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IMPORTANT SAFETY INFORMATION

CLADRIBINE may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • Risk of birth defects. CLADRIBINE may cause birth defects if used during pregnancy. Women 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. You should stop treatment with CLADRIBINE and contact your healthcare provider right away if you become pregnant during treatment with CLADRIBINE.

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 CLADRIBINE 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 CLADRIBINE should use effective birth control (contraception) on the days on which they take CLADRIBINE and for at least 6 months after the last dose of each yearly treatment course.
 
 

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 safety profile, CLADRIBINE is typically used in people who have tried another type of medication for MS 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 and is therefore not recommended.

IMPORTANT SAFETY INFORMATION

CLADRIBINE may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • Risk of birth defects. CLADRIBINE may cause birth defects if used during pregnancy. Women 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. You should stop treatment with CLADRIBINE and contact your healthcare provider right away if you become pregnant during treatment with CLADRIBINE.

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 CLADRIBINE 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 CLADRIBINE should use effective birth control (contraception) on the days on which they take CLADRIBINE and for at least 6 months after the last dose of each yearly treatment course.

Do not take 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.
  • 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 CLADRIBINE, 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.
  • have had a recent vaccination or are scheduled to receive any vaccinations.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed.

How should I take CLADRIBINE?

  • CLADRIBINE is given as two yearly treatment courses, consisting of 2 treatment weeks (cycles) about a month apart.
  • Handle CLADRIBINE with dry hands and take immediately after opening the blister pack.
  • Take with water and do not chew the tablet.
  • CLADRIBINE can be taken with or without food and should be taken at least 3 hours apart from other medicines.
  • Wash your hands after handling CLADRIBINE.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes, take your missed dose the next day. Do not take 2 doses at the same time.

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.

CLADRIBINE can cause serious side effects. Call your healthcare provider right away if you experience:

  • Low blood cell counts, which can increase your risk of infections.
  • Serious infections including TB, hepatitis B or C, and shingles.
  • Progressive multifocal leukoencephalopathy (PML).
  • Liver problems.
  • Allergic reactions.
  • Heart failure.

The most common side effects of CLADRIBINE include upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of CLADRIBINE. Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact APOTEX at 1-800-706-5575 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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