MEDICATION GUIDE

Cladribine (klad′ ri been) Tablets,

for oral use

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

Cladribine tablets can cause serious side effects, including:

• Risk of cancer (malignancies). Treatment with cladribine tablets may increase your risk of developing cancer. Talk to your healthcare provider about your risk of developing cancer if you receive cladribine tablets. You should follow your healthcare provider's instructions about screening for cancer.
• Cladribine tablets may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with cladribine tablets or become pregnant during cladribine tablets dosing and within 6 months after the last dose of each yearly treatment course. Stop your treatment with cladribine tablets and call your healthcare provider right away if you become pregnant during treatment with cladribine tablets.
  • 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 tablets 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 tablets 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 tablets and for at least 14 weeks after the last dose of each yearly treatment course.

What are cladribine tablets?

Cladribine tablets are prescription medicine used to treat relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults. Because of its risks, cladribine tablets are generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

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

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

Do not take cladribine tablets 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 tablets?”
• 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 tablets, tell your healthcare provider about all of your medical conditions, including if you:”

Before you take cladribine tablets, 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 tablets. You should not receive these types of vaccines during your treatment with cladribine tablets 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 tablets can pass into your breast milk and may harm your baby. Do not breastfeed on the days you take cladribine tablets, and for 10 days after the last dose. See Do not take cladribine tablets 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 tablets?

• Cladribine tablets are 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 tablets for each treatment week. The prescribed number of tablets per day are provided in child resistant day packs.
• Take cladribine tablets exactly as your healthcare provider tells you. Do not change your dose or stop taking cladribine tablets unless your healthcare provider tells you to.
• Take cladribine tablets with water and swallow whole without chewing. Cladribine tablets can be taken with or without food.
• Swallow cladribine tablets right away after opening the blister pack.
• Your hands must be dry when handling cladribine tablets 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 tablets on your skin or on any surface, wash it right away with water.
• Take cladribine tablets 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 tablets. It is not known if cladribine tablets are safe and effective in people who restart cladribine treatment more than 2 years after completing 2 yearly treatment courses.

What are the possible side effects of cladribine tablets?

Cladribine tablets can cause serious side effects, including:

• See “What is the most important information I should know about cladribine tablets?”
• low blood cell counts. Low blood cell counts have happened and can increase your risk of infections during your treatment with cladribine tablets. Your healthcare provider will do blood tests before you start treatment with cladribine tablets, during your treatment with cladribine tablets, and afterward, as needed.
• serious infections such as:
  • Infections caused by bacteria, viruses, parasites, or fungi that may be life-threatening or cause death.
  • 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
    • loss of appetite
    • aching painful muscles
    • burning, tingling, numbness or itchiness of the skin in the affected area
    • headache
    • skin blotches, blistered rash and severe pain
    • feeling of being generally unwell
  • 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 cladribine tablets, it may happen in people with weakened immune systems. Symptoms of PML get worse over days to weeks. Call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms of PML, that have lasted several days, including:
    • weakness on 1 side of your body
    • changes in your vision
    • loss of coordination in your arms and legs
    • changes in your thinking or memory
    • decreased strength
    • confusion
    • problems with balance
    • changes in your personality
• liver problems. Cladribine tablets may cause liver damage. Your risk of developing serious liver problems may be higher if you already have liver problems or take other medicines that also affect your liver. Your healthcare provider should do blood tests to check your liver:

  • before you start taking cladribine tablets

  • before each course and cycle of cladribine tablets treatment

    
    Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • nausea
  •  loss of appetite
  • vomiting
  • your skin or the whites or your eyes turn yellow
  • stomach pain
  • dark urine
  • tiredness
• allergic reactions (hypersensitivities). Cladribine tablets can cause serious allergic reactions. Stop your treatment with cladribine tablets and go to the closest emergency room for medical help right away if you have any signs or symptoms of allergic reactions. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
• heart failure. Cladribine tablets 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.

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

The most common side effects of cladribine tablets include:

• upper respiratory infection
• headache
• low white blood cell counts

These are not all the possible side effects of cladribine tablets. 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 tablets?

• Cladribine tablets comes in a child resistant package.
• Store cladribine tablets at room temperature between 68°F and 77°F (20°C and 25°C).
• Store cladribine tablets 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 tablets and all medicines out of the reach of children.

General information about the safe and effective use of cladribine tablets:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use cladribine tablets for a condition for which it was not prescribed. Do not give cladribine tablets 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 tablets that is written for health professionals.

What are the ingredients in cladribine tablets?

Active ingredient: cladribine  

Inactive ingredients: magnesium stearate and sorbitol. 

Cladribine tablets also contain hydroxypropyl betadex.

For more information, call toll-free 1-800-706-5575 or go to www.apotex.com  

Rx Only  

APOTEX INC. 

CLADRIBINE TABLETS

10 mg

Manufactured by: Genvion Corporation Winnipeg, Manitoba R2J 4K2 Canada

Manufactured for: Apotex Corp. Weston, Florida USA 33326

Revised: May 2026

Rev: 5

This Medication Guide has been approved by the U.S. Food and Drug Administration.