Multiple Sclerosis
Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator 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. MAYZENT film-coated tablets are supplied as follows:
0.25 mg tablet: Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with Novartis logo on one side and �T� on other side.
Starter Pack* � blister card of twelve 0.25 mg tablets in a calendarized blister wallet...............NDC 0078-0979-12
*This starter pack is only intended for patients who will receive the 2 mg maintenance dosage.
Bottle of 28 tablets........................................................................................................................NDC 0078-0979-50
2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with Novartis logo on one side and �II� on other side.
Bottle of 30 tablets.........................................................................................................................NDC 0078-0986-15
16.2 Storage and Handling
Unopened Containers
Store unopened containers of MAYZENT 0.25 mg and 2 mg film-coated tablets in a refrigerator between 2�C to 8�C (36�F to 46�F).
Opened Containers
Store opened containers of MAYZENT as follows:
Starter Pack/Blister Card
MAYZENT 0.25 mg film-coated tablets in the Starter Pack may be stored at 20�C to 25�C (68�F to 77�F) [see USP Controlled Room Temperature] for up to 1 week after opening the blister. Store in original container.
Bottles
MAYZENT 0.25 mg and 2 mg film-coated tablets in bottles may be stored at 20�C to 25�C (68�F to 77�F) [see USP Controlled Room Temperature] for up to 1 month after opening the bottles. These highlights do not include all the information needed to use MAYZENT safely and effectively. See full prescribing information for MAYZENT.
MAYZENT� (siponimod) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
MAYZENT 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. (1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating MAYZENT (2.1)
Titration is required for treatment initiation (2.2, 2.3)
The recommended maintenance dosage is 2 mg (2.2)
The recommended maintenance dosage in patients with a CYP2C9*1/*3 or *2/*3 genotype is 1 mg (2.3)
First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree [Mobitz type I] atrioventricular (AV) block, or a history of myocardial infarction or heart failure (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg and 2 mg (3)
CONTRAINDICATIONS
Patients with a CYP2C9*3/*3 genotype (4)
In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (4)
Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker (4)
WARNINGS AND PRECAUTIONS
Infections: MAYZENT may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment. Do not start in patients with active infection. (5.1)
Macular Edema: An ophthalmic evaluation is recommended before starting treatment and if there is any change in vision while taking MAYZENT. Diabetes mellitus and uveitis increase the risk. (5.2)
Bradyarrhythmia and Atrioventricular Conduction Delays: MAYZENT may result in a transient decrease in heart rate; titration is required for treatment initiation. Consider resting heart rate with concomitant beta-blocker use; obtain cardiologist consultation before concomitant use with other drugs that decrease heart rate (5.3, 7.2, 7.3)
Respiratory Effects: May cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated. (5.4)
Liver Injury: Obtain liver enzyme results before initiation. Closely monitor patients with severe hepatic impairment. Discontinue if significant liver injury occurs. (5.5)
Increased Blood Pressure (BP): Monitor BP during treatment. (5.6)
Fetal Risk: Women of childbearing potential should use effective contraception during and for 10 days after stopping MAYZENT. (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Vaccines: Avoid live attenuated vaccines during and for up to 4 weeks after treatment with MAYZENT (7.4)
CYP2C9 and CYP3A4 Inhibitors: Increase in siponimod exposure; concomitant use of MAYZENT with moderate CYP2C9 and moderate or strong CYP3A4 inhibitors is not recommended (7.5)
CYP2C9 and CYP3A4 Inducers: Decrease in siponimod exposure; concomitant use of MAYZENT with moderate CYP2C9 and strong CYP3A4 inducers is not recommended (7.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2019
