Siponimod (Mayzent)

Trade Name : MAYZENT

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 0.25 mg/1

SIPONIMOD

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Siponimod (Mayzent) which is also known as MAYZENT and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.25 mg/1 per ml. Read more

Siponimod (Mayzent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 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.
  • No data
  • Assessments are required prior to initiating MAYZENT ()
  • Titration is required for treatment initiation (, )
  • The recommended maintenance dosage is 2 mg ()
  • The recommended maintenance dosage in patients with a CYP2C9*1/*3 or *2/*3 genotype is 1 mg ()
  • 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 ()
  • 0.25 mg tablet: Pale red, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side & u2018Tu2019 on other side.
  • 2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side & u2018IIu2019 on other side.
  • Tablets: 0.25 mg and 2 mg
  • MAYZENT is contraindicated in patients who have:
  • Patients with a CYP2C9*3/*3 genotype ()
  • In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure ()
  • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker ()
  • No data
  • Infections:
  • Macular Edema:
  • Bradyarrhythmia and Atrioventricular Conduction Delays:
  • Respiratory Effects:
  • Liver Injury:
  • Increased Blood Pressure (BP):
  • Fetal Risk:
  • The following serious adverse reactions are described elsewhere in labeling:
  • Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • A total of 1737 MS patients have received MAYZENT at doses of at least 2 mg daily. These patients were included in Study 1 and in a Phase 2 placebo-controlled study in patients with MS. In Study 1, 67% of MAYZENT-treated patients completed the double-blind part of the study, compared to 59.0% of patients receiving placebo. Adverse events led to discontinuation of treatment in 8.5% of MAYZENT-treated patients, compared to 5.1% of patients receiving placebo. The most common adverse reactions (incidence at least 10%) in MAYZENT-treated patients in Study 1 were headache, hypertension, and transaminase increases.
  • Table 3 lists adverse reactions that occurred in at least 5% of MAYZENT-treated patients and at a rate at least 1% higher than in patients receiving placebo.
  • The following adverse reactions have occurred in less than 5% of MAYZENT-treated patients but at a rate at least 1% higher than in patients receiving placebo: herpes zoster, lymphopenia, seizure, tremor, macular edema, AV block (1st and 2nd degree), asthenia, and pulmonary function test decreased .
  • Seizures
  • In Study 1, cases of seizures were reported in 1.7% of MAYZENT-treated patients, compared to 0.4% in patients receiving placebo. It is not known whether these events were related to the effects of MS, to MAYZENT, or to a combination of both.
  • Respiratory Effects
  • Dose-dependent reductions in forced expiratory volume over 1 second (FEV) were observed in patients treated with MAYZENT .
  • Vascular Events
  • Vascular events, including ischemic strokes, pulmonary embolisms, and myocardial infarctions, were reported in 3.0% of MAYZENT-treated patients compared to 2.6% of patients receiving placebo. Some of these events were fatal. Physicians and patients should remain alert for the development of vascular events throughout treatment, even in the absence of previous vascular symptoms. Patients should be informed about the symptoms of cardiac or cerebral ischemia caused by vascular events and the steps to take if they occur.
  • Malignancies
  • Malignancies such as malignant melanoma and seminoma were reported in MAYZENT-treated patients in Study 1. An increased risk of cutaneous malignancies has been reported in association with another S1P modulator.
  • Most common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases. ()
  • No data
  • Vaccines:
  • CYP2C9 and CYP3A4 Inhibitors:
  • CYP2C9 and CYP3A4 Inducers:
  • No data
  • In patients with overdosage of MAYZENT, it is important to observe for signs and symptoms of bradycardia, which may include overnight monitoring. Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed .
  • There is no specific antidote to siponimod available. Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body. The decrease in heart rate induced by MAYZENT can be reversed by atropine or isoprenaline.
  • MAYZENT tablets contains siponimod, a sphingosine 1-phosphate receptor modulator, as 2:1 co-crystal of siponimod and fumaric acid and has the following chemical name:
  • 1-[[4-[(1E)-1-[[[4-Cyclohexyl-3-(trifluoromethyl)phenyl]methoxy]imino]ethyl]-2-ethylphenyl]methyl]-3-azetidinecarboxylic acid (2E)-2-butenedioate (2:1). Its molecular formula is CHOu2022 2CHFNO, and its molecular weight is 1149.29 g/mol.
  • Its structure is shown below:
