare provider promptly, and have an eye examination before starting and if you notice any visual disturbance.
Precautions & Warnings
- Mayzent is contraindicated in people with the CYP2C9*3/*3 genotype, in those who have had a recent heart attack, unstable angina, stroke, TIA, or decompensated heart failure within the previous 6 months, and in certain heart block or sick sinus syndrome without a pacemaker.
- Mayzent must not be used during pregnancy - it can harm an unborn baby - so women of childbearing potential need effective contraception during treatment and for 10 days after stopping.
- A baseline eye examination, including the macula, is recommended before starting and periodically afterward, especially in people with diabetes or uveitis.
- Because Mayzent slows the heart rate, some patients with pre-existing bradycardia or conduction problems need 6-hour first-dose monitoring with hourly pulse, blood pressure, and an ECG.
- Avoid live or live-attenuated vaccines during treatment and for 4 weeks afterward.
- Blood counts and liver function should be checked before and periodically during treatment.
Avoid Interactions
- Avoid Interactions: strong CYP2C9 inhibitors (such as fluconazole) are not recommended with Mayzent because they can raise siponimod levels substantially, and combining a moderate CYP2C9 inhibitor with a strong CYP3A4 inducer is also avoided.
- Beta-blockers and other heart-rate-lowering drugs (such as calcium channel blockers or antiarrhythmics) increase the risk of a slow heart rate when started with Mayzent; your healthcare provider may pause a beta-blocker before your first Mayzent dose.
- Avoid live or live-attenuated vaccines while taking Mayzent and for 4 weeks after stopping, and complete any needed vaccinations before starting treatment where possible.
- Because Mayzent suppresses the immune system, combining it with other immunosuppressive or immune-modulating therapies is generally avoided.
- Tell your healthcare provider and pharmacist about every medicine, including over-the-counter products and supplements, before starting Mayzent.
References
Frequently Asked Questions
Mayzent (siponimod) treats relapsing forms of multiple sclerosis in adults, including active secondary progressive MS. In the EU it is approved only for secondary progressive MS with active disease. A CYP2C9 genetic test is required before starting.
Mayzent is a tablet taken by mouth once daily, starting with a short dose build-up over 5 to 6 days before reaching the usual 2 mg maintenance dose. Take it with or without food, at about the same time each day.
Headache, high blood pressure, and abnormal liver tests are the most common effects. Mayzent can also cause a slow heartbeat after the first dose and swelling at the back of the eye (macular oedema), so report vision changes or dizziness promptly.
Avoid live vaccines during treatment and for 4 weeks after stopping. Strong CYP2C9 inhibitors and certain heart-rate-lowering drugs need caution. Do not become pregnant while taking Mayzent. Tell your healthcare provider about every medicine you take before starting.
Everyone needs a CYP2C9 genotype test before starting Mayzent, because it affects how the drug is broken down. People with the CYP2C9*3/*3 genotype cannot take Mayzent at all, and some other genotypes need a lower 1 mg maintenance dose.
In the US, unopened Mayzent tablets are refrigerated at 2°C to 8°C; once dispensed, they can be kept at room temperature (20°C to 25°C) for up to 3 months. Check your pharmacy label, as EU packs may specify storage below 25°C instead.
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