Maby, MAVENCLAD patient, dosed in 2020 and 2021

The safety profile of MAVENCLAD has been extensively evaluated

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.

A timeline ranging from 2005 through 2024 with an arrow point beyond 2024. Text over the timeline reads "MAVENCLAD safety profile has been evaluated for 19+ years"

 

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.

 

100,000+ PEOPLE HAVE BEEN TREATED GLOBALLY WITH MAVENCLAD IN THE REAL-WORLD SETTING.


MAVENCLAD side effects

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.

Icon of two cells illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is it may increase your risk of developing cancer.

CANCER (MALIGNANCIES)

Treatment with MAVENCLAD may increase your risk of developing cancer. In clinical studies:

Black and orange text comparing two pieces of data with "vs" written in between them. The data is related to the instance of developing a malignancy among 1.1% of patients on MAVENCLAD® (cladribine) vs 0.5% of patients on placebo in clinical trials.

Work with your healthcare team to determine which cancer screenings are necessary.

Icon of a fetus in utero on an ultrasound image illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is birth defects.

BIRTH DEFECTS

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. Patients should use effective birth control (contraception) while on treatment with MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Icon of a blood cell with a downward pointing arrow illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is low blood cell counts.

LOW BLOOD CELL COUNTS

Low blood cell counts have happened and may increase the risk of infections during treatment with MAVENCLAD. Your healthcare provider will do blood tests before, during, and after your treatment with MAVENCLAD, as needed.

Icon of a virus cell with an exclamation point overlaidillustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is serious infections.

SERIOUS INFECTIONS

Life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi have been reported. Fatal cases of TB (1 case) and hepatitis (1 case) have happened with cladribine during clinical studies. In clinical studies:

Black and orange text comparing two pieces of data with "vs" written in between them. The data is related to the instance of developing serious infections among 2.4% of patients on MAVENCLAD® (cladribine) vs 2% of patients on placebo in clinical trials.

Talk to your healthcare provider to make sure your vaccinations are up to date.

Icon of a brain with a small circle encompassing dots overlaid on the frontal lobe, illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is progressive mulitfocal leukoencephalopathy (PML).

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

PML is a rare brain infection that usually leads to death or severe disability. No cases of PML have been seen in MS patients taking MAVENCLAD, but it may happen in people with weakened immune systems.

Icon of a liver with a small circle encompassing dots overlaid on the upper left corner, illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is liver problems.

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:

Black and orange text comparing two pieces of data with "vs" written in between them. The data is related to the instance of developing liver problems among 0.3% of patients on MAVENCLAD® (cladribine) vs 0% of patients on placebo in clinical trials.
Icon of a hand with palm facing up with a small circle encompassing dots overlaid on the palm under the pinky, illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is allergic reactions.

ALLERGIC REACTIONS (HYPERSENSITIVITIES)

MAVENCLAD can cause serious allergic reactions such as skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing. 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.

Icon of a heart shape with a circle with an arrow inside it overlaid, illustrating that a potential side effect of treatment with MAVENCLAD® (cladribine) is heart failure.

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 of heart failure. In clinical studies:

Black and orange text comparing two pieces of data with "vs" written in between them. The data is related to the instance of developing liver problems among 0.3% of patients on MAVENCLAD® (cladribine) vs 0% of patients on placebo in clinical trials.

*Includes patients treated with both oral and IV forms of cladribine.

Common side effects seen in clinical trials

Some of the most common side effects experienced by patients included:

An icon of human lungs with a small explanation point inside of a circle overlaid on the lower right corner. Text below provides data related to the instance of developing upper respiratory infection among 38% of patients on MAVENCLAD® (cladribine) vs 32% of patients on placebo in clinical trials.
An icon of a human head with a brain visible inside. A small lightning bolt inside of a circle is overlaid on the frontal lobe. Text below provides data related to the instance of developing a headache among 25% of patients on MAVENCLAD® (cladribine) vs 19% of patients on placebo in clinical trials.
An icon of a blood cell with an arrow pointing down inside of a circle overlaid on the lower right corner. Text below provides data related to the instance of developing lymphopenia among 24% of patients on MAVENCLAD® (cladribine) vs 2% of patients on placebo in clinical trials.

 

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please see the additional Important Safety Information, full MAVENCLAD Prescribing Information, and Medication Guide.
 

A smiling man sits in a chair with a phone to his ear and a laptop on his lap representing an MS patient discussing MAVENCLAD® (cladribine) treatment with their doctor. Not a real patient.

START THE CONVERSATION

Need help talking to your doctor about starting MAVENCLAD? Check out the Doctor Discussion Guide for talking points and helpful tips.

DOWNLOAD THE PDF
Expand

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. Women 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 women 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.
    • Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take 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.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses, consisting of 2 treatment weeks (cycles) about a month apart.
  • Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.
  • Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

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:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • 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. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow. Your doctor will perform blood tests to check your liver during treatment.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • 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 heartbeat, or unusual swelling in your body.

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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.

Expand

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. Women 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 women 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.
    • Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take 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.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses, consisting of 2 treatment weeks (cycles) about a month apart.
  • Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.
  • Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

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:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • 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. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow. Your doctor will perform blood tests to check your liver during treatment.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • 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 heartbeat, or unusual swelling in your body.

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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.

US-MAV-01395
Last update 04/2025

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