Cladribine is used to treat relapsing multiple sclerosis (MS) in adults. cladribine will not cure MS, it will only decrease the frequency of relapse symptoms.

Cladribine is usually given after other treatments have failed.

Cladribine may also be used for purposes not listed in this medication guide.

Do not take cladribine if you are pregnant. Both men and women should use effective birth control to prevent pregnancy while taking cladribine, and for 6 months after the last dose.

If you use birth control pills or other hormonal forms (implants, skin patches, vaginal rings), also use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while taking cladribine and for at least 4 weeks after your treatment course ends.

Taking cladribine may increase your risk of developing certain cancers.

Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using cladribine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Cladribine is taken in 2 treatment courses separated by about a year. There are 2 treatment cycles in each course. During each cycle, you will take the medicine for 4 or 5 days in a row. The 2 cycles are separated by about a month. Follow your doctor's dosing instructions very carefully.

Your doctor will determine how many treatment courses you should receive.

Take this medicine with a full glass of water. You may take cladribine with or without food.

Use dry hands to remove a tablet from the foil blister pack when you are ready to take the medicine.

Swallow the tablet whole and do not crush, chew, or break it.

Wash your hands after handling the tablet.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your eyes or nose, or on your skin. If this happens, rinse thoroughly with water. Ask your pharmacist how to safely dispose of a broken pill.

You may be given other medications to help prevent infections. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat.

Cladribine can have long lasting effects on your body. Your doctor will need to check your progress on a regular basis and for another 2 years after your last dose.

Usual Adult Dose for Hairy Cell Leukemia:

0.09 mg/kg/day by continuous IV infusion for 7 days

Alternate dosing recommendation:
-Subcutaneous bolus injection: 0.14 mg/kg/day subcutaneously for 5 consecutive days
-IV infusion: 0.1 mg/kg/day IV for 7 consecutive days
-Under certain hematological conditions (e.g., recovery of severe myelosuppression) a small number of patients may require a second cycle and occasionally a third cycle to achieve a stable and prolonged response.

Comments:
-Physicians should consider delaying or discontinuing therapy if neurotoxicity or renal toxicity occurs.
-Consult the individual manufacturer product information for dosing recommendations.

Use: For the primary or secondary treatment of patients with Hairy Cell Leukemia (HCL)

You should not take cladribine if you are allergic to it, or if you have:

• cancer;

• an active infection such as tuberculosis or hepatitis B or C;

• HIV or AIDS; or

• if you are pregnant or breastfeeding.

Tell your doctor if you have ever had:

• an active or chronic infection;

• heart problems;

• weak immune system (caused by disease or by using certain medicine);

• liver or kidney disease;

• cancer; or

• if you receive blood transfusions.

Tell your doctor if you have recently received a vaccine (within 4 to 6 weeks before you take cladribine).

Taking cladribine may increase your risk of developing certain cancers. Ask your doctor about this risk.

Do not take cladribine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

• Cladribinecan harm an unborn baby if the mother or the father is using cladribine.

• If you are a woman taking cladribine, you may need to have a negative pregnancy test before starting this medicine. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man taking cladribine, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking cladribine.

Cladribine can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while taking cladribine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using the second form of birth control for at least 4 weeks after your cladribine treatment course ends.

Do not breastfeed while taking cladribine, and for at least 10 days after your last dose.

Take the missed dose on the same day you remember it. If the day is almost over before you remember your dose, wait until the next day to take it.

Do not take 2 doses in one day. Take your next dose at the regular time and stay on your once-daily schedule, even if it adds an extra day to your treatment cycle for the week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Do not receive a "live" vaccine while using cladribine. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Your doctor will determine when it is safe for you to receive a vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cladribine may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

• heart problems--swelling, rapid weight gain, feeling short of breath;

• low blood cell counts--fever, swollen glands, stomach pain, cough, runny nose, joint pain, mouth sores, skin sores or rash, easy bruising, unusual bleeding;

• liver problems--nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of your skin or eyes, dark urine;

• signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body; or

• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects of cladribine may include:

• headache;

• low white blood cell counts; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you take any other medicines by mouth, take your cladribine dose 3 hours before or 3 hours after you take the other medicine.

Other drugs may affect cladribine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.