Potential side effects and risks of MAVENCLAD®

Potential side effects and risks of MAVENCLAD®

Welcome back to our MAVENCLAD series.

We’re going to help you understand the potential side effects and risks of MAVENCLAD.

MAVENCLAD may cause side effects. However, not everybody gets them and the types of side effects may vary.

You may experience side effects not mentioned here and it is important that you tell your healthcare professional about them straight away. You can also tell the adveva team by calling 1-888-677-3243.

MAVENCLAD affects the immune system.

Because of this, a very common, serious side effect is a reduction in the number of lymphocytes. This is known as lymphopenia.

You will have a blood test before starting MAVENCLAD in Year 1

and 2,

and between treatment courses and thereafter.

This is so that your healthcare professional can see if your lymphocytes are in an acceptable range. If your lymphocyte count is below an accepted level, your treatment will be delayed.

MAVENCLAD is associated with an increased risk of developing the infection shingles, also known as herpes zoster. Shingles is a common serious side effect caused by a viral infection (the same virus as chickenpox).

In some cases, people can get early warning signs of shingles, including

a headache,

burning,

tingling,

numbness or itchiness of the skin,

feeling generally unwell or having a fever.

The first symptom of shingles is usually a small area or localized band of severe pain, followed by a rash that can develop into itchy blisters.

Tell your healthcare professional and they may be able to give you treatments to relieve the symptoms of shingles. Your healthcare professional will be monitoring you for shingles. If necessary, you will be vaccinated against shingles before starting MAVENCLAD. If you’ve been vaccinated, you must wait 6 weeks before you can begin your treatment with MAVENCLAD.

MAVENCLAD can reduce lymphocytes in your blood and increase the likelihood of infection. Because of this, you will need to watch for any signs or symptoms of an infection.

The signs of infections can include

fever,

aching,

painful muscles,

headache,

generally feeling unwell

and loss of appetite.

It is important to talk to your healthcare professional if you think you have an infection before, during or after treatment.

Because MAVENCLAD suppresses the immune system and damages DNA, a possible risk of cancer can’t be ruled out. Please follow your healthcare professional’s instructions for cancer screening.

MAVENCLAD could potentially increase the risk of cancer. Please follow your healthcare professional’s instructions for cancer screening.

Before you start MAVENCLAD, your healthcare professional may perform an MRI scan. This is to check for progressive multifocal leukoencephalopathy, or PML.

PML is a rare brain infection. You can read more about PML in the patient information leaflet.

Talk to your healthcare professional as soon as possible if you think your MS is getting worse or if you experience any new symptoms, such as weakness on one side of the body that gets worse, clumsiness of your arms and legs, trouble with your vision, changes in your thinking and memory that lead to confusion and personality changes. These may be symptoms of PML.

If you have any concerns about taking MAVENCLAD or think you may be experiencing a side effect, talk to your doctor, MS nurse or pharmacist.

Or you can call the adveva team at 1-888-677-3243.

Thanks for watching this video and we will see you again soon.

Important information about MAVENCLAD

Do not use MAVENCLAD if you are allergic (hypersensitive) to cladribine or any of the other ingredients of MAVENCLAD; are at risk for infections because you have a weak immune system due to treatments you receive (for cancer, chronic corticosteroids, bone marrow transplant[s], etc.); or other medical conditions (for example, if you are infected with the human immunodeficiency virus [HIV]); have an active or inactive (past) infection, for example, tuberculosis or liver inflammation (hepatitis); have or had a type of rare infection of the brain called progressive multifocal leukoencephalopathy (PML); have an active cancer; have moderate or severe kidney problems; are pregnant or breastfeeding; are a woman of childbearing potential or a man who could potentially father a child and you are not using birth control.

Before you use MAVENCLAD

Talk to your healthcare professional if you have a weakened immune system due to treatments you receive or other medical conditions; have an infection; have liver problems; have recently been vaccinated; have or have previously had cancer; require blood transfusions; are pregnant, or are thinking of becoming pregnant as MAVENCLAD may harm your baby; are breastfeeding or plan to breastfeed (it is not known if MAVENCLAD goes into breast milk; do not breastfeed on the days you take MAVENCLAD, and for 10 days after the last dose); are less than 18 years of age.

