Cladribine

Cladribine may increase the risk that you will develop cancer. Tell your doctor if you have or have ever had cancer. Your doctor may tell you not to take cladribine. Talk to your doctor about what you should do to check for signs of cancer such as self-exams and screening tests.

Talk to your doctor about the risks of taking cladribine.

Do not take cladribine if you are pregnant or plan to become pregnant. If you become pregnant while taking cladribine, stop taking cladribine and call your doctor immediately. There is a risk that cladribine may cause loss of the pregnancy or will cause the baby to be born with birth defects (physical problems that are present at birth).

Your doctor will check to see if you are pregnant before you begin each course of treatment. You should use birth control to prevent pregnancy during each course of treatment with cladribine and for at least six months after your last dose of each treatment course. If you are using hormonal (estrogen) contraceptives (birth control pills, patches, rings, implants, or injections) you should also use another method of birth control during each course of treatment with cladribine and for at least 4 weeks after your last dose of each treatment course. If you are a male with a female partner who could become pregnant, be sure to use birth control during each course of treatment with cladribine and for at least six months after your last dose of each treatment course. Talk to your doctor about birth control methods that you can use during and after your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with cladribine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Cladribine is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control), including relapsing-remitting forms (course of disease where symptoms flare up from time to time) and active secondary progressive forms (course of disease that follows a relapsing-remitting course where symptoms gradually become worse over time). Cladribine is generally used in patients who have already tried another treatment for MS. Cladribine in a class of medications called purine antimetabolites. It works by stopping certain cells of the immune system from causing nerve damage.

Cladribine comes as a tablet to take by mouth with water. It is usually taken with or without food, once a day for 4 or 5 days in a row for one treatment cycle. A second treatment cycle should be repeated 23 to 27 days later to complete one treatment course. A second course (2 treatment cycles) is usually given at least 43 weeks after the last dose of the second cycle. Take cladribine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cladribine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Remove the tablet from the blister pack with dry hands and then swallow the tablet right away. Limit the time that the tablet is in contact with your skin. Avoid touching your nose, eyes, and other parts of your body. After you take the medication, wash your hands well with water. If the tablet comes in contact with any surfaces or other parts of your body, also wash them well with water right away.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking cladribine,

• tell your doctor and pharmacist if you are allergic to cladribine, any other medications, or any of the ingredients in cladribine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking any other medications by mouth, take them 3 hours before or 3 hours after cladribine.
• tell your doctor what nonprescription or herbal products you are taking, especially curcumin and St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking cladribine. Do not start any of these medications while taking cladribine without discussing with your healthcare provider.
• tell your doctor if you have human immunodeficiency virus (HIV), hepatitis (a virus that infects the liver and may cause severe liver damage), tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body), or other ongoing infections. Your doctor will probably tell you not to take cladribine.
• tell your doctor if you have or have ever had herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past) or liver, kidney, or heart disease. Also, tell your doctor if you have never had chickenpox and have not been vaccinated against this infection. Your doctor may tell you that you need to receive the chickenpox or shingles vaccine before or during your treatment with cladribine.
• tell your doctor if you are breast-feeding. You should not breast-feed during a treatment cycle, and for 10 days after the last dose of the treatment cycle.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking cladribine.
• do not have any vaccinations within 4 to 6 weeks before, during, or after your treatment with cladribine without talking to your doctor. Talk to your doctor about whether you should receive any vaccinations before you begin your treatment.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it on the same day. However, if it is not taken on the scheduled day, then take the missed dose on the following day and add another day to that treatment cycle. Do not take a double dose to make up for a missed one.

Cladribine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• back pain
• joint pain and stiffness
• difficulty falling asleep or staying asleep
• depression
• hair loss
• tingling, itching, or burning sores on gums, lips, or mouth

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, sore throat, chills, aching or painful muscles, cough, or other signs of infection
• cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, night sweats
• painful rash with blisters
• burning, tingling, numbness, or itchiness of the skin
• rash, difficulty breathing or swallowing, swelling or itching of the face, lips, tongue, or throat
• chills, fever, nausea, vomiting, pain in your back, side, or groin, frequent and painful urination
• unusual bleeding or bruising
• weakness on one side of your body, loss of coordination in your arms or legs, decreased strength, problems with balance, confusion, changes in your vision, thinking, memory, or personality
• shortness of breath, fast heartbeat, headache, dizziness, pale skin, confusion, tiredness
• nausea, vomiting, extreme tiredness, loss of appetite, pain in the upper right part of stomach, yellowing of the skin or eyes, dark urine
• shortness of breath, fast or irregular heartbeat, swelling in a part of your body

Cladribine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments wituh yor doctor and the laboratory. Your doctor will order certain tests before, during, and after your treatment to make sure it is safe for you to take cladribine and to check your body's response to cladribine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Mavenclad^®