What is the most important information I should know about cladribine?

Cladribine can cause serious side effects, including:

• Risk of cancer (malignancies).Treatment with cladribine may increase your risk of developing cancer. Talk to your healthcare provider about your risk of developing cancer if you receive cladribine. You should follow your healthcare provider's instructions about screening for cancer.
• Cladribine may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with cladribine or become pregnant during cladribine dosing and within 6 months after the last dose of each yearly treatment course. Stop your treatment with cladribine and call your healthcare provider right away if you become pregnant during treatment with cladribine.
  • For females who are able to become pregnant:
    • Your healthcare provider should order a pregnancy test for you before you begin your first and second yearly treatment course of cladribine to make sure that you are not pregnant. Your healthcare provider will decide when to do the test.
    • Use effective birth control (contraception) on the days on which you take cladribine and for at least 6 months after the last dose of each yearly treatment course.
      Ask your healthcare provider which contraception method is right for you.
  • For males with female partners who are able to become pregnant:
    • Use effective birth control (contraception) during the days on which you take cladribine and for at least 14 weeks after the last dose of each yearly treatment course.

• Cladribine Pregnancy Safety Study
  • For females treated with Cladribine: if you become pregnant while taking cladribine or during the 6 months after your last dose.
  • For males treated with cladribine with a female partner: if your partner becomes pregnant while you are taking cladribine or during the 14 weeks after your last dose.

What is cladribine?

Cladribine 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 risks, cladribine is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

Cladribine is not recommended for use in people with clinically isolated syndrome (CIS).

It is not known if cladribine is safe and effective in children under 18 years of age.

Do nottake cladribine 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. See " What is the most important information I should know about cladribine?"
• are human immunodeficiency virus (HIV) positive.
• have active infections, including tuberculosis (TB), hepatitis B or C.
• are allergic to cladribine.
• are breastfeeding. See " Before you take cladribine, tell your healthcare provider about all of your medical conditions, including if you:"

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

• think you have an infection.
• have heart failure.
• have liver or kidney problems.
• have taken, take, or plan to take medicines that affect your immune system or your 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 before you start your treatment with cladribine. You should not receive these types of vaccines during your treatment with cladribine and until your healthcare provider tells you that your immune system is no longer weakened.
• have or have had cancer.
• are breastfeeding or plan to breastfeed. Cladribine can pass into your breast milk and may harm your baby. Do not breastfeed on the days you take cladribine, and for 10 days after the last dose. See Do not take cladribine if you:

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take cladribine?

• Cladribine 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. Your healthcare provider will tell you when you have to start your treatment weeks and how many tablets per week you need, depending on your weight. Each treatment week is 4 or 5 days.
• Your pharmacist will dispense a carton of cladribine for each treatment week. The prescribed number of tablets per day are provided in child resistant day packs.
• Take cladribine exactly as your healthcare provider tells you. Do not change your dose or stop taking cladribine unless your healthcare provider tells you to.
• Take cladribine with water and swallow whole without chewing. Cladribine can be taken with or without food.
• Swallow cladribine right away after opening the blister pack.
• Your hands must be dry when handling cladribine 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 cladribine on your skin or on any surface, wash it right away with water.
• Take cladribine at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day cladribine 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 cladribine. It is not known if cladribine is safe and effective in people who restart cladribine treatment more than 2 years after completing 2 yearly treatment courses.

These are not all the possible side effects of cladribine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store cladribine?

• Cladribine comes in a child resistant package.
• Store cladribine at room temperature between 68°F and 77°F (20°C and 25°C).
• Store cladribine in the original package to protect from moisture.
• Ask your healthcare provider or pharmacist about how to safely throw away any unused or expired cladribine tablets and packaging.

Keep cladribine and all medicines out of the reach of children.

General information about the safe and effective use of cladribine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use cladribine for a condition for which it was not prescribed. Do not give cladribine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider for information about cladribine that is written for health professionals.