Side effects

MAVENCLAD may cause side effects. Not all possible side effects are listed here. The most common side effects are nausea and headache. Other common side effects include cold sores (oral herpes), rash, hair loss or thinning, fever, abdominal pain, toothache, flu and flu-like symptoms, cold symptoms, bronchitis or other chest infections, symptoms of gastroenteritis (diarrhea, vomiting, abdominal pain), back pain, anxiety, and vaginal infection.

Talk to your healthcare professional if you experience any of the following serious side effects: lymphopenia, a reduction in the number of certain white blood cells, with symptoms such as infections, feeling unusually tired, fever, aches, pain, and flu-like symptoms; shingles, with symptoms such as a localized “band” of severe pain and blistering rash, typically on one side of the upper body or the face, headache, burning, tingling, numbness or itchiness of the skin in the affected area, or feeling generally unwell or fever in the early stages of infection; liver problems, with symptoms such as nausea, vomiting, stomach pain, loss of appetite, fatigue, dark urine, or skin or whites of the eyes turning yellow; or tuberculosis, with symptoms such as a cough that does not go away, fever, or loss of weight. Stop taking MAVENCLAD and get immediate medical help if you experience an allergic reaction (hypersensitivity); symptoms include skin rash, hives, itching, swelling, shortness of breath, fever, wheezing, runny nose, or itchy or watery eyes. You should also talk to your healthcare professional if you have any troublesome symptoms or side effects not listed here or that become bad enough to interfere with your daily activities.

Other warnings you should know about

Blood tests

You will have blood tests conducted prior to starting treatment with MAVENCLAD and during and after treatment to ensure you can continue to take MAVENCLAD and are not developing any complications from the treatment.

General infections

You will be tested to see if you have any infections prior to starting treatment. It is important to talk to your healthcare professional if you think you have an infection before, during, or after treatment. Symptoms of infections can include: fever; aching, painful muscles; headache; generally feeling unwell; or loss of appetite. Your healthcare professional may delay starting treatment or interrupt current treatment, until the infection clears up.

Vaccination

Talk to your healthcare professional if you have recently been given, or might be given, vaccines called live or live attenuated vaccines. Treatment can only begin 6 weeks after you have been vaccinated. If necessary, you will be vaccinated against varicella (chickenpox) prior to starting treatment. You must not be vaccinated during treatment. You may only be vaccinated after treatment when your white blood cell count is normal.

Progressive multifocal leukoencephalopathy (PML)

PML is a rare brain disorder caused by infection; it is a serious condition that may lead to severe disability or death. As a precaution, you may have a head MRI (magnetic resonance imaging) prior to starting treatment. This is particularly important if you have previously taken other multiple sclerosis treatments where PML is a risk. Talk to your healthcare professional if you believe your multiple sclerosis is getting worse or if you notice any new symptoms, such as: weakness on one side of the body that gets worse, clumsiness of your arms and legs, trouble with your vision, changes in your thinking and memory that lead to confusion and personality changes.

Risk of cancer

MAVENCLAD could potentially increase the risk of cancer. Follow your healthcare professional’s instructions for screening for cancer.

Fructose intolerance

MAVENCLAD contains sorbitol. Do not take MAVENCLAD if you have hereditary problems of fructose intolerance.

Pregnancy and fertility

Both men and women must use effective contraception during treatment and for at least 6 months after the last dose. For female patients, it is not known if MAVENCLAD will reduce the effectiveness of birth control pills. Given this, a barrier method of contraception (for example, condoms) should be added during treatment and for at least 4 weeks after the last dose in each treatment year. If you or your partner becomes pregnant during treatment or within 6 months of finishing treatment, there may be a risk to the unborn baby. Your healthcare professional will stop treatment with MAVENCLAD if you are a woman and you get pregnant while taking it. MAVENCLAD may affect male fertility. Talk to your healthcare professional for more information. As it is not known if MAVENCLAD is detectable in semen, a barrier contraception method such as condoms should be used during treatment and for 10 days following the last dose.  

For more information, please consult the package insert that came with your medication.

 

 

Download

Explore possible side effects of MAVENCLAD®

    

    

    

Download

Print and complete this wallet card and keep it handy for your healthcare team or in case of emergency

    

    

 

 

    

MAVENCLAD is a trademark of Merck KGaA, Darmstadt, Germany or its affiliates.


    


 

CA-MAV-00087-E

Leaving site

You’ve clicked on an external link and are about to leave the adveva site.