ential for fetal harm. Malformations and embryolethality occurred in animals. Excludepregnancy before the start of treatment with MAVENCLAD in females of reproductivepotential. Advise females and males of reproductive potential to use effective contraceptionduring MAVENCLAD dosing and for 6 months after the last dose in each treatmentcourse. Stop MAVENCLAD if the patient becomes pregnant [see Contraindications (4),
Warnings and Precautions (5.2), and Use in Specific Populations (8.1, 8.3)].
1 INDICATIONS AND USAGE
MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), toinclude relapsing-remitting disease and active secondary progressive disease, in adults. Becauseof its safety profile, use of MAVENCLAD is generally recommended for patients who have hadan inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatmentof MS [see Warnings and Precautions (5)].
Limitations of Use
MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS)because of its safety profile [see Warnings and Precautions (5)].
2 DOSAGE AND ADMINISTRATION
2.1 Assessments Prior to Starting Each MAVENCLAD Treatment Course
Cancer Screening
Follow standard cancer screening guidelines because of the risk of malignancies [see BoxedWarning and Warnings and Precautions (5.1)].
Pregnancy
Exclude pregnancy prior to treatment with MAVENCLAD in females of reproductive potential[see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations(8.1, 8.3)].
Complete Blood Count (CBC)
Obtain a CBC with differential including lymphocyte count [see Dosage and Administration(2.5) and Warnings and Precautions (5.3)]. Lymphocytes must be:
• within normal limits before initiating the first treatment course
• at least 800 cells per microliter before initiating the second treatment course
If necessary, delay the second treatment course for up to 6 months to allow for recovery oflymphocytes to at least 800 cells per microliter. If this recovery takes more than 6 months, thepatient should not receive further treatment with MAVENCLAD.
Infections [see Warnings and Precautions (5.4)]
• Exclude HIV infection.
• Perform tuberculosis screening.
• Screen for hepatitis B and C.
• eva luate for acute infection. Consider a delay in MAVENCLAD treatment until anyacute infection is fully controlled.
• Vaccination of patients who are antibody-negative for varicella zoster virus isrecommended prior to initiation of MAVENCLAD.
• Administer all immunizations according to immunization guidelines prior to startingMAVENCLAD. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior tostarting MAVENCLAD.
• Obtain a baseline (within 3 months) magnetic resonance imaging prior to the firsttreatment course because of the risk of progressive multifocal leukoencephalopathy(PML).
Liver Injury
Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warningsand Precautions (5.7)].
2.2 Recommended Dosage
The recommended cumulative dosage of MAVENCLAD is 3.5 mg per kg body weightadministered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatmentcourse) (see Table 1). Each treatment course is divided into 2 treatment cycles:Administration of First Treatment Course
• First Course/First Cycle: start any t |
