This is MAVENCLAD^® (cladribine) tablets.

And this video will be your guide to the steps you’ll need to take when planning for year 2 of treatment and beyond. But before we get into it, let’s review some important information you’ll need to know about MAVENCLAD.

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.

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.

Completing your first year of treatment with MAVENCLAD is an important milestone.

During your first year, you’ll take MAVENCLAD for no more than 10 days.

After you’ve started treatment, your healthcare provider should want to check in on how you’re doing, for example, blood tests at 2 and 6 months.

With this unique dosing schedule, you’ll have up to 355 treatment-free days.

Spend this time doing things you enjoy.

Your healthcare provider will monitor your health during the 2 yearly treatment courses, as well as between treatment courses. You will continue to be monitored for at least another 2 years during which you do not need to take MAVENCLAD.

Your healthcare provider may delay or completely stop treatment with MAVENCLAD if you have severe side effects.

Once your first year is complete, you have 1 more year of treatment ahead.

After this, you will continue to be monitored for at least another 2 years during which you do not need to take MAVENCLAD.  It is not known if it is safe and effective for people to restart MAVENCLAD after that 4-year period.

Before you begin your second year of treatment, there are a few steps you’ll need to complete.

First, schedule an appointment with your healthcare provider. They will need to check on several things before you can start year 2 of MAVENCLAD, including:

A check for conditions such as cancer, liver injury, and infections such as HIV, tuberculosis, and hepatitis B or C. You should not take MAVENCLAD if you have any of these conditions.

A confirmation of your current weight. This can impact the amount of MAVENCLAD you’re prescribed because dosing is based on your weight.

Pregnant women must not take MAVENCLAD. Your healthcare provider will confirm that you are not pregnant. Both men and women should use effective birth control while taking MAVENCLAD and at least six months after the last dose.

In year 1 and year 2, your healthcare provider will look at your blood cell count. This is to ensure that cells called T and B cells have restored themselves to a safe level.

If your healthcare provider decides you’re not quite ready for your second year of treatment, based on the outcome of these tests they may delay the start for up to 6 months.

Next, check on your insurance coverage. Make sure MAVENCLAD is covered the same way it was in your first year.

If you don’t know where to start, call MS LifeLines to speak with a Financial Support Specialist. They may be able to help you understand your health insurance coverage for MAVENCLAD.

They are able to conduct benefits investigations to determine insurance coverage for MAVENCLAD and help navigate issues. They also can help determine whether you are eligible for a financial assistance program to help you afford your medication.

Call 1-877-447-3243 to speak with an MS LifeLines Financial Support Specialist.

Once you’ve covered all of these steps, it’s time to move on to your MAVENCLAD treatment. Here is what will happen at this point in the process.

First, your healthcare provider will prescribe the right amount of MAVENCLAD for you.

Again, this should be 1 to 2 tablets per day for up to 5 days in the first month and then 1 to 2 tablets a day for up to 5 days in the second month. Your healthcare provider may want to order blood tests two months and six months after treatment begins.

Remember, MS LifeLines offers one-on-one support for patients taking MAVENCLAD. This includes basic MS educational resources and assistance to help you stay on track with your MAVENCLAD treatment, such as an in-home nurse visit or treatment day reminders via email, text, or phone.

But once your treatment days are complete, you don’t need to take any more MAVENCLAD.

Remember that MAVENCLAD is still working—even when you’re not actively taking it.

Here’s why.

MAVENCLAD is believed to work by reducing the number of the T and B cells in the body.

Once you’ve finished your treatment for the year your immune system will begin to produce new T and B cells. It may take several months or more for the recovery of T and B cells. Although most patients recover, T and B cells may not go back to pre-treatment levels.

For most patients, the active ingredient in MAVENCLAD does not remain in the body beyond 1 week.

Once you’ve completed year 2, you can consider discussing pregnancy with your healthcare provider.

Both men and women should use effective birth control while taking MAVENCLAD and for at least 6 months after the last dose in year 1 and
year 2. Talk to your Healthcare provider if you use birth control pills.

You should use a second method of birth control on the days which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment courses.

However, it is safe to consider pregnancy 6 months after the last dose in your second year of treatment.