  • It is a white to almost white powder.
  • MAYZENT is provided as 0.25 mg and 2 mg film-coated tablets for oral use. Each tablet contains 0.25 mg or 2 mg siponimod, equivalent to 0.28 mg or 2.22 mg as 2:1 co-crystal of siponimod and fumaric acid, respectively.
  • MAYZENT tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, lactose monohydrate, microcrystalline cellulose, with a film coating containing iron oxides (black and red iron oxides for the 0.25 mg strength and red and yellow iron oxides for the 2 mg strength), lecithin (soy), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
  • No data
  • Carcinogenesis
  • Oral carcinogenicity studies of spinomod were conducted in mice and rats. In mice administered siponimod (0, 2, 8, or 25 mg/kg/day) for up to 104 weeks, there was an increase in malignant lymphoma in females at all doses and in hemangiosarcoma and combined hemangioma and hemangiosarcoma at all doses in males and females. The lowest dose tested is approximately 5 times the recommended human dose (RHD) of 2 mg/day, on a body surface area (mg/m) basis.
  • In rats, administration of siponimod (0, 10, 30, or 90 mg/kg/day in males; 0, 3, 10, or 30 mg/kg/day in females) for up to 104 weeks, there was an increase in thyroid follicular cell adenoma and combined thyroid follicular cell adenoma and carcinoma in males at the highest dose tested. These findings are considered secondary to liver enzyme induction in rats and are not considered relevant to humans. Plasma siponimod exposure (AUC) at the highest dose tested is approximately 200 times that in humans at the RHD.
  • Mutagenesis
  • Siponimod was negative in a battery of (Ames, chromosomal aberration in mammalian cells) and in vivo (micronucleus in mouse and rat) assays.
  • Impairment of Fertility
  • When siponimod was administered orally (0, 2, 20, or 200 mg/kg) to male rats (mated with untreated females) prior to and throughout the mating period, there was a dose-related increase in precoital interval at all doses. A decrease in implantation sites, an increase in preimplantation loss, and a decrease in the number of viable fetuses were observed at the highest dose tested. The higher no-effect dose for adverse effects on fertility (20 mg/kg) is approximately 100 times the RHD on a mg/m basis.
  • When siponimod was administered orally (0, 0.1, 0.3, or 1 mg/kg) to female rats (mated with untreated males) prior to and during mating, and continuing to Day 6 of gestation, no effects on fertility were observed up to the highest dose tested (1 mg/kg). Plasma siponimod exposure (AUC) at the highest dose tested is approximately 16 times that in humans at the RHD.
  • The efficacy of MAYZENT was demonstrated in Study 1, a randomized, double-blind, parallel-group, placebo-controlled, time-to-event study in patients with secondary progressive multiple sclerosis (SPMS) who had evidence of disability progression in the prior 2 years, no evidence of relapse in 3 months prior to study enrollment, and an Expanded Disability Status Scale (EDSS) score of 3.0-6.5 at study entry (NCT 01665144).
  • Patients were randomized to receive either once daily MAYZENT 2 mg or placebo, beginning with a dose titration . Evaluations were performed at screening, every 3 months during the study, and at the time of a suspected relapse. MRI evaluations were performed at screening and every 12 months.
  • The primary endpoint of the study was the time to 3-month confirmed disability progression (CDP), defined as at least a 1-point increase from baseline in EDSS (0.5-point increase for patients with baseline EDSS of 5.5 or higher) sustained for 3 months. A prespecified hierarchical analysis consisted of the primary endpoint and 2 secondary endpoints, the time to 3-month confirmed worsening of at least 20% from baseline on the timed 25-foot walk test and the change from baseline in T2 lesion volume. Additional endpoints included annualized relapse rate (relapses/year) and MRI measures of inflammatory disease activity.
  • Study duration was variable for individual patients (median study duration was 21 months, range 1 day-37 months).
  • Study 1 randomized 1651 patients to either MAYZENT 2 mg (N = 1105) or placebo (N = 546); 82% of MAYZENT-treated patients and 78% of placebo-treated patients completed the study. Median age was 49.0 years, 95% of patients were white, and 60% female. The median disease duration was 16.0 years, and median EDSS score at baseline was 6.0 (56% of patients had u2265 6.0 EDSS at baseline); 36% of patients had one or more relapses in the 2 years prior to study entry; 22% of those patients with available imaging had one or more gadolinium-enhancing lesions on their baseline MRI scan; 78% of patients had been previously treated with an MS therapy.
