Clofarabine Injection

WHY is this medicine prescribed?

Clofarabine is used to treat acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in children and young adults 1 to 21 years old who have already received at least two other treatments. Clofarabine is in a class of medications called purine nucleoside antimetabolites. It works by killing existing cancer cells and limiting the development of new cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Clofarabine comes as a solution to be injected into a vein. Clofarabine is administered by a doctor or nurse. It is usually given once a day for 5 days in a row. This dosing cycle may be repeated once every 2 to 6 weeks, depending on your response to the medication.

It will take at least 2 hours for you to receive each dose of clofarabine. Tell your doctor or other healthcare provider right away if you feel anxious or restless while you are receiving the medication.

What SPECIAL PRECAUTIONS should I follow?

Before using clofarabine,

• tell your doctor and pharmacist if you are allergic to clofarabine or any other medications.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications for high blood pressure and heart disease. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. Clofarabine may harm the fetus. You should use birth control to prevent pregnancy during your treatment with clofarabine. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using clofarabine, call your doctor.

• tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with clofarabine.

• you should know that clofarabine may cause a skin condition called hand-foot syndrome. If you develop this condition, you may experience tingling of the hands and feet, and then reddening, dryness, and flaking of the skin on the hands and feet. If this happens, ask your doctor to recommend a lotion that you can apply to these areas. You will need to apply the lotion lightly and avoid rubbing the areas forcefully. Your doctor may also prescribe medication to relieve these symptoms.

What SPECIAL DIETARY instructions should I follow?

Drink plenty of fluids every day during your treatment with clofarabine, especially if you vomit or have diarrhea.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• stomach pain
• diarrhea
• constipation
• loss of appetite
• weight loss
• swelling of the inside of the mouth and nose
• painful white patches in the mouth
• headache
• anxiety
• depression
• irritability
• pain in the back, joints, arms, or legs
• drowsiness
• dry, itchy, or irritated skin
• flushing

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

• fast heartbeat
• fast breathing
• shortness of breath
• dizziness
• lightheadedness
• fainting
• decreased urination
• sore throat, cough, fever, chills, and other signs of infection
• pale skin
• excessive tiredness
• weakness
• confusion
• unusual bruising or bleeding
• nosebleed
• bleeding gums
• blood in urine
• small red or purple spots under the skin
• yellowing of the skin or eyes
• itching
• red, warm, swollen, tender skin
• uncontrollable shaking of a part of the body

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

What should I know about STORAGE and DISPOSAL of this medication?

This medication will be stored in the hospital.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include:

• yellowing of the skin or eyes
• vomiting
• rash

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to clofarabine.

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.