Your safety is important–so please make sure you review the following information carefully to educate yourself about the possible risks of MAVENCLAD. You should discuss possible side effects with your healthcare provider.
About 24% of cladribine-treated patients in the clinical trial program were followed for up to 8 years. The mean 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. These clinical trials evaluated the risk of side effects from MAVENCLAD. Keep in mind that the types and seriousness of side effects vary from patient to patient.
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.
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.
CANCER (MALIGNANCIES)
Treatment with MAVENCLAD may increase your risk of developing cancer. In clinical trials, cancers (malignancies) occurred more frequently in MAVENCLAD-treated patients than in those on placebo.
In clinical studies, 1.1% of MAVENCLAD-treated patients developed a malignancy, compared to 0.5% of placebo patients. Based on this data, this means:
Images are for illustrative purposes only and do not depict the actual number of patients in the study.
PREGNANCY
Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant or of childbearing potential and not using effective birth control.
LOW BLOOD CELL COUNTS
Low blood cell counts have happened and can increase your risk of infections during your treatment with MAVENCLAD. Your healthcare provider will do blood tests before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
SERIOUS INFECTIONS
Patients have experienced TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB (1 case) and hepatitis (1 case) have happened with cladribine during clinical studies.
Shingles (herpes zoster)
In clinical studies, 2% of MAVENCLAD-treated patients developed a shingles infection,* compared to 0.2% of placebo patients.† Based on this data, this means:
*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.
Images are for illustrative purposes only and do not depict the actual number of patients in the study.
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems.
LIVER PROBLEMS
MAVENCLAD may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking MAVENCLAD.
In clinical studies, 0.3% of MAVENCLAD-treated patients had liver injury (serious or causing treatment discontinuation) that was considered related to treatment, compared to 0 placebo patients. Based on this data, this means:
Images are for illustrative purposes only and do not depict the actual number of patients in the study.
ALLERGIC REACTIONS (HYPERSENSITIVITIES)
MAVENCLAD can cause serious allergic reactions. Stop your treatment with MAVENCLAD and go to the closest emergency room for help right away if you have any signs or symptoms of allergic reactions.
HEART FAILURE
MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.
In clinical studies, 0.05% of MAVENCLAD-treated patients experienced heart failure, compared to 0% of placebo patients. Based on this data, this means:
Images are for illustrative purposes only and do not depict the actual number of patients in the study.
For more information, please see the additional Important Safety Information, full MAVENCLAD Prescribing Information, and Medication Guide.
The person in the photo below is not an actual MAVENCLAD patient.
Discover how MAVENCLAD was studied and how it is thought to work.
SEE THE STATSMAVENCLAD 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.
Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.
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.
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.
Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.