  • Results are presented in Table 4. MAYZENT was superior to placebo in reducing the risk of confirmed disability progression, based on a time-to-event analysis (hazard ratio 0.79, p < 0.0134; see Figure 1). MAYZENT did not significantly delay the time to 20% deterioration in the timed 25-foot walk, compared to placebo. Patients treated with MAYZENT had a 55% relative reduction in annualized relapse rate, compared to patients on placebo (nominal -value < 0.0001). The absolute reduction in the annualized relapse rate was 0.089. Although MAYZENT had a significant effect on disability progression compared to placebo in patients with active SPMS (e.g., SPMS patients with an MS relapse in the 2 years prior to the study), the effect of MAYZENT in patients with non-active SPMS was not statistically significant (see Figure 2).
  • Figure 1 tTime to Confirmed Disability Progression Based on EDSS (Study 1)
  • Figure 2tTime to Confirmed Disability Progression Based on EDSS (Study 1), Subgroup Analysis
  • * HR and 95% CI presented are model-based estimates for a range of values of age and EDSS.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • ntttttttTell patients not to discontinue MAYZENT without first discussing this with the prescribing physician. Advise patients to contact their physician if they accidently take more MAYZENT than prescribed.nttttttt
  • Risk of Infections
  • Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when taking MAYZENT, and that they should contact their physician if they develop symptoms of infection . Advise patients that the use of some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with MAYZENT and MAYZENT should be paused 1 week prior and until 4 weeks after a planned vaccination. Recommend that patients postpone treatment with MAYZENT for at least 1 month after VZV vaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.
  • Macular Edema
  • Advise patients that MAYZENT may cause macular edema, and that they should contact their physician if they experience any changes in their vision while taking MAYZENT . Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased.
  • Cardiac Effects
  • Advise patients that initiation of MAYZENT treatment results in transient decrease in heart rate . Inform patients that to reduce this effect, dosage titration is required. Advise patients that dosage titration is also required if a dose is missed for more than 24 hours during the titration or if 4 or more consecutive daily maintenance doses are missed . Inform certain patients with certain pre-existing cardiac conditions that they will need to be observed in the doctor's office or other facility for at least 6 hours after the first dose and after reinitiation if treatment is interrupted or discontinued for certain periods .
  • Respiratory Effects
  • Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea .
  • Liver Injury
  • Inform patients that MAYZENT may increase liver enzymes. Advise patient that they should contact their physician if they experience any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine during treatment .
  • Pregnancy and Fetal Risk
  • Inform patients that, based on animal studies MAYZENT may cause fetal harm . Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant. Advise women of childbearing potential of the need for effective contraception during treatment with MAYZENT and for 10 days after stopping MAYZENT. Advise a female patient to immediately inform that prescriber if she is pregnant or planning to become pregnant .
  • Posterior Reversible Encephalopathy Syndrome
  • Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological sequelae .
  • Severe Increase in Disability After Stopping MAYZENT
  • Inform patients that severe increase in disability has been reported after discontinuation of another sphingosine 1-phosphate (S1P) receptor modulator like MAYZENT. Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of MAYZENT .
  • Immune System Effects After Stopping MAYZENT
  • Advise patients that MAYZENT continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 3-4 weeks after the last dose .
  • Storage and Handling
  • Instruct patients to store any unopened containers of MAYZENT in a refrigerator. Inform patients that opened starter packs may be stored at room temperature for 1 week and opened bottles may be stored at room temperature for 1 month .
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • MAYZENT is a registered trademark of Novartis AG
  • u00a9 Novartis
  • T2019-45
  • T2019-46
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0979-50
  • Rx only
  • MAYZENTu00aentttttt
  • (siponimod) tablets
  • 0.25 mg
  • 28 tablets
  • Dispense with accompanyingMedication Guide.
  • NOVARTIS
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0986-15
  • Rx only
  • MAYZENTu00aentttttt
  • (siponimod) tablets
  • 2 mg
  • 30 tablets
  • Dispense with accompanyingMedication Guide.
  • NOVARTIS

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