MAYZENT- siponimod tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SIPONIMOD (UNII: RR6P8L282I) (SIPONIMOD - UNII:RR6P8L282I)

זמין מ:

Novartis Pharmaceuticals Corporation

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

MAYZENT is 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. MAYZENT is contraindicated in patients who have: - A CYP2C9*3/*3 genotype [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.5)] - In the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure - Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions (5.4)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MAYZENT during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the MotherToBaby Pregnancy Study in Multiple Sclerosis by calling

leaflet_short:

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 on one side and ‘T’ on other side.      Starter Pack for 1-mg maintenance dosage – blister card of seven 0.25 mg tablets in a calendarized blister wallet...............NDC 0078-0979-89      Starter Pack for 2-mg maintenance dosage – blister card of twelve 0.25 mg tablets in a calendarized blister wallet...............NDC 0078-0979-12      Bottle of 28 tablets........................................................................................................................NDC 0078-0979-50 1 mg tablet: Violet white, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side and ‘L’ on other side.      Bottle of 30 tablets.........................................................................................................................NDC 0078-1014-15 2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side and ‘II’ on other side.      Bottle of 30 tablets.........................................................................................................................NDC 0078-0986-15      Bottle of 15 tablets.........................................................................................................................NDC 0078-0986-45 Unopened Containers Store MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). After pharmacy dispensing to patient, MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] for up to 3 months. Opened Containers Bottles MAYZENT 0.25 mg, 1 mg, and 2 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] for up to 3 months. Do not refrigerate after opening. Starter Pack/Blister Card MAYZENT 0.25 mg film-coated tablets may be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] for up to 3 months. Do not refrigerate after opening. Store in original calendarized blister wallet container.

מצב אישור:

New Drug Application

עלון מידע

Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: August 2023
MEDICATION GUIDE
MAYZENT (Māʹzĕnt)
(siponimod)
tablets, for oral use
What is the most important information I should know about MAYZENT?
1. MAYZENT may cause serious side effects, including: Slow heart rate
(bradycardia or bradyarrhythmia)
when you start taking MAYZENT. MAYZENT can cause your heart rate to
slow down, especially after you
take your first dose. You should have a test to check the electrical
activity of your heart called an
electrocardiogram (ECG) before you take your first dose of MAYZENT.
During the initial updosing period (4 days for the 1 mg daily dose or
5 days for the 2 mg daily dose), if you
miss 1 or more doses of MAYZENT, you need to restart the updosing.
Call your healthcare provider if you
miss a dose of MAYZENT. See “How should I take MAYZENT?”
2. Infections. MAYZENT can increase your risk of serious infections
that can be life-threatening and cause
death. MAYZENT lowers the number of white blood cells (lymphocytes) in
your blood. This will usually go
back to normal within 3 to 4 weeks of stopping treatment. Your
healthcare provider should review a recent
blood test of your white blood cells before you start taking MAYZENT.
Call your healthcare provider right away if you have any of these
symptoms of an infection during treatment
with MAYZENT and for 3 to 4 weeks after your last dose of MAYZENT:
•
fever
•
tiredness
•
body aches
•
chills
•
nausea
•
vomiting
•
headache with fever, neck stiffness, sensitivity
to light, nausea, confusion (these may be
symptoms of meningitis, an infection of the
lining around your brain and spine and/or
encephalitis, an infection of the brain)
3. Progressive multifocal leukoencephalopathy (PML). MAYZENT can
increase your risk for PML, which
is a rare brain infection that usually leads to death or severe
disability. If PML happens, it usually happens in
people with weakened immune systems but

מאפייני מוצר

MAYZENT- SIPONIMOD TABLET, FILM COATED
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.2, 5.12)
8/2023
INDICATIONS AND USAGE
MAYZENT is a sphingosine 1-phosphate (S1P) 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)
Administer tablets whole; do not split, crush, or chew. (2.2, 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, 1 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)
Progressive Multifocal Leukoencephalopathy (PML): Withhold MAYZENT at
the first sign or symptom of
PML. (5.2)
Macular Edem