For thetreatment of people with secondary progressive multiple sclerosis.
Uponinitiation of treatment, the person should:
Have activedisease characterized by at least one of the following:
-A clinical relapse within the past two years.
-A new lesion in T2 within thelast year
-An increase in the volume of a T2 lesion inthe last year
-A gadolinium-enhanced lesion on magnetic resonanceimaging (MRI) within the last year
and have an EDSS score of less than 7
Approvals are given at a maximum dose of 2mg per day
The maximumduration of each authorization is 12 months
When requesting continued treatment, the physician must confirm that the EDSS score is below 7.
Mayzent is contraindicated in patients with:
unstable or severer cardiovascular or cerebrovascular disease or significant QT prolongation (QTc >500 msec) from any cause
cardiac arrhythmia including Mobitz type 2 AV block or type 3 AV block or sick sinus syndrome without a pacemaker or taking class 3 antiarrhythmic medications (amiodarone, sotalol)
untreated latent hepatitis B or C or TB, active severe ongoing infection
pregnancy or women of child bearing age who does not use effective contraception
active malignancy or predisposition to malignancy
carriers of the CYP2C9*3*3 genotype
hypersensitivity to peanuts , soya or any of its components
severe ongoing immunosuppression from any cause
history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema and should start treatement with the supervision of an opthalmologist
Before Initiation of Therapy :
-CBC,ALT, AST, LDH, bilirubin, TSH, HepBsAg, HepBcAB, HepBsAB, hepatitis C. HIV,VZV, and Measles serology, JCV index
vaccination status and update if necessary
Vaccinate for Pneumococcus, Hemophilus Influenza type B and VZV
-CYP2C9*3*3genotype (via the Go Program)
Chest Xray and/or Quantiferon
Treatment has to be initiated in all patients with a starter pack that lasts for 5 days . The dose titration starts with 0.25 mg once daily on day 1 and day 2, followed by once daily doses of 0.5 mg on day 3, 0.75 mg on day 4, and 1.25 mg on day 5 , to reach the maintenance dose of 2 mg* MAYZENT starting on day 6.
The recommended maintenance dose is 1 mg daily for patients with CYP2C9 *2*3 or *1*3 genotype
During titration (when using the starter pack), the recommended daily dose should be taken once daily in the morning with or without food. If a titration dose is missed on one day during the first 6 days of treatment (Day 1 to Day 6, from titration to the first day of the maintenance dose), treatment needs to be re-initiated with Day 1 of the titration regimen, using a new starter pack.
Monitoring During Therapy :
CBC,ALT, AST, LDH, bilirubin, TSH Q3months x4, then Q6months
monitor blood pressure
ophthalmological examination at month 3 or 4
If MAYZENT maintenance treatment is interrupted for 4 or more consecutive daily doses,treatment has to be re-initiated with Day 1 of the titration regimen, using a new starter pack
Discontine Therapy :
- There is evidence of a serious infection such as disseminated VZV or herpetic infection or cryptococcal meningitis
- PML is suspected
- There is a sustained 5X ULN increase in the transaminases level
- Evidence of PRES, macular edema
- There is a reduction in spirometric values
MAYZENT should not be used in patients with a CYP2C9*3*3 genotype (see CONTRAINDICATIONS; WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Pharmacogenomics; and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Initiation of treatment with MAYZENT causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should:
Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations and Bradyarrhythmia and Atrioventricular Conduction Delays).
Determine whether patients are taking concomitant medications that reduce heart rate or atrioventricular conduction (see WARNINGS AND PRECAUTIONS, Cardiovascular - Bradyarrhythmia and Atrioventricular Conduction Delays; and DRUG INTERACTIONS).
For patients with sinus bradycardia (heart rate (HR) <55 bpm), first or second-degree [Mobitz type I] atrioventricular block (AV block), or a history of myocardial infarction or heart failure, prepare to administer the first dose of MAYZENT in a clinical setting where they can be monitored for signs and symptoms of bradycardia, with hourly pulse and blood pressure measurements for at least 6 hours, and where symptomatic bradycardia can be managed (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations).
For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see WARNINGS AND PRECAUTIONS, Cardiovascular - Treatment Initiation Recommendations).
Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. It is recommended that patients with diabetes mellitus, uveitis or a history of retinal disorders undergo an ophthalmic evaluation prior to initiating MAYZENT therapy and during treatment (see WARNINGS AND PRECAUTIONS, Ophthalmologic; and ADVERSE REACTIONS, Macular edema).