When it comes to choosing a relapsing multiple sclerosis (MS) treatment, safety is a key factor. Clinical trial evaluations, follow-ups, and real-world experience support the safety profile of MAVENCLAD.
As part of the clinical trial program for MAVENCLAD, about 24% of cladribine-treated patients in the program were followed for up to 8 years. The average time of the study follow-up was about 4.8 years. This helped to provide a clearer picture of the long-term safety profile of MAVENCLAD.
It is not known if MAVENCLAD is safe and effective for people to restart MAVENCLAD treatment 2 years after completing their 2 yearly treatment courses.
56,000+ PEOPLE HAVE BEEN TREATED GLOBALLY WITH MAVENCLAD IN THE REAL-WORLD SETTING.
These clinical trials also evaluated the risk of side effects from MAVENCLAD. The types and seriousness of side effects vary from patient to patient. For a list of possible side effects and their symptoms, please see the Medication Guide.
This is not intended to replace discussions with your healthcare provider. If you think you are experiencing any of these side effects or symptoms, please talk to your healthcare provider immediately.
Below are some of the possible, serious side effects with MAVENCLAD.
Work with your healthcare team to determine which cancer screenings are necessary.
Talk to your healthcare provider to make sure your vaccinations are up to date.
*6% of MAVENCLAD-treated patients developed a herpes viral infection, of which 2% were herpes zoster and 2.6% were oral herpes.
†2% of placebo patients developed a herpes viral infection, of which 0.2% were herpes zoster and 1.2% were oral herpes.
*Includes patients treated with both oral and IV forms of cladribine.
Some of the most common side effects experienced by patients included:
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.
MAVENCLAD may cause serious side effects, including:
Do not take MAVENCLAD if you:
Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:
How should I take MAVENCLAD?
Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.
MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:
The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.
These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.