nhibitors
7.6 CYP2C9 and CYP3A4 Inducers
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 CYP2C9 Genotype
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.5 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolatedsyndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Assessments Prior to First Dose of MAYZENT
Before initiation of treatment with MAYZENT, assess the following:CYP2C9 Genotype DeterminationTest patients for CYP2C9 variants to determine CYP2C9 genotype [see Dosage and Administration (2.2, 2.3),Contraindications (4), and Use in Specific Populations (8.6)]. An FDA-cleared or -approved test for the detection ofCYP2C9 variants to direct the use of siponimod is not currently available.
Complete Blood CountReview results of a recent complete blood count (CBC) [see Warnings and Precautions (5.1)].
Ophthalmic eva luation
Obtain an eva luation of the fundus, including the macula [see Warnings and Precautions (5.2)].
Cardiac eva luation
Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patientswith certain preexisting conditions, advice from a cardiologist and first-dose monitoring is recommended [see Dosage andAdministration (2.4) and Warnings and Precautions (5.3)].
Determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see DrugInteractions (7.2, 7.3)].
Current or Prior Medications
If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prioruse of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment withMAYZENT [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].
Vaccinations
Test patients for antibodies to varicella zoster virus (VZV) before initiating MAYZENT; VZV vaccination of antibodynegativepatients is recommended prior to commencing treatment with MAYZENT [see Warnings and Precautions(5.1)].
Liver Function Tests
Obtain recent (i.e., within last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.5)].
2.2 Recommended Dosage in Patients With CYP2C9 Genotypes *1/*1, *1/*2, or *2/*2
Maintenance Dosage
After treatment titration (see Treatment Initiation), the recommended maintenance dosage of MAYZENT is 2 mg takenorally once daily starting on Day 6. Dosage adjustment is required in patients with a CYP2C9*1/*3 or *2/*3 genotype[see Dosage and Administration (2.3)].
Treatment Initiation
Initiate MAYZENT with a 5-day titration, as shown |
