Mavenclad Tablets - Drug Type: Medicine Raw Materials

WHAT IS MAVENCLAD?
MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.
MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).
It is not known if MAVENCLAD is safe and effective in children under 18 years of age, and is therefore not recommended.

IMPORTANT SAFETY INFORMATION
MAVENCLAD may cause serious side effects, including:
Risk of cancer (malignancies).You should follow healthcare provider instructions about screening for cancer.

MAVENCLAD may cause birth defects if used during pregnancy.Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.

For females who are able to become pregnant:Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.

Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.Talk to your healthcare provider if you use oral contraceptives (the "pill").
You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
For males with female partners who are able to become pregnant:
Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.Do nottake MAVENCLAD if you:have cancer (malignancy).
are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
are breastfeeding.
are human immunodeficiency virus (HIV) positive.
have active infections, including tuberculosis (TB), hepatitis B or C.
are allergic to cladribine.

How should I take MAVENCLAD?

MAVENCLAD is given as two yearly treatment courses.
Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
Take MAVENCLAD with water and swallow whole without chewing.