Remember to work closely with your healthcare provider if you’re considering pregnancy or if you have questions about your second year of treatment.

MS LifeLines Nurses may also be able to help answer questions that you have about MAVENCLAD. Call 1-877-447-3243 to speak with one.

Thanks for watching. Visit mavenclad.com for more information.

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.

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 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.
• 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. MAVENCLAD can be taken with or without food.
• Swallow MAVENCLAD right away after opening the blister pack.
• Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
• Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
• Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
• 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:
  • 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. Blood tests should be performed to check your liver before you start taking MAVENCLAD. 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.
• 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 heart beat, 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. 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.

This is MAVENCLAD® (cladribine) tablets.

And this video will cover how you store and take MAVENCLAD. But before we get into it, let’s review some important information you’ll need to know about MAVENCLAD.

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.

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 six 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.

o   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 six 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 four weeks after your last dose of each yearly treatment course.

o   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.

First, let’s talk about MAVENCLAD and then how it should be stored and taken.

MAVENCLAD comes in a box with the exact amount of MAVENCLAD you’ll need based on your weight. The box will include either 4 or 5 day packs.

Each day pack will contain 1 pill or 2 pills.

The day packs should be kept in the original packaging,

And out of children’s reach.

They should also be stored in a cool, dry place, where the temperature stays between 68 and 77 degrees.

Store MAVENCLAD in the original package to protect it from any moisture.

To help you remember which days to take it, make a note or set an alert in your phone. And if you’d like, MS LifeLines can also help you with reminders. You can arrange for emails, text messages, or a phone call from an MS LifeLine's nurse to help you stay on track with treatment.

Now that we’ve covered this, let’s get into the actual steps about how to take your MAVENCLAD.

Remember, take MAVENCLAD exactly as prescribed by your healthcare provider.

Do not change your dose or stop taking MAVENCLAD unless your healthcare provider tells you to.

Don’t take any other oral medications for 3 hours before or after you take MAVENCLAD.

STEP ONE: The preparation. Get yourself a glass of water, and make sure that your hands are clean and dry.

STEP TWO: Open up your box and take out your day pack. Open the flap, press down on the hooks on both sides of the day pack and pull out the tray until it stops.

STEP THREE: Remove a pill. Raise the blister pack by pushing your finger through the hole in the tray. Place your hand under the blister pack and push 1 or 2 pills into your hand, according to your prescribed dose. Push your medication out of the blister pack and directly into your hand. Now, swallow each pill immediately, with water. Pills should be swallowed whole, don’t chew them or let them dissolve in your mouth.

Contact with skin should be limited. Avoid touching your nose, eyes, and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.

Remember, MAVENCLAD pills are uncoated, so take them right away.

And lastly, STEP FOUR: Cleaning up. Wash your hands with soap and water. If you have placed your pill on a surface, wipe it down.

Here’s a quick recap. Take out the appropriate day pack from the box. Pop out 1 or 2 pills. Take with water. Do not chew. Wash hands thoroughly. And that’s it. You’re done for the day.

In case you do forget a dose, just take it as soon as you remember that same day. However, what you should NOT do is take your missed dose with your next scheduled dose. You can’t double a MAVENCLAD dose. And you if miss a full day, simply take the missed dose on the next day and then just extend the number of days in that treatment week.

Contact your healthcare provider if you miss a dose and are unsure of what to do next.

If you have any unused or expired MAVENCLAD tablets and packaging, you can ask your healthcare provider or pharmacist to about how to safely throw them away.

And finally, if you lose or misplace pills, call MS LifeLines at 1-877-447-3243. They may also be able to help answer other questions you have about treatment.

You can also visit mavenclad.com for additional information.

Thanks for watching. Come back for a refresher anytime.

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.

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 six 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.

o   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 six 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 four weeks after your last dose of each yearly treatment course.

o   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 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.

·  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. MAVENCLAD can be taken with or without food.

·  Swallow MAVENCLAD right away after opening the blister pack.

·  Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.

·  Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.

·  Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.

·  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:

·       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. Blood tests should be performed to check your liver before you start taking MAVENCLAD. 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.

·  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. 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.