Cladribine tablets

What is this medication?

CLADRIBINE (KLA dri been) may help prevent relapses of multiple sclerosis. This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): MAVENCLAD

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• HIV or AIDS
• immune system problems
• infection (especially a viral infection such as chickenpox, cold sores, or herpes)
• kidney disease
• liver disease
• low blood counts, like white cells, platelets, or red blood cells
• recently received or scheduled to receive a vaccine
• an unusual or allergic reaction to cladribine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your healthcare professional about what to do if you miss a dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may also interact with the following medications:

• birth control pills
• certain antivirals for HIV or hepatitis
• cilostazol
• curcumin
• cyclosporine
• dilazep
• dipyridamole
• eltrombopag
• medicines that lower your chance of fighting infection
• nifedipine
• nimodipine
• reserpine
• ribavirin
• rifampicin
• St. John's Wort
• steroid medicines like prednisone or cortisone
• sulindac

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your healthcare professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Call your healthcare professional if you are around anyone with measles, chickenpox, or if you develop blisters that do not heal properly.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your healthcare professional right away. If you cannot reach your healthcare professional, urgently seek other source of medical care.

Talk with your doctor if you have not had chickenpox or the vaccine for chickenpox.

This medicine can decrease the response to a vaccine. If you need to get vaccinated, tell your healthcare professional if you have received this medicine within the last 4 weeks. Extra booster doses may be needed. Talk to your healthcare professional to see if a different vaccination schedule is needed.

Talk to your healthcare professional about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 6 months after stopping it. There is potential for serious side effects to an unborn child. Talk to your healthcare professional for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• confusion
• loss of balance or coordination
• loss of memory
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• back pain
• hair loss
• headache
• joint pain
• nausea
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.