Cladribine Oral Tablets (10mg) for Multiple Sclerosis

The cladribine 10mg tablet 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, oral 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 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.

WARNING: Malignancies and birth defects

Cancer risk (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 instructions about screening for cancer.

Birth defects

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.

The most common side effects of cladribine tablets include:

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

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:

• tuberculosis (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 problems. Your healthcare provider should do blood tests to check your liver before you start taking cladribine tablets. 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 heart beat, or unusual swelling in your body. Your healthcare provider may delay or completely stop treatment with cladribine tablets if you have severe side effects.

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.

• Oral 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 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 tablets 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 is safe and effective in people who restart oral cladribine treatment more than 2 years after completing 2 yearly treatment courses.

• Immunosuppressive drugs
• Hematotoxic drugs
• Antiviral and antiretroviral drugs.
• BCRP or ENT/CNT inhibitors

Females must not be pregnant when they start treatment with cladribine tablets or become pregnant during cladribine dosing and within 6 months after the last dose of each yearly treatment course. Stop your treatment with Mcladribine tablets and call your healthcare provider right away if you become pregnant during treatment.

Do not breastfeed on the days you take cladribine tablets and for 10 days after the last dose.